SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00307047
• Collaborator: (none)
• Enrollment: 3,687
• Locations: 65
• Arms: 2
• Duration (Months): 69
• Patients Per Site: 56.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific.

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: XIENCE V® Everolimus Eluting Coronary Stent; Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent	Phase 3

Detailed Description

The completion of the SPIRIT IV clinical trial at three years is justified by the consistent long-term clinical evidence supporting the safety and efficacy of the XIENCE V EECSS in complex, real-world patients across multiple geographies. As SPIRIT IV was designed as a continued access trial, completing the clinical follow-up at the three-year visit does not conflict with any FDA requirements. Abbott Vascular is committed to providing clinical outcomes through three years. The clinical evidence provided from across multiple geographies, in complex populations thus supports Abbott Vascular's proposal to complete the SPIRIT IV RCT at the three-year clinical follow-up.

The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3687 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XIENCE V®	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: TAXUS™ EXPRESS2™	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. Ischemia Driven Target Lesion Failure (TLF) [1 year]

   Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Secondary Outcome Measures

1. Ischemia Driven Target Vessel Failure (TVF) [30 days]

   Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

2. Ischemia Driven Target Vessel Failure (TVF) [180 days]

   Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

3. Ischemia Driven Target Vessel Failure (TVF) [270 days]

   Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

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

   Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

5. Ischemia Driven Target Vessel Failure (TVF) [2 years]

   Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

6. Ischemia Driven Target Vessel Failure (TVF) [3 years]

   Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR

7. Ischemia Driven Target Lesion Revascularization (TLR) [30 days]

   Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

8. Ischemia Driven Target Lesion Revascularization (TLR) [180 days]

   Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

9. Ischemia Driven Target Lesion Revascularization (TLR) [270 days]

   Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

10. Ischemia Driven Target Lesion Revascularization (TLR) [1 year]

    Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

11. Ischemia Driven Target Lesion Revascularization (TLR) [2 years]

    Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

12. Ischemia Driven Target Lesion Revascularization (TLR) [3 years]

    Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

13. Ischemia Driven Target Vessel Revascularization (TVR) [30 days]

    Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

14. Ischemia Driven Target Vessel Revascularization (TVR) [180 days]

    Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

15. Ischemia Driven Target Vessel Revascularization (TVR) [270 days]

    Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

16. Ischemia Driven Target Vessel Revascularization (TVR) [1 year]

    Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

17. Ischemia Driven Target Vessel Revascularization (TVR) [2 years]

    Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

18. Ischemia Driven Target Vessel Revascularization (TVR) [3 years]

    Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study

19. Ischemia Driven Major Adverse Cardiac Events (MACE) [30 days]

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

20. Ischemia Driven Major Adverse Cardiac Events (MACE) [180 days]

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

21. Ischemia Driven Major Adverse Cardiac Events (MACE) [270 days]

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

22. Ischemia Driven Major Adverse Cardiac Events (MACE) [1 years]

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

23. Ischemia Driven Major Adverse Cardiac Events (MACE) [2 years]

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

24. Ischemia Driven Major Adverse Cardiac Events (MACE) [3 years]

    Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR

25. Acute Success (Clinical Device) [Acute: At time of index procedure]

    Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.

26. Acute Success (Clinical Procedure) [Acute: At time of index procedure]

    Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.

27. All Myocardial Infarction (MI) [30 days]

28. All MI [180 days]

29. All MI [270 days]

30. All MI [1 year]

31. All MI [2 years]

32. All MI [3 years]

33. All Cause Mortality [30 days]

34. All Cause Mortality [180 days]

35. All Cause Mortality [270 days]

36. All Cause Mortality [1 year]

37. All Cause Mortality [2 years]

38. All Cause Mortality [3 years]

39. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR) [30 days]

40. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR) [180 days]

41. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR) [270 days]

42. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR) [1 year]

43. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR) [2 years]

44. Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR) [3 years]

45. Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition [0-30 days]

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

46. Definite + Probable Stent Thrombosis Rate Based on ARC Definition [31-393 days]

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

47. Definite + Probable Stent Thrombosis Rate Based on ARC Definition [0 -393 days]

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

48. Definite + Probable Stent Thrombosis Rate Based on ARC Definition [0-758 days]

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

49. Definite + Probable Stent Thrombosis Rate Based on ARC Definition [0-1123 days]

    ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.

50. Protocol Defined Stent Thrombosis Rate [0-30 days]

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

51. Protocol Defined Stent Thrombosis Rate [31-393 days]

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

52. Protocol Defined Stent Thrombosis Rate [0-393 days]

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

53. Protocol Defined Stent Thrombosis Rate [0-758 days]

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

54. Protocol Defined Stent Thrombosis Rate [0-1123 days]

    ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

55. Cardiac Death or Target Vessel MI Rate [30 days]

56. Cardiac Death or Target Vessel MI Rate [180 days]

57. Cardiac Death or Target Vessel MI Rate [270 days]

58. Cardiac Death or Target Vessel MI Rate [1 year]

59. Cardiac Death or Target Vessel MI Rate [2 years]

60. Cardiac Death or Target Vessel MI Rate [3 years]

61. Ischemia Driven Target Lesion Failure (TLF) [30 days]

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

62. Ischemia Driven Target Lesion Failure (TLF) [180 days]

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

63. Ischemia Driven Target Lesion Failure (TLF) [270 days]

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

64. Ischemia Driven Target Lesion Failure (TLF) [2 years]

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

65. Ischemia Driven Target Lesion Failure (TLF) [3 years]

    Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Eligibility Criteria

Criteria

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

General Inclusion Criteria:

• Subject must be at least 18 years of age

• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)

• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

• Subject must agree to undergo all protocol-required follow-up procedures

• Subject must agree not to participate in any other clinical study for a period of one year following the index procedure

Angiographic Inclusion Criteria:

• Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available)

• Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)

• If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria

• If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria

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

• Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure

• Non-study percutaneous intervention for lesions in a non-target vessel involving:

• Successful and uncomplicated (visually estimated diameter stenosis < 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be < 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted

• Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure

• Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure

• Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure

General Exclusion Criteria:

• Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure

• The subject is currently experiencing clinical symptoms consistent with AMI

• Subject has current unstable arrhythmias

• Subject has a known left ventricular ejection fraction (LVEF) < 30%

• Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant

• Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure

• Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)

• Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)

• Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated

• Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure

• Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)

• Subject has known renal insufficiency (e.g., serum creatinine level of > 2.5 mg/dL or subject on dialysis)

• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

• Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

• Subject has had a significant GI or urinary bleed within the past six months

• Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion

• Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year

• Subject is already participating in another clinical study that has not yet reached its primary endpoint

• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure)

• Angiographic Exclusion Criteria

• The target lesion(s) meets any of the following criteria:

• Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded)

• Located within 2 mm of the origin of the LAD or LCX

• Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis > 20%) arterial or saphenous vein graft

• Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation

• Involves a side branch requiring pre-dilatation

• Total occlusion (TIMI flow 0) prior to wire crossing

• Excessive tortuosity proximal to or within the lesion

• Extreme angulation (≥ 90º) proximal to or within the lesion

• Heavy calcification

• Restenotic from previous intervention

• Subject has received brachytherapy in any epicardial vessel (including side branches)

• The target vessel contains thrombus

• Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure

• Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Healthcare	Scottsdale	Arizona	United States	85260
2	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
3	Inova Fairfax Hospital	Fairfax	California	United States	22031
4	San Diego Cardiovascular Associates	La Jolla	California	United States	92037
5	Scripps Memorial Hospital	La Jolla	California	United States	92037
6	Good Samaritan Hospital - LA	Los Angeles	California	United States	90017
7	Mercy General Hospital	Sacramento	California	United States	95819
8	Sutter Medical Center of Santa Rosa	Santa Rosa	California	United States	95404-1797
9	The Medical Center of Aurora	Aurora	Colorado	United States	80012
10	Poudre Valley Hospital	Fort Collins	Colorado	United States	80528
11	Washington Hospital Center	Washington	District of Columbia	United States	20010
12	Sacred Heart Hospital	Pensacola	Florida	United States	32504-8721
13	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
14	St. Francis Hospital and Health Centers	Indianapolis	Indiana	United States	46237
15	The Heart Center of Indiana	Indianapolis	Indiana	United States	46290
16	Iowa Heart Center P.C.	Des Moines	Iowa	United States	50266
17	University of Kansas Hospital	Kansas City	Kansas	United States	66160
18	Central Baptist Hospital	Lexington	Kentucky	United States	40503
19	Jewish Hospital	Louisville	Kentucky	United States	40202
20	Maine Medical Center	Portland	Maine	United States	04102
21	Union Memorial Hospital	Baltimore	Maryland	United States	21218
22	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
23	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912
24	St. Joseph Medical Center	Towson	Maryland	United States	21204
25	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
26	Saint Vincent Hospital	Worcester	Massachusetts	United States	01608
27	UMass Memorial Medical Center	Worcester	Massachusetts	United States	01655
28	Bay Regional Medical Center	Bay City	Michigan	United States	48706
29	Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48124
30	Spectrum Health Hospital	Grand Rapids	Michigan	United States	49503
31	Borgess Medical Center	Kalamazoo	Michigan	United States	49048
32	Ingham Regional Medical Center	Lansing	Michigan	United States	48910
33	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
34	St. Luke's Hospital	Kansas City	Missouri	United States	64111
35	Research Medical Center	Kansas City	Missouri	United States	64132
36	St. Patrick Hospital	Missoula	Montana	United States	59802
37	Nebraska Heart Hospital	Lincoln	Nebraska	United States	68526
38	Dartmouth Hitchock Medical Center	Lebanon	New Hampshire	United States	03756
39	Millard Fillmore Hospital	Buffalo	New York	United States	14209
40	New York Presbyterian Hospital-Cornell	New York City	New York	United States	10021
41	Columbia University Medical Center	New York	New York	United States	10032
42	The Valley Hospital	Pomona	New York	United States	10970
43	Stony Brook Hospital and Medical Center	Stony Brook	New York	United States	11794
44	St. Joseph's Hospital Health Center	Syracuse	New York	United States	13203
45	Presbyterian Hospital - Charlotte	Charlotte	North Carolina	United States	28233
46	Pitt County Memorial Hospital	Greenville	North Carolina	United States	27834
47	Wake Medical Center	Raleigh	North Carolina	United States	27610
48	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
49	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
50	The Christ Hospital	Cincinnati	Ohio	United States	45219
51	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
52	EMH Regional Medical Center	Elyria	Ohio	United States	44035
53	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
54	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
55	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania	United States	15213
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 (MUSC)	Charleston	South Carolina	United States	29425
59	Sisters of Charity Providence Hospitals	Columbia	South Carolina	United States	29204
60	St. Francis Health System	Greenville	South Carolina	United States	29605
61	Vanderbilt Vniversity Medical Center	Nashville	Tennessee	United States	37205
62	Plaza Medical Center of Fort Worth	Fort Worth	Texas	United States	76104
63	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
64	Sentara Norfolk General	Norfolk	Virginia	United States	23507
65	St. Luke's Medical Center - Milwaukee	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Gregg W Stone, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00307047
• Other Study ID Numbers: 05-368
• First Posted: Mar 27, 2006
• Last Update Posted: Nov 7, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Abbott Medical Devices: Stents; Angioplasty; Total coronary occlusion; coronary restenosis; stent thrombosis
• Additional relevant MeSH terms: Coronary Artery Disease; Paclitaxel; Albumin-Bound Paclitaxel; Everolimus

Study Results

Participant Flow

Recruitment Details	Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. Recruitment may have, but was not limited to a hospital or an interventional cardiology clinic. The enrollment period was August 10, 2006 through July 30, 2008.
Pre-assignment Detail	Patients who met inclusion/exclusion criteria were offered participation in the study, and randomized until the total trial population was reached.

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Period Title: Overall Study
STARTED	2458	1229
COMPLETED	2389	1180
NOT COMPLETED	69	49

Baseline Characteristics

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™	Total
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent	Total of all reporting groups
Overall Participants	2458	1229	3687
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1373 55.9%	677 55.1%	2050 55.6%
>=65 years	1085 44.1%	552 44.9%	1637 44.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.25 (10.52)	63.34 (10.23)	63.28 (10.42)
Sex: Female, Male (Count of Participants)
Female	793 32.3%	396 32.2%	1189 32.2%
Male	1665 67.7%	833 67.8%	2498 67.8%
Region of Enrollment (participants) [Number]
United States	2458 100%	1229 100%	3687 100%

Outcome Measures

1. Secondary Outcome

Title	Ischemia Driven Target Vessel Failure (TVF)
Description	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [percentage of participants]	1.9 0.1%	3.1 0.3%

2. Secondary Outcome

Title	Ischemia Driven Target Vessel Failure (TVF)
Description	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [percentage of participants]	3.4 0.1%	6.2 0.5%

3. Secondary Outcome

Title	Ischemia Driven Target Vessel Failure (TVF)
Description	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [percentage of participants]	4.6 0.2%	7.2 0.6%

4. Secondary Outcome

Title	Ischemia Driven Target Vessel Failure (TVF)
Description	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

ITT, @ 1 yr

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [percentage of participants]	5.6 0.2%	7.9 0.6%

5. Secondary Outcome

Title	Ischemia Driven Target Vessel Failure (TVF)
Description	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT, @ 2 years

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [percentage of participants]	9.6 0.4%	11.8 1%

6. Secondary Outcome

Title	Ischemia Driven Target Vessel Failure (TVF)
Description	Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT, @ 3 years

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [percentage of participants]	13.3 0.5%	14.5 1.2%

7. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (TLR)
Description	Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [percentage of participants]	0.4 0%	1.1 0.1%

8. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (TLR)
Description	Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [percentage of participants]	1.1 0%	3.2 0.3%

9. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (TLR)
Description	Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [percentage of participants]	1.9 0.1%	4.1 0.3%

10. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (TLR)
Description	Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [percentage of participants]	2.5 0.1%	4.6 0.4%

11. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (TLR)
Description	Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [percentage of participants]	4.4 0.2%	6.9 0.6%

12. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (TLR)
Description	Revascularization of a target lesion associated with any of the following: positive functional ischemia study ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [percentage of participants]	6.3 0.3%	7.9 0.6%

13. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (TVR)
Description	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [percentage of participants]	0.7 0%	1.6 0.1%

14. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (TVR)
Description	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [percentage of participants]	1.9 0.1%	4.3 0.3%

15. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (TVR)
Description	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [percentage of participants]	3.0 0.1%	5.3 0.4%

16. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (TVR)
Description	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [percentage of participants]	3.9 0.2%	5.9 0.5%

17. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (TVR)
Description	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [percentage of participants]	7.0 0.3%	8.9 0.7%

18. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (TVR)
Description	Revascularization of a lesion within the target vessel associated with any of the following: positive functional ischemia study ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [percentage of participants]	10.1 0.4%	10.6 0.9%

19. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Events (MACE)
Description	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [Percentage of participants]	1.6 0.1%	2.7 0.2%

20. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Events (MACE)
Description	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [Percentage of participants]	2.6 0.1%	5.3 0.4%

21. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Events (MACE)
Description	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [Percentage of participants]	3.5 0.1%	6.2 0.5%

22. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Events (MACE)
Description	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Time Frame	1 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [Percentage of participants]	4.2 0.2%	6.9 0.6%

23. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Events (MACE)
Description	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [Percentage of participants]	7.2 0.3%	10.2 0.8%

24. Secondary Outcome

Title	Ischemia Driven Major Adverse Cardiac Events (MACE)
Description	Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [Percentage of participants]	9.8 0.4%	12.3 1%

25. Secondary Outcome

Title	Acute Success (Clinical Device)
Description	Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.
Time Frame	Acute: At time of index procedure

Outcome Measure Data

Analysis Population Description

clinical device success is computed per lesion

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	3058	1551
Number [Percent of success]	92.0	90.7

26. Secondary Outcome

Title	Acute Success (Clinical Procedure)
Description	Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.
Time Frame	Acute: At time of index procedure

Outcome Measure Data

Analysis Population Description

Clinical procedure success is computed per subject

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2434	1216
Number [Percentage of success]	98.6	98.1

27. Secondary Outcome

Title	All Myocardial Infarction (MI)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [Percentage of participants]	1.5 0.1%	2.1 0.2%

28. Secondary Outcome

Title	All MI
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [Percentage of participants]	1.6 0.1%	2.9 0.2%

29. Secondary Outcome

Title	All MI
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [Percentage of participants]	1.8 0.1%	3.0 0.2%

30. Secondary Outcome

Title	All MI
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [Percentage of participants]	1.9 0.1%	3.1 0.3%

31. Secondary Outcome

Title	All MI
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [Percentage of participants]	2.6 0.1%	3.9 0.3%

32. Secondary Outcome

Title	All MI
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [Percentage of participants]	3.1 0.1%	4.7 0.4%

33. Secondary Outcome

Title	All Cause Mortality
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [Percentage of participants]	0.0 0%	0.2 0%

34. Secondary Outcome

Title	All Cause Mortality
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [Percentage of participants]	0.5 0%	0.6 0%

35. Secondary Outcome

Title	All Cause Mortality
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [Percentage of participants]	0.7 0%	0.9 0.1%

36. Secondary Outcome

Title	All Cause Mortality
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [Percentage of participants]	1.0 0%	1.3 0.1%

37. Secondary Outcome

Title	All Cause Mortality
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [Percentage of participants]	2.1 0.1%	2.7 0.2%

38. Secondary Outcome

Title	All Cause Mortality
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [Percentage of participants]	3.4 0.1%	5.2 0.4%

39. Secondary Outcome

Title	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [Percentage of participants]	2.4 0.1%	3.6 0.3%

40. Secondary Outcome

Title	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [Percentage of participants]	5.5 0.2%	7.5 0.6%

41. Primary Outcome

Title	Ischemia Driven Target Lesion Failure (TLF)
Description	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [Percentage of participants]	4.2 0.2%	6.8 0.6%

42. Secondary Outcome

Title	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [Percentage of participants]	7.2 0.3%	9.3 0.8%

43. Secondary Outcome

Title	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [Percentage of participants]	9.0 0.4%	10.5 0.9%

44. Secondary Outcome

Title	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [Percentage of participants]	15.5 0.6%	16.2 1.3%

45. Secondary Outcome

Title	Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [Percentage of participants]	21.4 0.9%	22.5 1.8%

46. Secondary Outcome

Title	Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
Description	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Time Frame	0-30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1221
Number [Percentage of participants]	0.16 0%	0.74 0.1%

47. Secondary Outcome

Title	Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Description	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Time Frame	31-393 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2391	1181
Number [Percentage of participants]	0.13 0%	0.42 0%

48. Secondary Outcome

Title	Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Description	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Time Frame	0 -393 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2391	1181
Number [Percentage of participants]	0.29 0%	1.10 0.1%

49. Secondary Outcome

Title	Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Description	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Time Frame	0-758 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2313	1135
Number [Percentage of participants]	0.48 0%	1.32 0.1%

50. Secondary Outcome

Title	Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Description	ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Time Frame	0-1123 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2263	1098
Number [Percentage of participants]	0.62 0%	1.73 0.1%

51. Secondary Outcome

Title	Protocol Defined Stent Thrombosis Rate
Description	ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	0-30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1221
Number [Percentage of participants]	0.12 0%	0.57 0%

52. Secondary Outcome

Title	Protocol Defined Stent Thrombosis Rate
Description	ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	31-393 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2389	1181
Number [Percentage of participants]	0.04 0%	0.34 0%

53. Secondary Outcome

Title	Protocol Defined Stent Thrombosis Rate
Description	ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	0-393 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2389	1181
Number [Percentage of participants]	0.17 0%	0.85 0.1%

54. Secondary Outcome

Title	Protocol Defined Stent Thrombosis Rate
Description	ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	0-758 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2313	1137
Number [Percentage of participants]	0.52 0%	1.23 0.1%

55. Secondary Outcome

Title	Protocol Defined Stent Thrombosis Rate
Description	ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of ST In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	0-1123 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2266	1104
Number [Percentage of participants]	0.79 0%	1.99 0.2%

56. Secondary Outcome

Title	Cardiac Death or Target Vessel MI Rate
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [Percentage of participants]	1.5 0.1%	2.1 0.2%

57. Secondary Outcome

Title	Cardiac Death or Target Vessel MI Rate
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [Percentage of participants]	1.8 0.1%	2.8 0.2%

58. Secondary Outcome

Title	Cardiac Death or Target Vessel MI Rate
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [Percentage of participants]	2.1 0.1%	3.0 0.2%

59. Secondary Outcome

Title	Cardiac Death or Target Vessel MI Rate
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2416	1195
Number [Percentage of participants]	2.2 0.1%	3.2 0.3%

60. Secondary Outcome

Title	Cardiac Death or Target Vessel MI Rate
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [Percentage of participants]	3.2 0.1%	4.3 0.3%

61. Secondary Outcome

Title	Cardiac Death or Target Vessel MI Rate
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [Percentage of participants]	4.1 0.2%	5.5 0.4%

62. Secondary Outcome

Title	Ischemia Driven Target Lesion Failure (TLF)
Description	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2451	1222
Number [Percentage of participants]	1.6 0.1%	2.7 0.2%

63. Secondary Outcome

Title	Ischemia Driven Target Lesion Failure (TLF)
Description	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2435	1208
Number [Percentage of participants]	2.5 0.1%	5.1 0.4%

64. Secondary Outcome

Title	Ischemia Driven Target Lesion Failure (TLF)
Description	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2419	1201
Number [Percentage of participants]	3.4 0.1%	6.1 0.5%

65. Secondary Outcome

Title	Ischemia Driven Target Lesion Failure (TLF)
Description	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2388	1190
Number [Percentage of participants]	7.0 0.3%	10.0 0.8%

66. Secondary Outcome

Title	Ischemia Driven Target Lesion Failure (TLF)
Description	Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V®	TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent	Patients receiving the TAXUS™ EXPRESS 2™ stent
Measure Participants	2348	1158
Number [Percentage of participants]	9.5 0.4%	11.9 1%

Adverse Events

Time Frame	1 year
Arm/Group Title	XIENCE V®		TAXUS™ EXPRESS 2™
Arm/Group Description	Patients recieving the XIENCE V® stent		Patients receiving the TAXUS™ EXPRESS 2™ stent
All Cause Mortality
	XIENCE V®		TAXUS™ EXPRESS 2™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	XIENCE V®		TAXUS™ EXPRESS 2™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	913/2436 (37.5%)		468/1214 (38.6%)
Blood and lymphatic system disorders
Anaemia	17/2436 (0.7%)	17	11/1214 (0.9%)	12
Haemorrhagic anaemia	1/2436 (0%)	1	1/1214 (0.1%)	1
Iron deficiency anaemia	2/2436 (0.1%)	2	0/1214 (0%)	0
Leukocytosis	1/2436 (0%)	1	0/1214 (0%)	0
Lymphadenopathy mediastinal	1/2436 (0%)	1	0/1214 (0%)	0
Normochromic normocytic anemia	2/2436 (0.1%)	2	0/1214 (0%)	0
Pancytopenia	0/2436 (0%)	0	1/1214 (0.1%)	1
Thrombocytopenia	2/2436 (0.1%)	2	0/1214 (0%)	0
Cardiac disorders
Acute coronary syndrome	3/2436 (0.1%)	3	2/1214 (0.2%)	2
Acute myocardial infarction	9/2436 (0.4%)	11	5/1214 (0.4%)	5
Angina pectoris	304/2436 (12.5%)	406	153/1214 (12.6%)	196
Angina unstable	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Aortic stenosis	1/2436 (0%)	1	0/1214 (0%)	0
Aortic valve incompetence	1/2436 (0%)	1	0/1214 (0%)	0
Aortic valve stenosis	0/2436 (0%)	0	1/1214 (0.1%)	2
Arrhythmia	60/2436 (2.5%)	70	43/1214 (3.5%)	48
Arteriospasm coronary	1/2436 (0%)	1	0/1214 (0%)	0
Atrial fibrillation	9/2436 (0.4%)	9	4/1214 (0.3%)	4
Atrial flutter	1/2436 (0%)	1	0/1214 (0%)	0
Bradycardia	7/2436 (0.3%)	7	1/1214 (0.1%)	1
Cardiac arrest	4/2436 (0.2%)	4	0/1214 (0%)	0
Cardiac failure congestive	30/2436 (1.2%)	44	15/1214 (1.2%)	19
Cardiac perforation	1/2436 (0%)	1	0/1214 (0%)	0
Cardiac tamponade	1/2436 (0%)	1	0/1214 (0%)	0
Cardio-respiratory arrest	2/2436 (0.1%)	2	0/1214 (0%)	0
Coronary artery dissection	17/2436 (0.7%)	18	13/1214 (1.1%)	13
Coronary artery occlusion	0/2436 (0%)	0	2/1214 (0.2%)	2
Coronary artery perforation	4/2436 (0.2%)	4	0/1214 (0%)	0
Coronary artery stenosis	1/2436 (0%)	1	0/1214 (0%)	0
Coronary artery thrombosis	2/2436 (0.1%)	2	0/1214 (0%)	0
Intracardiac thrombus	1/2436 (0%)	1	0/1214 (0%)	0
Ischaemic cardiomyopathy	0/2436 (0%)	0	1/1214 (0.1%)	1
Mitral valve incompetence	2/2436 (0.1%)	2	0/1214 (0%)	0
Myocardial infarction	58/2436 (2.4%)	62	42/1214 (3.5%)	43
Myocardial ischemia	46/2436 (1.9%)	49	18/1214 (1.5%)	20
Palpitations	0/2436 (0%)	0	3/1214 (0.2%)	3
Pericardial effusion	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Sick sinus syndrome	2/2436 (0.1%)	2	0/1214 (0%)	0
Sinus bradycardia	1/2436 (0%)	1	1/1214 (0.1%)	1
Supraventricular tachycardia	0/2436 (0%)	0	1/1214 (0.1%)	1
Ventricular fibrillation	1/2436 (0%)	1	1/1214 (0.1%)	1
Ventricular tachycardia	3/2436 (0.1%)	3	1/1214 (0.1%)	1
Ear and labyrinth disorders
Vertigo	2/2436 (0.1%)	2	0/1214 (0%)	0
Endocrine disorders
Autoimmune thyroiditis	1/2436 (0%)	1	0/1214 (0%)	0
Goitre	0/2436 (0%)	0	1/1214 (0.1%)	1
Hyperparathyroidism	1/2436 (0%)	1	0/1214 (0%)	0
Hyperthyroidism	0/2436 (0%)	0	2/1214 (0.2%)	2
Thyroid mass	1/2436 (0%)	1	0/1214 (0%)	0
Eye disorders
Cataract	0/2436 (0%)	0	1/1214 (0.1%)	1
Gaze palsy	1/2436 (0%)	1	0/1214 (0%)	0
Gastrointestinal disorders
Abdominal hernia	2/2436 (0.1%)	2	0/1214 (0%)	0
Abdominal hernia obstructive	0/2436 (0%)	0	1/1214 (0.1%)	1
Abdominal pain	13/2436 (0.5%)	13	7/1214 (0.6%)	7
Abdominal pain lower	1/2436 (0%)	1	0/1214 (0%)	0
Abdominal pain upper	4/2436 (0.2%)	4	2/1214 (0.2%)	2
Abdominal symptom	0/2436 (0%)	0	1/1214 (0.1%)	1
Appendicitis perforated	1/2436 (0%)	1	1/1214 (0.1%)	1
Colitis	2/2436 (0.1%)	2	0/1214 (0%)	0
Colitis ischaemic	1/2436 (0%)	1	0/1214 (0%)	0
Colitis ulcerative	1/2436 (0%)	1	0/1214 (0%)	0
Colonic polyp	1/2436 (0%)	1	0/1214 (0%)	0
Crohn's disease	1/2436 (0%)	1	0/1214 (0%)	0
Diarrhoea	6/2436 (0.2%)	6	2/1214 (0.2%)	2
Diverticular perforation	1/2436 (0%)	1	0/1214 (0%)	0
Diverticulitis	5/2436 (0.2%)	5	3/1214 (0.2%)	4
Diverticulum	0/2436 (0%)	0	1/1214 (0.1%)	1
Dyspepsia	1/2436 (0%)	1	0/1214 (0%)	0
Dysphagia	4/2436 (0.2%)	4	1/1214 (0.1%)	1
Enteritis	1/2436 (0%)	1	0/1214 (0%)	0
Epigastric discomfort	0/2436 (0%)	0	1/1214 (0.1%)	1
Erosive duodenitis	1/2436 (0%)	1	0/1214 (0%)	0
Gastric disorder	1/2436 (0%)	1	1/1214 (0.1%)	1
Gastritis	4/2436 (0.2%)	4	1/1214 (0.1%)	1
Gastritis erosive	1/2436 (0%)	1	0/1214 (0%)	0
Gastroduodenitis	1/2436 (0%)	1	0/1214 (0%)	0
Gastrointestinal pain	1/2436 (0%)	1	0/1214 (0%)	0
Gastrooesophageal reflux disease	6/2436 (0.2%)	6	3/1214 (0.2%)	3
Gastrooesophagitis	0/2436 (0%)	0	1/1214 (0.1%)	1
Gingivitis	0/2436 (0%)	0	1/1214 (0.1%)	1
Haemorrhoids	0/2436 (0%)	0	1/1214 (0.1%)	1
Hiatus hernia	2/2436 (0.1%)	2	0/1214 (0%)	0
Impaired gastric emptying	1/2436 (0%)	1	1/1214 (0.1%)	1
Inguinal hernia	1/2436 (0%)	1	0/1214 (0%)	0
Inguinal hernia, obstructive	1/2436 (0%)	1	0/1214 (0%)	0
Intestinal malrotation	1/2436 (0%)	1	0/1214 (0%)	0
Intestinal mass	1/2436 (0%)	1	0/1214 (0%)	0
Irritable bowel syndrome	0/2436 (0%)	0	1/1214 (0.1%)	1
Large intestine perforation	0/2436 (0%)	0	1/1214 (0.1%)	1
Nausea	3/2436 (0.1%)	3	1/1214 (0.1%)	1
Oesophageal obstruction	1/2436 (0%)	1	0/1214 (0%)	0
Oesophageal pain	1/2436 (0%)	1	0/1214 (0%)	0
Oesophageal stenosis	2/2436 (0.1%)	2	0/1214 (0%)	0
Oesophagitis	1/2436 (0%)	1	2/1214 (0.2%)	2
Pancreatitis	3/2436 (0.1%)	4	3/1214 (0.2%)	3
Pancreatitis acute	1/2436 (0%)	1	2/1214 (0.2%)	2
Pancreatitis necrotising	1/2436 (0%)	1	0/1214 (0%)	0
Salivary gland mass	1/2436 (0%)	1	0/1214 (0%)	0
Small intestinal obstruction	2/2436 (0.1%)	2	2/1214 (0.2%)	2
Vomiting	2/2436 (0.1%)	4	4/1214 (0.3%)	4
General disorders
Adverse drug reaction	2/2436 (0.1%)	2	0/1214 (0%)	0
Asthenia	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Cardiac death	1/2436 (0%)	1	1/1214 (0.1%)	1
Catheter site haematoma	14/2436 (0.6%)	16	7/1214 (0.6%)	7
Catheter site haemorrhage	1/2436 (0%)	1	0/1214 (0%)	0
Catheter site infection	1/2436 (0%)	1	0/1214 (0%)	0
Catheter site pain	0/2436 (0%)	0	1/1214 (0.1%)	2
Chest discomfort	8/2436 (0.3%)	8	4/1214 (0.3%)	4
Chest pain	47/2436 (1.9%)	54	24/1214 (2%)	29
Cyst	1/2436 (0%)	1	0/1214 (0%)	0
Flank pain	1/2436 (0%)	1	0/1214 (0%)	0
Hernia	1/2436 (0%)	1	0/1214 (0%)	0
Hyperhidrosis	0/2436 (0%)	0	1/1214 (0.1%)	1
Impaired healing	0/2436 (0%)	0	1/1214 (0.1%)	2
Multi-organ failure	1/2436 (0%)	1	0/1214 (0%)	0
Non-cardiac chest pain	57/2436 (2.3%)	82	28/1214 (2.3%)	30
Oedema peripheral	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Pain	3/2436 (0.1%)	3	0/1214 (0%)	0
Pyrexia	5/2436 (0.2%)	5	0/1214 (0%)	0
Radiation associated pain	0/2436 (0%)	0	1/1214 (0.1%)	1
Sudden death	1/2436 (0%)	1	0/1214 (0%)	0
Swelling	0/2436 (0%)	0	1/1214 (0.1%)	1
Systemic inflammatory response syndrome	1/2436 (0%)	1	0/1214 (0%)	0
Hepatobiliary disorders
Bile duct stone	1/2436 (0%)	1	0/1214 (0%)	0
Biliary colic	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Biliary dilatation	0/2436 (0%)	0	1/1214 (0.1%)	1
Cholangitis	1/2436 (0%)	1	0/1214 (0%)	0
Cholecystitis	2/2436 (0.1%)	2	3/1214 (0.2%)	3
Cholelithiasis	8/2436 (0.3%)	8	4/1214 (0.3%)	4
Gallbladder disorder	0/2436 (0%)	0	5/1214 (0.4%)	6
Hepatic cirrhosis	1/2436 (0%)	1	1/1214 (0.1%)	1
Hepatitis	0/2436 (0%)	0	1/1214 (0.1%)	1
Ischaemic hepatitis	0/2436 (0%)	0	1/1214 (0.1%)	1
Immune system disorders
Anaphylactic reaction	1/2436 (0%)	1	0/1214 (0%)	0
Infections and infestations
Abscess fungal	1/2436 (0%)	1	0/1214 (0%)	0
Abscess neck	0/2436 (0%)	0	1/1214 (0.1%)	1
Acute sinusitis	1/2436 (0%)	1	0/1214 (0%)	0
Appendicitis	6/2436 (0.2%)	6	0/1214 (0%)	0
Arthritis infective	1/2436 (0%)	1	0/1214 (0%)	0
Breast cellulitis	1/2436 (0%)	1	0/1214 (0%)	0
Bronchitis	4/2436 (0.2%)	4	2/1214 (0.2%)	2
Bronchitis viral	0/2436 (0%)	0	1/1214 (0.1%)	1
Clostridial infection	1/2436 (0%)	1	1/1214 (0.1%)	1
Clostridium difficile colitis	1/2436 (0%)	1	1/1214 (0.1%)	1
Enterococcal infection	1/2436 (0%)	1	0/1214 (0%)	0
Escherichia sepsis	0/2436 (0%)	0	1/1214 (0.1%)	1
Gangrene	1/2436 (0%)	1	1/1214 (0.1%)	3
Gastroenteritis	3/2436 (0.1%)	3	3/1214 (0.2%)	3
Gastroenteritis viral	1/2436 (0%)	1	0/1214 (0%)	0
Helicobacter gastritis	1/2436 (0%)	1	0/1214 (0%)	0
Infected sebaceous cyst	0/2436 (0%)	0	1/1214 (0.1%)	1
Influenza	1/2436 (0%)	1	0/1214 (0%)	0
Klebsiella bacteraemia	2/2436 (0.1%)	2	0/1214 (0%)	0
Labyrinthitis	0/2436 (0%)	0	1/1214 (0.1%)	1
Localised infection	1/2436 (0%)	1	1/1214 (0.1%)	1
Osteomyelitis	1/2436 (0%)	1	2/1214 (0.2%)	5
Pharyngitis streptococcal	0/2436 (0%)	0	1/1214 (0.1%)	1
Pneumonia	37/2436 (1.5%)	42	24/1214 (2%)	26
Postoperative wound infection	0/2436 (0%)	0	1/1214 (0.1%)	1
Pseudomembranous colitis	1/2436 (0%)	1	0/1214 (0%)	0
Pyelonephritis	1/2436 (0%)	1	1/1214 (0.1%)	1
Sepsis	2/2436 (0.1%)	2	0/1214 (0%)	0
Septic shock	3/2436 (0.1%)	4	0/1214 (0%)	0
Sinusitis	1/2436 (0%)	1	0/1214 (0%)	0
Staphylococcal abscess	1/2436 (0%)	1	0/1214 (0%)	0
Staphylococcal infection	3/2436 (0.1%)	3	0/1214 (0%)	0
Tooth abscess	0/2436 (0%)	0	1/1214 (0.1%)	1
Urinary tract infection	8/2436 (0.3%)	8	6/1214 (0.5%)	6
Urosepsis	4/2436 (0.2%)	4	1/1214 (0.1%)	1
Vulvovaginal mycotic infection	1/2436 (0%)	1	0/1214 (0%)	0
Injury, poisoning and procedural complications
Animal bite	1/2436 (0%)	1	0/1214 (0%)	0
Ankle fracture	3/2436 (0.1%)	3	0/1214 (0%)	0
Asbestosis	0/2436 (0%)	0	1/1214 (0.1%)	1
Brachial plexus injury	0/2436 (0%)	0	1/1214 (0.1%)	1
Central line infection	0/2436 (0%)	0	1/1214 (0.1%)	1
Coronary artery reocclusion	2/2436 (0.1%)	2	0/1214 (0%)	0
Device failure	1/2436 (0%)	1	0/1214 (0%)	0
Eye injury	1/2436 (0%)	1	0/1214 (0%)	0
Face injury	1/2436 (0%)	1	0/1214 (0%)	0
Fall	1/2436 (0%)	1	0/1214 (0%)	0
Femur fracture	3/2436 (0.1%)	3	0/1214 (0%)	0
Fibula fracture	1/2436 (0%)	1	0/1214 (0%)	0
Foot fracture	1/2436 (0%)	1	0/1214 (0%)	0
Fracture nonunion	2/2436 (0.1%)	2	0/1214 (0%)	0
Head injury	1/2436 (0%)	1	0/1214 (0%)	0
Hip fracture	4/2436 (0.2%)	4	2/1214 (0.2%)	2
Humerus fracture	3/2436 (0.1%)	3	0/1214 (0%)	0
Implantable defibrillator malfunction	1/2436 (0%)	1	0/1214 (0%)	0
In-stent coronary artery restenosis	4/2436 (0.2%)	4	2/1214 (0.2%)	2
Injury	1/2436 (0%)	1	0/1214 (0%)	0
Intentional overdose	0/2436 (0%)	0	1/1214 (0.1%)	1
Limb injury	1/2436 (0%)	1	0/1214 (0%)	0
Limb traumatic amputation	1/2436 (0%)	1	0/1214 (0%)	0
Lower limb fracture	1/2436 (0%)	1	0/1214 (0%)	0
Mechanical complication of implant	1/2436 (0%)	1	1/1214 (0.1%)	1
Meniscus lesion	1/2436 (0%)	1	0/1214 (0%)	0
Multiple fractures	0/2436 (0%)	0	1/1214 (0.1%)	1
Multiple injuries	1/2436 (0%)	1	2/1214 (0.2%)	2
Post procedural complication	1/2436 (0%)	1	0/1214 (0%)	0
Post procedural haematoma	0/2436 (0%)	0	1/1214 (0.1%)	1
Postoperative abscess	0/2436 (0%)	0	1/1214 (0.1%)	1
Postoperative ileus	1/2436 (0%)	1	0/1214 (0%)	0
Procedural pain	1/2436 (0%)	1	0/1214 (0%)	0
Reperfusion injury	2/2436 (0.1%)	2	0/1214 (0%)	0
Rib fracture	0/2436 (0%)	0	2/1214 (0.2%)	2
Road traffic accident	1/2436 (0%)	1	2/1214 (0.2%)	2
Scrotal hematoma	1/2436 (0%)	1	0/1214 (0%)	0
Skin laceration	0/2436 (0%)	0	1/1214 (0.1%)	1
Splenic rupture	1/2436 (0%)	1	0/1214 (0%)	0
Stent-graft endoleak	1/2436 (0%)	1	0/1214 (0%)	0
Thoracic vertebral fracture	0/2436 (0%)	0	1/1214 (0.1%)	1
Thrombosis in device	2/2436 (0.1%)	2	2/1214 (0.2%)	2
Tibia fracture	1/2436 (0%)	1	0/1214 (0%)	0
Traumatic brain injury	1/2436 (0%)	1	0/1214 (0%)	0
Traumatic intracranial haemorrhage	1/2436 (0%)	1	0/1214 (0%)	0
Wound dehiscence	1/2436 (0%)	1	0/1214 (0%)	0
Wrist fracture	0/2436 (0%)	0	1/1214 (0.1%)	1
Investigations
Arteriogram coronary	1/2436 (0%)	1	0/1214 (0%)	0
Arthroscopy	0/2436 (0%)	0	1/1214 (0.1%)	1
Blood creatine phosphokinase increased	2/2436 (0.1%)	2	3/1214 (0.2%)	3
Blood creatine phosphokinase mb increased	0/2436 (0%)	0	1/1214 (0.1%)	1
Blood creatinine increased	2/2436 (0.1%)	2	2/1214 (0.2%)	2
Blood glucose flactuation	0/2436 (0%)	0	1/1214 (0.1%)	1
Blood glucose increased	2/2436 (0.1%)	2	0/1214 (0%)	0
Blood potassium decreased	1/2436 (0%)	1	0/1214 (0%)	0
Blood urine present	1/2436 (0%)	1	0/1214 (0%)	0
Body temperature increased	0/2436 (0%)	0	1/1214 (0.1%)	1
Cardiac enzymes increased	4/2436 (0.2%)	4	4/1214 (0.3%)	4
Cardiac stress test abnormal	3/2436 (0.1%)	3	3/1214 (0.2%)	3
Cardiac ventriculogram abnormal	1/2436 (0%)	1	0/1214 (0%)	0
Computerised tomogram	0/2436 (0%)	0	1/1214 (0.1%)	1
Fibrin d dimer increased	1/2436 (0%)	1	0/1214 (0%)	0
Hepatic enzyme increased	1/2436 (0%)	1	0/1214 (0%)	0
Laboratory test abnormal	1/2436 (0%)	1	1/1214 (0.1%)	1
Liver function test abnormal	0/2436 (0%)	0	1/1214 (0.1%)	1
Mediastinoscopy	1/2436 (0%)	1	0/1214 (0%)	0
Occult blood positive	1/2436 (0%)	1	0/1214 (0%)	0
Platelet count decreased	1/2436 (0%)	1	0/1214 (0%)	0
Renal function test abnormal	1/2436 (0%)	1	0/1214 (0%)	0
Troponin increased	1/2436 (0%)	1	0/1214 (0%)	0
Metabolism and nutrition disorders
Cachexia	1/2436 (0%)	1	0/1214 (0%)	0
Dehydration	7/2436 (0.3%)	7	3/1214 (0.2%)	4
Diabetes mellitus	1/2436 (0%)	1	2/1214 (0.2%)	2
Diabetes mellitus inadequate control	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Diabetes mellitus poor control	1/2436 (0%)	1	0/1214 (0%)	0
Diabetic foot	0/2436 (0%)	0	1/1214 (0.1%)	1
Diabetic retinal oedema	0/2436 (0%)	0	1/1214 (0.1%)	1
Diabetic ulcer	0/2436 (0%)	0	1/1214 (0.1%)	1
Electrolyte imbalance	1/2436 (0%)	1	0/1214 (0%)	0
Hyperglycaemia	2/2436 (0.1%)	2	0/1214 (0%)	0
Hyperkalaemia	2/2436 (0.1%)	2	2/1214 (0.2%)	2
Hyponatraemia	4/2436 (0.2%)	5	2/1214 (0.2%)	2
Obesity	2/2436 (0.1%)	2	0/1214 (0%)	0
Type 1 diabetes mellitus	0/2436 (0%)	0	1/1214 (0.1%)	1
Type 2 diabetes mellitus	1/2436 (0%)	1	1/1214 (0.1%)	1
Weight loss poor	1/2436 (0%)	1	0/1214 (0%)	0
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	0/2436 (0%)	0	1/1214 (0.1%)	1
Arthralgia	7/2436 (0.3%)	7	1/1214 (0.1%)	1
Arthritis	4/2436 (0.2%)	5	3/1214 (0.2%)	4
Back pain	12/2436 (0.5%)	12	8/1214 (0.7%)	9
Costochondritis	1/2436 (0%)	1	0/1214 (0%)	0
Intervertebral disc disorder	1/2436 (0%)	1	0/1214 (0%)	0
Joint stiffness	0/2436 (0%)	0	1/1214 (0.1%)	1
Lumbar spinal stenosis	2/2436 (0.1%)	2	0/1214 (0%)	0
Muscular weakness	0/2436 (0%)	0	1/1214 (0.1%)	1
Musculoskeletal chest pain	0/2436 (0%)	0	1/1214 (0.1%)	1
Musculoskeletal disorder	0/2436 (0%)	0	1/1214 (0.1%)	1
Musculoskeletal pain	1/2436 (0%)	1	1/1214 (0.1%)	1
Myalgia	0/2436 (0%)	0	1/1214 (0.1%)	1
Myositis	0/2436 (0%)	0	1/1214 (0.1%)	1
Neck pain	2/2436 (0.1%)	2	0/1214 (0%)	0
Osteoarthritis	15/2436 (0.6%)	15	5/1214 (0.4%)	5
Pain in extremity	5/2436 (0.2%)	5	3/1214 (0.2%)	3
Pain in jaw	0/2436 (0%)	0	1/1214 (0.1%)	1
Polymyalgia rheumatica	1/2436 (0%)	1	0/1214 (0%)	0
Rhabdomyolysis	1/2436 (0%)	1	1/1214 (0.1%)	1
Rotator cuff syndrome	1/2436 (0%)	1	1/1214 (0.1%)	1
Spinal column stenosis	1/2436 (0%)	1	0/1214 (0%)	0
Spinal disorder	1/2436 (0%)	1	0/1214 (0%)	0
Spinal osteoarthritis	1/2436 (0%)	1	0/1214 (0%)	0
Spondylolisthesis	1/2436 (0%)	1	0/1214 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Arachnoid cyst	1/2436 (0%)	1	0/1214 (0%)	0
B-cell lymphoma	1/2436 (0%)	4	0/1214 (0%)	0
Benign renal neoplasm	1/2436 (0%)	1	0/1214 (0%)	0
Bile duct cancer	0/2436 (0%)	0	1/1214 (0.1%)	1
Bladder cancer	4/2436 (0.2%)	6	0/1214 (0%)	0
Bone neoplasm	0/2436 (0%)	0	1/1214 (0.1%)	1
Brain cancer metastatic	0/2436 (0%)	0	1/1214 (0.1%)	1
Breast cancer	2/2436 (0.1%)	2	2/1214 (0.2%)	2
Carcinoid tumour of the duodenum	1/2436 (0%)	1	0/1214 (0%)	0
Colon cancer	2/2436 (0.1%)	2	3/1214 (0.2%)	3
Dementia alzheimer's type	0/2436 (0%)	0	1/1214 (0.1%)	1
Dizziness	12/2436 (0.5%)	12	6/1214 (0.5%)	6
Facial palsy	0/2436 (0%)	0	1/1214 (0.1%)	1
Gastric cancer	1/2436 (0%)	1	1/1214 (0.1%)	1
Glioblastoma	1/2436 (0%)	1	0/1214 (0%)	0
Head and neck cancer	0/2436 (0%)	0	1/1214 (0.1%)	1
Hemiparesis	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Hypoaesthesia	2/2436 (0.1%)	2	0/1214 (0%)	0
Leukaemia	1/2436 (0%)	1	0/1214 (0%)	0
Lipoma	1/2436 (0%)	1	0/1214 (0%)	0
Lung adenocarcinoma	0/2436 (0%)	0	1/1214 (0.1%)	1
Lung neoplasm	0/2436 (0%)	0	2/1214 (0.2%)	2
Lung neoplasm malignant	11/2436 (0.5%)	11	7/1214 (0.6%)	7
Lung squamous cell carcinoma stage unspecified	0/2436 (0%)	0	1/1214 (0.1%)	1
Lymphoma	0/2436 (0%)	0	1/1214 (0.1%)	1
Malignant urinary tract neoplasm	1/2436 (0%)	1	0/1214 (0%)	0
Metastatic squamous cell carcinoma	1/2436 (0%)	1	0/1214 (0%)	0
Multiple myeloma	2/2436 (0.1%)	3	0/1214 (0%)	0
Oesophageal adenocarcinoma	2/2436 (0.1%)	2	0/1214 (0%)	0
Pancreatic carcinoma	2/2436 (0.1%)	2	0/1214 (0%)	0
Pancreatic carcinoma metastatic	1/2436 (0%)	1	0/1214 (0%)	0
Papillary thyroid cancer	1/2436 (0%)	1	0/1214 (0%)	0
Polyp	1/2436 (0%)	1	0/1214 (0%)	0
Prostate cancer	3/2436 (0.1%)	3	0/1214 (0%)	0
Rectal cancer	1/2436 (0%)	2	0/1214 (0%)	0
Renal neoplasm	1/2436 (0%)	1	0/1214 (0%)	0
Small cell lung cancer metastatic	0/2436 (0%)	0	1/1214 (0.1%)	1
Small cell lung cancer stage unspecified	0/2436 (0%)	0	1/1214 (0.1%)	1
Throat cancer	1/2436 (0%)	1	0/1214 (0%)	0
Tonsil cancer	1/2436 (0%)	1	0/1214 (0%)	0
Nervous system disorders
Altered state of consciousness	0/2436 (0%)	0	1/1214 (0.1%)	1
Amnesia	1/2436 (0%)	1	0/1214 (0%)	0
Ataxia	2/2436 (0.1%)	2	0/1214 (0%)	0
Carpal tunnel syndrome	1/2436 (0%)	1	0/1214 (0%)	0
Cerebral ventricle dilatation	0/2436 (0%)	0	1/1214 (0.1%)	1
Cerebrovascular accident	14/2436 (0.6%)	14	12/1214 (1%)	12
Cervicobrachial syndrome	1/2436 (0%)	1	0/1214 (0%)	0
Convulsion	3/2436 (0.1%)	3	0/1214 (0%)	0
Haemorrhage intracranial	6/2436 (0.2%)	6	2/1214 (0.2%)	2
Headache	4/2436 (0.2%)	4	1/1214 (0.1%)	1
Hypoaesthesia facial	1/2436 (0%)	1	0/1214 (0%)	0
Metabolic encephalopathy	1/2436 (0%)	1	0/1214 (0%)	0
Nervous system disorder	0/2436 (0%)	0	2/1214 (0.2%)	2
Occipital neuralgia	1/2436 (0%)	1	0/1214 (0%)	0
Paraesthesia	0/2436 (0%)	0	1/1214 (0.1%)	1
Presyncope	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Spondylitic myelopathy	1/2436 (0%)	1	0/1214 (0%)	0
Syncope	17/2436 (0.7%)	17	7/1214 (0.6%)	8
Transient ischaemic attack	11/2436 (0.5%)	11	7/1214 (0.6%)	7
Unresponsive to stimuli	1/2436 (0%)	1	0/1214 (0%)	0
Psychiatric disorders
Acute prerenal failure	1/2436 (0%)	1	0/1214 (0%)	0
Anxiety	3/2436 (0.1%)	3	2/1214 (0.2%)	2
Confusional state	4/2436 (0.2%)	4	0/1214 (0%)	0
Conversion disorder	1/2436 (0%)	1	0/1214 (0%)	0
Depression	3/2436 (0.1%)	3	3/1214 (0.2%)	3
Drug abuse	1/2436 (0%)	1	0/1214 (0%)	0
Mental status changes	1/2436 (0%)	1	1/1214 (0.1%)	1
Suicidal ideation	1/2436 (0%)	1	0/1214 (0%)	0
Renal and urinary disorders
Bladder mass	1/2436 (0%)	1	0/1214 (0%)	0
Bladder prolapse	1/2436 (0%)	1	0/1214 (0%)	0
Calculus ureteric	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Haematuria	5/2436 (0.2%)	7	3/1214 (0.2%)	3
Hydronephrosis	1/2436 (0%)	1	0/1214 (0%)	0
Nephrolithiasis	5/2436 (0.2%)	6	0/1214 (0%)	0
Nephrotic syndrome	1/2436 (0%)	1	0/1214 (0%)	0
Renal artery occlusion	1/2436 (0%)	1	0/1214 (0%)	0
Renal artery stenosis	5/2436 (0.2%)	5	2/1214 (0.2%)	2
Renal dysplasia	0/2436 (0%)	0	1/1214 (0.1%)	1
Renal failure	5/2436 (0.2%)	6	5/1214 (0.4%)	5
Renal failure acute	20/2436 (0.8%)	23	3/1214 (0.2%)	3
Renal failure chronic	2/2436 (0.1%)	2	0/1214 (0%)	0
Renal hypertension	0/2436 (0%)	0	1/1214 (0.1%)	1
Renal impairment	1/2436 (0%)	1	0/1214 (0%)	0
Renal mass	3/2436 (0.1%)	3	0/1214 (0%)	0
Renal tubular necrosis	1/2436 (0%)	1	0/1214 (0%)	0
Renal vessel disorder	1/2436 (0%)	1	0/1214 (0%)	0
Urinary retention	0/2436 (0%)	0	1/1214 (0.1%)	1
Urinary tract disorder	0/2436 (0%)	0	1/1214 (0.1%)	1
Reproductive system and breast disorders
Acute respiratory distress syndrome	0/2436 (0%)	0	1/1214 (0.1%)	1
Benign prostatic hyperplasia	1/2436 (0%)	1	0/1214 (0%)	0
Hydrocele	1/2436 (0%)	1	0/1214 (0%)	0
Prostatitis	1/2436 (0%)	1	1/1214 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	0/2436 (0%)	0	2/1214 (0.2%)	2
Atelectasis	0/2436 (0%)	0	1/1214 (0.1%)	1
Bronchitis chronic	0/2436 (0%)	0	1/1214 (0.1%)	1
Chronic obstructive pulmonary disease	22/2436 (0.9%)	27	10/1214 (0.8%)	11
Cough	1/2436 (0%)	1	1/1214 (0.1%)	1
Dyspnoea	20/2436 (0.8%)	22	7/1214 (0.6%)	8
Dyspnoea exertional	2/2436 (0.1%)	2	6/1214 (0.5%)	6
Hypoxia	2/2436 (0.1%)	2	0/1214 (0%)	0
Increased upper airway secretion	1/2436 (0%)	1	0/1214 (0%)	0
Interstitial lung disease	2/2436 (0.1%)	2	0/1214 (0%)	0
Lung infiltration	1/2436 (0%)	1	0/1214 (0%)	0
Pharyngeal fistula	1/2436 (0%)	1	0/1214 (0%)	0
Pleural disorder	0/2436 (0%)	0	1/1214 (0.1%)	1
Pleural effusion	9/2436 (0.4%)	10	4/1214 (0.3%)	5
Pleurisy	1/2436 (0%)	1	0/1214 (0%)	0
Pleuritic pain	1/2436 (0%)	1	1/1214 (0.1%)	1
Pneumonitis	1/2436 (0%)	1	0/1214 (0%)	0
Pneumothorax	1/2436 (0%)	1	1/1214 (0.1%)	1
Pulmonary embolism	5/2436 (0.2%)	5	7/1214 (0.6%)	7
Pulmonary fibrosis	1/2436 (0%)	1	0/1214 (0%)	0
Pulmonary mass	0/2436 (0%)	0	1/1214 (0.1%)	1
Pulmonary oedema	2/2436 (0.1%)	2	0/1214 (0%)	0
Respiratory disorder	1/2436 (0%)	1	0/1214 (0%)	0
Respiratory distress	3/2436 (0.1%)	3	1/1214 (0.1%)	1
Respiratory failure	7/2436 (0.3%)	7	3/1214 (0.2%)	3
Restrictive pulmonary disease	1/2436 (0%)	1	0/1214 (0%)	0
Sleep apnoea syndrome	3/2436 (0.1%)	3	0/1214 (0%)	0
Throat irritation	1/2436 (0%)	1	0/1214 (0%)	0
Throat tightness	0/2436 (0%)	0	1/1214 (0.1%)	1
Wheezing	1/2436 (0%)	1	0/1214 (0%)	0
Skin and subcutaneous tissue disorders
Cellulitis	12/2436 (0.5%)	12	5/1214 (0.4%)	9
Pruritus	0/2436 (0%)	0	1/1214 (0.1%)	1
Rash	2/2436 (0.1%)	2	0/1214 (0%)	0
Scar pain	1/2436 (0%)	1	0/1214 (0%)	0
Skin burning sensation	1/2436 (0%)	1	0/1214 (0%)	0
Skin ulcer	1/2436 (0%)	1	0/1214 (0%)	0
Stasis dermatitis	1/2436 (0%)	1	0/1214 (0%)	0
Urticaria	0/2436 (0%)	0	1/1214 (0.1%)	1
Surgical and medical procedures
Arterial bypass operation	1/2436 (0%)	1	0/1214 (0%)	0
Arterial stent insertion	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Bladder neoplasm surgery	1/2436 (0%)	1	0/1214 (0%)	0
Cardiac pacemaker insertion	2/2436 (0.1%)	2	0/1214 (0%)	0
Carotid artery stent insertion	0/2436 (0%)	0	1/1214 (0.1%)	1
Carotid endarterectomy	0/2436 (0%)	0	1/1214 (0.1%)	1
Chemotherapy	1/2436 (0%)	1	0/1214 (0%)	0
Cholecystectomy	1/2436 (0%)	1	2/1214 (0.2%)	2
Colostomy closure	1/2436 (0%)	1	0/1214 (0%)	0
Coronary angioplasty	1/2436 (0%)	1	0/1214 (0%)	0
Coronary arterial stent insertion	1/2436 (0%)	1	0/1214 (0%)	0
Coronary artery bypass	1/2436 (0%)	1	0/1214 (0%)	0
Coronary artery bypass graft	0/2436 (0%)	0	1/1214 (0.1%)	1
Coronary revascularisation	1/2436 (0%)	1	1/1214 (0.1%)	1
Fluid replacement	1/2436 (0%)	1	0/1214 (0%)	0
Gastric banding	0/2436 (0%)	0	1/1214 (0.1%)	1
Gastric bypass	0/2436 (0%)	0	1/1214 (0.1%)	1
Hip arthroplasty	1/2436 (0%)	1	1/1214 (0.1%)	1
Implantable defibrillator insertion	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Implantable defibrillator replacement	1/2436 (0%)	1	0/1214 (0%)	0
Knee arthroplasty	3/2436 (0.1%)	3	0/1214 (0%)	0
Lung lobectomy	1/2436 (0%)	1	0/1214 (0%)	0
Nephrectomy	1/2436 (0%)	1	0/1214 (0%)	0
Parathyroid gland operation	1/2436 (0%)	1	0/1214 (0%)	0
Percutaneous coronary intervention	1/2436 (0%)	1	0/1214 (0%)	0
Physiotherapy	0/2436 (0%)	0	1/1214 (0.1%)	1
Renal artery stent placement	1/2436 (0%)	1	0/1214 (0%)	0
Rotator cuff repair	1/2436 (0%)	1	0/1214 (0%)	0
Salivary gland operation	0/2436 (0%)	0	1/1214 (0.1%)	1
Skin neoplasm excision	0/2436 (0%)	0	1/1214 (0.1%)	2
Spinal fusion surgery	0/2436 (0%)	0	1/1214 (0.1%)	1
Spinal laminectomy	0/2436 (0%)	0	1/1214 (0.1%)	1
Spinal operation	1/2436 (0%)	1	0/1214 (0%)	0
Surgery	1/2436 (0%)	1	0/1214 (0%)	0
Transfusion	1/2436 (0%)	1	0/1214 (0%)	0
Ureteral stent insertion	0/2436 (0%)	0	1/1214 (0.1%)	1
Vascular disorders
Aortic aneurysm	3/2436 (0.1%)	3	3/1214 (0.2%)	4
Aortic aneurysm rupture	0/2436 (0%)	0	1/1214 (0.1%)	1
Aortic dissection	0/2436 (0%)	0	1/1214 (0.1%)	1
Arterial thrombosis	1/2436 (0%)	1	0/1214 (0%)	0
Arteriosclerosis	1/2436 (0%)	1	1/1214 (0.1%)	1
Arteriovenous fistula	1/2436 (0%)	1	0/1214 (0%)	0
Carotid artery disease	1/2436 (0%)	1	1/1214 (0.1%)	1
Carotid artery occlusion	1/2436 (0%)	1	0/1214 (0%)	0
Carotid artery stenosis	9/2436 (0.4%)	9	5/1214 (0.4%)	6
Deep vein thrombosis	7/2436 (0.3%)	7	2/1214 (0.2%)	2
Epistaxis	1/2436 (0%)	1	2/1214 (0.2%)	2
Femoral arterial stenosis	4/2436 (0.2%)	7	1/1214 (0.1%)	1
Femoral artery occlusion	4/2436 (0.2%)	4	0/1214 (0%)	0
Gastrointestinal haemorrhage	47/2436 (1.9%)	57	20/1214 (1.6%)	26
Haematemesis	0/2436 (0%)	0	1/1214 (0.1%)	1
Haematochezia	1/2436 (0%)	2	0/1214 (0%)	0
Haematoma	4/2436 (0.2%)	4	0/1214 (0%)	0
Haemoptysis	0/2436 (0%)	0	2/1214 (0.2%)	2
Haemorrhage	1/2436 (0%)	1	1/1214 (0.1%)	1
Hypertension	11/2436 (0.5%)	11	4/1214 (0.3%)	4
Hypertensive crisis	1/2436 (0%)	1	2/1214 (0.2%)	2
Hypotension	13/2436 (0.5%)	13	3/1214 (0.2%)	3
Hypovolaemic shock	1/2436 (0%)	1	1/1214 (0.1%)	1
Iliac artery occlusion	2/2436 (0.1%)	2	1/1214 (0.1%)	1
Intermittent claudication	2/2436 (0.1%)	2	2/1214 (0.2%)	2
Labile hypertension	1/2436 (0%)	1	1/1214 (0.1%)	1
Melaena	1/2436 (0%)	1	0/1214 (0%)	0
Orthostatic hypotension	1/2436 (0%)	1	1/1214 (0.1%)	1
Peripheral ischaemia	8/2436 (0.3%)	10	2/1214 (0.2%)	3
Peripheral vascular disorder	7/2436 (0.3%)	7	1/1214 (0.1%)	1
Peritoneal haemorrhage	1/2436 (0%)	1	0/1214 (0%)	0
Post procedural haemorrhage	3/2436 (0.1%)	3	7/1214 (0.6%)	7
Presyncope	0/2436 (0%)	0	1/1214 (0.1%)	1
Procedural hypotension	0/2436 (0%)	0	1/1214 (0.1%)	1
Pulmonary embolism	1/2436 (0%)	1	0/1214 (0%)	0
Rectal haemorrhage	0/2436 (0%)	0	1/1214 (0.1%)	1
Renal artery stenosis	1/2436 (0%)	1	0/1214 (0%)	0
Renovascular hypertension	0/2436 (0%)	0	1/1214 (0.1%)	1
Retroperitoneal haemorrhage	6/2436 (0.2%)	6	3/1214 (0.2%)	3
Subarachnoid haemorrhage	1/2436 (0%)	1	1/1214 (0.1%)	1
Subclavian steal syndrome	0/2436 (0%)	0	1/1214 (0.1%)	1
Subdural hematoma	2/2436 (0.1%)	3	3/1214 (0.2%)	4
Syncope vasovagal	2/2436 (0.1%)	2	2/1214 (0.2%)	2
Vascular occlusion	1/2436 (0%)	2	1/1214 (0.1%)	1
Vascular pseudoaneurysm	21/2436 (0.9%)	21	7/1214 (0.6%)	7
Vasospasm	0/2436 (0%)	0	1/1214 (0.1%)	1
Wound haemorrhage	0/2436 (0%)	0	1/1214 (0.1%)	1
Other (Not Including Serious) Adverse Events
	XIENCE V®		TAXUS™ EXPRESS 2™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	762/2436 (31.3%)		407/1214 (33.5%)
Cardiac disorders
Angina pectoris	398/2436 (16.3%)	493	198/1214 (16.3%)	236
General disorders
Catheter site haematoma	177/2436 (7.3%)	181	98/1214 (8.1%)	102
Musculoskeletal and connective tissue disorders
Back pain	193/2436 (7.9%)	194	130/1214 (10.7%)	139
Respiratory, thoracic and mediastinal disorders
Dyspnoea	121/2436 (5%)	126	64/1214 (5.3%)	67

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

Investigators will not use Trial related data without written consent of sponsor for any purpose other than Trial completion or generation of publication material. Publication or presentation of results from a trial site are not allowed until publication and/or presentation of multi-center results. Sponsor must receive materials at least 60 days prior to the proposed date of the presentation or the initial submission of proposed publication in order to be reviewed by the sponsor.