Trial Outcomes & Findings for A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT) (NCT NCT01923740)

NCT ID: NCT01923740

Last Updated: 2019-12-04

Results Overview

In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

Recruitment status

COMPLETED

Study phase

Target enrollment

480 participants

Primary outcome timeframe

1 year

Results posted on

2019-12-04

Participant Flow

The enrollment of the ABSORB China RCT began on July 31, 2013 \& completed on March 13, 2014 with the first subject randomized on 2 August 2013. A total of 480 subjects (Intent-to-treat (ITT) population) were randomized (Absorb BVS:241\&XIENCE:239) at 24 clinical sites in mainland China. Last subject completed the 5 year follow-up on March 7, 2019.

Of the 480 ITT subjects, 21 were excluded from the PTE population due to pre-specified protocol/treatment deviations or due to subject withdrawal prior to any study device attempts during the index procedure. Thus, of the 459 subjects in the PTE population, 227 were randomized to the Absorb BVS arm and 232 were randomized to the XIENCE V arm

Participant milestones

Participant milestones
Measure	Absorb BVS System Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS XIENCE V EECSS: Subjects receiving XIENCE V
Overall Study STARTED	227	232
Overall Study COMPLETED	221	223
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Absorb BVS System Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS XIENCE V EECSS: Subjects receiving XIENCE V
Overall Study Lost to Follow-up	4	9
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V	Total n=459 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 11.4 • n=5 Participants	57.7 years STANDARD_DEVIATION 9.6 • n=7 Participants	57.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	61 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	161 Participants n=5 Participants	171 Participants n=7 Participants	332 Participants n=5 Participants
Region of Enrollment China	227 Participants n=5 Participants	232 Participants n=7 Participants	459 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=200 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=196 Participants XIENCE V EECSS: Subjects receiving XIENCE V
In-segment Late Loss (LL) - Per Subject Analysis	0.19 Millimeter Standard Deviation 0.38	0.13 Millimeter Standard Deviation 0.38

PRIMARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=209 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
In-segment Late Loss (LL) - Per Lesion Analysis	0.19 Millimeter Standard Deviation 0.40	0.13 Millimeter Standard Deviation 0.37

SECONDARY outcome

Timeframe: < or = 1 day

Population: Intent to treat set (ITT). Four subjects (1 in the Absorb BVS arm and 3 in the XIENCE V arm) were excluded from the data analysis for acute success. During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts,3 in the Absorb BVS arm and 2 in the XIENCE V arm were excluded from all data analyses.

Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=250 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=249 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Acute Device Success	98.0 Percentage of target lesions	99.6 Percentage of target lesions

SECONDARY outcome

Timeframe: At time of procedure up to 7 days in hospital

Population: ITT set. Four subjects (Absorb BVS (1) arm and XIENCE V arm (3)) were excluded from the data analysis for acute success. During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts. Data from these 5 subjects (3 in the Absorb BVS arm and 2 in the XIENCE V arm) were excluded from all data analyses.

Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success. Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=237 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=234 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Acute Procedural Success	230 Participants	230 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 37days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	1 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death (Cardiac, Vascular, Non-cardiovascular)	6 Participants	7 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment-Evaluable Population. Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Myocardial Infarction	7 Participants	6 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	12 Participants	9 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TLR (ID-TLR) * Not ischemia-driven TLR (NID-TLR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Lesion Revascularization (TLR)	12 Participants	9 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	9 Participants	12 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	11 Participants	13 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	14 Participants	13 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	16 Participants	16 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

* Ischemia-driven TVR (ID-TVR) * Not ischemia-driven TVR (NID-TVR)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Target Vessel Revascularization (TVR)	16 Participants	16 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 37days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 0 to 298 Days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	16 Participants	17 Participants

SECONDARY outcome

Timeframe: 2 year

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

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	21 Participants	20 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	24 Participants	21 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	27 Participants	26 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Coronary Revascularization (PCI and CABG)	28 Participants	26 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	3 Participants	6 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	6 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	11 Participants	10 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Death/All MI	13 Participants	10 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	7 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	9 Participants	6 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Cardiac Death/All MI	10 Participants	6 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	3 Participants	7 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	3 Participants	8 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	17 Participants	22 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	22 Participants	26 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	26 Participants	27 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	31 Participants	34 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With All Death/All MI/All Revascularization (DMR)	34 Participants	34 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	7 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	12 Participants	10 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	15 Participants	12 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]	16 Participants	12 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	11 Participants	15 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	14 Participants	15 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

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 System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	18 Participants	19 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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 System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]	19 Participants	19 Participants

SECONDARY outcome

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

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 to 37 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 208 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 0 to 298 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	7 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	10 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	13 Participants	11 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=230 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	16 Participants	13 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

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

Outcome measures

Outcome measures
Measure	Absorb BVS System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])	17 Participants	13 Participants

SECONDARY outcome

Timeframe: < or = 1 day

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation).

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) Definite	0 Participants	0 Participants
Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: >1 to 30 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=227 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) Definite	0 Participants	0 Participants
Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) Probable	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 31 to 365 days

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=226 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=228 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) Probable	0 Participants	0 Participants
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) Definite	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 366 to 730 days

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 System n=225 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=225 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) Definite	1 Participants	0 Participants
Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 731 to 1095 days

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 System n=223 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=225 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) Definite	0 Participants	0 Participants
Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 366-1095 days

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 System n=224 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=225 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) Definite	1 Participants	0 Participants
Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1096-1460 days

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 System n=221 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=223 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) Definite	0 Participants	0 Participants
Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) Probable	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 1461-1825 days

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 System n=216 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=215 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) Definite	0 Participants	0 Participants
Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) Probable	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1096-1825 days

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 System n=217 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=216 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) Definite	0 Participants	0 Participants
Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) Probable	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-1825 days

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 System n=218 Participants Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=216 Participants XIENCE V EECSS: Subjects receiving XIENCE V
Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis Definite	1 Participants	0 Participants
Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis Probable	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=210 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
In-Device Minimum Lumen Diameter (MLD)	2.24 Millimeter Standard Deviation 0.48	2.50 Millimeter Standard Deviation 0.46

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections. INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=210 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
In-Segment Minimum Lumen Diameter (MLD)	2.11 Millimeter Standard Deviation 0.47	2.17 Millimeter Standard Deviation 0.49

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment-Evaluable Population (PTE) Population. Analysis population exclude subjects who are truly lost-to-follow-up.

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=208 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=205 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Proximal Minimum Lumen Diameter (MLD)	2.64 Millimeter Standard Deviation 0.48	2.68 Millimeter Standard Deviation 0.56

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=210 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=209 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Distal Minimum Lumen Diameter (MLD)	2.39 Millimeter Standard Deviation 0.45	2.37 Millimeter Standard Deviation 0.50

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

The Percent Diameter Stenosis value calculated as 100 \* (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=210 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
In-Segment Percent Diameter Stenosis (%DS)	24.02 Percent Diameter stenosis Standard Deviation 13.23	22.96 Percent Diameter stenosis Standard Deviation 13.18

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=210 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
In-Device Percent Diameter Stenosis (%DS)	19.16 Percent Diameter stenosis Standard Deviation 14.36	11.15 Percent Diameter stenosis Standard Deviation 11.38

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=208 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=205 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Proximal Percent Diameter Stenosis (%DS)	11.09 Percent Diameter stenosis Standard Deviation 10.13	12.12 Percent Diameter stenosis Standard Deviation 11.63

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=208 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=205 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)	1.0 Percentage of participants	1.5 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=210 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=209 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Distal Percent Diameter Stenosis (%DS)	8.53 Percent Diameter stenosis Standard Deviation 8.15	8.14 Percent Diameter stenosis Standard Deviation 11.86

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=210 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)	4.2 percentage of participants	2.9 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=210 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)	3.3 Percentage of participants	1.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=209 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
In-Segment Late Loss (LL)	0.19 Millimeter Standard Deviation 0.40	0.13 Millimeter Standard Deviation 0.37

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=210 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=209 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)	0.0 Percentage of participants	1.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).

Outcome measures

Outcome measures
Measure	Absorb BVS System n=212 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=209 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
In-Device Late Loss (LL)	0.24 Millimeter Standard Deviation 0.39	0.10 Millimeter Standard Deviation 0.32

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup. Proximal is defined as within 5 mm of healthy tissue proximal to the device placement.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=205 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=198 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Proximal Late Loss (LL)	0.19 Millimeter Standard Deviation 0.39	0.13 Millimeter Standard Deviation 0.42

SECONDARY outcome

Timeframe: 1 year

Population: Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.

Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup. Distal is defined as within 5 mm of healthy tissue distal to the device placement.

Outcome measures

Outcome measures
Measure	Absorb BVS System n=210 Target lesions Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=207 Target lesions XIENCE V EECSS: Subjects receiving XIENCE V
Distal Late Loss (LL)	0.08 Millimeter Standard Deviation 0.31	0.03 Millimeter Standard Deviation 0.33

Adverse Events

Absorb BVS System

Serious events: 94 serious events

Other events: 151 other events

Deaths: 6 deaths

XIENCE V EECSS

Serious events: 81 serious events

Other events: 135 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Absorb BVS System n=227 participants at risk Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 participants at risk XIENCE V EECSS: Subjects receiving XIENCE V
Cardiac disorders Atrial fibrillation	0.88% 2/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Cardiac disorders Coronary artery dissection	1.8% 4/227 • 5 years PTE population.	2.2% 5/232 • 5 years PTE population.
Cardiac disorders Coronary artery stenosis	4.4% 10/227 • 5 years PTE population.	3.4% 8/232 • 5 years PTE population.
Cardiac disorders Myocardial infarction	1.8% 4/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Cardiac disorders Palpitations	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Ventricular arrhythmia	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Ear and labyrinth disorders Meniere's disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Eye disorders Cataract	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/227 • 5 years PTE population.	1.3% 3/232 • 5 years PTE population.
Gastrointestinal disorders Hematochezia	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Intestinal obstruction	0.88% 2/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
General disorders Application site hematoma	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
General disorders Chest discomfort	3.5% 8/227 • 5 years PTE population.	2.2% 5/232 • 5 years PTE population.
General disorders Chest pain	0.88% 2/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
General disorders Drug resistance	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Hepatobiliary disorders Cholangitis acute	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Hepatobiliary disorders Bile duct stone	0.00% 0/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Hepatobiliary disorders Cholelithiasis	0.00% 0/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Infections and infestations Appendicitis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Lung infection	0.88% 2/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Infections and infestations Pneumonia	0.44% 1/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Injury, poisoning and procedural complications Coronary artery restenosis	4.0% 9/227 • 5 years PTE population.	4.7% 11/232 • 5 years PTE population.
Injury, poisoning and procedural complications Electric injury	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Injury, poisoning and procedural complications Joint injury	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Procedural hypotension	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Metabolism and nutrition disorders Diabetes mellitus	0.88% 2/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumor	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Carotid artery disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Cerebral atrophy	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Cerebrovascular disorder	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Subarachnoid hemorrhage	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Renal and urinary disorders Calculus ureteric	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Vascular disorders Hypertension	1.8% 4/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Acute coronary syndrome	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Acute myocardial infarction	0.44% 1/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Cardiac disorders Angina pectoris	5.3% 12/227 • 5 years PTE population.	2.2% 5/232 • 5 years PTE population.
Cardiac disorders Angina unstable	6.6% 15/227 • 5 years PTE population.	4.3% 10/232 • 5 years PTE population.
Cardiac disorders Cardiac failure	1.3% 3/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Coronary artery disease	4.8% 11/227 • 5 years PTE population.	1.7% 4/232 • 5 years PTE population.
Cardiac disorders Extrasystoles	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Cardiac disorders Myocardial ischaemia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Sinus bradycardia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Ventricular extrasystoles	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Ear and labyrinth disorders Deafness unilateral	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Endocrine disorders Goitre	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Gastric ulcer	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Haemorrhoids	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Inguinal hernia	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Periodontal disease	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Adverse drug reaction	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
General disorders Mass	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
General disorders Non-cardiac chest pain	1.3% 3/227 • 5 years PTE population.	1.7% 4/232 • 5 years PTE population.
Infections and infestations Bronchitis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Gastroenteritis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Investigations Arteriogram coronary	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Investigations Blood glucose increased	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Investigations Physical examination	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Juvenile arthritis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glomus tumour	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignent	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Brain oedema	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Brain stem infarction	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Carotid artery stenosis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Cerebral artery occlusion	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Cerebral infarction	0.88% 2/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Nervous system disorders Lacunar infarction	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Parkinson's disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Syncope	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Renal and urinary disorders Nephrolithiasis	0.44% 1/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Renal and urinary disorders Renal disorder	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Renal and urinary disorders Renal failure chronic	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Cardiac disorders Ischaemic Cardiomyopathy	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Constipation	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Intestinal Polyp	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Pulmonary Tuberculosis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Cerebral Haemorrhage	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Ischaemic Stroke	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Neuromyelitis Optica	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Ear and labyrinth disorders Middle Ear Inflammation	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.

Other adverse events

Other adverse events
Measure	Absorb BVS System n=227 participants at risk Absorb BVS System: Subjects receiving Absorb BVS System	XIENCE V EECSS n=232 participants at risk XIENCE V EECSS: Subjects receiving XIENCE V
Gastrointestinal disorders Constipation	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Blood and lymphatic system disorders Anaemia	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Blood and lymphatic system disorders Leukopenia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Angina pectoris	12.3% 28/227 • 5 years PTE population.	6.9% 16/232 • 5 years PTE population.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Cardiac disorders Atrial fibrillation	0.88% 2/227 • 5 years PTE population.	1.3% 3/232 • 5 years PTE population.
Cardiac disorders Acute coronary syndrome	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Coronary artery dissection	1.8% 4/227 • 5 years PTE population.	2.2% 5/232 • 5 years PTE population.
Cardiac disorders Coronary artery stenosis	4.4% 10/227 • 5 years PTE population.	3.4% 8/232 • 5 years PTE population.
Cardiac disorders Coronary artery disease	5.3% 12/227 • 5 years PTE population.	1.7% 4/232 • 5 years PTE population.
Cardiac disorders Acute myocardial infarction	0.44% 1/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Cardiac disorders Cardiac disorder	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Cardiac failure	1.3% 3/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Myocardial infarction	1.8% 4/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Cardiac disorders Myocardial ischaemia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Palpitations	1.3% 3/227 • 5 years PTE population.	1.7% 4/232 • 5 years PTE population.
Cardiac disorders Extrasystoles	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Cardiac disorders Angina unstable	7.0% 16/227 • 5 years PTE population.	5.2% 12/232 • 5 years PTE population.
Cardiac disorders Ventricular arrhythmia	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Ear and labyrinth disorders Meniere's disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Eye disorders Cataract	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Aphthous stomatitis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Faeces discoloured	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Duodenal ulcer	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Enteritis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/227 • 5 years PTE population.	1.3% 3/232 • 5 years PTE population.
Gastrointestinal disorders Hematochezia	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Intestinal obstruction	0.88% 2/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Tooth socket haemorrhage	0.00% 0/227 • 5 years PTE population.	1.3% 3/232 • 5 years PTE population.
General disorders Application site haematoma	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
General disorders Catheter site haemorrhage	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
General disorders Chest discomfort	11.0% 25/227 • 5 years PTE population.	6.0% 14/232 • 5 years PTE population.
General disorders Non-cardiac chest pain	3.5% 8/227 • 5 years PTE population.	4.7% 11/232 • 5 years PTE population.
General disorders Chest pain	0.88% 2/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
General disorders Irritability	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
General disorders Drug resistance	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
General disorders Mass	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
General disorders Sensation of foreign body	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Hepatobiliary disorders Cholangitis acute	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Hepatobiliary disorders Bile duct stone	0.00% 0/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Hepatobiliary disorders Cholelithiasis	0.44% 1/227 • 5 years PTE population.	1.3% 3/232 • 5 years PTE population.
Immune system disorders Hypersensitivity	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Appendicitis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Bronchitis	0.88% 2/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Infections and infestations Gastroenteritis	1.8% 4/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Infections and infestations Lung infection	0.88% 2/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Infections and infestations Pneumonia	0.44% 1/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Infections and infestations Respiratory tract infection	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Coronary artery restenosis	4.0% 9/227 • 5 years PTE population.	4.7% 11/232 • 5 years PTE population.
Injury, poisoning and procedural complications Electric injury	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Injury, poisoning and procedural complications Joint injury	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Procedural vomiting	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Procedural hypotension	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Investigations Blood pressure increased	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Investigations Cardiac enzymes increased	4.4% 10/227 • 5 years PTE population.	3.9% 9/232 • 5 years PTE population.
Investigations Blood creatine phosphokinase MB increased	3.1% 7/227 • 5 years PTE population.	1.7% 4/232 • 5 years PTE population.
Investigations Blood creatine phosphokinase increased	2.2% 5/227 • 5 years PTE population.	1.7% 4/232 • 5 years PTE population.
Investigations Blood creatinine increased	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Investigations Troponin I increased	11.0% 25/227 • 5 years PTE population.	13.8% 32/232 • 5 years PTE population.
Investigations Troponin T increased	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Investigations Troponin increased	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Metabolism and nutrition disorders Diabetes mellitus	0.88% 2/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Metabolism and nutrition disorders Hyperglycemia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumor	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Aphasia	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Carotid artery disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Cerebral atrophy	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Cerebral hemorrhage	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Cerebrovascular disorder	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Dizziness	0.88% 2/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Nervous system disorders Brain oedema	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Subarachnoid hemorrhage	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Psychiatric disorders Anxiety disorder	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Renal and urinary disorders Haematuria	0.88% 2/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Renal and urinary disorders Calculus ureteric	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Cough	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Skin and subcutaneous tissue disorders Ecchymosis	0.88% 2/227 • 5 years PTE population.	1.3% 3/232 • 5 years PTE population.
Skin and subcutaneous tissue disorders Hemorrhage subcutaneous	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Skin and subcutaneous tissue disorders Rash	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Vascular disorders Hypertension	1.8% 4/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Vascular disorders Hypotension	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Vascular disorders Venous thrombosis limb	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Cardiac disorders Sinus bradycardia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Cardiac disorders Ventricular extrasystoles	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Ear and labyrinth disorders Deafness neurosensory	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Ear and labyrinth disorders Deafness unilateral	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Endocrine disorders Goitre	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Eye disorders Xerophthalmia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Eye disorders Conjunctival haemorrhage	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Gastric ulcer	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Gastritis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Gingivitis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Haemorrhoids	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Gastrointestinal disorders Inguinal hernia	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Periodontal disease	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Vomiting	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
General disorders Adverse drug reaction	0.00% 0/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
General disorders Pain	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
General disorders Oedema peripheral	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Hiccups	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Herpes virus infection	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Nasopharyngitis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Infections and infestations Rhinitis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Skin infection	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Infections and infestations Tracheitis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.44% 1/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Infections and infestations Vaginal infection	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Upper respiratory tract infection	1.3% 3/227 • 5 years PTE population.	1.3% 3/232 • 5 years PTE population.
Cardiac disorders Ischaemic Cardiomyopathy	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Contusion	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Fall	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Injury, poisoning and procedural complications Laceration	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Investigations Arteriogram coronary	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Investigations Blood glucose increased	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Investigations Physical examination	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Investigations Transaminases increased	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Metabolism and nutrition disorders Gout	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Metabolism and nutrition disorders Hypoproteinaemia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Arthralgia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Juvenile arthritis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glomus tumour	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Brain stem infarction	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Carotid artery stenosis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Nervous system disorders Cerebral artery occlusion	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Cerebral infarction	0.88% 2/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Nervous system disorders Hypoaesthesia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Lacunar infarction	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Parkinson's disease	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Syncope	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Psychiatric disorders Depression	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Renal and urinary disorders Nephrolithiasis	0.88% 2/227 • 5 years PTE population.	0.86% 2/232 • 5 years PTE population.
Renal and urinary disorders Renal disorder	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Renal and urinary disorders Renal failure chronic	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Reproductive system and breast disorders Breast pain	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Vascular disorders Aortic aneurysm	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Vascular disorders Hypertensive crisis	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Intestinal Polyp	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Infections and infestations Pulmonary Tuberculosis	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Ischaemic Stroke	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Nervous system disorders Neuromyelitis Optica	0.44% 1/227 • 5 years PTE population.	0.00% 0/232 • 5 years PTE population.
Ear and labyrinth disorders Middle Ear Inflammation	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/227 • 5 years PTE population.	0.43% 1/232 • 5 years PTE population.

Additional Information

Siok Hwee Tan

Abbott Vascular

Phone: +1 408-845-3581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60