Trial Outcomes & Findings for AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population (NCT NCT01844284)

Last Updated: 2020-10-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

400 participants

Primary outcome timeframe

1 year

Results posted on

2020-10-08

Participant Flow

The target sample size was approximately 400 subjects (266 in the Absorb arm and 134 in the XIENCE arm) enrolled in approximately 40 investigational sites in Japan. First subject was enrolled on April 27, 2013 and the last subject completed 5-year follow-up on January 16, 2019.

Participant milestones

Participant milestones
Measure	Absorb BVS Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition Subjects receiving XIENCE PRIME/XIENCE Xpedition
Overall Study STARTED	266	134
Overall Study COMPLETED	254	127
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Absorb BVS Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition Subjects receiving XIENCE PRIME/XIENCE Xpedition
Overall Study Lost to Follow-up	12	7

Baseline Characteristics

AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Absorb BVS n=266 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=134 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition	Total n=400 Participants Total of all reporting groups
Age, Continuous	67.1 years STANDARD_DEVIATION 9.4 • n=5 Participants	67.3 years STANDARD_DEVIATION 9.6 • n=7 Participants	67.2 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	35 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	210 Participants n=5 Participants	99 Participants n=7 Participants	309 Participants n=5 Participants
Region of Enrollment Japan	266 participants n=5 Participants	134 participants n=7 Participants	400 participants n=5 Participants

PRIMARY 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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	11 Participants	5 Participants

SECONDARY outcome

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

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 Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month

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 Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

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 Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	10 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.

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	26 Participants	11 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 Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	52 Participants	16 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 Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	62 Participants	26 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 Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	70 Participants	32 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 Myocardial infarction (MI) and All Revascularization

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Any Death/Any MI/Revascularization (DMR)	74 Participants	34 Participants

SECONDARY outcome

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

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	9 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 Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	16 Participants	7 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

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	29 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 Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	34 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.

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	40 Participants	14 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

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel Failure (TVF)	41 Participants	17 Participants

SECONDARY outcome

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

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	8 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 Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	19 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

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	23 Participants	7 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

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	27 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

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Lesion Failure (TLF)	28 Participants	10 Participants

SECONDARY outcome

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

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	8 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	9 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	15 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	17 Participants	4 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	18 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death/All MI	20 Participants	8 Participants

SECONDARY outcome

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

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	6 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	13 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	25 Participants	10 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	31 Participants	12 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	37 Participants	14 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Vessel Revascularization (TVR)	38 Participants	17 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	6 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	13 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	24 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	28 Participants	9 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	34 Participants	10 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven TVR (ID-TVR)	34 Participants	13 Participants

SECONDARY outcome

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

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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	5 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	7 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	15 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	21 Participants	9 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	25 Participants	10 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Target Lesion Revascularization (TLR)	26 Participants	11 Participants

SECONDARY outcome

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

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

A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	5 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	7 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	14 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	18 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	21 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	21 Participants	6 Participants

SECONDARY outcome

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

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), unwitnessed death and death of unknown cause, all study 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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	1 Participants	0 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	2 Participants	0 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	4 Participants	0 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	7 Participants	2 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	10 Participants	2 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	15 Participants	4 Participants

SECONDARY outcome

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

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

\- 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

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	8 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	9 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	14 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	16 Participants	4 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	17 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	19 Participants	7 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	7 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	9 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=261 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	13 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=258 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=128 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	14 Participants	4 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=255 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	15 Participants	6 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Target Vessel MI (TV-MI)	17 Participants	6 Participants

SECONDARY outcome

Timeframe: Acute (≤ 1 day)

Population: Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.

ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation

Outcome measures

Outcome measures
Measure	Absorb BVS n=266 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Stent/Scaffold Thrombosis Definite	0 Participants	0 Participants
Number of Participants With Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Subacute (>1 - 30 days)

Outcome measures

Outcome measures
Measure	Absorb BVS n=265 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Stent/Scaffold Thrombosis Definite	3 Participants	1 Participants
Number of Participants With Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Late (31 - 365 days)

Outcome measures

Outcome measures
Measure	Absorb BVS n=262 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=133 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Stent/Scaffold Thrombosis Definite	1 Participants	0 Participants
Number of Participants With Stent/Scaffold Thrombosis Probable	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Very Late (366 - 730 days)

Outcome measures

Outcome measures
Measure	Absorb BVS n=256 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=130 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Stent/Scaffold Thrombosis Definite	4 Participants	0 Participants
Number of Participants With Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Very Late (731 - 1095 days)

Outcome measures

Outcome measures
Measure	Absorb BVS n=249 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=126 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Stent/Scaffold Thrombosis Definite	1 Participants	0 Participants
Number of Participants With Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Very Late (1096 - 1460 days)

Outcome measures

Outcome measures
Measure	Absorb BVS n=240 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=125 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants
Number of Participants With Stent/Scaffold Thrombosis Definite	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Very Late (1461 - 1825 days)

Outcome measures

Outcome measures
Measure	Absorb BVS n=234 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=122 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Stent/Scaffold Thrombosis Definite	0 Participants	0 Participants
Number of Participants With Stent/Scaffold Thrombosis Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 13 months

Population: Full Analysis Set Population

Outcome measures

Outcome measures
Measure	Absorb BVS n=260 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=129 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
In-segment Late Loss (Non-inferiority)	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Full Analysis Set Population

Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=82 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=43 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)	2.43 millimetre Standard Deviation 0.52	2.76 millimetre Standard Deviation 0.52

SECONDARY outcome

Timeframe: 2 years

Population: Full Analysis Set Population

Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG)

Outcome measures

Outcome measures
Measure	Absorb BVS n=82 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=43 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation	0.06 millimetre Standard Deviation 0.14	0.07 millimetre Standard Deviation 0.17

SECONDARY outcome

Timeframe: 2 years

Population: Full Analysis Set Population

Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.

Outcome measures

Outcome measures
Measure	Absorb BVS n=82 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=43 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)	2.49 millimetre Standard Deviation 0.54	2.82 millimetre Standard Deviation 0.54

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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)	30 Participants	11 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Not Ischemia-driven TLR (NID-TLR)	6 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.

Outcome measures

Outcome measures
Measure	Absorb BVS n=254 Participants Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=127 Participants Subjects receiving XIENCE PRIME/XIENCE Xpedition
Number of Participants With Non-Target Vessel MI (NTV-MI)	3 Participants	2 Participants

Adverse Events

Absorb BVS

Serious events: 127 serious events

Other events: 217 other events

Deaths: 15 deaths

XIENCE PRIME/XIENCE Xpedition

Serious events: 61 serious events

Other events: 110 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Absorb BVS n=266 participants at risk Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=134 participants at risk Subjects receiving XIENCE PRIME/XIENCE Xpedition
Infections and infestations SEPTIC SHOCK	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders SPINAL LIGAMENT OSSIFICATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLESTEATOMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON NEOPLASM	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER STAGE 0	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM MALIGNANT RECURRENT	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIP AND/OR ORAL CAVITY CANCER	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER STAGE UNSPECIFIED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TRANSITIONAL CELL CARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders CAROTID ARTERY STENOSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders CEREBRAL INFARCTION	2.6% 7/266 • 5 years	2.2% 3/134 • 5 years
Nervous system disorders CERVICAL MYELOPATHY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders DIZZINESS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders EMBOLIC STROKE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders HYPOGLYCAEMIC ENCEPHALOPATHY	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders INTRACRANIAL HYPOTENSION	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders POST HERPETIC NEURALGIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders SYNCOPE	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders THALAMUS HAEMORRHAGE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Psychiatric disorders ANXIETY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Renal and urinary disorders CALCULUS URETERIC	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Renal and urinary disorders DYSURIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders RENAL FAILURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.75% 2/266 • 5 years	1.5% 2/134 • 5 years
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders SUBCUTANEOUS EMPHYSEMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders AORTIC ANEURYSM	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders AORTIC RUPTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders ARTERIOVENOUS FISTULA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders EXTREMITY NECROSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders HYPERTENSION	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders REPERFUSION INJURY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders SUBCLAVIAN ARTERY STENOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations URINARY TRACT INFECTION	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications ANKLE FRACTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders ANGINA PECTORIS	3.4% 9/266 • 5 years	3.0% 4/134 • 5 years
Cardiac disorders ANGINA UNSTABLE	0.38% 1/266 • 5 years	2.2% 3/134 • 5 years
Cardiac disorders AORTIC VALVE STENOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders ARRHYTHMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders ATRIAL FIBRILLATION	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Cardiac disorders ATRIAL FLUTTER	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders ATRIAL TACHYCARDIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Cardiac disorders CARDIAC ARREST	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CARDIAC FAILURE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders CARDIAC FAILURE ACUTE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CORONARY ARTERY DISEASE	3.4% 9/266 • 5 years	2.2% 3/134 • 5 years
Cardiac disorders CORONARY ARTERY OCCLUSION	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications COMMINUTED FRACTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CORONARY ARTERY STENOSIS	6.0% 16/266 • 5 years	8.2% 11/134 • 5 years
Injury, poisoning and procedural complications CORONARY ARTERY RESTENOSIS	7.9% 21/266 • 5 years	6.0% 8/134 • 5 years
Cardiac disorders IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders INTRACARDIAC THROMBUS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders MYOCARDIAL INFARCTION	4.5% 12/266 • 5 years	2.2% 3/134 • 5 years
Cardiac disorders MYOCARDIAL ISCHAEMIA	1.9% 5/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders PERICARDITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders POSTINFARCTION ANGINA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders PRINZMETAL ANGINA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders SINUS ARREST	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders VENTRICULAR FIBRILLATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Ear and labyrinth disorders VERTIGO	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Eye disorders ANGLE CLOSURE GLAUCOMA	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Eye disorders CATARACT	3.0% 8/266 • 5 years	2.2% 3/134 • 5 years
Eye disorders CORNEAL DEGENERATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders DIABETIC RETINOPATHY	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders EYELID PTOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders MACULAR FIBROSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders RETINAL DETACHMENT	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders VITREOUS HAEMORRHAGE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders COLONIC POLYP	0.75% 2/266 • 5 years	2.2% 3/134 • 5 years
Gastrointestinal disorders ENTERITIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders GASTRITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders HAEMORRHOIDS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders ILEUS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders INGUINAL HERNIA	2.3% 6/266 • 5 years	1.5% 2/134 • 5 years
Gastrointestinal disorders PERIODONTITIS	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders RECTAL POLYP	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
General disorders DISUSE SYNDROME	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
General disorders NON-CARDIAC CHEST PAIN	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
General disorders PYREXIA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
General disorders THROMBOSIS IN DEVICE	3.4% 9/266 • 5 years	0.75% 1/134 • 5 years
Hepatobiliary disorders DRUG-INDUCED LIVER INJURY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations BACTERAEMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations BURSITIS INFECTIVE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Infections and infestations CELLULITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations DIABETIC GANGRENE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations GASTROENTERITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations HERPES ZOSTER	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations PNEUMONIA	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations SEPSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications FALL	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications FIBULA FRACTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	2.6% 7/266 • 5 years	3.0% 4/134 • 5 years
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications RIB FRACTURE	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Injury, poisoning and procedural complications SUBCUTANEOUS HAEMATOMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Investigations BLOOD GLUCOSE ABNORMAL	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations ELECTROCARDIOGRAM T WAVE PEAKED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations TRANSAMINASES INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/266 • 5 years	2.2% 3/134 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years

Other adverse events

Other adverse events
Measure	Absorb BVS n=266 participants at risk Subjects receiving Absorb BVS	XIENCE PRIME/XIENCE Xpedition n=134 participants at risk Subjects receiving XIENCE PRIME/XIENCE Xpedition
Ear and labyrinth disorders VERTIGO	1.5% 4/266 • 5 years	0.75% 1/134 • 5 years
General disorders CATHETER SITE HAEMORRHAGE	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
General disorders CATHETER SITE PAIN	0.75% 2/266 • 5 years	1.5% 2/134 • 5 years
General disorders CATHETER SITE RASH	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
General disorders CHEST DISCOMFORT	3.8% 10/266 • 5 years	7.5% 10/134 • 5 years
General disorders DISUSE SYNDROME	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
General disorders INFLUENZA LIKE ILLNESS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
General disorders INJECTION SITE PHLEBITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
General disorders MALAISE	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
General disorders NON-CARDIAC CHEST PAIN	2.3% 6/266 • 5 years	3.0% 4/134 • 5 years
General disorders OEDEMA PERIPHERAL	2.3% 6/266 • 5 years	0.00% 0/134 • 5 years
General disorders PYREXIA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
General disorders THROMBOSIS IN DEVICE	3.4% 9/266 • 5 years	0.75% 1/134 • 5 years
Hepatobiliary disorders CHOLANGITIS ACUTE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Hepatobiliary disorders DRUG-INDUCED LIVER INJURY	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Hepatobiliary disorders HEPATIC STEATOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Immune system disorders ANAPHYLACTOID REACTION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Immune system disorders CONTRAST MEDIA ALLERGY	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Immune system disorders DRUG HYPERSENSITIVITY	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations BACTERAEMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations BRONCHITIS	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations BRONCHOPNEUMONIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations BURSITIS INFECTIVE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Infections and infestations CAMPYLOBACTER GASTROENTERITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations CELLULITIS	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations CYSTITIS	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Infections and infestations DEVICE RELATED INFECTION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations DIABETIC GANGRENE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations ERYSIPELAS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations GASTROENTERITIS	1.5% 4/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations HERPES ZOSTER	1.5% 4/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations HORDEOLUM	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations INFLUENZA	1.5% 4/266 • 5 years	0.75% 1/134 • 5 years
Infections and infestations NASOPHARYNGITIS	10.2% 27/266 • 5 years	10.4% 14/134 • 5 years
Infections and infestations PHARYNGITIS	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Infections and infestations PNEUMONIA	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations PYODERMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations RESPIRATORY TRACT INFECTION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations SEPSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations SEPTIC SHOCK	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations SINUSITIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Infections and infestations TINEA INFECTION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Infections and infestations URINARY TRACT INFECTION	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications ANASTOMOTIC LEAK	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications ANKLE FRACTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Injury, poisoning and procedural complications COMMINUTED FRACTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications CONTRAST MEDIA REACTION	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications CONTUSION	2.6% 7/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications CORONARY ARTERY RESTENOSIS	7.9% 21/266 • 5 years	6.0% 8/134 • 5 years
Injury, poisoning and procedural complications FALL	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications FIBULA FRACTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications IN-STENT CORONARY ARTERY RESTENOSIS	2.6% 7/266 • 5 years	3.0% 4/134 • 5 years
Injury, poisoning and procedural complications LACERATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications OPEN WOUND	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications RADIUS FRACTURE	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications RIB FRACTURE	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.75% 2/266 • 5 years	1.5% 2/134 • 5 years
Injury, poisoning and procedural complications SUBCUTANEOUS HAEMATOMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications TENDON RUPTURE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	15.0% 40/266 • 5 years	12.7% 17/134 • 5 years
Investigations BLOOD CREATINE PHOSPHOKINASE MB INCREASED	7.1% 19/266 • 5 years	9.0% 12/134 • 5 years
Investigations BLOOD GLUCOSE ABNORMAL	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations BLOOD PRESSURE DECREASED	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Investigations BLOOD PRESSURE INCREASED	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Investigations C-REACTIVE PROTEIN INCREASED	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Investigations CARDIAC ENZYMES INCREASED	4.9% 13/266 • 5 years	3.7% 5/134 • 5 years
Investigations ELECTROCARDIOGRAM ABNORMAL	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Investigations ELECTROCARDIOGRAM ST SEGMENT ELEVATION	1.9% 5/266 • 5 years	0.75% 1/134 • 5 years
Investigations ELECTROCARDIOGRAM T WAVE PEAKED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations HEPATIC ENZYME INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations LIVER FUNCTION TEST ABNORMAL	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Investigations N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations OCCULT BLOOD POSITIVE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Investigations TRANSAMINASES INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Investigations TROPONIN I INCREASED	1.1% 3/266 • 5 years	2.2% 3/134 • 5 years
Investigations WEIGHT DECREASED	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Investigations WHITE BLOOD CELL COUNT INCREASED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS	3.0% 8/266 • 5 years	7.5% 10/134 • 5 years
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders DYSLIPIDAEMIA	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders GOUT	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Metabolism and nutrition disorders HYPERKALAEMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders HYPERLIPIDAEMIA	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Metabolism and nutrition disorders HYPERURICAEMIA	0.75% 2/266 • 5 years	1.5% 2/134 • 5 years
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.38% 1/266 • 5 years	2.2% 3/134 • 5 years
Metabolism and nutrition disorders HYPOKALAEMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Metabolism and nutrition disorders METABOLIC ALKALOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Musculoskeletal and connective tissue disorders BACK PAIN	3.0% 8/266 • 5 years	2.2% 3/134 • 5 years
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Musculoskeletal and connective tissue disorders NECK PAIN	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders SERONEGATIVE ARTHRITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders SPINAL LIGAMENT OSSIFICATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADRENAL NEOPLASM	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLESTEATOMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON NEOPLASM	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC ADENOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER STAGE 0	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL STROMAL TUMOUR	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM MALIGNANT RECURRENT	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIP AND/OR ORAL CAVITY CANCER	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL NEOPLASM	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER STAGE UNSPECIFIED	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TRANSITIONAL CELL CARCINOMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders CAROTID ARTERY STENOSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders CEREBRAL INFARCTION	2.6% 7/266 • 5 years	2.2% 3/134 • 5 years
Nervous system disorders CERVICAL MYELOPATHY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders CHOLINERGIC SYNDROME	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders DIZZINESS	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders DIZZINESS POSTURAL	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders DYSGEUSIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders EMBOLIC STROKE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders HEADACHE	1.1% 3/266 • 5 years	1.5% 2/134 • 5 years
Nervous system disorders HYPERTENSIVE ENCEPHALOPATHY	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders HYPOGLYCAEMIC ENCEPHALOPATHY	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders INTERCOSTAL NEURALGIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders INTRACRANIAL HYPOTENSION	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders NEURALGIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Nervous system disorders POST HERPETIC NEURALGIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders PRESYNCOPE	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders SCIATICA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders SYNCOPE	1.1% 3/266 • 5 years	1.5% 2/134 • 5 years
Nervous system disorders TENSION HEADACHE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders THALAMUS HAEMORRHAGE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Nervous system disorders VOCAL CORD PARALYSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Psychiatric disorders ANXIETY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Psychiatric disorders DEPRESSION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Psychiatric disorders HEAD BANGING	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Psychiatric disorders INSOMNIA	1.5% 4/266 • 5 years	2.2% 3/134 • 5 years
Psychiatric disorders NEUROSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Renal and urinary disorders CALCULUS URETERIC	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders CALCULUS URINARY	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Renal and urinary disorders CYSTITIS NONINFECTIVE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders DYSURIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders HAEMATURIA	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Renal and urinary disorders NEPHROLITHIASIS	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders POLLAKIURIA	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Renal and urinary disorders RENAL FAILURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Renal and urinary disorders RENAL IMPAIRMENT	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Renal and urinary disorders URATE NEPHROPATHY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Reproductive system and breast disorders HAEMATOSPERMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Reproductive system and breast disorders UTERINE PROLAPSE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders COUGH	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Respiratory, thoracic and mediastinal disorders EPISTAXIS	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.75% 2/266 • 5 years	1.5% 2/134 • 5 years
Respiratory, thoracic and mediastinal disorders NASAL MUCOSAL DISORDER	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders PAINFUL RESPIRATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders RESPIRATORY ALKALOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMMATION	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders DERMATITIS	1.9% 5/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders DIABETIC BULLOSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders ECZEMA	1.9% 5/266 • 5 years	1.5% 2/134 • 5 years
Skin and subcutaneous tissue disorders ECZEMA ASTEATOTIC	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Skin and subcutaneous tissue disorders ECZEMA NUMMULAR	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/266 • 5 years	2.2% 3/134 • 5 years
Skin and subcutaneous tissue disorders HAEMORRHAGE SUBCUTANEOUS	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Skin and subcutaneous tissue disorders HYPERKERATOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders PARAPSORIASIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders PRURIGO	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Skin and subcutaneous tissue disorders PRURITUS	1.1% 3/266 • 5 years	1.5% 2/134 • 5 years
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Skin and subcutaneous tissue disorders PSORIASIS	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Skin and subcutaneous tissue disorders RASH	1.5% 4/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders RASH PRURITIC	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders SENILE PRURITUS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders SOLAR DERMATITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Skin and subcutaneous tissue disorders SUBCUTANEOUS EMPHYSEMA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Skin and subcutaneous tissue disorders URTICARIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Surgical and medical procedures TOOTH EXTRACTION	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders AORTIC ANEURYSM	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders AORTIC RUPTURE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders ARTERIOVENOUS FISTULA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders CIRCULATORY COLLAPSE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders EXTRAVASATION BLOOD	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders EXTREMITY NECROSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders HYPERTENSION	2.6% 7/266 • 5 years	3.7% 5/134 • 5 years
Vascular disorders HYPOTENSION	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders ORTHOSTATIC HYPOTENSION	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders PERIPHERAL COLDNESS	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders REPERFUSION INJURY	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Vascular disorders SUBCLAVIAN ARTERY STENOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders VARICOPHLEBITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Vascular disorders VENOUS INSUFFICIENCY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Ear and labyrinth disorders VERTIGO POSITIONAL	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Endocrine disorders PITUITARY HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Endocrine disorders STEROID WITHDRAWAL SYNDROME	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders AGE-RELATED MACULAR DEGENERATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders ANGLE CLOSURE GLAUCOMA	0.00% 0/266 • 5 years	1.5% 2/134 • 5 years
Eye disorders CATARACT	3.4% 9/266 • 5 years	2.2% 3/134 • 5 years
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Eye disorders CONJUNCTIVITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders CONJUNCTIVITIS ALLERGIC	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Eye disorders CORNEAL DEGENERATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders DIABETIC RETINOPATHY	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders EYELID PTOSIS	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Blood and lymphatic system disorders ANAEMIA	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Blood and lymphatic system disorders LEUKOPENIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Blood and lymphatic system disorders LYMPHADENOPATHY	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders ANGINA PECTORIS	12.4% 33/266 • 5 years	9.0% 12/134 • 5 years
Cardiac disorders ANGINA UNSTABLE	0.38% 1/266 • 5 years	2.2% 3/134 • 5 years
Cardiac disorders AORTIC VALVE STENOSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders ARRHYTHMIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders ARTERIOSPASM CORONARY	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders ATRIAL FIBRILLATION	0.75% 2/266 • 5 years	1.5% 2/134 • 5 years
Cardiac disorders ATRIAL FLUTTER	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders ATRIAL TACHYCARDIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.38% 1/266 • 5 years	1.5% 2/134 • 5 years
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CARDIAC ARREST	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CARDIAC FAILURE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders CARDIAC FAILURE ACUTE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CORONARY ARTERY DISEASE	4.5% 12/266 • 5 years	3.0% 4/134 • 5 years
Cardiac disorders CORONARY ARTERY DISSECTION	2.3% 6/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders CORONARY ARTERY EMBOLISM	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders CORONARY ARTERY OCCLUSION	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders CORONARY ARTERY STENOSIS	7.5% 20/266 • 5 years	9.7% 13/134 • 5 years
Cardiac disorders IN-STENT CORONARY ARTERY RESTENOSIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders INTRACARDIAC THROMBUS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders MYOCARDIAL INFARCTION	4.9% 13/266 • 5 years	3.0% 4/134 • 5 years
Cardiac disorders MYOCARDIAL ISCHAEMIA	2.6% 7/266 • 5 years	1.5% 2/134 • 5 years
Cardiac disorders PALPITATIONS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders PERICARDITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders POSTINFARCTION ANGINA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders PRINZMETAL ANGINA	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders SINUS ARREST	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.75% 2/266 • 5 years	1.5% 2/134 • 5 years
Cardiac disorders VENTRICULAR FIBRILLATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Cardiac disorders VENTRICULAR TACHYCARDIA	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Ear and labyrinth disorders SUDDEN HEARING LOSS	1.1% 3/266 • 5 years	1.5% 2/134 • 5 years
Eye disorders MACULAR FIBROSIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders MACULAR OEDEMA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders POSTERIOR CAPSULE OPACIFICATION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders RETINAL DETACHMENT	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders RETINAL VEIN OCCLUSION	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders VISUAL IMPAIRMENT	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Eye disorders VITREOUS HAEMORRHAGE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders ABDOMINAL PAIN	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders ABDOMINAL PAIN UPPER	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders ABDOMINAL WALL HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders CHEILITIS	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders COLONIC POLYP	2.3% 6/266 • 5 years	3.0% 4/134 • 5 years
Gastrointestinal disorders CONSTIPATION	2.6% 7/266 • 5 years	1.5% 2/134 • 5 years
Gastrointestinal disorders DENTAL CARIES	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders DIARRHOEA	1.1% 3/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders DIVERTICULUM INTESTINAL	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders DYSPEPSIA	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders ENTERITIS	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders EPIGASTRIC DISCOMFORT	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders GASTRIC ULCER	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders GASTRIC ULCER HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders GASTRITIS	1.9% 5/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders GASTRITIS ATROPHIC	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders GASTRITIS EROSIVE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	1.5% 4/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders HAEMORRHOIDS	1.1% 3/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders ILEUS	0.38% 1/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders INGUINAL HERNIA	2.3% 6/266 • 5 years	1.5% 2/134 • 5 years
Gastrointestinal disorders MELAENA	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders NAUSEA	0.75% 2/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders PAROTID GLAND ENLARGEMENT	0.00% 0/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders PERIODONTITIS	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
Gastrointestinal disorders RECTAL POLYP	0.38% 1/266 • 5 years	0.00% 0/134 • 5 years
Gastrointestinal disorders VOMITING	0.75% 2/266 • 5 years	0.75% 1/134 • 5 years
General disorders ADVERSE DRUG REACTION	3.8% 10/266 • 5 years	2.2% 3/134 • 5 years
General disorders CATHETER SITE HAEMATOMA	1.1% 3/266 • 5 years	1.5% 2/134 • 5 years

Additional Information

Hajime Kusano

Abbott Vascular

Phone: 408-845-1626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place