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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01178268
• Collaborator: (none)
• Enrollment: 546
• Locations: 2
• Arms: 2
• Duration (Months): 49
• Patients Per Site: 273
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.

Condition or Disease	Intervention/Treatment	Phase
Coronary Occlusion; Thrombosis (Stent Thrombosis); Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis	Device: XIENCE V EECSS; Device: CYPHER SELECT PLUS SECSS	Phase 4

Detailed Description

Objectives

• Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China

• Evaluate patient compliance with dual antiplatelet therapy (DAPT)

• Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization

Study Design

• Study Type: Interventional
• Actual Enrollment: 546 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: XIENCE V EECSS Patients who will receive this stent.	Device: XIENCE V EECSS; Patients who will receive this stent.
Active Comparator: CYPHER SELECT PLUS SECSS Patients who will receive this stent.	Device: CYPHER SELECT PLUS SECSS; Patients who will receive this stent.

Outcome Measures

Primary Outcome Measures

1. In-stent Late Loss (LL) [>=13 months]

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

2. Ischemia-driven Target Vessel Failure (ID-TVF) [12 months]

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

3. Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) [12 months]

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

Secondary Outcome Measures

1. Ischemia-driven Target Vessel Failure (ID-TVF) [30 days]

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

2. Ischemia-driven Target Vessel Failure (ID-TVF) [6 months]

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

3. Ischemia-driven Target Vessel Failure (ID-TVF) [9 months]

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

4. Ischemia-driven Target Vessel Failure (ID-TVF) [24 months]

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

5. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). [30 days]

6. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). [6 months]

7. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) [9 months]

8. Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) [24 months]

9. Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) [12 months]

   The is the major Secondary Efficacy Endpoint.

10. Ischemia-driven Target Lesion Failure (ID-TLF) [30 days]

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

11. Ischemia-driven Target Lesion Failure (ID-TLF) [6 months]

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

12. Ischemia-driven Target Lesion Failure (ID-TLF) [9 months]

    This is one of the Secondary Composite Endpoints.

13. Ischemia-driven Target Lesion Failure (ID-TLF) [12 months]

    This is one of the Secondary Composite Endpoints.

14. Ischemia-driven Target Lesion Failure (ID-TLF) [24 months]

    This is one of the Secondary Composite Endpoints.

15. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) [30 days]

16. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) [6 months]

17. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) [9 months]

18. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) [12 months]

19. Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) [24 months]

20. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [30 days]

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

21. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [6 months]

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

22. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [9 months]

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

23. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [12 months]

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

24. All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) [24 months]

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

25. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [30 days]

26. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [6 months]

27. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [9 months]

28. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [12 months]

29. Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI [24 months]

30. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [30 days]

31. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [6 months]

32. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [9 months]

33. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [12 months]

34. Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) [24 months]

35. All Revascularization (TLR, TVR, and Non-TVR) [30 Days]

36. All Revascularization (TLR, TVR, and Non-TVR) [6 Months]

37. All Revascularization (TLR, TVR, and Non-TVR) [9 Months]

38. All Revascularization (TLR, TVR, and Non-TVR) [12 months]

39. All Revascularization (TLR, TVR, and Non-TVR) [24 months]

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

40. All Death [30 days]

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

41. All Death [6 months]

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

42. All Death [9 months]

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

43. All Death [12 months]

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

44. All Death [24 months]

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

45. All Protocol MI (Including Q-wave or Non-Q-wave) [30 days]

    This is one of the secondary safety endpoint.

46. All Protocol MI (Including Q-wave or Non-Q-wave) [6 months]

    This is one of the secondary safety endpoint.

47. All Protocol MI (Including Q-wave or Non-Q-wave) [9 months]

    This is one of the secondary safety endpoint.

48. All Protocol MI (Including Q-wave or Non-Q-wave) [12 months]

    This is one of the secondary safety endpoint.

49. All Protocol MI (Including Q-wave or Non-Q-wave) [24 months]

    This is one of the secondary safety endpoint.

50. Target Vessel Protocol MI (TV-MI) [30 days]

    This is one of the secondary safety endpoint.

51. Target Vessel Protocol MI (TV-MI) [6 months]

    This is one of the secondary safety endpoint.

52. Target Vessel Protocol MI (TV-MI) [9 months]

    This is one of the secondary safety endpoint.

53. Target Vessel Protocol MI (TV-MI) [12 months]

    This is one of the secondary safety endpoint.

54. Target Vessel Protocol MI (TV-MI) [24 months]

    This is one of the secondary safety endpoint.

55. Major Bleeding Complications [30 days]

    Secondary safety endpoint.

56. Major Bleeding Complications [6 months]

    Secondary safety endpoint.

57. Major Bleeding Complications [9 months]

    Secondary safety endpoint.

58. Major Bleeding Complications [12 months]

    Secondary safety endpoint.

59. Major Bleeding Complications [24 months]

    Secondary safety endpoint.

60. Definite / Probable Stent Thrombosis [Acute (<1 day)]

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

61. Definite / Probable Stent Thrombosis [Subacute (1 - 30 days)]

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

62. Definite / Probable Stent Thrombosis [Early (0 - 30 days)]

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

63. Definite / Probable Stent Thrombosis [Late (31 - 365 days)]

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

64. Definite / Probable Stent Thrombosis [Very late (366 - 772 days)]

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

65. Definite / Probable Stent Thrombosis [Overall (0 - 772 days)]

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

66. Patient Compliance With Dual Antiplatelet Therapy (DAPT) [30 days]

67. Patient Compliance With Dual Antiplatelet Therapy (DAPT) [6 months]

68. Patient Compliance With Dual Antiplatelet Therapy (DAPT) [9 months]

69. Patient Compliance With Dual Antiplatelet Therapy (DAPT) [12 months]

70. Patient Compliance With Dual Antiplatelet Therapy (DAPT) [24 months]

71. Acute Device Success [< or = 1 day]

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

72. Acute Procedure Success [< or = 1 day]

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

73. Procedure Time [On day 0, during the procedure.]

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

74. Amount of Contrast Used [On day 0, during the procedure.]

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

75. Fluoroscopy Time [On day 0, during the procedure.]

    This is the procedure related endpoint.

76. XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire [During the procedure]

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

77. Follow-up Late Loss [≥13 months.]

    This is one of the Secondary Angiographic Endpoint.

78. Follow-up In-stent Minimum Lumen Diameter (MLD) [≥13 months]

79. Follow-up In-stent Percent Diameter Stenosis (DS) [≥13 months]

80. Follow-up In-stent Angiographic Binary Restenosis (ABR) [≥13 months]

81. Follow-up In-segment Minimum Lumen Diameter (MLD) [≥13 months]

82. Follow-up In-segment Percent Diameter Stenosis (DS) [≥13 months]

83. Follow-up In-segment Angiographic Binary Restenosis (ABR) [≥13 months]

84. Percent Diameter Stenosis [pre procedure]

85. Percent Diameter Stenosis (%DS) [post procedure on 0 day]

86. Acute Gain [post procedure on 0 day]

Other Outcome Measures

1. ID-TVF Rate in Patients With Diabetic Disease [24 months]

   ID-TVF rate in All Diabetes patients.

2. ID-TVF Rate in Patients Without Diabetic Disease [24 months]

   ID-TVF rate in Non Diabetes

3. ID-TVF Rate in Single Lesion Treated Subgroup [24 months]

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

4. ID-TVF Rate in Dual Lesion Treated Subgroup [24 months]

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

5. ID-TVF Rate in Single Vessel Treated Subgroup [24 months]

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

6. ID-TVF Rate in Dual Vessel Treated Subgroup [24 months]

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

7. The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease. [24 months]

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

8. The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease [24 months]

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

9. The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup [24 months]

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

10. The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup [24 months]

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

11. The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup [24 months]

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

12. The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup [24 months]

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

13. ID-TLR Rate in Patients With Diabetic Disease. [24 months]

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

14. ID-TLR Rate in Patients Without Diabetic Disease [24 months]

    Ischemia-driven target lesion revascularization rate in Non Diabetes

15. ID-TLR Rate in Single Lesion Treated Subgroup [24 months]

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

16. ID-TLR Rate in Dual Lesion Treated Subgroup [24 months]

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

17. ID-TLR Rate in Single Vessel Treated Subgroup [24 months]

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

18. ID-TLR Rate in Dual Vessel Treated Subgroup [24 months]

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• General Inclusion Criteria

1. Patient must be at least 18 years of age

2. The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure.

3. Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.

4. Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up.

Angiographic Inclusion Criteria

1. Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm.

2. Target lesion(s) must measure ≤ 28 mm in length by visual estimation.

3. A maximum of two de novo lesions can be treated, ie,

4. One lesion in one vessel, OR

5. One lesion in each of two vessels, OR

6. Two lesions in one vessel

Exclusion Criteria:

• General Exclusion Criteria

1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure

2. Patients with known renal insufficiency or failure (eg, serum creatinine level of

2.5 mg/dL, or patient is on dialysis)

1. Patient had an MI within 72 hours and creatine kinase-myocardial band isoenzyme (CK-MB) has not returned to the normal range at the index procedure

2. Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure

3. Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure

4. Left ventricular ejection fraction (LVEF) of < 30%.

5. Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year

6. Patient's current medical condition has a life expectancy of < 2 years

7. Patient meets contraindications of the IFU

Angiographic Exclusion Criteria

1. Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft

2. Lesion located in left main coronary artery

3. Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)

4. 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

5. Total occluded lesions (TIMI=0)

6. Restenotic lesions

7. Thrombus-containing vessel

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

9. Excessive tortuosity proximal to or within the lesion

10. Heavy calcification

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fu Wai Hospital	Beijing		China	100037
2	Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.	Shanghai		China	200122

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Gao Runlin, MD, FACC, Fu Wai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01178268
• Other Study ID Numbers: 10-387
• First Posted: Aug 10, 2010
• Last Update Posted: Aug 24, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Abbott Medical Devices: Drug eluting stents; Stents; Angioplasty
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Thrombosis; Vascular Diseases; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia

Study Results

Participant Flow

Recruitment Details	A total of 488 patients in the Per-protocol (PP) population for final analysis. First Patient Enrolled on August 18, 2010, Last Patient Enrolled on August 31, 2011 and the Final Database Lock was on September 26, 2013. The total patient enrollment rate was 0.5 patients/site/week based on 489 patients enrolled over 54 weeks at 20 sites.
Pre-assignment Detail	All of the 546 patients, 57 (28:XIENCE;29:CYPHER)were excluded from the Per-protocol (PP) population, leaving a baseline population of 489 patients. Whereas because of patient disposition results in a total of 488 patients in the PP population for final analysis.

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Period Title: Overall Study
STARTED	367	121
COMPLETED	360	120
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS	Total
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.	Total of all reporting groups
Overall Participants	367	121	488
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.60 (10.65)	58.74 (9.12)	58.64 (10.28)
Age, Customized (participants) [Number]
Age ≥ 65 years	95 25.9%	33 27.3%	128 26.2%
Age < 65 years	272 74.1%	88 72.7%	360 73.8%
Sex: Female, Male (Count of Participants)
Female	95 25.9%	40 33.1%	135 27.7%
Male	272 74.1%	81 66.9%	353 72.3%
Race/Ethnicity, Customized (participants) [Number]
Chinese	367 100%	121 100%	488 100%
Region of Enrollment (participants) [Number]
China	367 100%	121 100%	488 100%

Outcome Measures

1. Primary Outcome

Title	In-stent Late Loss (LL)
Description	This is the primary angiographic endpoint. In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)
Time Frame	>=13 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	279	98
Measure Lesions	279	98
Mean (Standard Deviation) [Millimeter]	0.19 (0.28)	0.21 (0.28)

2. Primary Outcome

Title	Ischemia-driven Target Vessel Failure (ID-TVF)
Description	This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number (95% Confidence Interval) [percentage of participants]	4.4 1.2%	6.6 5.5%

3. Primary Outcome

Title	Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Description	The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number (95% Confidence Interval) [percentage of participants]	1.6 0.4%	1.7 1.4%

4. Secondary Outcome

Title	Ischemia-driven Target Vessel Failure (ID-TVF)
Description	Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

5. Secondary Outcome

Title	Ischemia-driven Target Vessel Failure (ID-TVF)
Description	Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

6. Secondary Outcome

Title	Ischemia-driven Target Vessel Failure (ID-TVF)
Description	Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.4 0.4%	3.3 2.7%

7. Secondary Outcome

Title	Ischemia-driven Target Vessel Failure (ID-TVF)
Description	Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	4.7 1.3%	7.4 6.1%

8. Secondary Outcome

Title	Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

9. Secondary Outcome

Title	Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

10. Secondary Outcome

Title	Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.4 0.4%	1.7 1.4%

11. Secondary Outcome

Title	Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	1.9 0.5%	1.7 1.4%

12. Secondary Outcome

Title	Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
Description	The is the major Secondary Efficacy Endpoint.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number (95% Confidence Interval) [percentage of participants]	1.9 0.5%	3.3 2.7%

13. Secondary Outcome

Title	Ischemia-driven Target Lesion Failure (ID-TLF)
Description	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

14. Secondary Outcome

Title	Ischemia-driven Target Lesion Failure (ID-TLF)
Description	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

15. Secondary Outcome

Title	Ischemia-driven Target Lesion Failure (ID-TLF)
Description	This is one of the Secondary Composite Endpoints.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.4 0.4%	2.5 2.1%

16. Secondary Outcome

Title	Ischemia-driven Target Lesion Failure (ID-TLF)
Description	This is one of the Secondary Composite Endpoints.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	3.5 1%	5.0 4.1%

17. Secondary Outcome

Title	Ischemia-driven Target Lesion Failure (ID-TLF)
Description	This is one of the Secondary Composite Endpoints.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	3.9 1.1%	5.0 4.1%

18. Secondary Outcome

Title	Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

19. Secondary Outcome

Title	Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

20. Secondary Outcome

Title	Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.4 0.4%	1.7 1.4%

21. Secondary Outcome

Title	Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.6 0.4%	1.7 1.4%

22. Secondary Outcome

Title	Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	1.7 0.5%	1.7 1.4%

23. Secondary Outcome

Title	All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description	This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	1.7 1.4%

24. Secondary Outcome

Title	All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description	This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.6 0.4%	2.5 2.1%

25. Secondary Outcome

Title	All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description	This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	2.2 0.6%	5.0 4.1%

26. Secondary Outcome

Title	All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description	This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	6.3 1.7%	10.7 8.8%

27. Secondary Outcome

Title	All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
Description	This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	8.5 2.3%	11.6 9.6%

28. Secondary Outcome

Title	Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

29. Secondary Outcome

Title	Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

30. Secondary Outcome

Title	Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.4 0.4%	1.7 1.4%

31. Secondary Outcome

Title	Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.6 0.4%	1.7 1.4%

32. Secondary Outcome

Title	Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	1.9 0.5%	1.7 1.4%

33. Secondary Outcome

Title	Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

34. Secondary Outcome

Title	Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

35. Secondary Outcome

Title	Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.4 0.4%	2.5 2.1%

36. Secondary Outcome

Title	Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	3.5 1%	5.0 4.1%

37. Secondary Outcome

Title	Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	3.9 1.1%	5.0 4.1%

38. Secondary Outcome

Title	All Revascularization (TLR, TVR, and Non-TVR)
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.3 0.1%	0.8 0.7%

39. Secondary Outcome

Title	All Revascularization (TLR, TVR, and Non-TVR)
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.5 0.1%	1.7 1.4%

40. Secondary Outcome

Title	All Revascularization (TLR, TVR, and Non-TVR)
Time Frame	9 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	3.3 2.7%

41. Secondary Outcome

Title	All Revascularization (TLR, TVR, and Non-TVR)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	4.6 1.3%	9.1 7.5%

42. Secondary Outcome

Title	All Revascularization (TLR, TVR, and Non-TVR)
Description	One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	6.6 1.8%	9.9 8.2%

43. Secondary Outcome

Title	All Death
Description	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.0 0%	0.0 0%

44. Secondary Outcome

Title	All Death
Description	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.3 0.1%	0.0 0%

45. Secondary Outcome

Title	All Death
Description	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.5 0.1%	0.8 0.7%

46. Secondary Outcome

Title	All Death
Description	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.5 0.1%	0.8 0.7%

47. Secondary Outcome

Title	All Death
Description	This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

48. Secondary Outcome

Title	All Protocol MI (Including Q-wave or Non-Q-wave)
Description	This is one of the secondary safety endpoint.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

49. Secondary Outcome

Title	All Protocol MI (Including Q-wave or Non-Q-wave)
Description	This is one of the secondary safety endpoint.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

50. Secondary Outcome

Title	All Protocol MI (Including Q-wave or Non-Q-wave)
Description	This is one of the secondary safety endpoint.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

51. Secondary Outcome

Title	All Protocol MI (Including Q-wave or Non-Q-wave)
Description	This is one of the secondary safety endpoint.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

52. Secondary Outcome

Title	All Protocol MI (Including Q-wave or Non-Q-wave)
Description	This is one of the secondary safety endpoint.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

53. Secondary Outcome

Title	Target Vessel Protocol MI (TV-MI)
Description	This is one of the secondary safety endpoint.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

54. Secondary Outcome

Title	Target Vessel Protocol MI (TV-MI)
Description	This is one of the secondary safety endpoint.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

55. Secondary Outcome

Title	Target Vessel Protocol MI (TV-MI)
Description	This is one of the secondary safety endpoint.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.8 0.2%	0.8 0.7%

56. Secondary Outcome

Title	Target Vessel Protocol MI (TV-MI)
Description	This is one of the secondary safety endpoint.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

57. Secondary Outcome

Title	Target Vessel Protocol MI (TV-MI)
Description	This is one of the secondary safety endpoint.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	363	121
Number [percentage of participants]	1.1 0.3%	0.8 0.7%

58. Secondary Outcome

Title	Major Bleeding Complications
Description	Secondary safety endpoint.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.0 0%	0.0 0%

59. Secondary Outcome

Title	Major Bleeding Complications
Description	Secondary safety endpoint.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.0 0%	0.0 0%

60. Secondary Outcome

Title	Major Bleeding Complications
Description	Secondary safety endpoint.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	366	121
Number [percentage of participants]	0.0 0%	0.0 0%

61. Secondary Outcome

Title	Major Bleeding Complications
Description	Secondary safety endpoint.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	365	121
Number [percentage of participants]	0.5 0.1%	0.0 0%

62. Secondary Outcome

Title	Major Bleeding Complications
Description	Secondary safety endpoint.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	360	120
Number [percentage of participants]	0.8 0.2%	0.0 0%

63. Secondary Outcome

Title	Definite / Probable Stent Thrombosis
Description	Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame	Acute (<1 day)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.27 0.1%	0.00 0%

64. Secondary Outcome

Title	Definite / Probable Stent Thrombosis
Description	Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame	Subacute (1 - 30 days)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.27 0.1%	0.00 0%

65. Secondary Outcome

Title	Definite / Probable Stent Thrombosis
Description	Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame	Early (0 - 30 days)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.54 0.1%	0.00 0%

66. Secondary Outcome

Title	Definite / Probable Stent Thrombosis
Description	Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame	Late (31 - 365 days)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.00 0%	0.00 0%

67. Secondary Outcome

Title	Definite / Probable Stent Thrombosis
Description	Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame	Very late (366 - 772 days)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.00 0%	0.00 0%

68. Secondary Outcome

Title	Definite / Probable Stent Thrombosis
Description	Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.
Time Frame	Overall (0 - 772 days)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	0.54 0.1%	0.00 0%

69. Secondary Outcome

Title	Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	362	121
Number [percentage of participants]	99.2 27%	99.2 82%

70. Secondary Outcome

Title	Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	362	121
Number [percentage of participants]	99.2 27%	97.5 80.6%

71. Secondary Outcome

Title	Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	362	121
Number [percentage of participants]	98.1 26.7%	95.9 79.3%

72. Secondary Outcome

Title	Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	362	121
Number [percentage of participants]	94.5 25.7%	93.4 77.2%

73. Secondary Outcome

Title	Patient Compliance With Dual Antiplatelet Therapy (DAPT)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	362	121
Number [percentage of participants]	58.0 15.8%	55.4 45.8%

74. Secondary Outcome

Title	Acute Device Success
Description	Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.
Time Frame	< or = 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Measure Target lesions	399	129
Number [percentage of participants]	97.2 26.5%	98.4 81.3%

75. Secondary Outcome

Title	Acute Procedure Success
Description	Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay.
Time Frame	< or = 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Number [percentage of participants]	98.1 26.7%	99.2 82%

76. Secondary Outcome

Title	Procedure Time
Description	This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.
Time Frame	On day 0, during the procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Median (Standard Deviation) [Minutes]	29.6 (19.3)	28.6 (15.8)

77. Secondary Outcome

Title	Amount of Contrast Used
Description	Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.
Time Frame	On day 0, during the procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Median (Standard Deviation) [Milliliter]	132.1 (53.2)	145.4 (59.2)

78. Secondary Outcome

Title	Fluoroscopy Time
Description	This is the procedure related endpoint.
Time Frame	On day 0, during the procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Median (Standard Deviation) [Minutes]	7.0 (4.7)	7.4 (4.7)

79. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V EECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.
Measure Participants	367
Number [percentage of participants]	93.2 25.4%

80. Secondary Outcome

Title	Follow-up Late Loss
Description	This is one of the Secondary Angiographic Endpoint.
Time Frame	≥13 months.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	279	98
Measure Target lesions	279	98
In-Segment	0.15 (0.35)	0.27 (0.35)
Proximal	0.20 (0.34)	0.33 (0.39)
Distal	0.11 (0.32)	0.20 (0.33)

81. Secondary Outcome

Title	Follow-up In-stent Minimum Lumen Diameter (MLD)
Time Frame	≥13 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	280	98
Measure Target lesions	280	98
Mean (Standard Deviation) [Millimeter]	2.62 (0.50)	2.63 (0.48)

82. Secondary Outcome

Title	Follow-up In-stent Percent Diameter Stenosis (DS)
Time Frame	≥13 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	280	98
Measure Target lesions	280	98
Mean (Standard Deviation) [percent Diameter stenosis]	10.56 (10.18)	11.82 (10.30)

83. Secondary Outcome

Title	Follow-up In-stent Angiographic Binary Restenosis (ABR)
Time Frame	≥13 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	280	98
Measure Target lesions	280	98
Number [percentage of participants]	1.1 0.3%	1.0 0.8%

84. Secondary Outcome

Title	Follow-up In-segment Minimum Lumen Diameter (MLD)
Time Frame	≥13 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	280	98
Measure Target lesions	280	98
Mean (Standard Deviation) [Millimeter]	2.34 (0.52)	2.33 (0.50)

85. Secondary Outcome

Title	Follow-up In-segment Percent Diameter Stenosis (DS)
Time Frame	≥13 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	280	98
Measure Target lesions	280	98
Mean (Standard Deviation) [percent Diameter stenosis]	16.79 (12.36)	18.79 (12.42)

86. Secondary Outcome

Title	Follow-up In-segment Angiographic Binary Restenosis (ABR)
Time Frame	≥13 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	280	98
Measure Target lesions	280	98
Number [percentage of participants]	2.1 0.6%	3.1 2.6%

87. Secondary Outcome

Title	Percent Diameter Stenosis
Time Frame	pre procedure

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Measure Target lesions	398	129
Mean (Standard Deviation) [percent Diameter stenosis]	64.97 (11.90)	64.95 (12.01)

88. Secondary Outcome

Title	Percent Diameter Stenosis (%DS)
Time Frame	post procedure on 0 day

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Measure Target lesions	398	129
in-stent %DS	8.09 (6.31)	8.56 (5.78)
in-segment %DS	14.40 (8.09)	12.46 (7.41)

89. Secondary Outcome

Title	Acute Gain
Time Frame	post procedure on 0 day

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	367	121
Measure Target lesions	398	129
In-Stent	1.79 (0.44)	1.77 (0.43)
In-Segment	1.48 (0.49)	1.52 (0.44)
Proximal	2.03 (0.53)	2.06 (0.49)
Distal	1.54 (0.54)	1.60 (0.51)

90. Other Pre-specified Outcome

Title	ID-TVF Rate in Patients With Diabetic Disease
Description	ID-TVF rate in All Diabetes patients.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	87	29
Number [percentage of participants]	5.7 1.6%	13.8 11.4%

91. Other Pre-specified Outcome

Title	ID-TVF Rate in Patients Without Diabetic Disease
Description	ID-TVF rate in Non Diabetes
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	272	91
Number [percentage of participants]	4.4 1.2%	5.5 4.5%

92. Other Pre-specified Outcome

Title	ID-TVF Rate in Single Lesion Treated Subgroup
Description	ID-TVF rate in Patients with single lesion treated during the index procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	332	113
Number [percentage of participants]	4.8 1.3%	7.1 5.9%

93. Other Pre-specified Outcome

Title	ID-TVF Rate in Dual Lesion Treated Subgroup
Description	ID-TVF rate in Patients with dual lesion treated during the index procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	30	8
Number [percentage of participants]	3.3 0.9%	12.5 10.3%

94. Other Pre-specified Outcome

Title	ID-TVF Rate in Single Vessel Treated Subgroup
Description	ID-TVF rate in Patients with single vessels treated during the index procedure.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	339	114
Number [percentage of participants]	4.7 1.3%	7.0 5.8%

95. Other Pre-specified Outcome

Title	ID-TVF Rate in Dual Vessel Treated Subgroup
Description	ID-TVF rate in Patients with dual vessel treated during the index procedure.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	24	7
Number [percentage of participants]	4.2 1.1%	14.3 11.8%

96. Other Pre-specified Outcome

Title	The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.
Description	The composite of ST, all death, and all MI rate in All Diabetes patients.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	87	29
Number [percentage of participants]	1.1 0.3%	3.4 2.8%

97. Other Pre-specified Outcome

Title	The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease
Description	The composite of ST, all death, and all MI rate in Non Diabetes
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	272	91
Number [percentage of participants]	2.2 0.6%	1.1 0.9%

98. Other Pre-specified Outcome

Title	The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup
Description	The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	332	113
Number [percentage of participants]	1.8 0.5%	1.8 1.5%

99. Other Pre-specified Outcome

Title	The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup
Description	The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	30	8
Number [percentage of participants]	3.3 0.9%	0.0 0%

100. Other Pre-specified Outcome

Title	The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup
Description	The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	339	114
Number [percentage of participants]	1.8 0.5%	1.8 1.5%

101. Other Pre-specified Outcome

Title	The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup
Description	The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	24	7
Number [percentage of participants]	4.2 1.1%	0.0 0%

102. Other Pre-specified Outcome

Title	ID-TLR Rate in Patients With Diabetic Disease.
Description	Ischemia-driven target lesion revascularization rate in All Diabetes patients.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	87	29
Number [percentage of participants]	3.4 0.9%	3.4 2.8%

103. Other Pre-specified Outcome

Title	ID-TLR Rate in Patients Without Diabetic Disease
Description	Ischemia-driven target lesion revascularization rate in Non Diabetes
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	272	91
Number [percentage of participants]	1.8 0.5%	3.3 2.7%

104. Other Pre-specified Outcome

Title	ID-TLR Rate in Single Lesion Treated Subgroup
Description	Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	332	113
Number [percentage of participants]	2.4 0.7%	2.7 2.2%

105. Other Pre-specified Outcome

Title	ID-TLR Rate in Dual Lesion Treated Subgroup
Description	Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	30	8
Number [percentage of participants]	0.00 0%	12.5 10.3%

106. Other Pre-specified Outcome

Title	ID-TLR Rate in Single Vessel Treated Subgroup
Description	Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	339	114
Number [percentage of participants]	2.4 0.7%	2.6 2.1%

107. Other Pre-specified Outcome

Title	ID-TLR Rate in Dual Vessel Treated Subgroup
Description	Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	XIENCE V EECSS	CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.	Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
Measure Participants	24	7
Number [percentage of participants]	0.0 0%	14.3 11.8%

Adverse Events

Time Frame	2 Years
Arm/Group Title	XIENCE V EECSS		CYPHER SELECT PLUS SECSS
Arm/Group Description	Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent.		Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent.
All Cause Mortality
	XIENCE V EECSS		CYPHER SELECT PLUS SECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	XIENCE V EECSS		CYPHER SELECT PLUS SECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/360 (14.7%)		24/120 (20%)
Blood and lymphatic system disorders
Thrombocytopenic Purpura	1/360 (0.3%)	1	0/120 (0%)	0
Cardiac disorders
Angina	7/360 (1.9%)	8	3/120 (2.5%)	3
Arrhythmia	1/360 (0.3%)	1	0/120 (0%)	0
Atrioventricular Block (AVB)	1/360 (0.3%)	1	0/120 (0%)	0
Coronary Artery Disease	1/360 (0.3%)	1	1/120 (0.8%)	1
Coronary Dissection	1/360 (0.3%)	1	0/120 (0%)	0
Coronary Heart Disease	1/360 (0.3%)	1	1/120 (0.8%)	1
Fibrillation Atrial	2/360 (0.6%)	2	0/120 (0%)	0
Hear Failure	1/360 (0.3%)	1	2/120 (1.7%)	3
Unstable Angina	4/360 (1.1%)	5	3/120 (2.5%)	3
Extrasystole; Fibrillation Atrial	0/360 (0%)	0	1/120 (0.8%)	2
Coronary heart disease (CHD), Coronary Revascularization	0/360 (0%)	0	1/120 (0.8%)	1
Paroxysmal Atrial Fibrillation	0/360 (0%)	0	1/120 (0.8%)	3
Gastrointestinal disorders
Gastric Ulcer With Bleeding	1/360 (0.3%)	1	0/120 (0%)	0
Gastrointestinal Bleeding	1/360 (0.3%)	1	0/120 (0%)	0
Melena	2/360 (0.6%)	2	0/120 (0%)	0
Upper Gastrointestinal Bleeding	1/360 (0.3%)	1	2/120 (1.7%)	2
General disorders
Chest Pain	3/360 (0.8%)	3	1/120 (0.8%)	1
Death	3/360 (0.8%)	3	0/120 (0%)	0
Investigations
Creatine kinase MB (CK-MB) increased	1/360 (0.3%)	1	0/120 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver Cancer	0/360 (0%)	0	1/120 (0.8%)	1
Nervous system disorders
Subarachnoid Hemorrhage	1/360 (0.3%)	1	0/120 (0%)	0
Syncope	1/360 (0.3%)	1	0/120 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory Fail, Chronic Bronchitis	1/360 (0.3%)	1	0/120 (0%)	0
Surgical and medical procedures
Non-Targeted Vessel Revascularization	1/360 (0.3%)	1	0/120 (0%)	0
Restenosis	3/360 (0.8%)	3	3/120 (2.5%)	4
Revascularization	9/360 (2.5%)	9	0/120 (0%)	0
Target Lesion Revascularization	2/360 (0.6%)	2	1/120 (0.8%)	1
Non-Target Vascular Stenosis	2/360 (0.6%)	2	0/120 (0%)	0
Target Vessel Revasculization	0/360 (0%)	0	1/120 (0.8%)	1
Non-Target Vessel Restenosis	0/360 (0%)	0	1/120 (0.8%)	1
Vascular disorders
Vascular Stenosis	1/360 (0.3%)	1	1/120 (0.8%)	1
Other (Not Including Serious) Adverse Events
	XIENCE V EECSS		CYPHER SELECT PLUS SECSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/360 (8.9%)		14/120 (11.7%)
Cardiac disorders
Angina	1/360 (0.3%)	1	1/120 (0.8%)	1
Coronary Artery Disease	1/360 (0.3%)	1	0/120 (0%)	0
Myocardial infarction (MI)	1/360 (0.3%)	1	0/120 (0%)	0
Gastrointestinal disorders
Melena	1/360 (0.3%)	1	0/120 (0%)	0
Gastrorrhagia	0/360 (0%)	0	1/120 (0.8%)	1
General disorders
Chest Distress Because Of Air Pollution	1/360 (0.3%)	1	0/120 (0%)	0
Chest Distress Occasionally	1/360 (0.3%)	1	1/120 (0.8%)	1
Chest Pain Happens More Frequently	1/360 (0.3%)	1	0/120 (0%)	0
Chest Tightness	1/360 (0.3%)	1	1/120 (0.8%)	1
Premature Beat	1/360 (0.3%)	1	0/120 (0%)	0
Breathing Difficulty	0/360 (0%)	0	1/120 (0.8%)	1
Investigations
Creatine kinase-MB (CK-MB0 Increase	1/360 (0.3%)	1	0/120 (0%)	0
Cardiac troponin T increased (cTnI)	6/360 (1.7%)	6	2/120 (1.7%)	2
Cardiac troponin T of Post-Procedure Increased	1/360 (0.3%)	1	0/120 (0%)	0
The Cardiac Enzyme Is Higher	1/360 (0.3%)	1	0/120 (0%)	0
Abnormal troponin I (TnI)	1/360 (0.3%)	1	0/120 (0%)	0
Troponin I (TnI) Increase	5/360 (1.4%)	5	2/120 (1.7%)	2
Troponin I (TnI) Increase Significantly	2/360 (0.6%)	2	1/120 (0.8%)	1
Troponin I (TnI) Of Post Procedure Increased	2/360 (0.6%)	2	2/120 (1.7%)	2
Troponin T (TnT) of Post Procedure Increased	1/360 (0.3%)	1	0/120 (0%)	0
Respiratory, thoracic and mediastinal disorders
Nasal Bleeding	0/360 (0%)	0	1/120 (0.8%)	1
Surgical and medical procedures
Peri-procedural PCI and MI	2/360 (0.6%)	2	0/120 (0%)	0
Vessel Interlayer	1/360 (0.3%)	1	0/120 (0%)	0
Complication of percutaneous coronary intervention (PCI) Procedure	0/360 (0%)	0	1/120 (0.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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