SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00180479
• Collaborator: (none)
• Enrollment: 1,002
• Locations: 65
• Arms: 2
• Duration (Months): 77
• Patients Per Site: 15.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is divided into 5 arms:

1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System

2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS

3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS

4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS

5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan

The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.

Condition or Disease	Intervention/Treatment	Phase
Stents; Coronary Artery Disease; Total Coronary Occlusion; Coronary Artery Restenosis; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis	Device: XIENCE V® Everolimus Eluting Coronary Stent; Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent	Phase 3

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:

1. 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

2. 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

3. 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.

4. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1002 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 XIENCE V® Everolimus Eluting Coronary Stent System	Device: XIENCE V® Everolimus Eluting Coronary Stent; Drug eluting stent implantation stent in the treatment of coronary artery disease.; Other Names: XIENCE V® Everolimus Eluting Coronary Stent System
Active Comparator: 2 TAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System	Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent; Drug eluting stent implantation stent in the treatment of coronary artery disease.; Other Names: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Outcome Measures

Primary Outcome Measures

1. Primary Endpoint: In-segment Late Loss (LL) [240 days]

   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.

Secondary Outcome Measures

1. Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [270 days]

   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

2. Target Vessel Failure (TVF) [30 days]

   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

3. Target Vessel Failure (TVF) [180 days]

   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

4. Target Vessel Failure (TVF) [1 year]

   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

5. Target Vessel Failure (TVF) [2 year]

   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

6. Target Vessel Failure (TVF) [3 year]

   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

7. Target Vessel Failure (TVF) [4 year]

   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

8. Ischemia Driven Target Lesion Revascularization (ID-TLR) [30 days]

   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

9. Ischemia Driven Target Lesion Revascularization (ID-TLR) [180 days]

   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

10. Ischemia Driven Target Lesion Revascularization (ID-TLR) [270 days]

    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

11. Ischemia Driven Target Lesion Revascularization (ID-TLR) [1 years]

    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

12. Ischemia Driven Target Lesion Revascularization (ID-TLR) [2 years]

    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

13. Ischemia Driven Target Lesion Revascularization (ID-TLR) [3 year]

    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

14. Ischemia Driven Target Lesion Revascularization (ID-TLR) [4 year]

    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

15. Ischemia Driven Target Vessel Revascularization (ID-TVR) [30 days]

    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

16. Ischemia Driven Target Vessel Revascularization (ID-TVR) [180 days]

    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

17. Ischemia Driven Target Vessel Revascularization (ID-TVR) [270 days]

    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

18. Ischemia Driven Target Vessel Revascularization (ID-TVR) [1 year]

    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

19. Ischemia Driven Target Vessel Revascularization (ID-TVR) [2 years]

    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

20. Ischemia Driven Target Vessel Revascularization (ID-TVR) [3 years]

    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

21. Ischemia Driven Target Vessel Revascularization (ID-TVR) [4 years]

    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

22. Ischemia Driven Major Adverse Cardiac Event (MACE) [30 days]

    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

23. Ischemia Driven Major Adverse Cardiac Event (MACE) [180 days]

    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

24. Ischemia Driven Major Adverse Cardiac Event (MACE) [270 days]

    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

25. Ischemia Driven Major Adverse Cardiac Event (MACE) [1 year]

    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

26. Ischemia Driven Major Adverse Cardiac Event(MACE) [2 years]

    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

27. Ischemia Driven Major Adverse Cardiac Event (MACE) [3 year]

    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

28. Ischemia Driven Major Adverse Cardiac Event (MACE) [4 year]

    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

29. In-stent % Angiographic Binary Restenosis (% ABR) Rate [at 240 days]

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

30. In-segment % Angiographic Binary Restenosis (% ABR) Rate [240 days]

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

31. Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection [at 240 days]

    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.

32. Acute Success: Clinical Device [In-hospital]

    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%.

33. Acute Success: Clinical Procedure [In-hospital]

    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%.

34. Proximal Late Loss [at 240 days]

    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)

35. Distal Late Loss [240 days]

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

36. In-stent Late Loss [at 240 days]

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

37. % Volume Obstruction (% VO) [at 240 days]

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

38. In-stent % Diameter Stenosis (% DS) [at 240 days]

    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.

39. In-segment % Diameter Stenosis (% DS) [240 days]

    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.

40. Target Vessel Failure (TVF) [5 years]

    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

41. Ischemia Driven Target Lesion Revascularization (ID-TLR) [5 years]

    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

42. Ischemia Driven Target Vessel Revascularization (ID-TVR) [5 years]

    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

43. Ischemia Driven Major Adverse Cardiac Event (MACE) [5 years]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm

• The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1

• Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)

Exclusion Criteria:

• Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft

• Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation

• Located in a major epicardial vessel that has been previously treated with brachytherapy

• Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure

• Total occlusion (TIMI flow 0), prior to wire passing

• The target vessel contains thrombus

• Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center Princeton	Birmingham	Alabama	United States	35211
2	Baptist Health System - Montclair	Birmingham	Alabama	United States	35213
3	Arizona Heart Hospital	Phoenix	Arizona	United States	85016
4	Scripps Memorial Hospital	La Jolla	California	United States	92037
5	Good Samaritan Hospital	Los Angeles	California	United States	87106
6	Alta Bates Summit Medical Center	Oakland	California	United States	94609
7	Mercy General Hospital	Sacramento	California	United States	95819
8	Poudre Valley Hospital	Fort Collins	Colorado	United States	80528
9	Washington Hospital Center	Washington	District of Columbia	United States	20010
10	Holy Cross Medical Center (prev. North Ridge MC)	Fort Lauderdale	Florida	United States	33308
11	Baptist Hospital of Miami	Miami	Florida	United States	33176
12	Emory Crawford Long Hospital	Atlanta	Georgia	United States	30308
13	Piedmont Hospital	Atlanta	Georgia	United States	30309
14	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
15	Rush University Medical Center	Chicago	Illinois	United States	60612
16	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60148
17	St. John's Hospital	Springfield	Illinois	United States	62701
18	The Heart Center of IN, LLC	Indianapolis	Indiana	United States	46290
19	Jewish Hospital	Louisville	Kentucky	United States	40202
20	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
21	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
22	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912
23	St. Joseph Medical Center	Towson	Maryland	United States	21204
24	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
25	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
26	St John Hospital & Medical Center	Detroit	Michigan	United States	48236
27	Spectrum Health Hospital	Grand Rapids	Michigan	United States	49503
28	Borgess Medical Center	Kalamazoo	Michigan	United States	49048
29	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
30	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
31	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
32	St. Luke's Hospital	Kansas City	Missouri	United States	64111
33	Barnes Jewish Hospital	St. Louis	Missouri	United States	63110
34	St. Patrick Hospital	Missoula	Montana	United States	59802
35	Nebraska Heart Hospital	Lincoln	Nebraska	United States	68526
36	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
37	Hackensack Medical Center	Hackensack	New Jersey	United States	07601
38	The Valley Hospital	Ridgewood	New Jersey	United States	07450
39	Presbyterian Hospital	Albuquerque	New Mexico	United States	28204
40	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
41	Columbia University Medical Center	New York	New York	United States	10032
42	St. Joseph's Hospital Health Center	Syracuse	New York	United States	13203
43	Presbyterian Hospital	Charlotte	North Carolina	United States	87106
44	Duke University Medical Center	Durham	North Carolina	United States	27710
45	Wake Medical Center	Raleigh	North Carolina	United States	27610
46	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
47	The Christ Hospital	Cincinnati	Ohio	United States	45219
48	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
49	EMH Regional Medical Center	Elyria	Ohio	United States	44035
50	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
51	Integris Baptist Medical, Inc.	Oklahoma City	Oklahoma	United States	73112
52	Sacred Heart Medical Center	Eugene	Oregon	United States	97401
53	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
54	Pinnacle Health @ Harrisburg Hospital	Harrisburg	Pennsylvania	United States	17043
55	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
56	Rhode Island Hospital	Providence	Rhode Island	United States	02903
57	The Miriam Hospital	Providence	Rhode Island	United States	02906
58	Medical University of South Carolina	Charleston	South Carolina	United States	29403
59	Heart Hospital of Austin	Austin	Texas	United States	78756
60	Medical City Dallas Hospital	Dallas	Texas	United States	75230
61	Methodist Hospital	Houston	Texas	United States	77030
62	TexSan Heart Hospital	San Antonio	Texas	United States	78215
63	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
64	Swedish Medical Center	Seattle	Washington	United States	98104
65	St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Gregg W Stone, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00180479
• Other Study ID Numbers: 03-360
• First Posted: Sep 16, 2005
• Last Update Posted: Nov 23, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Abbott Medical Devices: Everolimus
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Thrombosis; Vascular Diseases; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia; Paclitaxel; Albumin-Bound Paclitaxel; Everolimus

Study Results

Participant Flow

Recruitment Details	1002 subjects were recruited at 65 sites. Eligible subjects invited to participate either in-hospital or in-clinic prior to first procedure and required to provide signed informed consent prior to enrollment. Final eligibility based on angiogram before the intended procedure. Dates of recruitment: 6/22/05 through 3/15/06.
Pre-assignment Detail	Subjects were randomized via telephone randomization and stratified by single and dual lesion/vessel treatment, diabetes mellitus status, and study sites. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Period Title: Overall Study
STARTED	669	333
COMPLETED	653	320
NOT COMPLETED	16	13

Baseline Characteristics

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS	Total
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.	Total of all reporting groups
Overall Participants	669	333	1002
Age (participants) [Number]
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	376 56.2%	191 57.4%	567 56.6%
>=65 years	293 43.8%	141 42.3%	434 43.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.23 (10.53)	62.80 (10.24)	63.08 (10.43)
Gender (participants) [Number]
Female	200 29.9%	114 34.2%	314 31.3%
Male	469 70.1%	218 65.5%	687 68.6%
Region of Enrollment (participants) [Number]
United States	669 100%	333 100%	1002 100%

Outcome Measures

1. Primary Outcome

Title	Primary Endpoint: In-segment Late Loss (LL)
Description	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.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	301	134
Mean (Standard Deviation) [millimeters]	0.14 (0.41)	0.28 (0.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XIENCE V® EECSS, TAXUS® EXPRESS2™ ECSS
	Comments	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.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	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.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

Title	Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
Description	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
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	657	321
Number [percentage of participants]	7.2 1.1%	9.0 2.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	XIENCE V® EECSS, TAXUS® EXPRESS2™ ECSS
	Comments	Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments

3. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	667	330
Number [percentage of participants]	1.6 0.2%	3.3 1%

4. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	664	326
Number [percentage of participants]	4.1 0.6%	5.5 1.7%

5. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	654	319
Number [percentage of participants]	8.6 1.3%	11.6 3.5%

6. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	637	305
Number [percentage of participants]	11.3 1.7%	16.4 4.9%

7. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	629	305
Number [percentage of participants]	14.3 2.1%	20.0 6%

8. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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
Time Frame	4 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	615	302
Number [percentage of participants]	18.5 2.8%	22.5 6.8%

9. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	667	330
Number [percentage of participants]	0.4 0.1%	0.3 0.1%

10. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	664	326
Number [percentage of participants]	1.5 0.2%	2.1 0.6%

11. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	659	320
Number [percentage of participants]	2.7 0.4%	5.0 1.5%

12. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	1 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	654	319
Number [percentage of participants]	3.4 0.5%	5.6 1.7%

13. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	637	305
Number [percentage of participants]	5.7 0.9%	9.2 2.8%

14. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	629	305
Number [percentage of participants]	5.7 0.9%	9.2 2.8%

15. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	4 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	615	302
Number [percentage of participants]	8.0 1.2%	10.6 3.2%

16. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	667	330
Number [percentage of participants]	0.3 0%	0.9 0.3%

17. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	664	326
Number [percentage of participants]	1.2 0.2%	1.8 0.5%

18. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	659	320
Number [percentage of participants]	2.9 0.4%	4.1 1.2%

19. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	654	319
Number [percentage of participants]	3.1 0.5%	4.7 1.4%

20. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	637	305
Number [percentage of participants]	4.9 0.7%	6.6 2%

21. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	629	305
Number [percentage of participants]	6.7 1%	8.9 2.7%

22. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	615	302
Number [percentage of participants]	7.8 1.2%	9.6 2.9%

23. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	667	330
Number [percentage of participants]	1.3 0.2%	3.0 0.9%

24. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Description	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
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	664	326
Number [percentage of participants]	2.9 0.4%	5.2 1.6%

25. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Description	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
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	659	320
Number [percentage of participants]	5.0 0.7%	8.8 2.6%

26. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Description	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
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	654	319
Number [percentage of participants]	6.0 0.9%	10.3 3.1%

27. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event(MACE)
Description	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
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	637	305
Number [percentage of participants]	7.7 1.2%	13.8 4.1%

28. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Description	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
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	629	305
Number [percentage of participants]	9.7 1.4%	16.4 4.9%

29. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Description	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
Time Frame	4 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	615	302
Number [percentage of participants]	12.8 1.9%	18.5 5.6%

30. Secondary Outcome

Title	In-stent % Angiographic Binary Restenosis (% ABR) Rate
Description	Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
Time Frame	at 240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	343	158
Number [percentage of participants]	2.3 0.3%	5.7 1.7%

31. Secondary Outcome

Title	In-segment % Angiographic Binary Restenosis (% ABR) Rate
Description	Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	344	158
Number [percentage of participants]	4.7 0.7%	8.9 2.7%

32. Secondary Outcome

Title	Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
Description	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.
Time Frame	at 240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	90	43
Number [percentage of participants]	24.4 3.6%	14.0 4.2%

33. Secondary Outcome

Title	Acute Success: Clinical Device
Description	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%.
Time Frame	In-hospital

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	763	379
Number [percentage of participants]	98.3 14.7%	98.7 29.6%

34. Secondary Outcome

Title	Acute Success: Clinical Procedure
Description	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%.
Time Frame	In-hospital

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	661	331
Number [percentage of participants]	98.5 14.7%	97.3 29.2%

35. Secondary Outcome

Title	Proximal Late Loss
Description	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)
Time Frame	at 240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	293	134
Mean (Standard Deviation) [millimeters]	0.12 (0.40)	0.20 (0.41)

36. Secondary Outcome

Title	Distal Late Loss
Description	Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	327	154
Mean (Standard Deviation) [millimeters]	0.09 (0.36)	0.10 (0.37)

37. Secondary Outcome

Title	In-stent Late Loss
Description	In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)
Time Frame	at 240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	342	158
Mean (Standard Deviation) [millimeters]	0.16 (0.41)	0.30 (0.53)

38. Secondary Outcome

Title	% Volume Obstruction (% VO)
Description	Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.
Time Frame	at 240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	98	39
Mean (Standard Deviation) [percent of volume obstruction]	6.91 (6.35)	11.21 (9.86)

39. Secondary Outcome

Title	In-stent % Diameter Stenosis (% DS)
Description	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.
Time Frame	at 240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	343	158
Mean (Standard Deviation) [percent diameter stenosis]	5.92 (16.40)	10.30 (21.43)

40. Secondary Outcome

Title	In-segment % Diameter Stenosis (% DS)
Description	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.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	344	158
Mean (Standard Deviation) [percent of in-segment diameter stenosis]	18.77 (14.43)	22.82 (16.35)

41. Secondary Outcome

Title	Target Vessel Failure (TVF)
Description	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
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	605	286
Number [percentage of participants]	20.3 3%	26.6 8%

42. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	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
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	605	286
Number [percentage of participants]	8.9 1.3%	12.9 3.9%

43. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	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
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	605	286
Number [percentage of participants]	8.8 1.3%	11.9 3.6%

44. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Event (MACE)
Description	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
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	XIENCE V® EECSS	TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System	TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
Measure Participants	605	286
Number [percentage of participants]	14.4 2.2%	22.0 6.6%

Adverse Events

Arm/Group Title	XIENCE V® EECSS		TAXUS® EXPRESS2™ ECSS
Arm/Group Description	XIENCE V® Everolimus Eluting Coronary Stent System		TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
All Cause Mortality
	XIENCE V® EECSS		TAXUS® EXPRESS2™ ECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	XIENCE V® EECSS		TAXUS® EXPRESS2™ ECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	219/ (NaN)		126/ (NaN)
Blood and lymphatic system disorders
Anaemia	1/438 (0.2%)	3	5/211 (2.4%)	6
Thrombocytopenia	1/438 (0.2%)	2	0/211 (0%)	0
Cardiac disorders
Acute coronary syndrome	2/438 (0.5%)	2	0/211 (0%)	0
Acute myocardial infarction	1/438 (0.2%)	1	1/211 (0.5%)	1
Angina pectoris	42/438 (9.6%)	51	37/211 (17.5%)	41
Angina unstable	4/438 (0.9%)	4	2/211 (0.9%)	2
Arrhythmia	6/438 (1.4%)	7	2/211 (0.9%)	4
Arteriospasm coronary	0/438 (0%)	0	1/211 (0.5%)	1
Atrial fibrillation	2/438 (0.5%)	2	3/211 (1.4%)	3
Atrial flutter	0/438 (0%)	0	1/211 (0.5%)	1
Atrioventricular block first degree	1/438 (0.2%)	1	1/211 (0.5%)	1
Bradycardia	2/438 (0.5%)	2	2/211 (0.9%)	2
Cardiac failure congestive	6/438 (1.4%)	8	6/211 (2.8%)	7
Cardiorespiratory arrest	1/438 (0.2%)	1	0/211 (0%)	0
Chest pain	5/438 (1.1%)	5	1/211 (0.5%)	1
Cor pulmonale	0/438 (0%)	0	1/211 (0.5%)	1
Coronary artery disease	7/438 (1.6%)	7	0/211 (0%)	0
Coronary artery dissection	1/438 (0.2%)	1	1/211 (0.5%)	1
Coronary artery occlusion	2/438 (0.5%)	2	1/211 (0.5%)	1
Coronary artery stenosis	7/438 (1.6%)	7	3/211 (1.4%)	3
Coronary artery thrombosis	0/438 (0%)	0	1/211 (0.5%)	1
Diastolic dysfunction	0/438 (0%)	0	1/211 (0.5%)	1
Instent coronary artery restenosis	1/438 (0.2%)	1	1/211 (0.5%)	1
Ischaemic cardiomyopathy	0/438 (0%)	0	1/211 (0.5%)	1
Mitral valve incompetence	1/438 (0.2%)	1	0/211 (0%)	0
Myocardial infarction	11/438 (2.5%)	11	10/211 (4.7%)	10
Myocardial ischaemia	25/438 (5.7%)	27	12/211 (5.7%)	15
Sick sinus syndrome	1/438 (0.2%)	1	0/211 (0%)	0
Supraventricular tachycardia	0/438 (0%)	0	1/211 (0.5%)	2
Tachycardia	0/438 (0%)	0	1/211 (0.5%)	1
Tachycardia paroxysmal	1/438 (0.2%)	1	0/211 (0%)	0
Ventricular fibrillation	1/438 (0.2%)	1	0/211 (0%)	0
Ventricular tachycardia	0/438 (0%)	0	1/211 (0.5%)	1
Ear and labyrinth disorders
Vertigo	1/438 (0.2%)	1	0/211 (0%)	0
Gastrointestinal disorders
Abdominal pain	4/438 (0.9%)	4	3/211 (1.4%)	3
Abdominal pain lower	0/438 (0%)	0	1/211 (0.5%)	1
Abdominal pain upper	1/438 (0.2%)	1	0/211 (0%)	0
Appendicitis perforated	0/438 (0%)	0	1/211 (0.5%)	1
Colonic obstruction	1/438 (0.2%)	1	0/211 (0%)	0
Colonic polyp	0/438 (0%)	0	1/211 (0.5%)	1
Diarrhoea	2/438 (0.5%)	2	1/211 (0.5%)	1
Dyspepsia	2/438 (0.5%)	2	0/211 (0%)	0
Gastric ulcer	1/438 (0.2%)	1	1/211 (0.5%)	1
Gastritis erosive	0/438 (0%)	0	1/211 (0.5%)	1
Gastroenteritis	0/438 (0%)	0	1/211 (0.5%)	1
Gastrooesophageal reflux disease	0/438 (0%)	0	2/211 (0.9%)	2
Hiatus hernia	1/438 (0.2%)	1	0/211 (0%)	0
Impaired gastric emptying	0/438 (0%)	0	1/211 (0.5%)	1
Nausea	0/438 (0%)	0	1/211 (0.5%)	1
Pancreatitis	2/438 (0.5%)	2	0/211 (0%)	0
Pyrexia	1/438 (0.2%)	1	0/211 (0%)	0
Small intestinal obstruction	1/438 (0.2%)	1	1/211 (0.5%)	1
Upper gastrointestinal haemorrhage	1/438 (0.2%)	1	0/211 (0%)	0
Vomiting	1/438 (0.2%)	1	2/211 (0.9%)	2
General disorders
Adverse drug reaction	0/438 (0%)	0	2/211 (0.9%)	2
Catheter site haematoma	3/438 (0.7%)	3	2/211 (0.9%)	2
Catheter site haemorrhage	0/438 (0%)	0	1/211 (0.5%)	1
Chest discomfort	2/438 (0.5%)	2	3/211 (1.4%)	3
Fatigue	1/438 (0.2%)	1	0/211 (0%)	0
Hernia obstructive	0/438 (0%)	0	1/211 (0.5%)	1
Noncardiac chest pain	16/438 (3.7%)	20	11/211 (5.2%)	14
Pain	1/438 (0.2%)	1	0/211 (0%)	0
Hepatobiliary disorders
Cholecystitis	1/438 (0.2%)	1	1/211 (0.5%)	1
Cholecystitis acute	1/438 (0.2%)	1	0/211 (0%)	0
Gallbladder disorder	1/438 (0.2%)	1	1/211 (0.5%)	1
Infections and infestations
Abscess limb	1/438 (0.2%)	1	0/211 (0%)	0
Cellulitis	0/438 (0%)	0	1/211 (0.5%)	1
Diverticulitis	2/438 (0.5%)	2	1/211 (0.5%)	1
Gastroenteritis viral	0/438 (0%)	0	1/211 (0.5%)	1
Osteomyelitis	1/438 (0.2%)	1	0/211 (0%)	0
Pneumonia	6/438 (1.4%)	6	1/211 (0.5%)	1
Pneumonia fungal	1/438 (0.2%)	1	0/211 (0%)	0
Respiratory tract infection	0/438 (0%)	0	1/211 (0.5%)	1
Staphylococcal infection	1/438 (0.2%)	1	0/211 (0%)	0
Urinary tract infection	1/438 (0.2%)	1	0/211 (0%)	0
Urosepsis	0/438 (0%)	0	1/211 (0.5%)	1
Injury, poisoning and procedural complications
Brain contusion	0/438 (0%)	0	1/211 (0.5%)	1
Contusion	1/438 (0.2%)	1	0/211 (0%)	0
Device dislocation	1/438 (0.2%)	1	0/211 (0%)	0
Fall	3/438 (0.7%)	3	1/211 (0.5%)	1
Fracture	0/438 (0%)	0	1/211 (0.5%)	1
Hip fracture	0/438 (0%)	0	1/211 (0.5%)	1
Implantable defibrillator malfunction	0/438 (0%)	0	1/211 (0.5%)	1
Injury	0/438 (0%)	0	1/211 (0.5%)	1
Operative haemorrhage	1/438 (0.2%)	1	0/211 (0%)	0
Overdose	0/438 (0%)	0	1/211 (0.5%)	1
Road traffic accident	1/438 (0.2%)	1	0/211 (0%)	0
Skin laceration	1/438 (0.2%)	1	0/211 (0%)	0
Thrombosis in device	1/438 (0.2%)	1	0/211 (0%)	0
Investigations
Arteriogram coronary	2/438 (0.5%)	2	2/211 (0.9%)	2
Blood creatinine increased	0/438 (0%)	0	2/211 (0.9%)	2
Blood glucose increased	3/438 (0.7%)	3	0/211 (0%)	0
Blood pressure decreased	1/438 (0.2%)	1	0/211 (0%)	0
Body temperature increased	1/438 (0.2%)	1	0/211 (0%)	0
Cardiac enzymes increased	0/438 (0%)	0	2/211 (0.9%)	2
Cardiac stress test abnormal	2/438 (0.5%)	2	1/211 (0.5%)	1
Dehydration	1/438 (0.2%)	1	0/211 (0%)	0
Electrocardiogram abnormal	0/438 (0%)	0	1/211 (0.5%)	1
Haemoglobin decreased	1/438 (0.2%)	1	0/211 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus	1/438 (0.2%)	1	0/211 (0%)	0
Fluid retention	1/438 (0.2%)	1	0/211 (0%)	0
Gout	1/438 (0.2%)	1	0/211 (0%)	0
Hyperglycaemia	1/438 (0.2%)	1	0/211 (0%)	0
Hyperkalaemia	0/438 (0%)	0	1/211 (0.5%)	1
Hypoglycaemia	0/438 (0%)	0	2/211 (0.9%)	2
Type 2 diabetes mellitus	1/438 (0.2%)	1	0/211 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/438 (0%)	0	1/211 (0.5%)	1
Compartment syndrome	1/438 (0.2%)	1	0/211 (0%)	0
Muscle spasms	0/438 (0%)	0	1/211 (0.5%)	1
Osteoarthritis	0/438 (0%)	0	1/211 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/438 (0.2%)	1	0/211 (0%)	0
Lung neoplasm malignant	0/438 (0%)	0	1/211 (0.5%)	1
Neoplasm malignant	1/438 (0.2%)	1	0/211 (0%)	0
Oesophageal carcinoma	2/438 (0.5%)	2	0/211 (0%)	0
Prostate cancer	1/438 (0.2%)	1	0/211 (0%)	0
Thymoma	0/438 (0%)	0	1/211 (0.5%)	1
Nervous system disorders
Carotid artery stenosis	2/438 (0.5%)	2	2/211 (0.9%)	2
Central nervous system lesion	1/438 (0.2%)	1	0/211 (0%)	0
Cerebrovascular accident	4/438 (0.9%)	4	1/211 (0.5%)	2
Cervicobrachial syndrome	1/438 (0.2%)	1	0/211 (0%)	0
Dementia	0/438 (0%)	0	1/211 (0.5%)	1
Dizziness	4/438 (0.9%)	4	0/211 (0%)	0
Encephalopathy	0/438 (0%)	0	1/211 (0.5%)	1
Headache	1/438 (0.2%)	1	1/211 (0.5%)	1
Syncope	5/438 (1.1%)	6	2/211 (0.9%)	2
Transient ischaemic attack	3/438 (0.7%)	3	1/211 (0.5%)	1
Psychiatric disorders
Acute psychosis	0/438 (0%)	0	1/211 (0.5%)	1
Agitation	0/438 (0%)	0	1/211 (0.5%)	1
Anxiety	0/438 (0%)	0	1/211 (0.5%)	1
Depression	0/438 (0%)	0	1/211 (0.5%)	1
Renal and urinary disorders
Renal artery stenosis	1/438 (0.2%)	1	0/211 (0%)	0
Renal disorder	0/438 (0%)	0	1/211 (0.5%)	1
Renal failure	1/438 (0.2%)	1	2/211 (0.9%)	4
Renal failure acute	1/438 (0.2%)	1	1/211 (0.5%)	1
Renal failure chronic	0/438 (0%)	0	1/211 (0.5%)	4
Urinary retention	0/438 (0%)	0	2/211 (0.9%)	2
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/438 (0.2%)	1	0/211 (0%)	0
Uterine prolapse	1/438 (0.2%)	1	0/211 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/438 (0.5%)	3	1/211 (0.5%)	1
Cough	1/438 (0.2%)	1	0/211 (0%)	0
Dyspnoea	1/438 (0.2%)	1	3/211 (1.4%)	3
Dyspnoea exertional	1/438 (0.2%)	1	1/211 (0.5%)	1
Lung disorder	0/438 (0%)	0	1/211 (0.5%)	1
Pleural effusion	1/438 (0.2%)	1	0/211 (0%)	0
Pleuritic pain	1/438 (0.2%)	1	0/211 (0%)	0
Pulmonary embolism	0/438 (0%)	0	1/211 (0.5%)	1
Sleep apnoea syndrome	1/438 (0.2%)	1	0/211 (0%)	0
Skin and subcutaneous tissue disorders
Eczema	1/438 (0.2%)	1	0/211 (0%)	0
Social circumstances
Physical disability	0/438 (0%)	0	1/211 (0.5%)	1
Surgical and medical procedures
Aortic aneurysm repair	1/438 (0.2%)	1	0/211 (0%)	0
Aortic valve replacement	1/438 (0.2%)	1	0/211 (0%)	0
Atherectomy	3/438 (0.7%)	3	2/211 (0.9%)	2
Breast lump removal	1/438 (0.2%)	1	0/211 (0%)	0
Cardiac pacemaker replacement	2/438 (0.5%)	2	0/211 (0%)	0
Carotid artery stent insertion	1/438 (0.2%)	1	1/211 (0.5%)	1
Carotid endarterectomy	2/438 (0.5%)	2	0/211 (0%)	0
Cholecystectomy	1/438 (0.2%)	1	0/211 (0%)	0
Colectomy	1/438 (0.2%)	1	1/211 (0.5%)	1
Coronary angioplasty	9/438 (2.1%)	9	9/211 (4.3%)	10
Coronary arterial stent insertion	3/438 (0.7%)	3	2/211 (0.9%)	2
Coronary artery bypass graft	10/438 (2.3%)	28	3/211 (1.4%)	5
Coronary revascularisation	60/438 (13.7%)	94	43/211 (20.4%)	68
Implantable defibrillator replacement	1/438 (0.2%)	1	0/211 (0%)	0
Knee arthroplasty	1/438 (0.2%)	1	1/211 (0.5%)	1
Prostatectomy	1/438 (0.2%)	1	0/211 (0%)	0
Renal artery stent placement	1/438 (0.2%)	1	1/211 (0.5%)	1
Spinal operation	1/438 (0.2%)	1	2/211 (0.9%)	2
Thrombectomy	1/438 (0.2%)	1	0/211 (0%)	0
Thyroidectomy	1/438 (0.2%)	1	0/211 (0%)	0
Vascular disorders
Aortic aneurysm	1/438 (0.2%)	1	0/211 (0%)	0
Arterial thrombosis limb	1/438 (0.2%)	1	0/211 (0%)	0
Deep vein thrombosis	0/438 (0%)	0	1/211 (0.5%)	1
Femoral arterial stenosis	1/438 (0.2%)	1	0/211 (0%)	0
Gastrointestinal haemorrhage	6/438 (1.4%)	6	4/211 (1.9%)	4
Hypertension	1/438 (0.2%)	1	3/211 (1.4%)	3
Hypotension	4/438 (0.9%)	4	2/211 (0.9%)	2
Iliact artery stenosis	1/438 (0.2%)	1	0/211 (0%)	0
Peripheral ischaemia	4/438 (0.9%)	4	3/211 (1.4%)	3
Peripheral vascular disorder	1/438 (0.2%)	1	3/211 (1.4%)	3
Phlebitis superficial	0/438 (0%)	0	1/211 (0.5%)	1
Retroperitoneal haemorrhage	2/438 (0.5%)	2	0/211 (0%)	0
Vascular pseudoaneurysm	5/438 (1.1%)	5	3/211 (1.4%)	3
Other (Not Including Serious) Adverse Events
	XIENCE V® EECSS		TAXUS® EXPRESS2™ ECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	71/ (NaN)		55/ (NaN)
Cardiac disorders
Angina pectoris	71/438 (16.2%)	93	35/211 (16.6%)	44
Myocardial infarction	7/438 (1.6%)	7	11/211 (5.2%)	11
General disorders
Catheter site haematoma	12/438 (2.7%)	12	11/211 (5.2%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.