Trial Outcomes & Findings for XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT) (NCT NCT01178268)

Results Overview

This is the primary angiographic endpoint. In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

546 participants

Primary outcome timeframe

>=13 months

Results posted on

2016-08-24

Participant Flow

A total of 488 patients in the Per-protocol (PP) population for final analysis. First Patient Enrolled on August 18, 2010, Last Patient Enrolled on August 31, 2011 and the Final Database Lock was on September 26, 2013. The total patient enrollment rate was 0.5 patients/site/week based on 489 patients enrolled over 54 weeks at 20 sites.

All of the 546 patients, 57 (28:XIENCE;29:CYPHER)were excluded from the Per-protocol (PP) population, leaving a baseline population of 489 patients. Whereas because of patient disposition results in a total of 488 patients in the PP population for final analysis.

Participant milestones

Participant milestones
Measure	XIENCE V EECSS Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Overall Study STARTED	367	121
Overall Study COMPLETED	360	120
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.	Total n=488 Participants Total of all reporting groups
Age, Continuous	58.60 years STANDARD_DEVIATION 10.65 • n=5 Participants	58.74 years STANDARD_DEVIATION 9.12 • n=7 Participants	58.64 years STANDARD_DEVIATION 10.28 • n=5 Participants
Age, Customized Age ≥ 65 years	95 participants n=5 Participants	33 participants n=7 Participants	128 participants n=5 Participants
Age, Customized Age < 65 years	272 participants n=5 Participants	88 participants n=7 Participants	360 participants n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	40 Participants n=7 Participants	135 Participants n=5 Participants
Sex: Female, Male Male	272 Participants n=5 Participants	81 Participants n=7 Participants	353 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	367 participants n=5 Participants	121 participants n=7 Participants	488 participants n=5 Participants
Region of Enrollment China	367 participants n=5 Participants	121 participants n=7 Participants	488 participants n=5 Participants

PRIMARY outcome

Timeframe: >=13 months

Population: The number of participants with angiographic follow up available was analysed.

This is the primary angiographic endpoint. In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=279 Lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
In-stent Late Loss (LL)	0.19 Millimeter Standard Deviation 0.28	0.21 Millimeter Standard Deviation 0.28

PRIMARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Vessel Failure (ID-TVF)	4.4 percentage of participants Interval 2.51 to 6.98	6.6 percentage of participants Interval 2.9 to 12.61

PRIMARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)	1.6 percentage of participants Interval 0.6 to 3.52	1.7 percentage of participants Interval 0.2 to 5.84

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\])

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Vessel Failure (ID-TVF)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\]).

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Vessel Failure (ID-TVF)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\])

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Vessel Failure (ID-TVF)	1.4 percentage of participants	3.3 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV \[PCI and CABG\])

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Vessel Failure (ID-TVF)	4.7 percentage of participants	7.4 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)	1.4 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)	1.9 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

The is the major Secondary Efficacy Endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])	1.9 percentage of participants Interval 0.77 to 3.89	3.3 percentage of participants Interval 0.91 to 8.25

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Lesion Failure (ID-TLF)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Lesion Failure (ID-TLF)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoints.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Lesion Failure (ID-TLF)	1.4 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoints.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Lesion Failure (ID-TLF)	3.5 percentage of participants	5.0 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoints.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Ischemia-driven Target Lesion Failure (ID-TLF)	3.9 percentage of participants	5.0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)	1.4 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)	1.6 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)	1.7 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	1.1 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	1.6 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	2.2 percentage of participants	5.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	6.3 percentage of participants	10.7 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization \[(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) \[Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)\].

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)	8.5 percentage of participants	11.6 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI	1.4 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI	1.6 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI	1.9 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)	1.4 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)	3.5 percentage of participants	5.0 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)	3.9 percentage of participants	5.0 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Revascularization (TLR, TVR, and Non-TVR)	0.3 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 Months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Revascularization (TLR, TVR, and Non-TVR)	0.5 percentage of participants	1.7 percentage of participants

SECONDARY outcome

Timeframe: 9 Months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Revascularization (TLR, TVR, and Non-TVR)	0.8 percentage of participants	3.3 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Revascularization (TLR, TVR, and Non-TVR)	4.6 percentage of participants	9.1 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Revascularization (TLR, TVR, and Non-TVR)	6.6 percentage of participants	9.9 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death	0.3 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death	0.5 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death	0.5 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Death	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Protocol MI (Including Q-wave or Non-Q-wave)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Protocol MI (Including Q-wave or Non-Q-wave)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Protocol MI (Including Q-wave or Non-Q-wave)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Protocol MI (Including Q-wave or Non-Q-wave)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Protocol MI (Including Q-wave or Non-Q-wave)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Target Vessel Protocol MI (TV-MI)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Target Vessel Protocol MI (TV-MI)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Target Vessel Protocol MI (TV-MI)	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Target Vessel Protocol MI (TV-MI)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

This is one of the secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=363 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Target Vessel Protocol MI (TV-MI)	1.1 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Bleeding Complications	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Bleeding Complications	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

Secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=366 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Bleeding Complications	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

Secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=365 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Bleeding Complications	0.5 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Secondary safety endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=360 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=120 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Major Bleeding Complications	0.8 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Acute (<1 day)

Population: The number of participants with angiographic follow up available was analysed.

Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Definite / Probable Stent Thrombosis	0.27 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Subacute (1 - 30 days)

Population: The number of participants with angiographic follow up available was analysed.

Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Definite / Probable Stent Thrombosis	0.27 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Early (0 - 30 days)

Population: The number of participants with angiographic follow up available was analysed.

Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Definite / Probable Stent Thrombosis	0.54 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Late (31 - 365 days)

Population: The number of participants with angiographic follow up available was analysed.

Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Definite / Probable Stent Thrombosis	0.00 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Very late (366 - 772 days)

Population: The number of participants with angiographic follow up available was analysed.

Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Definite / Probable Stent Thrombosis	0.00 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Overall (0 - 772 days)

Population: The number of participants with angiographic follow up available was analysed.

Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Definite / Probable Stent Thrombosis	0.54 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=362 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Patient Compliance With Dual Antiplatelet Therapy (DAPT)	99.2 percentage of participants	99.2 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=362 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Patient Compliance With Dual Antiplatelet Therapy (DAPT)	99.2 percentage of participants	97.5 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=362 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Patient Compliance With Dual Antiplatelet Therapy (DAPT)	98.1 percentage of participants	95.9 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=362 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Patient Compliance With Dual Antiplatelet Therapy (DAPT)	94.5 percentage of participants	93.4 percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=362 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Patient Compliance With Dual Antiplatelet Therapy (DAPT)	58.0 percentage of participants	55.4 percentage of participants

SECONDARY outcome

Timeframe: < or = 1 day

Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of \< 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=399 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=129 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Acute Device Success	97.2 percentage of participants	98.4 percentage of participants

SECONDARY outcome

Timeframe: < or = 1 day

Per-protocol procedure success is defined as the achievement of a final in-stent DS of \< 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Acute Procedure Success	98.1 percentage of participants	99.2 percentage of participants

SECONDARY outcome

Timeframe: On day 0, during the procedure.

This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Procedure Time	29.6 Minutes Standard Deviation 19.3	28.6 Minutes Standard Deviation 15.8

SECONDARY outcome

Timeframe: On day 0, during the procedure.

Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Amount of Contrast Used	132.1 Milliliter Standard Deviation 53.2	145.4 Milliliter Standard Deviation 59.2

SECONDARY outcome

Timeframe: On day 0, during the procedure.

This is the procedure related endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=121 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Fluoroscopy Time	7.0 Minutes Standard Deviation 4.7	7.4 Minutes Standard Deviation 4.7

SECONDARY outcome

Timeframe: During the procedure

A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=367 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire	93.2 percentage of participants	—

SECONDARY outcome

Timeframe: ≥13 months.

Population: The number of participants with angiographic follow up available was analysed.

This is one of the Secondary Angiographic Endpoint.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=279 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Follow-up Late Loss In-Segment	0.15 Millimeter Standard Deviation 0.35	0.27 Millimeter Standard Deviation 0.35
Follow-up Late Loss Proximal	0.20 Millimeter Standard Deviation 0.34	0.33 Millimeter Standard Deviation 0.39
Follow-up Late Loss Distal	0.11 Millimeter Standard Deviation 0.32	0.20 Millimeter Standard Deviation 0.33

SECONDARY outcome

Timeframe: ≥13 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=280 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Follow-up In-stent Minimum Lumen Diameter (MLD)	2.62 Millimeter Standard Deviation 0.50	2.63 Millimeter Standard Deviation 0.48

SECONDARY outcome

Timeframe: ≥13 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=280 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Follow-up In-stent Percent Diameter Stenosis (DS)	10.56 percent Diameter stenosis Standard Deviation 10.18	11.82 percent Diameter stenosis Standard Deviation 10.30

SECONDARY outcome

Timeframe: ≥13 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=280 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Follow-up In-stent Angiographic Binary Restenosis (ABR)	1.1 percentage of participants	1.0 percentage of participants

SECONDARY outcome

Timeframe: ≥13 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=280 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Follow-up In-segment Minimum Lumen Diameter (MLD)	2.34 Millimeter Standard Deviation 0.52	2.33 Millimeter Standard Deviation 0.50

SECONDARY outcome

Timeframe: ≥13 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=280 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Follow-up In-segment Percent Diameter Stenosis (DS)	16.79 percent Diameter stenosis Standard Deviation 12.36	18.79 percent Diameter stenosis Standard Deviation 12.42

SECONDARY outcome

Timeframe: ≥13 months

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=280 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=98 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Follow-up In-segment Angiographic Binary Restenosis (ABR)	2.1 percentage of participants	3.1 percentage of participants

SECONDARY outcome

Timeframe: pre procedure

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=398 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=129 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Percent Diameter Stenosis	64.97 percent Diameter stenosis Standard Deviation 11.90	64.95 percent Diameter stenosis Standard Deviation 12.01

SECONDARY outcome

Timeframe: post procedure on 0 day

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=398 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=129 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Percent Diameter Stenosis (%DS) in-stent %DS	8.09 Percent Diameter stenosis Standard Deviation 6.31	8.56 Percent Diameter stenosis Standard Deviation 5.78
Percent Diameter Stenosis (%DS) in-segment %DS	14.40 Percent Diameter stenosis Standard Deviation 8.09	12.46 Percent Diameter stenosis Standard Deviation 7.41

SECONDARY outcome

Timeframe: post procedure on 0 day

Population: The number of participants with angiographic follow up available was analysed.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=398 Target lesions Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=129 Target lesions Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Acute Gain In-Stent	1.79 Millimeter Standard Deviation 0.44	1.77 Millimeter Standard Deviation 0.43
Acute Gain In-Segment	1.48 Millimeter Standard Deviation 0.49	1.52 Millimeter Standard Deviation 0.44
Acute Gain Proximal	2.03 Millimeter Standard Deviation 0.53	2.06 Millimeter Standard Deviation 0.49
Acute Gain Distal	1.54 Millimeter Standard Deviation 0.54	1.60 Millimeter Standard Deviation 0.51

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

ID-TVF rate in All Diabetes patients.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=87 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=29 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TVF Rate in Patients With Diabetic Disease	5.7 percentage of participants	13.8 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

ID-TVF rate in Non Diabetes

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=272 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=91 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TVF Rate in Patients Without Diabetic Disease	4.4 percentage of participants	5.5 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

ID-TVF rate in Patients with single lesion treated during the index procedure

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=332 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=113 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TVF Rate in Single Lesion Treated Subgroup	4.8 percentage of participants	7.1 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

ID-TVF rate in Patients with dual lesion treated during the index procedure

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=30 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=8 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TVF Rate in Dual Lesion Treated Subgroup	3.3 percentage of participants	12.5 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

ID-TVF rate in Patients with single vessels treated during the index procedure.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=339 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=114 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TVF Rate in Single Vessel Treated Subgroup	4.7 percentage of participants	7.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

ID-TVF rate in Patients with dual vessel treated during the index procedure.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=24 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=7 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TVF Rate in Dual Vessel Treated Subgroup	4.2 percentage of participants	14.3 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

The composite of ST, all death, and all MI rate in All Diabetes patients.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=87 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=29 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.	1.1 percentage of participants	3.4 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

The composite of ST, all death, and all MI rate in Non Diabetes

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=272 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=91 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease	2.2 percentage of participants	1.1 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=332 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=113 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup	1.8 percentage of participants	1.8 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=30 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=8 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup	3.3 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=339 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=114 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup	1.8 percentage of participants	1.8 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=24 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=7 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup	4.2 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Ischemia-driven target lesion revascularization rate in All Diabetes patients.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=87 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=29 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TLR Rate in Patients With Diabetic Disease.	3.4 percentage of participants	3.4 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Ischemia-driven target lesion revascularization rate in Non Diabetes

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=272 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=91 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TLR Rate in Patients Without Diabetic Disease	1.8 percentage of participants	3.3 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=332 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=113 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TLR Rate in Single Lesion Treated Subgroup	2.4 percentage of participants	2.7 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=30 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=8 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TLR Rate in Dual Lesion Treated Subgroup	0.00 percentage of participants	12.5 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=339 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=114 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TLR Rate in Single Vessel Treated Subgroup	2.4 percentage of participants	2.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The number of participants with angiographic follow up available was analysed.

Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.

Outcome measures

Outcome measures
Measure	XIENCE V EECSS n=24 Participants Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=7 Participants Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
ID-TLR Rate in Dual Vessel Treated Subgroup	0.0 percentage of participants	14.3 percentage of participants

Adverse Events

XIENCE V EECSS

Serious events: 53 serious events

Other events: 32 other events

Deaths: 0 deaths

CYPHER SELECT PLUS SECSS

Serious events: 24 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	XIENCE V EECSS n=360 participants at risk Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=120 participants at risk Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Cardiac disorders Angina	1.9% 7/360 • Number of events 8 • 2 Years	2.5% 3/120 • Number of events 3 • 2 Years
Cardiac disorders Arrhythmia	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Atrioventricular Block (AVB)	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
General disorders Chest Pain	0.83% 3/360 • Number of events 3 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Investigations Creatine kinase MB (CK-MB) increased	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Coronary Artery Disease	0.28% 1/360 • Number of events 1 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Cardiac disorders Coronary Dissection	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Coronary Heart Disease	0.28% 1/360 • Number of events 1 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
General disorders Death	0.83% 3/360 • Number of events 3 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Fibrillation Atrial	0.56% 2/360 • Number of events 2 • 2 Years	0.00% 0/120 • 2 Years
Gastrointestinal disorders Gastric Ulcer With Bleeding	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Gastrointestinal disorders Gastrointestinal Bleeding	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Hear Failure	0.28% 1/360 • Number of events 1 • 2 Years	1.7% 2/120 • Number of events 3 • 2 Years
Gastrointestinal disorders Melena	0.56% 2/360 • Number of events 2 • 2 Years	0.00% 0/120 • 2 Years
Surgical and medical procedures Non-Targeted Vessel Revascularization	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Surgical and medical procedures Restenosis	0.83% 3/360 • Number of events 3 • 2 Years	2.5% 3/120 • Number of events 4 • 2 Years
Surgical and medical procedures Revascularization	2.5% 9/360 • Number of events 9 • 2 Years	0.00% 0/120 • 2 Years
Nervous system disorders Subarachnoid Hemorrhage	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Nervous system disorders Syncope	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Surgical and medical procedures Target Lesion Revascularization	0.56% 2/360 • Number of events 2 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Surgical and medical procedures Non-Target Vascular Stenosis	0.56% 2/360 • Number of events 2 • 2 Years	0.00% 0/120 • 2 Years
Blood and lymphatic system disorders Thrombocytopenic Purpura	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Respiratory, thoracic and mediastinal disorders Respiratory Fail, Chronic Bronchitis	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Unstable Angina	1.1% 4/360 • Number of events 5 • 2 Years	2.5% 3/120 • Number of events 3 • 2 Years
Gastrointestinal disorders Upper Gastrointestinal Bleeding	0.28% 1/360 • Number of events 1 • 2 Years	1.7% 2/120 • Number of events 2 • 2 Years
Vascular disorders Vascular Stenosis	0.28% 1/360 • Number of events 1 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Cardiac disorders Extrasystole; Fibrillation Atrial	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 2 • 2 Years
Cardiac disorders Coronary heart disease (CHD), Coronary Revascularization	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver Cancer	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Cardiac disorders Paroxysmal Atrial Fibrillation	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 3 • 2 Years
Surgical and medical procedures Target Vessel Revasculization	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Surgical and medical procedures Non-Target Vessel Restenosis	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years

Other adverse events

Other adverse events
Measure	XIENCE V EECSS n=360 participants at risk Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	CYPHER SELECT PLUS SECSS n=120 participants at risk Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Cardiac disorders Angina	0.28% 1/360 • Number of events 1 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
General disorders Chest Distress Because Of Air Pollution	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
General disorders Chest Distress Occasionally	0.28% 1/360 • Number of events 1 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
General disorders Chest Pain Happens More Frequently	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
General disorders Chest Tightness	0.28% 1/360 • Number of events 1 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Investigations Creatine kinase-MB (CK-MB0 Increase	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Coronary Artery Disease	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Investigations Cardiac troponin T increased (cTnI)	1.7% 6/360 • Number of events 6 • 2 Years	1.7% 2/120 • Number of events 2 • 2 Years
Investigations Cardiac troponin T of Post-Procedure Increased	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Gastrointestinal disorders Melena	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Cardiac disorders Myocardial infarction (MI)	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Surgical and medical procedures Peri-procedural PCI and MI	0.56% 2/360 • Number of events 2 • 2 Years	0.00% 0/120 • 2 Years
General disorders Premature Beat	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Investigations The Cardiac Enzyme Is Higher	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Investigations Abnormal troponin I (TnI)	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Investigations Troponin I (TnI) Increase	1.4% 5/360 • Number of events 5 • 2 Years	1.7% 2/120 • Number of events 2 • 2 Years
Investigations Troponin I (TnI) Increase Significantly	0.56% 2/360 • Number of events 2 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Investigations Troponin I (TnI) Of Post Procedure Increased	0.56% 2/360 • Number of events 2 • 2 Years	1.7% 2/120 • Number of events 2 • 2 Years
Investigations Troponin T (TnT) of Post Procedure Increased	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
Surgical and medical procedures Vessel Interlayer	0.28% 1/360 • Number of events 1 • 2 Years	0.00% 0/120 • 2 Years
General disorders Breathing Difficulty	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Surgical and medical procedures Complication of percutaneous coronary intervention (PCI) Procedure	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Gastrointestinal disorders Gastrorrhagia	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years
Respiratory, thoracic and mediastinal disorders Nasal Bleeding	0.00% 0/360 • 2 Years	0.83% 1/120 • Number of events 1 • 2 Years

Additional Information

Dana Haudek

Abbott Vascular

Phone: 928-925-4054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place