SPIRIT III Clinical Trial of the XIENCE V® Everolimus Elu... | NCT00180479

Description Module

Detailed Description

The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).

The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 3.75 mm.

The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:

105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 2.25 mm and < 2.5 mm and lesion length <= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm
80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.75 mm and >= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm
105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.0 mm and < 4.25 mm and lesion length > 24 mm and < 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.
88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes >= 2.5 mm and <= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.

All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.

Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:

Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)

All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).

All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.

All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.

All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.

Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD >= 2.5 mm and <= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and <= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm and < 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and <= 4.25 mm) and 38 mm length stent (RVD > 3.0 mm and <= 4.25 mm and lesion length > 24 mm and <= 32 mm), respectively in the US.

A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.

Label	Type	Description	Intervention Names
1	Experimental	XIENCE V® Everolimus Eluting Coronary Stent System	Device: XIENCE V® Everolimus Eluting Coronary Stent
2	Active Comparator	TAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System	Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent

Name	Type	Description	Arm Group Labels	Other Names
XIENCE V® Everolimus Eluting Coronary Stent	Device	Drug eluting stent implantation stent in the treatment of coronary artery disease.	1

Measure	Description	Time Frame
Primary Endpoint: In-segment Late Loss (LL)	In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.	240 days

Measure	Description	Time Frame
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)	The composite endpoint comprised of: Cardiac death (death in which a cardiac cause cannot be excluded) Myocardial infarction (MI, classified as Q-wave and non-Q wave) Ischemia-driven target lesion revascularization (TLR) by CABG or PCI Ischemia-driven target vessel revascularization (TVR) by CABG or PCI	270 days

Eligibility Module

Name	Affiliation	Role
Gregg W Stone, MD	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Baptist Medical Center Princeton		Birmingham	Alabama	35211	United States
Baptist Health System - Montclair

PubMed Identifier	Type	Citation	Retractions
18430909	Result	Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
19171853

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
FG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Primary Endpoint: In-segment Late Loss (LL)

In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.

Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.

Posted

Mean

Standard Deviation

millimeters

240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000301 OG001134

Title

Denominators

Categories

Title	Measurements
	OG0000.14± 0.41 OG0010.28± 0.48

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Primary endpoint analyzed for intent-to-treat & per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.	t-test, 1 sided		<0.0001													Yes	Non-Inferiority or Equivalence	Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.

Secondary

Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

All patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Posted

Number

percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Target Vessel Failure (TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Target Vessel Failure (TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Target Vessel Failure (TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Target Vessel Failure (TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

Posted

Number

percentage of participants

2 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Target Vessel Failure (TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

Posted

Nov 2009

Number

percentage of participants

3 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Target Vessel Failure (TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

Posted

Nov 2009

Number

percentage of participants

4 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

Posted

Number

percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

Posted

Number

percentage of participants

1 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

Posted

Nov 2009

Number

percentage of participants

3 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

Posted

Nov 2009

Number

percentage of participants

4 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

4 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Major Adverse Cardiac Event (MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Event (MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Event (MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Number

percentage of participants

270 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Event (MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Event(MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Event (MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Nov 2009

Number

percentage of participants

3 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Ischemia Driven Major Adverse Cardiac Event (MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Nov 2009

Number

percentage of participants

4 year

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

In-stent % Angiographic Binary Restenosis (% ABR) Rate

Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)

Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.

Posted

Number

percentage of participants

at 240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

In-segment % Angiographic Binary Restenosis (% ABR) Rate

Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA

Posted

Number

percentage of participants

240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection

Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.

Persisting dissection @ follow-up, present post-procedure.

Posted

Number

percentage of participants

at 240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts

Secondary

Acute Success: Clinical Device

Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.

Posted

Number

percentage of participants

In-hospital

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Acute Success: Clinical Procedure

Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.

Posted

Number

percentage of participants

In-hospital

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Proximal Late Loss

Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)

Posted

Mean

Standard Deviation

millimeters

at 240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

Distal Late Loss

Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)

Posted

Mean

Standard Deviation

millimeters

240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

In-stent Late Loss

In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)

Posted

Mean

Standard Deviation

millimeters

at 240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

% Volume Obstruction (% VO)

Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.

Posted

Mean

Standard Deviation

percent of volume obstruction

at 240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

In-stent % Diameter Stenosis (% DS)

In-stent: Within the margins of the stent, the value calculated as 100 * (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Posted

Mean

Standard Deviation

percent diameter stenosis

at 240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Secondary

In-segment % Diameter Stenosis (% DS)

Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

Posted

Mean

Standard Deviation

percent of in-segment diameter stenosis

240 days

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Target Vessel Failure (TVF)

The composite endpoint comprised of:

Cardiac death (death in which a cardiac cause cannot be excluded)
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Ischemia-driven target vessel revascularization (TVR) by CABG or PCI

Posted

Nov 2009

Number

percentage of participants

5 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Lesion Revascularization (ID-TLR)

Revascularization @ target lesion associated w/ any of following:

Posted

Nov 2009

Number

percentage of participants

5 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Target Vessel Revascularization (ID-TVR)

Revascularization at the target vessel associated with any of the following

Positive functional ischemia study
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events

Posted

Number

percentage of participants

5 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants

Secondary

Ischemia Driven Major Adverse Cardiac Event (MACE)

The composite endpoint comprised of:

Cardiac death
Myocardial infarction (MI, classified as Q-wave and non-Q wave)
Ischemia-driven target lesion revascularization (TLR) by CABG or PCI

Posted

Nov 2009

Number

percentage of participants

5 years

ID	Title	Description
OG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
OG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected438 at risk EG0013 events3 affected211 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Abscess limb	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0002 events2 affected438 at risk EG0010 events0 affected211 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Acute psychosis	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Adverse drug reaction	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0012 events2 affected211 at risk
Agitation	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11	Systematic Assessment	EG0003 events1 affected438 at risk EG0016 events5 affected211 at risk
Angina pectoris	Cardiac disorders	MedDRA 11	Systematic Assessment	EG00051 events42 affected438 at risk EG00141 events37 affected211 at risk
Angina unstable	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0004 events4 affected438 at risk EG0012 events2 affected211 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Aortic aneurysm	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Aortic aneurysm repair	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Appendicitis perforated	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Arrhythmia	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0007 events6 affected438 at risk EG0014 events2 affected211 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Arteriogram coronary	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0012 events2 affected211 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Atherectomy	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected438 at risk EG0012 events2 affected211 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0002 events2 affected438 at risk EG0013 events3 affected211 at risk
Atrial flutter	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Blood creatinine increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0012 events2 affected211 at risk
Blood glucose increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected438 at risk EG0010 events0 affected211 at risk
Blood pressure decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Body temperature increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Bradycardia	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0002 events2 affected438 at risk EG0012 events2 affected211 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Breast lump removal	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Cardiac enzymes increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0012 events2 affected211 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0008 events6 affected438 at risk EG0017 events6 affected211 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0010 events0 affected211 at risk
Cardiac stress test abnormal	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0011 events1 affected211 at risk
Cardiorespiratory arrest	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0012 events2 affected211 at risk
Carotid artery stent insertion	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Carotid endarterectomy	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0010 events0 affected211 at risk
Catheter site haematoma	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected438 at risk EG0012 events2 affected211 at risk
Catheter site haemorrhage	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected438 at risk EG0012 events1 affected211 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Chest discomfort	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0013 events3 affected211 at risk
Chest pain	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0005 events5 affected438 at risk EG0011 events1 affected211 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 events2 affected438 at risk EG0011 events1 affected211 at risk
Colectomy	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Cor pulmonale	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0009 events9 affected438 at risk EG00110 events9 affected211 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected438 at risk EG0012 events2 affected211 at risk
Coronary artery bypass graft	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG00028 events10 affected438 at risk EG0015 events3 affected211 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0007 events7 affected438 at risk EG0010 events0 affected211 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0002 events2 affected438 at risk EG0011 events1 affected211 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0007 events7 affected438 at risk EG0013 events3 affected211 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG00094 events60 affected438 at risk EG00168 events43 affected211 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Dehydration	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Dementia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0011 events1 affected211 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Diverticulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0011 events1 affected211 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected438 at risk EG0010 events0 affected211 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0010 events0 affected211 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0013 events3 affected211 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Electrocardiogram abnormal	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Encephalopathy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected438 at risk EG0011 events1 affected211 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Gastrointestinal haemorrhage	Vascular disorders	MedDRA 11,0	Systematic Assessment	EG0006 events6 affected438 at risk EG0014 events4 affected211 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0012 events2 affected211 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Haemoglobin decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Hernia obstructive	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0013 events3 affected211 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0012 events2 affected211 at risk
Hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected438 at risk EG0012 events2 affected211 at risk
Iliact artery stenosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Implantable defibrillator malfunction	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Implantable defibrillator replacement	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Instent coronary artery restenosis	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 11	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00011 events11 affected438 at risk EG00110 events10 affected211 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00027 events25 affected438 at risk EG00115 events12 affected211 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Noncardiac chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG00020 events16 affected438 at risk EG00114 events11 affected211 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0010 events0 affected211 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Osteomyelitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0010 events0 affected211 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected438 at risk EG0013 events3 affected211 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0013 events3 affected211 at risk
Phlebitis superficial	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Physical disability	Social circumstances	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0006 events6 affected438 at risk EG0011 events1 affected211 at risk
Pneumonia fungal	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Prostatectomy	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Pyrexia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Renal artery stent placement	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Renal disorder	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0014 events2 affected211 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0014 events1 affected211 at risk
Respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Retroperitoneal haemorrhage	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected438 at risk EG0010 events0 affected211 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0011 events1 affected211 at risk
Spinal operation	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0012 events2 affected211 at risk
Staphylococcal infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0012 events1 affected211 at risk
Syncope	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 events5 affected438 at risk EG0012 events2 affected211 at risk
Tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Thrombectomy	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11	Systematic Assessment	EG0002 events1 affected438 at risk EG0010 events0 affected211 at risk
Thrombosis in device	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected438 at risk EG0011 events1 affected211 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0012 events2 affected211 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Urosepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Vascular pseudoaneurysm	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected438 at risk EG0013 events3 affected211 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected438 at risk EG0011 events1 affected211 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0010 events0 affected211 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected438 at risk EG0012 events2 affected211 at risk

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

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

ID	Title	Description
BG000	XIENCE V® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System
BG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
BG002	Total	Total of all reporting 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® EECSS	XIENCE V® Everolimus Eluting Coronary Stent System			219		71
EG001	TAXUS® EXPRESS2™ ECSS	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.			126		55

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG00093 events71 affected438 at risk EG00144 events35 affected211 at risk
Catheter site haematoma	General disorders	MedDRA	Systematic Assessment	EG00012 events12 affected438 at risk EG00111 events11 affected211 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events7 affected438 at risk EG00111 events11 affected211 at risk