Trial Outcomes & Findings for SPIRIT Small Vessel Registry (NCT NCT00783796)

NCT ID: NCT00783796

Last Updated: 2019-05-08

Results Overview

This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-05-08

Participant Flow

150 subjects were recruited at 33 sites from the general interventional cardiology population. Dates of recruitment: 12/08/08 through 11/04/09.

Subjects were screened for study eligibility by a member of the study team. Subjects meeting eligibility criteria were asked to sign an informed consent form. Pre-procedure angiography was used for final assessment of eligibility.

Participant milestones

Measure	2.25mm XIENCE V® Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Overall Study STARTED	150
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	2.25mm XIENCE V® Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Overall Study Did not receive any stent	4
Overall Study Received non-XIENCE V stent	1
Overall Study Received commercial XIENCE V stent	1

Baseline Characteristics

SPIRIT Small Vessel Registry

Baseline characteristics by cohort

Measure	2.25mm XIENCE V® n=150 Participants Patients receiving the 2.25 mm XIENCE V® stent
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants
Age, Categorical >=65 years	65 Participants n=5 Participants
Age, Continuous	62.97 years STANDARD_DEVIATION 10.59 • n=5 Participants
Sex/Gender, Customized Female	57 participants n=5 Participants
Sex/Gender, Customized Male	92 participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).	8.1 Percentage of Participants

PRIMARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).	8.3 Percentage of Participants

PRIMARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).	12.1 Percentage of Participants

SECONDARY outcome

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

Population: Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects

Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.

Outcome measures

Measure	2.25mm XIENCE V® n=149 Lesions Patients receiving the 2.25 mm XIENCE V® stent
Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)	95.21 Percentage of Lesions

SECONDARY outcome

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

Population: Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.

Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.

Outcome measures

Measure	2.25mm XIENCE V® n=145 Participants Patients receiving the 2.25 mm XIENCE V® stent
Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)	97.93 Percentage of Participants

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.

Outcome measures

Measure	2.25mm XIENCE V® n=52 Participants Patients receiving the 2.25 mm XIENCE V® stent
In-Stent Late Loss	0.20 Millimeters Standard Deviation 0.40

SECONDARY outcome

Timeframe: 240 Days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.

Outcome measures

Measure	2.25mm XIENCE V® n=52 Participants Patients receiving the 2.25 mm XIENCE V® stent
In-segment Late Loss (LL)	0.16 Millimeters Standard Deviation 0.41

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).

Outcome measures

Measure	2.25mm XIENCE V® n=34 Participants Patients receiving the 2.25 mm XIENCE V® stent
Proximal Late Loss	0.21 Millimeter Standard Deviation 0.35

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).

Outcome measures

Measure	2.25mm XIENCE V® n=45 Participants Patients receiving the 2.25 mm XIENCE V® stent
Distal Late Loss	0.00 Millimeter Standard Deviation 0.28

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.

Outcome measures

Measure	2.25mm XIENCE V® n=52 Participants Patients receiving the 2.25 mm XIENCE V® stent
In-stent % Diameter Stenosis	12.86 Percentage Standard Deviation 19.58

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.

Outcome measures

Measure	2.25mm XIENCE V® n=52 Participants Patients receiving the 2.25 mm XIENCE V® stent
In-segment % Diameter Stenosis	20.85 Percentage Standard Deviation 22.53

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.

Outcome measures

Measure	2.25mm XIENCE V® n=37 Participants Patients receiving the 2.25 mm XIENCE V® stent
Proximal % Diameter Stenosis	14.31 Percentage Standard Deviation 13.16

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.

Outcome measures

Measure	2.25mm XIENCE V® n=46 Participants Patients receiving the 2.25 mm XIENCE V® stent
Distal % Diameter Stenosis	10.4 Percentage Standard Deviation 8.45

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.

Outcome measures

Measure	2.25mm XIENCE V® n=52 Participants Patients receiving the 2.25 mm XIENCE V® stent
In-stent Angiographic Binary Restenosis (ABR) Rate	3.8 Percentage of Participants Interval 0.47 to 13.21

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.

Outcome measures

Measure	2.25mm XIENCE V® n=52 Participants Patients receiving the 2.25 mm XIENCE V® stent
In-segment Angiographic Binary Restenosis (ABR) Rate	9.6 Percentage of Participants Interval 3.2 to 21.03

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.

Outcome measures

Measure	2.25mm XIENCE V® n=37 Participants Patients receiving the 2.25 mm XIENCE V® stent
Proximal Angiographic Binary Restenosis (ABR) Rate	2.7 Percentage of Participants Interval 0.07 to 14.16

SECONDARY outcome

Timeframe: 240 days

Population: Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.

Outcome measures

Measure	2.25mm XIENCE V® n=46 Participants Patients receiving the 2.25 mm XIENCE V® stent
Distal Angiographic Binary Restenosis (ABR) Rate	0.0 Percentage of Participants Interval 0.0 to 7.71

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death (Cardiac, Vascular, Non-cardiovascular)	0.7 Percentage of Participants Interval 0.02 to 3.81

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death (Cardiac, Vascular, Non-cardiovascular)	1.4 Percentage of Participants Interval 0.17 to 5.1

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death (Cardiac, Vascular, Non-cardiovascular)	1.5 Percentage of Participants Interval 0.18 to 5.21

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

All death, including death from cardiac, vascular, and non-cardiovascular causes.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death (Cardiac, Vascular, Non-cardiovascular)	1.5 percentage of participants Interval 0.18 to 5.33

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death (Cardiac, Vascular, Non-cardiovascular)	3.8 percentage of participants Interval 1.24 to 8.62

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)	1.4 Percentage of Participants Interval 0.17 to 4.93

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)	1.4 Percentage of Participants Interval 0.17 to 5.1

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)	1.5 Percentage of Participants Interval 0.18 to 5.21

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)	1.5 percentage of participants Interval 0.18 to 5.33

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)	1.5 percentage of participants Interval 0.18 to 5.37

SECONDARY outcome

Timeframe: 0 to 1 day (Acute)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=142 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: greater than 1 day to 30 days (Subacute)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=140 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	0.7 Percentage of Participants

SECONDARY outcome

Timeframe: 31 days - 393 days (Late)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=135 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	1.5 Percentage of Participants

SECONDARY outcome

Timeframe: >1 year (Very late)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=130 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: 394 - 758 days (Very Late)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=129 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: 394 - 1123 days (Very Late)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=128 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	0.78 Percentage of Participants

SECONDARY outcome

Timeframe: Overall (0 - 393 days)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=138 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	2.17 Percentage of Participants

SECONDARY outcome

Timeframe: Overall (0 - 758 days)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=131 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	2.29 Percentage of Participants

SECONDARY outcome

Timeframe: Overall (0 - 1123 days)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=130 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (ARC Defined)	3.08 Percentage of Participants

SECONDARY outcome

Timeframe: 0 to 1 day (Acute)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=142 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: > 1 day to 30 days (Subacute)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=140 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	0.7 Percentage of Participants

SECONDARY outcome

Timeframe: 31 days to 393 days (Late)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=135 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	1.5 Percentage of Participants

SECONDARY outcome

Timeframe: 31 - 758 days (Late)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=130 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	1.5 Percentage of Participants

SECONDARY outcome

Timeframe: 31 - 1123 days (Late)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=129 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	2.3 Percentage of Participants

SECONDARY outcome

Timeframe: Overall (0 - 393 days)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=138 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	2.2 percentage of participants

SECONDARY outcome

Timeframe: Overall (0 - 758 days)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	2.27 percentage of participants

SECONDARY outcome

Timeframe: Overall (0 - 1123 days)

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

Outcome measures

Measure	2.25mm XIENCE V® n=130 Participants Patients receiving the 2.25 mm XIENCE V® stent
Stent Thrombosis (Protocol Defined)	3.1 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death/ All MI/All Coronary Revascularization	3.5 Percentage of Participants Interval 1.14 to 7.92

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death/ All MI/All Coronary Revascularization	15.1 Percentage of Participants Interval 9.6 to 22.16

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death/ All MI/All Coronary Revascularization	16.9 Percentage of Participants Interval 11.03 to 24.29

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death/ All MI/All Coronary Revascularization	22.6 percentage of participants Interval 15.77 to 30.61

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Death/ All MI/All Coronary Revascularization	26.5 percentage of participants Interval 19.21 to 34.9

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/ All MI /CI-TLR	2.1 Percentage of Participants Interval 0.43 to 5.97

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/ All MI /CI-TLR	7.2 Percentage of Participants Interval 3.5 to 12.83

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/ All MI /CI-TLR	8.1 Percentage of Participants Interval 4.11 to 14.01

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/ All MI /CI-TLR	8.3 percentage of participants Interval 4.2 to 14.32

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/ All MI /CI-TLR	12.1 percentage of participants Interval 7.09 to 18.94

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/MI	2.1 Percentage of Participants Interval 0.43 to 5.97

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/MI	2.9 Percentage of Participants Interval 0.79 to 7.2

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/MI	2.9 Percentage of Participants Interval 0.81 to 7.36

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/MI	3.0 percentage of participants Interval 0.83 to 7.52

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Cardiac Death/MI	5.3 percentage of participants Interval 2.16 to 10.62

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Coronary Revascularization (TVR and Non-TVR)	2.1 Percentage of Participants Interval 0.43 to 5.97

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Coronary Revascularization (TVR and Non-TVR)	12.9 Percentage of Participants Interval 7.86 to 19.69

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Coronary Revascularization (TVR and Non-TVR)	14.7 Percentage of Participants Interval 9.22 to 21.79

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Coronary Revascularization (TVR and Non-TVR)	20.3 percentage of participants Interval 13.83 to 28.14

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
All Coronary Revascularization (TVR and Non-TVR)	23.5 percentage of participants Interval 16.55 to 31.65

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TVR (CI and Non-CI)	1.4 Percentage of Participants Interval 0.17 to 4.93

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TVR (CI and Non-CI)	8.6 Percentage of Participants Interval 4.54 to 14.59

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TVR (CI and Non-CI)	10.3 Percentage of Participants Interval 5.74 to 16.67

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TVR (CI and Non-CI)	11.3 percentage of participants Interval 6.45 to 17.92

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TVR (CI and Non-CI)	13.6 percentage of participants Interval 8.29 to 20.69

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TLR (CI and Non-CI)	0.7 Percentage of Participants Interval 0.02 to 3.81

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TLR (CI and Non-CI)	5.8 Percentage of Participants Interval 2.52 to 11.03

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TLR (CI and Non-CI)	6.6 Percentage of Participants Interval 3.07 to 12.19

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TLR (CI and Non-CI)	6.8 percentage of participants Interval 3.14 to 12.46

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
All TLR (CI and Non-CI)	8.3 percentage of participants Interval 4.23 to 14.42

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Vessel Revascularization (TVR)	1.4 Percentage of Participants Interval 0.17 to 4.93

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Vessel Revascularization	7.2 Percentage of Participants Interval 3.5 to 12.83

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Vessel Revascularization	8.8 Percentage of Participants Interval 4.64 to 14.91

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Vessel Revascularization	9.8 percentage of participants Interval 5.31 to 16.13

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Vessel Revascularization	12.1 percentage of participants Interval 7.09 to 18.94

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Lesion Revascularization (CI-TLR)	0.0 Percentage of Participants Interval 0.0 to 2.53

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Lesion Revascularization (CI-TLR)	4.3 Percentage of Participants Interval 1.6 to 9.16

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Lesion Revascularization (CI-TLR)	5.1 Percentage of Participants Interval 2.09 to 10.32

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Lesion Revascularization (CI-TLR)	5.3 percentage of participants Interval 2.14 to 10.54

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Clinically Indicated Target Lesion Revascularization (CI-TLR)	6.8 percentage of participants Interval 3.16 to 12.55

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 Percentage of Participants Interval 0.0 to 2.53

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 Percentage of Participants Interval 0.0 to 2.62

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 Percentage of Participants Interval 0.0 to 2.68

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 percentage of participants Interval 0.0 to 2.74

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

Outcome measures

Measure	2.25mm XIENCE V® n=132 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)	0.0 percentage of participants Interval 0.0 to 2.76

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)	6.3 Percentage of Participants Interval 2.9 to 11.53

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)	6.5 Percentage of Participants Interval 3.0 to 11.94

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)	6.6 Percentage of Participants Interval 3.07 to 12.19

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=134 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)	6.7 percentage of participants Interval 3.12 to 12.37

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)	7.5 percentage of participants Interval 3.66 to 13.39

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=144 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	0.0 Percentage of participants Interval 0.0 to 2.53

SECONDARY outcome

Timeframe: 240 days

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=139 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	1.4 Percentage of participants Interval 0.17 to 5.1

SECONDARY outcome

Timeframe: 1 year

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=136 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	1.5 Percentage of participants Interval 0.18 to 5.21

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=134 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	1.5 percentage of participants Interval 0.18 to 5.29

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Outcome measures

Measure	2.25mm XIENCE V® n=133 Participants Patients receiving the 2.25 mm XIENCE V® stent
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)	4.5 percentage of participants Interval 1.67 to 9.56

Adverse Events

2.25mm XIENCE V®

Serious events: 79 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Measure	2.25mm XIENCE V® n=139 participants at risk Patients receiving the 2.25 mm XIENCE V® stent
Nervous system disorders Post-traumatic headache	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Blood and lymphatic system disorders Deficiency anaemia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Blood and lymphatic system disorders Thrombocytopenia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Acute coronary syndrome	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Acute myocardial infarction	3.6% 5/139 • Number of events 5 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Angina pectoris	19.4% 27/139 • Number of events 33 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Angina unstable	5.8% 8/139 • Number of events 8 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Aortic valve stenosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Arteriosclerosis coronary artery	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Atrial fibrillation	4.3% 6/139 • Number of events 8 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Atrial flutter	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Atrial thrombosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Atrioventricular block second degree	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Bradycardia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Bundle branch block right	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Cardiac failure congestive	2.9% 4/139 • Number of events 5 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Cardiac tamponade	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Cardiomyopathy	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Coronary artery disease	4.3% 6/139 • Number of events 7 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Coronary artery dissection	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Coronary artery perforation	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Coronary artery stenosis	4.3% 6/139 • Number of events 6 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Myocardial ischaemia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Sick sinus syndrome	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Cardiac disorders Ventricular tachycardia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Ear and labyrinth disorders Vestibular disorder	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Eye disorders Blindness	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Gastrointestinal disorders Abdominal pain	0.72% 1/139 • Number of events 4 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Gastrointestinal disorders Dysphagia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Gastrointestinal disorders Nausea	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Gastrointestinal disorders Pancreatitis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Gastrointestinal disorders Rectal haemorrhage	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Gastrointestinal disorders Vomiting	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
General disorders Asthenia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
General disorders Catheter site haematoma	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
General disorders Catheter site haemorrhage	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
General disorders Non-cardiac chest pain	4.3% 6/139 • Number of events 11 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Immune system disorders Sarcoidosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Appendicitis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Beta haemolytic streptococcal infection	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Bronchitis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Lobar pneumonia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Pneumonia	2.2% 3/139 • Number of events 3 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Pyelonephritis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Upper respiratory tract infection	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Urinary tract infection	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Infections and infestations Wound infection staphylococcal	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Injury, poisoning and procedural complications Ankle fracture	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	3.6% 5/139 • Number of events 6 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Injury, poisoning and procedural complications Mechanical complication of implant	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Injury, poisoning and procedural complications Traumatic brain injury	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Investigations Cardiac enzymes increased	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Metabolism and nutrition disorders Hyperglycaemia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Metabolism and nutrition disorders Hypoglycaemia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Metabolism and nutrition disorders Hyponatraemia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Arthritis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Back pain	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Costochondritis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.2% 3/139 • Number of events 3 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Cerebellar infarction	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Cerebrovascular accident	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Convulsion	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Dementia Alzheimer's type	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Dizziness	0.72% 1/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Encephalopathy	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Headache	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Hypertensive encephalopathy	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Intracranial aneurysm	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Lacunar infarction	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Migraine	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Presyncope	1.4% 2/139 • Number of events 3 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Syncope	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Transient ischaemic attack	2.9% 4/139 • Number of events 4 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Vertigo	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Psychiatric disorders Mental status changes	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Psychiatric disorders Suicidal ideation	0.72% 1/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Renal and urinary disorders Calculus bladder	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Renal and urinary disorders Haematuria	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Renal and urinary disorders Renal failure	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Renal and urinary disorders Renal failure acute	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Renal and urinary disorders Renal mass	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Skin and subcutaneous tissue disorders Rash	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Surgical and medical procedures Cardiac ablation	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Surgical and medical procedures Surgery	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Aortic aneurysm	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Arteriosclerosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Carotid arteriosclerosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Carotid artery disease	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Carotid artery occlusion	1.4% 2/139 • Number of events 2 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Deep vein thrombosis	1.4% 2/139 • Number of events 3 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Gastric ulcer haemorrhage	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Hypertensive emergency	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Intestinal haemorrhage	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Renal artery stenosis	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Vascular pseudoaneurysm	0.72% 1/139 • Number of events 1 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.

Other adverse events

Measure	2.25mm XIENCE V® n=139 participants at risk Patients receiving the 2.25 mm XIENCE V® stent
Cardiac disorders Angina pectoris	28.1% 39/139 • Number of events 50 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.0% 7/139 • Number of events 7 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
General disorders Fatigue	6.5% 9/139 • Number of events 10 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
General disorders Non-cardiac chest pain	18.0% 25/139 • Number of events 30 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Back pain	12.2% 17/139 • Number of events 17 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Musculoskeletal and connective tissue disorders Myalgia	5.0% 7/139 • Number of events 8 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Nervous system disorders Dizziness	9.4% 13/139 • Number of events 15 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.1% 14/139 • Number of events 16 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Contusion	5.0% 7/139 • Number of events 8 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Vascular disorders Hypertension	5.0% 7/139 • Number of events 7 • 0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device. The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.

Additional Information

David R Rutledge

Abbott Vascular

Phone: (408) 845-3820

Email: david.rutledge@av.abbott.com

Results disclosure agreements

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

Restriction type: GT60