Trial Outcomes & Findings for ABSORB II Randomized Controlled Trial (NCT NCT01425281)

NCT ID: NCT01425281

Last Updated: 2019-11-13

Results Overview

In-scaffold:Within the margins of the scaffold.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 501 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2019-11-13

Participant Flow

A total of 501 patients (335 participants in the Absorb arm and 166 subjects in the XIENCE arm) were randomized into the ABSORB II Randomized controlled trial (RCT) at 46 international outside the United States (OUS) sites study sites. First subject was randomized on 28 November 2011 and the last subject randomized on 04 June 2013.

Early termination by 5-year affected 120 patients due to subject withdrew consent (n=20), withdrawn by the site (n=1), lost to follow-up (n=9), death (n=20),early termination due to a lapse in the protocol renewal by the Polish Ethics Committee (n=37) and early terminations due to 'other' reasons (n=33).

Participant milestones

Measure	Absorb BVS™ Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: ABSORB bioresorbable vascular scaffold (Absorb BVS) implantation in the treatment of coronary artery disease.	XIENCE™ Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
At 30-day Clinical Follow-up STARTED	335	166
At 30-day Clinical Follow-up COMPLETED	334	166
At 30-day Clinical Follow-up NOT COMPLETED	1	0
At 180-day Clinical Follow-up STARTED	334	166
At 180-day Clinical Follow-up COMPLETED	331	165
At 180-day Clinical Follow-up NOT COMPLETED	3	1
At 1-year Clinical Follow-up STARTED	331	165
At 1-year Clinical Follow-up COMPLETED	329	164
At 1-year Clinical Follow-up NOT COMPLETED	2	1
At 2-year Clinical Follow-up STARTED	329	164
At 2-year Clinical Follow-up COMPLETED	323	163
At 2-year Clinical Follow-up NOT COMPLETED	6	1
At 3-year Clinical Follow-up STARTED	323	163
At 3-year Clinical Follow-up COMPLETED	318	157
At 3-year Clinical Follow-up NOT COMPLETED	5	6
At 4-year Clinical Follow-up STARTED	318	157
At 4-year Clinical Follow-up COMPLETED	288	136
At 4-year Clinical Follow-up NOT COMPLETED	30	21
At 5-year Clinical Follow-up STARTED	288	136
At 5-year Clinical Follow-up COMPLETED	256	125
At 5-year Clinical Follow-up NOT COMPLETED	32	11

Reasons for withdrawal

Measure	Absorb BVS™ Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: ABSORB bioresorbable vascular scaffold (Absorb BVS) implantation in the treatment of coronary artery disease.	XIENCE™ Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
At 30-day Clinical Follow-up Withdrawal by Subject	1	0
At 180-day Clinical Follow-up Withdrawal by Subject	3	0
At 180-day Clinical Follow-up Death	0	1
At 1-year Clinical Follow-up Withdrawal by Subject	1	1
At 1-year Clinical Follow-up Withdrawal by Physician/Site	1	0
At 2-year Clinical Follow-up Withdrawal by Subject	2	1
At 2-year Clinical Follow-up Death	2	0
At 2-year Clinical Follow-up Lost to Follow-up	1	0
At 2-year Clinical Follow-up Patient did not want to participate in t	1	0
At 3-year Clinical Follow-up Withdrawal by Subject	3	3
At 3-year Clinical Follow-up Death	2	3
At 4-year Clinical Follow-up Death	7	3
At 4-year Clinical Follow-up Withdrawal by Subject	3	2
At 4-year Clinical Follow-up Did not consent for follow-up after 3 ye	10	10
At 4-year Clinical Follow-up Terminated by Polish Ethics Committee	6	5
At 4-year Clinical Follow-up Lost to Follow-up	4	1
At 5-year Clinical Follow-up Death	2	0
At 5-year Clinical Follow-up Lost to Follow-up	2	1
At 5-year Clinical Follow-up Terminated by Polish Ethics Committee	19	7
At 5-year Clinical Follow-up Refused/terminated	9	3

Baseline Characteristics

ABSORB II Randomized Controlled Trial

Baseline characteristics by cohort

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.	Total n=501 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	202 Participants n=5 Participants	102 Participants n=7 Participants	304 Participants n=5 Participants
Age, Categorical >=65 years	133 Participants n=5 Participants	64 Participants n=7 Participants	197 Participants n=5 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 10.0 • n=5 Participants	60.9 years STANDARD_DEVIATION 10.0 • n=7 Participants	61.3 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	34 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	253 Participants n=5 Participants	132 Participants n=7 Participants	385 Participants n=5 Participants
Region of Enrollment Austria	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Belgium	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Denmark	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment France	51 Participants n=5 Participants	25 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment Germany	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Israel	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Italy	33 Participants n=5 Participants	13 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Netherlands	48 Participants n=5 Participants	34 Participants n=7 Participants	82 Participants n=5 Participants
Region of Enrollment New Zealand	15 Participants n=5 Participants	8 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Poland	26 Participants n=5 Participants	16 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment Portugal	11 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Spain	63 Participants n=5 Participants	28 Participants n=7 Participants	91 Participants n=5 Participants
Region of Enrollment Switzerland	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United Kingdom	37 Participants n=5 Participants	17 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

In-scaffold:Within the margins of the scaffold.

Outcome measures

Measure	Absorb BVS™ n=258 Target lesions Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=130 Target lesions Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)	0.05 mm Standard Deviation 0.11	0.06 mm Standard Deviation 0.12

PRIMARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

In-scaffold:Within the margins of the scaffold.

Outcome measures

Measure	Absorb BVS™ n=298 Target lesions Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=151 Target lesions Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter	-0.37 mm Standard Deviation 0.45	-0.25 mm Standard Deviation 0.25

SECONDARY outcome

Timeframe: From the start of index procedure to end of index procedure

Population: Device Success is measured on a per Lesion basis. Some patients had more than one lesion treated so the total number of lesions is larger than the number of patients.

Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).

Outcome measures

Measure	Absorb BVS™ n=364 Target lesions Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=182 Target lesions Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Device Success	99.5 Percentage of lesions	100 Percentage of lesions

SECONDARY outcome

Timeframe: From the start of index procedure to end of index procedure

Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Procedural Success	322 Participants	164 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 180 Days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	8 Participants	6 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	11 Participants	7 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	13 Participants	7 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	15 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	19 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	27 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	27 Participants	5 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Myocardial Infarction (Per Protocol Definition)	27 Participants	6 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	24 Participants	8 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	27 Participants	8 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Revascularization (TLR)	28 Participants	8 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	15 Participants	9 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	33 Participants	19 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	38 Participants	19 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Revascularization (TVR)	41 Participants	19 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non Target Vessel Revascularization (Non-TVR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non Target Vessel Revascularization (Non-TVR)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non Target Vessel Revascularization (Non-TVR)	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non Target Vessel Revascularization (Non-TVR)	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non Target Vessel Revascularization (Non-TVR)	10 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non Target Vessel Revascularization (Non-TVR)	22 Participants	19 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non Target Vessel Revascularization (Non-TVR)	29 Participants	20 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Non-Target Vessel Revascularization (Non-TVR)	30 Participants	20 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Revascularization:

Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.

Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.

Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	12 Participants	12 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	22 Participants	18 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	49 Participants	33 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Revascularization:

• Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
• Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
• Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
• Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	57 Participants	34 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With All Revascularization	59 Participants	34 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI)

• Q wave MI Development of new, pathological Q wave on the ECG.
• Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI)

• Q wave MI Development of new, pathological Q wave on the ECG.
• Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	14 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	15 Participants	3 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	22 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	33 Participants	11 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI)
• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	35 Participants	12 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

All deaths includes

• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI)
• Q wave MI Development of new, pathological Q wave on the ECG.
• Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing All Death/All MI	37 Participants	13 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR)	12 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR)	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)	13 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)	16 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)	23 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)	34 Participants	8 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)	37 Participants	9 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)	38 Participants	9 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	14 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	17 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	25 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	38 Participants	11 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	40 Participants	12 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)	41 Participants	13 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	14 Participants	3 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	15 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	18 Participants	8 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	28 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	41 Participants	20 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	45 Participants	21 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)	47 Participants	22 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	14 Participants	4 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	19 Participants	9 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Intent-to-Treat Population (ITT).The number of participants analyzed include subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	24 Participants	15 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	38 Participants	21 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	68 Participants	39 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	76 Participants	40 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

DMR is the composite of All Death, All MI, All Revascularization

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With DMR (All Death, All MI, All Revascularization)	80 Participants	41 Participants

SECONDARY outcome

Timeframe: In-hospital (≤ 7 days of post index procedure)

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 180 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=332 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=331 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=165 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	15 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=327 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	20 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI)

• Q wave MI: Development of new, pathological Q wave on the ECG.
• Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=325 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=161 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	28 Participants	8 Participants

SECONDARY outcome

Timeframe: 4 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=308 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=147 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	29 Participants	9 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Outcome measures

Measure	Absorb BVS™ n=285 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=138 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants Experiencing Cardiac Death/All MI	29 Participants	10 Participants

SECONDARY outcome

Timeframe: <=1 day

Population: ITT population. .

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

Timings:

Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window

-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

Pathological confirmation:Evidence of recent thrombus.

Probable stent thrombosis may occur after intracoronary stenting due to:

• Unexplained death within first 30 days
• Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

Outcome measures

Measure	Absorb BVS™ n=335 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Acute Stent/Scaffold Thrombosis Definite	1 Participants	0 Participants
Number of Participants With Acute Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: > 1-30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

Timings:

Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window

-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

Pathological confirmation:Evidence of recent thrombus.

Probable stent thrombosis may occur after intracoronary stenting due to:

• Unexplained death within first 30 days
• Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Subacute Stent/Scaffold Thrombosis Definite	1 Participants	0 Participants
Number of Participants With Subacute Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-30 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

Timings:

Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window

-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

Pathological confirmation:Evidence of recent thrombus.

Probable stent thrombosis may occur after intracoronary stenting due to:

• Unexplained death within first 30 days
• Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

Outcome measures

Measure	Absorb BVS™ n=334 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=166 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis Definite	2 Participants	0 Participants
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 31-365 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

Timings:

Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window

-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

Pathological confirmation:Evidence of recent thrombus.

Probable stent thrombosis may occur after intracoronary stenting due to:

• Unexplained death within first 30 days
• Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

Outcome measures

Measure	Absorb BVS™ n=329 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Late Stent/Scaffold Thrombosis Probable	1 Participants	0 Participants
Number of Participants With Late Stent/Scaffold Thrombosis Definite	0 Participants	0 Participants

SECONDARY outcome

Timeframe: > 365 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

Timings:

Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window

-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

Pathological confirmation:Evidence of recent thrombus.

Probable stent thrombosis may occur after intracoronary stenting due to:

• Unexplained death within first 30 days
• Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

Outcome measures

Measure	Absorb BVS™ n=329 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=164 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Very Late Stent/Scaffold Thrombosis Definite	6 Participants	0 Participants
Number of Participants With Very Late Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-1853 days

Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

Timings:

Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window

-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus

Pathological confirmation:Evidence of recent thrombus.

Probable stent thrombosis may occur after intracoronary stenting due to:

• Unexplained death within first 30 days
• Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.

Outcome measures

Measure	Absorb BVS™ n=263 Participants Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.	XIENCE™ n=129 Participants Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.
Number of Participants With Cumulative Stent/Scaffold Thrombosis Probable	1 Participants	0 Participants
Number of Participants With Cumulative Stent/Scaffold Thrombosis Definite	8 Participants	0 Participants

Adverse Events

XIENCE™

Serious events: 84 serious events

Other events: 151 other events

Deaths: 7 deaths

Absorb BVS™

Serious events: 165 serious events

Other events: 296 other events

Deaths: 13 deaths

Serious adverse events

Measure	XIENCE™ n=159 participants at risk Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.	Absorb BVS™ n=318 participants at risk Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.
Blood and lymphatic system disorders ANAEMIA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders ACUTE CORONARY SYNDROME	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	1.3% 2/159 • 5 years	3.5% 11/318 • 5 years
Cardiac disorders ANGINA PECTORIS	17.0% 27/159 • 5 years	13.2% 42/318 • 5 years
Cardiac disorders ANGINA UNSTABLE	2.5% 4/159 • 5 years	1.6% 5/318 • 5 years
Cardiac disorders ATRIAL FIBRILLATION	0.63% 1/159 • 5 years	2.2% 7/318 • 5 years
Cardiac disorders ATRIAL FLUTTER	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders ATRIAL TACHYCARDIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders BUNDLE BRANCH BLOCK	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders CARDIAC ARREST	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders CARDIAC FAILURE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders CORONARY ARTERY DISEASE	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Cardiac disorders CORONARY ARTERY DISSECTION	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Cardiac disorders CORONARY ARTERY OCCLUSION	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Cardiac disorders CORONARY ARTERY PERFORATION	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders CORONARY ARTERY STENOSIS	3.1% 5/159 • 5 years	1.6% 5/318 • 5 years
Cardiac disorders CORONARY ARTERY THROMBOSIS	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Cardiac disorders LEFT VENTRICULAR FAILURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders MYOCARDIAL INFARCTION	2.5% 4/159 • 5 years	1.6% 5/318 • 5 years
Cardiac disorders MYOCARDIAL ISCHAEMIA	1.3% 2/159 • 5 years	1.3% 4/318 • 5 years
Cardiac disorders PALPITATIONS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders PERICARDITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Cardiac disorders SICK SINUS SYNDROME	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders SINUS TACHYCARDIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders VENTRICULAR FIBRILLATION	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders VENTRICULAR TACHYCARDIA	1.3% 2/159 • 5 years	0.63% 2/318 • 5 years
Congenital, familial and genetic disorders BICUSPID AORTIC VALVE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Congenital, familial and genetic disorders HYDROCELE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders CATARACT	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Eye disorders MACULAR DEGENERATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders CONSTIPATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders DIARRHOEA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders ENTEROCOLITIS HAEMORRHAGIC	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders GASTROINTESTINAL ULCER HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders HAEMATEMESIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders INGUINAL HERNIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders MESENTERIC ARTERY STENOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders VOMITING	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders ADVERSE DRUG REACTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders CATHETER SITE HAEMATOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders CATHETER SITE HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders CHEST DISCOMFORT	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
General disorders CHEST PAIN	1.9% 3/159 • 5 years	1.3% 4/318 • 5 years
General disorders DEATH	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
General disorders MICROLITHIASIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
General disorders NON-CARDIAC CHEST PAIN	1.9% 3/159 • 5 years	3.5% 11/318 • 5 years
General disorders Other	5.0% 8/159 • 5 years	5.0% 16/318 • 5 years
General disorders PELVIC MASS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders SUDDEN DEATH	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders THROMBOSIS IN DEVICE	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
General disorders VASCULAR COMPLICATION ASSOCIATED WITH DEVICE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Hepatobiliary disorders CHOLECYSTITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Hepatobiliary disorders CHOLELITHIASIS	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Hepatobiliary disorders JAUNDICE CHOLESTATIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Immune system disorders DRUG HYPERSENSITIVITY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Immune system disorders ANAPHYLACTIC REACTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Immune system disorders HYPERSENSITIVITY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations APPENDICITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations CELLULITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations CYSTITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations DOUGLAS' ABSCESS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations ERYSIPELAS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations GASTROENTERITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations GINGIVAL INFECTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations OSTEOMYELITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations PNEUMONIA	1.9% 3/159 • 5 years	1.6% 5/318 • 5 years
Infections and infestations URINARY TRACT INFECTION BACTERIAL	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations UROSEPSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations CATHETER SITE ABSCESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations ORCHITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations PYELONEPHRITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations SEPSIS	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Infections and infestations URINARY TRACT INFECTION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications CATHETER SITE HAEMATOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications CORONARY ARTERY RESTENOSIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Injury, poisoning and procedural complications ESCHAR	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications FALL	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications GRAFT THROMBOSIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications LIMB CRUSHING INJURY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications LIMB INJURY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications NERVE ROOT INJURY LUMBAR	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications POST PROCEDURAL MYOCARDIAL INFARCTION	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Injury, poisoning and procedural complications POSTOPERATIVE FEVER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications SPINAL CORD INJURY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications TENDON RUPTURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications CONFUSION POSTOPERATIVE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/159 • 5 years	1.6% 5/318 • 5 years
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations CARDIAC STRESS TEST ABNORMAL	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Investigations ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Investigations ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations EXERCISE TEST ABNORMAL	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Investigations BIOPSY PROSTATE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations BLOOD GLUCOSE ABNORMAL	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations ELECTROCARDIOGRAM ABNORMAL	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders OBESITY	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders TYPE 1 DIABETES MELLITUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders BACK PAIN	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Musculoskeletal and connective tissue disorders DUPUYTREN'S CONTRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISCOMFORT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Musculoskeletal and connective tissue disorders PAIN IN JAW	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Musculoskeletal and connective tissue disorders TRIGGER FINGER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders ARTHROPATHY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders POLYARTHRITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders TENDON DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA PANCREAS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN SALIVARY GLAND NEOPLASM	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON NEOPLASM	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOBLASTOMA MULTIFORME	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL CANCER	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA RECURRENT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LUNG	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE TUMOUR	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL NEOPLASM	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SCROTAL CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA METASTATIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL CARCINOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL CARCINOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROOESOPHAGEAL CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CARPAL TUNNEL SYNDROME	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CEREBROVASCULAR ACCIDENT	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Nervous system disorders DIZZINESS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders EPILEPSY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders HYDROCEPHALUS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders NEUROPATHY PERIPHERAL	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders PRE SYNCOPE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders SENSORY LOSS	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders SYNCOPE	1.9% 3/159 • 5 years	0.94% 3/318 • 5 years
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CLONIC CONVULSION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Psychiatric disorders DEPRESSION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Psychiatric disorders MENTAL DISORDER	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Renal and urinary disorders RENAL ARTERY STENOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders RENAL FAILURE CHRONIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders URINARY TRACT DISORDER	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Renal and urinary disorders VESICAL FISTULA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders RENAL ANEURYSM	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders CALCULUS URINARY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Reproductive system and breast disorders PROSTATOMEGALY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.63% 1/159 • 5 years	1.3% 4/318 • 5 years
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Respiratory, thoracic and mediastinal disorders TACHYPNOEA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Surgical and medical procedures SHOULDER OPERATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Surgical and medical procedures SPINAL LAMINECTOMY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Surgical and medical procedures INGUINAL HERNIA REPAIR	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Vascular disorders AORTIC STENOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders HYPERTENSION	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders TEMPORAL ARTERITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders AORTIC ANEURYSM	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Vascular disorders FEMORAL ARTERIAL STENOSIS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders ARTERIAL THROMBOSIS LIMB	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders HYPERTENSIVE CRISIS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders INTERMITTENT CLAUDICATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders VARICOSE VEIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders ARRHYTHMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CEREBRAL HAEMATOMA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years

Other adverse events

Measure	XIENCE™ n=159 participants at risk Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System: XIENCE implantation in the treatment of coronary artery disease.	Absorb BVS™ n=318 participants at risk Abbott Vascular Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System: Absorb BVS implantation in the treatment of coronary artery disease.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders VITAMIN B12 DEFICIENCY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders AORTIC STENOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders HYDROCEPHALUS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders HYPOKINESIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.63% 1/159 • 5 years	3.1% 10/318 • 5 years
Vascular disorders ARTERIAL THROMBOSIS LIMB	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.5% 4/159 • 5 years	1.9% 6/318 • 5 years
Blood and lymphatic system disorders ANAEMIA	1.9% 3/159 • 5 years	1.6% 5/318 • 5 years
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Blood and lymphatic system disorders NORMOCHROMIC NORMOCYTIC ANAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders ACUTE CORONARY SYNDROME	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	1.3% 2/159 • 5 years	3.8% 12/318 • 5 years
Cardiac disorders ANGINA PECTORIS	34.0% 54/159 • 5 years	27.4% 87/318 • 5 years
Cardiac disorders ANGINA UNSTABLE	3.1% 5/159 • 5 years	1.6% 5/318 • 5 years
Cardiac disorders ARRHYTHMIA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders ARTERIOSPASM CORONARY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders ATRIAL FIBRILLATION	2.5% 4/159 • 5 years	3.1% 10/318 • 5 years
Cardiac disorders ATRIAL FLUTTER	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders ATRIAL TACHYCARDIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders BRADYCARDIA	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders CARDIAC FAILURE	0.00% 0/159 • 5 years	1.9% 6/318 • 5 years
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders CORONARY ARTERY DISEASE	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Cardiac disorders CORONARY ARTERY DISSECTION	3.8% 6/159 • 5 years	2.2% 7/318 • 5 years
Cardiac disorders CORONARY ARTERY OCCLUSION	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders CORONARY ARTERY PERFORATION	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders CORONARY ARTERY STENOSIS	3.1% 5/159 • 5 years	1.9% 6/318 • 5 years
Cardiac disorders CORONARY ARTERY THROMBOSIS	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Cardiac disorders MYOCARDIAL INFARCTION	2.5% 4/159 • 5 years	1.6% 5/318 • 5 years
Cardiac disorders MYOCARDIAL ISCHAEMIA	1.9% 3/159 • 5 years	3.1% 10/318 • 5 years
Cardiac disorders PALPITATIONS	1.9% 3/159 • 5 years	1.6% 5/318 • 5 years
Cardiac disorders PERICARDITIS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders PRINZMETAL ANGINA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Cardiac disorders SICK SINUS SYNDROME	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders SINUS TACHYCARDIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Cardiac disorders TACHYCARDIA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders VENTRICULAR FIBRILLATION	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Cardiac disorders VENTRICULAR TACHYCARDIA	1.3% 2/159 • 5 years	1.6% 5/318 • 5 years
Cardiac disorders ATRIOVENTRICULAR EXTRASYSTOLES	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders BUNDLE BRANCH BLOCK	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders CARDIAC ARREST	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders LEFT VENTRICULAR FAILURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Cardiac disorders TACHYARRHYTHMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Congenital, familial and genetic disorders BICUSPID AORTIC VALVE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Congenital, familial and genetic disorders HYDROCELE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Ear and labyrinth disorders CERUMEN IMPACTION	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Ear and labyrinth disorders EXTERNAL EAR PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Ear and labyrinth disorders TINNITUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Ear and labyrinth disorders VERTIGO	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Ear and labyrinth disorders AURICULAR PERICHONDRITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Endocrine disorders BASEDOW'S DISEASE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Endocrine disorders GOITRE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Endocrine disorders HYPOTHYROIDISM	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Endocrine disorders THYROIDITIS CHRONIC	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders AGE-RELATED MACULAR DEGENERATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders CATARACT	0.00% 0/159 • 5 years	2.2% 7/318 • 5 years
Eye disorders CHOROIDAL HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Eye disorders CORNEAL EROSION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders DIABETIC RETINOPATHY	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders EYE HAEMORRHAGE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Eye disorders EYE PRURITUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders GLAUCOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders KERATITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Eye disorders MACULAR OEDEMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders OCULAR DISCOMFORT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders ULCERATIVE KERATITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders UVEITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders VISION BLURRED	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Eye disorders VISUAL IMPAIRMENT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders IRIDOCYCLITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders MACULAR DEGENERATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Eye disorders MACULAR HOLE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders ABDOMINAL DISCOMFORT	1.3% 2/159 • 5 years	1.3% 4/318 • 5 years
Gastrointestinal disorders ABDOMINAL PAIN	1.3% 2/159 • 5 years	1.3% 4/318 • 5 years
Gastrointestinal disorders ABDOMINAL PAIN UPPER	2.5% 4/159 • 5 years	1.9% 6/318 • 5 years
Gastrointestinal disorders ANAL FISSURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders ANAL FISTULA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders COLONIC POLYP	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Gastrointestinal disorders CONSTIPATION	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Gastrointestinal disorders DIARRHOEA	2.5% 4/159 • 5 years	1.6% 5/318 • 5 years
Gastrointestinal disorders DIVERTICULUM	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders DRY MOUTH	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders DYSPEPSIA	2.5% 4/159 • 5 years	1.6% 5/318 • 5 years
Gastrointestinal disorders DYSPHAGIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRIC DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRIC INTESTINAL HAEMORRHAGE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRITIS	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Gastrointestinal disorders GINGIVAL BLEEDING	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders GINGIVITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders HAEMATEMESIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders HAEMORRHOIDS	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders HIATUS HERNIA	1.3% 2/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders HYPERCHLORHYDRIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders ILEITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders INGUINAL HERNIA	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders IRRITABLE BOWEL SYNDROME	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders MELAENA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders MESENTERIC ARTERY STENOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders MESENTERIC PANNICULITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders NAUSEA	1.9% 3/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders ORAL LICHEN PLANUS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders PANCREATIC FISTULA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders PANCREATITIS CHRONIC	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders RECTAL POLYP	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Gastrointestinal disorders TOOTHACHE	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders VOMITING	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Gastrointestinal disorders CHANGE OF BOWEL HABIT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders ENTEROCOLITIS HAEMORRHAGIC	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRIC MUCOSAL LESION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTRITIS EROSIVE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Gastrointestinal disorders GASTROINTESTINAL ULCER HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders ADVERSE DRUG REACTION	8.8% 14/159 • 5 years	9.4% 30/318 • 5 years
General disorders CATHETER SITE HAEMATOMA	2.5% 4/159 • 5 years	1.9% 6/318 • 5 years
General disorders CATHETER SITE HAEMORRHAGE	3.1% 5/159 • 5 years	2.5% 8/318 • 5 years
General disorders CATHETER SITE PAIN	0.63% 1/159 • 5 years	1.9% 6/318 • 5 years
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
General disorders CATHETER SITE PHLEBITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders CATHETER SITE SWELLING	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
General disorders CHEST DISCOMFORT	1.3% 2/159 • 5 years	1.6% 5/318 • 5 years
General disorders CHEST PAIN	5.0% 8/159 • 5 years	4.7% 15/318 • 5 years
General disorders DEATH	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
General disorders FATIGUE	0.63% 1/159 • 5 years	4.4% 14/318 • 5 years
General disorders HERNIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
General disorders MALAISE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
General disorders MASS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
General disorders MICROLITHIASIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
General disorders NON-CARDIAC CHEST PAIN	10.7% 17/159 • 5 years	12.6% 40/318 • 5 years
General disorders OEDEMA PERIPHERAL	0.63% 1/159 • 5 years	1.3% 4/318 • 5 years
General disorders Other	8.2% 13/159 • 5 years	6.3% 20/318 • 5 years
General disorders PELVIC MASS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders PERIODONTITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders PYREXIA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
General disorders SUDDEN DEATH	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders THROMBOSIS IN DEVICE	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
General disorders VASCULAR COMPLICATION ASSOCIATED WITH DEVICE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders ASTHENIA	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
General disorders DRUG INTOLERANCE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
General disorders THIRST	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Hepatobiliary disorders CHOLECYSTITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Hepatobiliary disorders CHOLELITHIASIS	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Hepatobiliary disorders HEPATIC CYST	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Hepatobiliary disorders HEPATIC STEATOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Hepatobiliary disorders JAUNDICE CHOLESTATIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Hepatobiliary disorders LIVER DISORDER	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Hepatobiliary disorders NON-ALCOHOLIC STEATOHEPATITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Immune system disorders CONTRAST MEDIA ALLERGY	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Immune system disorders DRUG HYPERSENSITIVITY	2.5% 4/159 • 5 years	0.31% 1/318 • 5 years
Immune system disorders HYPERSENSITIVITY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Immune system disorders ANAPHYLACTIC REACTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations ACARODERMATITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations APPENDICITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations BRONCHITIS	0.63% 1/159 • 5 years	2.2% 7/318 • 5 years
Infections and infestations CANDIDIASIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations CATHETER SITE ABSCESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations CELLULITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations CHLAMYDIAL INFECTION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations DIVERTICULITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations DOUGLAS' ABSCESS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations EAR INFECTION	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Infections and infestations ERYSIPELAS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations FUNGAL INFECTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations FUNGAL OESOPHAGITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations GASTROENTERITIS	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Infections and infestations GINGIVAL INFECTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations HELICOBACTER INFECTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations INFLUENZA	1.3% 2/159 • 5 years	1.6% 5/318 • 5 years
Infections and infestations KIDNEY INFECTION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations LABYRINTHITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations LOCALISED INFECTION	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	1.3% 2/159 • 5 years	1.6% 5/318 • 5 years
Infections and infestations LUNG INFECTION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations LYMPHANGITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations NASOPHARYNGITIS	1.3% 2/159 • 5 years	2.2% 7/318 • 5 years
Infections and infestations ORCHITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations OSTEOMYELITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations PARONYCHIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations PHARYNGITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations PNEUMONIA	1.9% 3/159 • 5 years	2.2% 7/318 • 5 years
Infections and infestations PYELONEPHRITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations RESPIRATORY TRACT INFECTION	2.5% 4/159 • 5 years	2.2% 7/318 • 5 years
Infections and infestations SEPSIS	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Infections and infestations SEPTIC SHOCK	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations SINUSITIS	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations TOOTH INFECTION	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations URINARY TRACT INFECTION	2.5% 4/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations UROSEPSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations VAGINAL INFECTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations VIRAL INFECTION	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Infections and infestations VULVAL ABSCESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations HERPES ZOSTER	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations URINARY TRACT INFECTION BACTERIAL	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations CYSTITIS	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Infections and infestations HELICOBACTER GASTRITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations HERPES OPHTHALMIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Infections and infestations LYME DISEASE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations ORAL INFECTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations OTITIS EXTERNA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications CONTUSION	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Injury, poisoning and procedural complications CORONARY ARTERY RESTENOSIS	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Injury, poisoning and procedural complications ESCHAR	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications EXPOSURE TO CHEMICAL POLLUTION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications FALL	3.1% 5/159 • 5 years	1.9% 6/318 • 5 years
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications GRAFT THROMBOSIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications HAND FRACTURE	1.9% 3/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications JOINT DISLOCATION	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications LIGAMENT INJURY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications LIMB INJURY	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications MOUNTAIN SICKNESS ACUTE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications MUSCLE STRAIN	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications NERVE ROOT INJURY LUMBAR	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications POISONING	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications POST PROCEDURAL MYOCARDIAL INFARCTION	0.63% 1/159 • 5 years	1.9% 6/318 • 5 years
Injury, poisoning and procedural complications POSTOPERATIVE FEVER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications PROCEDURAL HEADACHE	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Injury, poisoning and procedural complications PROCEDURAL HYPERTENSION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications PROCEDURAL HYPOTENSION	1.9% 3/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications PROCEDURAL NAUSEA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications RIB FRACTURE	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Injury, poisoning and procedural complications SCIATIC NERVE INJURY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications SPINAL CORD INJURY	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Injury, poisoning and procedural complications SYNOVIAL RUPTURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications TENDON RUPTURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications WOUND	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications WOUND HAEMORRHAGE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications LIMB CRUSHING INJURY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications INJURY	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Injury, poisoning and procedural complications LACERATION	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications TRAUMATIC HAEMATOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications CONFUSION POSTOPERATIVE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications CONTRAST MEDIA ALLERGY	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications EPICONDYLITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications EXPOSURE TO TOXIC AGENT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/159 • 5 years	1.9% 6/318 • 5 years
Injury, poisoning and procedural complications INTENTIONAL OVERDOSE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications MUSCLE RUPTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Injury, poisoning and procedural complications TRAUMATIC ULCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations ANGIOGRAM	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Investigations ANGIOTENSIN CONVERTING ENZYME INCREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations ARTERIOGRAM CORONARY	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Investigations BIOPSY PROSTATE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations BLOOD CHOLESTEROL INCREASED	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	1.3% 2/159 • 5 years	1.6% 5/318 • 5 years
Investigations BLOOD CREATINE PHOSPHOKINASE MB INCREASED	2.5% 4/159 • 5 years	1.6% 5/318 • 5 years
Investigations BLOOD CREATININE INCREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations BLOOD GLUCOSE FLUCTUATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations BLOOD GLUCOSE INCREASED	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Investigations BLOOD PRESSURE INCREASED	1.3% 2/159 • 5 years	0.63% 2/318 • 5 years
Investigations BLOOD TRIGLYCERIDES INCREASED	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Investigations BLOOD URINE PRESENT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations CARDIAC ENZYMES INCREASED	22.0% 35/159 • 5 years	23.3% 74/318 • 5 years
Investigations CARDIAC STRESS TEST ABNORMAL	3.1% 5/159 • 5 years	1.9% 6/318 • 5 years
Investigations ELECTROCARDIOGRAM ABNORMAL	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Investigations ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Investigations ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	1.3% 2/159 • 5 years	0.63% 2/318 • 5 years
Investigations ELECTROCARDIOGRAM ST SEGMENT ELEVATION	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Investigations EXERCISE TEST ABNORMAL	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Investigations GLYCOSYLATED HAEMOGLOBIN INCREASED	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Investigations HEART RATE INCREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations HEPATIC ENZYME INCREASED	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Investigations HIGH DENSITY LIPOPROTEIN DECREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Investigations TROPONIN I INCREASED	7.5% 12/159 • 5 years	9.4% 30/318 • 5 years
Investigations TROPONIN INCREASED	22.0% 35/159 • 5 years	23.0% 73/318 • 5 years
Investigations TROPONIN T INCREASED	6.9% 11/159 • 5 years	4.1% 13/318 • 5 years
Investigations WEIGHT DECREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations BLOOD GLUCOSE ABNORMAL	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Investigations HAEMOGLOBIN DECREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations HEART RATE DECREASED	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Investigations LOW DENSITY LIPOPROTEIN INCREASED	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Investigations STOOL ANALYSIS ABNORMAL	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations TRANSAMINASES INCREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Investigations WEIGHT INCREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS	1.3% 2/159 • 5 years	1.6% 5/318 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Metabolism and nutrition disorders GOUT	0.63% 1/159 • 5 years	1.3% 4/318 • 5 years
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Metabolism and nutrition disorders HYPERURICAEMIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Metabolism and nutrition disorders HYPOGLYCAEMIA	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Metabolism and nutrition disorders HYPOKALAEMIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Metabolism and nutrition disorders LIPID METABOLISM DISORDER	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Metabolism and nutrition disorders OBESITY	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders TYPE 1 DIABETES MELLITUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Metabolism and nutrition disorders HYPERHOMOCYSTEINAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders ARTHRALGIA	2.5% 4/159 • 5 years	2.5% 8/318 • 5 years
Musculoskeletal and connective tissue disorders BACK PAIN	4.4% 7/159 • 5 years	2.5% 8/318 • 5 years
Musculoskeletal and connective tissue disorders DUPUYTREN'S CONTRACTURE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISCOMFORT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	1.9% 3/159 • 5 years	1.9% 6/318 • 5 years
Musculoskeletal and connective tissue disorders MYALGIA	1.9% 3/159 • 5 years	2.8% 9/318 • 5 years
Musculoskeletal and connective tissue disorders NECK PAIN	1.3% 2/159 • 5 years	0.63% 2/318 • 5 years
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.3% 2/159 • 5 years	1.9% 6/318 • 5 years
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	2.5% 4/159 • 5 years	4.4% 14/318 • 5 years
Musculoskeletal and connective tissue disorders PAIN IN JAW	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Musculoskeletal and connective tissue disorders PLANTAR FASCIITIS	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders POLYARTHRITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders TENOSYNOVITIS STENOSANS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Musculoskeletal and connective tissue disorders TRIGGER FINGER	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Musculoskeletal and connective tissue disorders ARTHROPATHY	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders SPONDYLITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders EXOSTOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders TENDON DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders BURSITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Musculoskeletal and connective tissue disorders SENSATION OF HEAVINESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders SJOGREN'S SYNDROME	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Musculoskeletal and connective tissue disorders TENDONITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA PANCREAS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN SALIVARY GLAND NEOPLASM	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL CARCINOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON NEOPLASM	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL CARCINOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROOESOPHAGEAL CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GLIOBLASTOMA MULTIFORME	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL CANCER	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.63% 1/159 • 5 years	1.9% 6/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.63% 1/159 • 5 years	1.3% 4/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOCYTIC NAEVUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE TUMOUR	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL NEOPLASM	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA METASTATIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SWEAT GLAND TUMOUR	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LUNG	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SCROTAL CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA RECURRENT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER RECURRENT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Nervous system disorders AMNESIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders APHASIA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders CARPAL TUNNEL SYNDROME	1.3% 2/159 • 5 years	0.94% 3/318 • 5 years
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CEREBROVASCULAR ACCIDENT	1.3% 2/159 • 5 years	1.3% 4/318 • 5 years
Nervous system disorders DISTURBANCE IN ATTENTION	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders DIZZINESS	4.4% 7/159 • 5 years	3.8% 12/318 • 5 years
Nervous system disorders DIZZINESS POSTURAL	0.00% 0/159 • 5 years	1.6% 5/318 • 5 years
Nervous system disorders DYSARTHRIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders EXTRAPYRAMIDAL DISORDER	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders HEADACHE	1.3% 2/159 • 5 years	1.9% 6/318 • 5 years
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders NEUROPATHY PERIPHERAL	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Nervous system disorders PARAESTHESIA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders PARKINSON'S DISEASE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders PARKINSONISM	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders POLYNEUROPATHY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders PRESYNCOPE	1.3% 2/159 • 5 years	0.63% 2/318 • 5 years
Nervous system disorders SCIATICA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders SENSORY DISTURBANCE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders SENSORY LOSS	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Nervous system disorders SYNCOPE	3.1% 5/159 • 5 years	2.2% 7/318 • 5 years
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	2.5% 4/159 • 5 years	0.63% 2/318 • 5 years
Nervous system disorders VIITH NERVE PARALYSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders DEMENTIA ALZHEIMER'S TYPE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders LETHARGY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CAROTID ARTERY STENOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders EPILEPSY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CLONIC CONVULSION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders MEMORY IMPAIRMENT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders MIGRAINE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Nervous system disorders TREMOR	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Psychiatric disorders ANXIETY	1.3% 2/159 • 5 years	1.3% 4/318 • 5 years
Psychiatric disorders DEPRESSED MOOD	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Psychiatric disorders DEPRESSION	3.8% 6/159 • 5 years	1.3% 4/318 • 5 years
Psychiatric disorders INSOMNIA	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Psychiatric disorders LIBIDO DECREASED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Psychiatric disorders MENTAL DISORDER	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Psychiatric disorders POST-TRAUMATIC STRESS DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Psychiatric disorders PANIC ATTACK	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Psychiatric disorders SLEEP DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders HAEMATURIA	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Renal and urinary disorders HYPERTONIC BLADDER	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders RENAL COLIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders RENAL FAILURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders RENAL PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders URETHRAL STENOSIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders URINARY RETENTION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders URINARY TRACT DISORDER	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Renal and urinary disorders VESICAL FISTULA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders CALCULUS URINARY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders POLLAKIURIA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Renal and urinary disorders DYSURIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders RENAL FAILURE CHRONIC	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Renal and urinary disorders URETHRAL HAEMORRHAGE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders NOCTURIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders RENAL ANEURYSM	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Renal and urinary disorders RENAL ARTERY STENOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	1.3% 2/159 • 5 years	0.63% 2/318 • 5 years
Reproductive system and breast disorders PROSTATISM	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Reproductive system and breast disorders PROSTATOMEGALY	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Reproductive system and breast disorders SCROTAL PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Reproductive system and breast disorders BALANITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Reproductive system and breast disorders PROSTATITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Reproductive system and breast disorders CYSTOCELE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Respiratory, thoracic and mediastinal disorders COUGH	5.7% 9/159 • 5 years	3.8% 12/318 • 5 years
Respiratory, thoracic and mediastinal disorders DRY THROAT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA	6.9% 11/159 • 5 years	6.3% 20/318 • 5 years
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	2.5% 4/159 • 5 years	0.00% 0/318 • 5 years
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Respiratory, thoracic and mediastinal disorders RHINITIS ATROPHIC	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders TACHYPNOEA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders VOCAL CORD LEUKOPLAKIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders ALLERGIC COUGH	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders IDIOPATHIC PULMONARY FIBROSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Respiratory, thoracic and mediastinal disorders PAINFUL RESPIRATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Respiratory, thoracic and mediastinal disorders SINUS DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Skin and subcutaneous tissue disorders DRUG ERUPTION	1.3% 2/159 • 5 years	0.00% 0/318 • 5 years
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Skin and subcutaneous tissue disorders PRURITUS	1.3% 2/159 • 5 years	1.3% 4/318 • 5 years
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders RASH PRURITIC	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders SEBORRHOEIC DERMATITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders SKIN LESION	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Skin and subcutaneous tissue disorders ACTINIC KERATOSIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Skin and subcutaneous tissue disorders BLISTER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders RASH	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Skin and subcutaneous tissue disorders DERMAL CYST	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders DIABETIC FOOT	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/159 • 5 years	0.63% 2/318 • 5 years
Skin and subcutaneous tissue disorders HYPERKERATOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders RASH GENERALISED	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Skin and subcutaneous tissue disorders SKIN DISORDER	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Surgical and medical procedures ELECTIVE PROCEDURE	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Surgical and medical procedures INGUINAL HERNIA REPAIR	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Surgical and medical procedures SHOULDER OPERATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Surgical and medical procedures SPINAL LAMINECTOMY	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Surgical and medical procedures TOOTH EXTRACTION	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders AORTIC ANEURYSM	1.3% 2/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders FEMORAL ARTERIAL STENOSIS	0.63% 1/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders HAEMATOMA	1.9% 3/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders HYPERTENSION	5.0% 8/159 • 5 years	6.6% 21/318 • 5 years
Vascular disorders HYPERTENSIVE CRISIS	2.5% 4/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders HYPOTENSION	0.63% 1/159 • 5 years	1.6% 5/318 • 5 years
Vascular disorders INTERMITTENT CLAUDICATION	0.63% 1/159 • 5 years	0.94% 3/318 • 5 years
Vascular disorders ISCHAEMIA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders PERIPHERAL COLDNESS	0.63% 1/159 • 5 years	0.63% 2/318 • 5 years
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Vascular disorders PHLEBITIS	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Vascular disorders TEMPORAL ARTERITIS	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders VARICOSE VEIN	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders HAEMODYNAMIC INSTABILITY	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders AORTIC DILATATION	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/159 • 5 years	1.3% 4/318 • 5 years
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.00% 0/159 • 5 years	0.94% 3/318 • 5 years
Vascular disorders RAYNAUD'S PHENOMENON	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years
Nervous system disorders CEREBRAL HAEMATOMA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.63% 1/159 • 5 years	0.00% 0/318 • 5 years
Injury, poisoning and procedural complications CATHETER SITE HAEMATOMA	0.00% 0/159 • 5 years	0.31% 1/318 • 5 years

Additional Information

Susan Veldhof

Abbott Vascular International BVBA

Phone: +31653428610

Email: susan.veldhof@av.abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60