XIENCE V: SPIRIT WOMEN Sub-study | NCT01182428

NCT01182428

Status Module

Description Module

Label	Type	Description	Intervention Names
XIENCE V® / XIENCE PRIME™	Experimental		Device: XIENCE V®/ XIENCE PRIME™
CYPHER SELECT	Active Comparator		Device: CYPHER SELECT

Name	Type	Description	Arm Group Labels	Other Names
XIENCE V®/ XIENCE PRIME™	Device	Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System	XIENCE V® / XIENCE PRIME™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).	This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.	at 1 year
In-stent Late Loss (LL) (Main Secondary Endpoint)	In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.	at 270 days

Secondary Outcomes

Measure	Description	Time Frame
Clinical Device Success	Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.	Intra-operative
Clinical Procedure Success

Eligibility Module

Eligibility Criteria

General Inclusion Criteria:

Patient must be female.
Patient must be at least 18 years of age.
Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Patient must agree to undergo all protocol-required follow-up examinations.
Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.

Angiographic Inclusion Criteria:

Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents.
Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).
Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
Target lesion greater than or equal to 28 mm in length by visual estimate.

General Exclusion Criteria:

Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)

Name	Affiliation	Role
Marie-Claude Morice	Institut Cardiovasculaire Paris Sud (ICPS), Paris, France	Principal Investigator
Stephan Windecker	University Hospital Bern, Bern, Switzerland	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hosital Italiano de Buenos Aires - Cardiologia		Buenos Aires	Buenos Aires	1181	Argentina
Instituto Cardiovascular de Buenos Aires-ICBA

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19072483	Background	Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.
28796809	Derived	Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
FG001	CYPHER® SELECT

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.37± 10.14 BG00169.85± 10.54 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000304 BG001151 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Spain

Title	Measurements
	BG00024 BG00113 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).

This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 1 year

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000293 OG001150

Title

Denominators

Categories

Title	Measurements
	OG00021.5(16.94 to 26.65) OG00122(15.65 to 29.49)

Secondary

Clinical Device Success

Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.

Based on Intent to Treat (ITT) population.

Posted

Number

95% Confidence Interval

Percentage of evaluated lesions

Intra-operative

Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Clinical Procedure Success

Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.

Based on Intent to Treat (ITT) population.

Posted

Number

95% Confidence Interval

Percentage of Participants

Intra-operative

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Stent Thrombosis (Definite, Probable)

Based on Intent to Treat (ITT) population.

Posted

Number

95% Confidence Interval

Percentage of Participants

< 1 day (Acute)

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Stent Thrombosis (Definite, Probable)

Based on Intent to Treat (ITT) population.

Posted

Number

95% Confidence Interval

Percentage of Participants

1 to 30 days (Sub-Acute)

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Stent Thrombosis (Definite, Probable)

Based on Intent to Treat (ITT) population. Population change based on follow up timeframe.

Posted

Number

95% Confidence Interval

Percentage of Participants

30 days to 1 year (Late)

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Stent Thrombosis (Definite, Probable, Possible)

Based on Intent to Treat (ITT) population.

Posted

Number

95% Confidence Interval

Percentage of Participants

30 days to 1 year (Late)

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 30 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 240 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 1 year

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 30 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 240 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Primary

In-stent Late Loss (LL) (Main Secondary Endpoint)

In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.

The angiographic analysis population may be than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.

Posted

Mean

Standard Deviation

millimeters

at 270 days

Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 30 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 240 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 1 year

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 30 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 240 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 1 year

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

In-segment Late Loss (LL)

LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up

The angiographic analysis population may be less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.

Posted

Mean

Standard Deviation

millimeters

at 270 days

Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

In-stent Angiographic Binary Restenosis Rates

Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).

The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.

Posted

Number

95% Confidence Interval

Percentage of Target Lesions

at 270 days

Target Lesion

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants

Secondary

In-segment Angiographic Binary Restenosis Rates

Posted

Number

95% Confidence Interval

Percentage of target lesions

at 270 days

Target Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants

Secondary

In-stent Percent Diameter Stenosis

Posted

Mean

Standard Deviation

% diameter stenosis

at 270 days

Target Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

In-segment Percent Diameter Stenosis

Posted

Mean

Standard Deviation

% diameter stenosis

at 270 days

Target Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Revascularization (TLR/TVR/All Revascularizations)

Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 30 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Revascularization (TLR/TVR/All Revascularizations)

Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 240 days

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Adjudicated Revascularization (TLR/TVR/All Revascularizations)

Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of Participants

at 1 year

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Aneurysm

All subjects with aneurysm of the target lesion up to the 270 day follow-up visit

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

% of target lesions with aneurysm

at 270 days

Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Thrombus

All subjects with thrombus of the target lesion up to the 270 day follow-up visit

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of evaluated lesions

at 270 days

Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Secondary

Persisting Dissection

All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit

Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

95% Confidence Interval

Percentage of evaluated lesions

at 270 days

Lesions

Participants

ID	Title	Description
OG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
OG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.			120	304	39	297
EG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.			61	151	11	149

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG00110 events4 affected149 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected149 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00044 events38 affected297 at risk EG00110 events8 affected149 at risk
Angina unstable	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0009 events8 affected297 at risk EG0012 events2 affected149 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Atrial flutter	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 events2 affected297 at risk EG0010 events0 affected149 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Cardiac failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected297 at risk EG0012 events2 affected149 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected297 at risk EG0016 events6 affected149 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected297 at risk EG0013 events3 affected149 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Palpitations	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Pericardial effusion	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Deafness	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Diplopia	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Ileus	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Melaena	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Periodontitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Catheter site haematoma	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected297 at risk EG0011 events1 affected149 at risk
Catheter site haemorrhage	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Chest discomfort	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 events2 affected297 at risk EG0011 events1 affected149 at risk
Non-cardiac chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0013 events3 affected149 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Hypersensitivity	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected149 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Cystitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Diverticulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Localised infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected149 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected149 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected297 at risk EG0016 events6 affected149 at risk
Nephropathy toxic	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Reperfusion injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Thrombosis in device	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Biopsy breast	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Haemoglobin decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Troponin increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected297 at risk EG0010 events0 affected149 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Cerebral infarction	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events1 affected297 at risk EG0010 events0 affected149 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected297 at risk EG0011 events1 affected149 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Paresis	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Syncope	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0011 events1 affected149 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected149 at risk
Vascular dementia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Renal colic	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected297 at risk EG0011 events1 affected149 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Arterial stent insertion	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Cardiac pacemaker battery replacement	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Cataract operation	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected149 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events2 affected149 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected297 at risk EG0012 events2 affected149 at risk
Scar excision	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Aortic aneurysm	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Arterial stenosis limb	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Duodenal ulcer haemorrhage	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Gastric haemorrhage	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Gastrointestinal haemorrhage	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected297 at risk EG0011 events1 affected149 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Hypertensive crisis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0012 events1 affected149 at risk
Intermittent claudication	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected297 at risk EG0010 events0 affected149 at risk
Lymphoedema	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Rectal haemorrhage	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Retroperitoneal hematoma	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected297 at risk EG0010 events0 affected149 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected297 at risk EG0011 events1 affected149 at risk
Vascular pseudoaneurysm	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected297 at risk EG0010 events0 affected149 at risk
Cardiac enzymes increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected297 at risk EG0014 events4 affected149 at risk

ID	Term
D023921	Coronary Stenosis
D003324	Coronary Artery Disease
D023903	Coronary Restenosis
D014652	Vascular Diseases
D017202	Myocardial Ischemia

ID	Term
D003327	Coronary Disease
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

ID	Title	Description
BG000	XIENCE V® / XIENCE PRIME®	Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
BG001	CYPHER® SELECT	Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
BG002	Total	Total of all reporting groups