XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01086228
• Collaborator: (none)
• Enrollment: 2,010
• Locations: 47
• Duration (Months): 77
• Patients Per Site: 42.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

Condition or Disease	Intervention/Treatment	Phase
Angina; Chronic Coronary Occlusion; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis	Device: XIENCE V / PROMUS stent

Detailed Description

The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.

Study Design

• Study Type: Observational
• Actual Enrollment: 2010 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
XIENCE V / PROMUS stent Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.	Device: XIENCE V / PROMUS stent; Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Stent Thrombosis (ST) as Per ARC Definition [Post Procedure to 1 Year]

   Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up

2. Number of Participants With Stent Thrombosis (ST) as Per ARC Definition [From 1 Year to 2 Years]

   Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up

3. Number of Participants With Stent Thrombosis (ST) as Per ARC Definition [From 2 years to 3 years]

   Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up

Secondary Outcome Measures

1. Number of Participants With Adverse Events Related to Anti-platelet Medication [From post-procedure to 1 year]

2. Number of Participants With Adverse Events Related to Anti-platelet Medication [From 1 year to 2 years]

3. Number of Participants With Adverse Events Related to Anti-platelet Medication [From 2 years to 3 years]

4. Number of Participants With Adverse Events Related to Anti-platelet Medication [From 3 years to 4 years]

5. Number of Participants With Adverse Events Related to Anti-platelet Medication [From 4 years to 5 years]

6. Percent Diameter Stenosis (%DS) [Baseline]

   Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

7. Percent Diameter Stenosis (%DS) [On day 0 after procedure]

   Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

8. Percent Diameter Stenosis (%DS) [At 8 months]

   Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

9. Acute Gain [On day 0 after procedure]

   The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

10. Late Loss [On day 0 after procedure]

    Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].

11. Net Gain [On day 0 after procedure]

    Net Gain = Acute Gain - Late Loss, paired analysis only.

12. Acute Success [On day 0 (Immediately post-index procedure)]

    Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met: Stent was successfully delivered to the intended location Stent was successfully deployed at the intended location Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure.

13. Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) [Post Procedure to 1 Year]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

14. Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) [From 1 to 2 years]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

15. Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) [From 2 years to 3 years]

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

16. Number of Participants With Myocardial Infarctions (MI) [Post Procedure to 1 Year]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

17. Number of Participants With Myocardial Infarctions (MI) [From 1 year to 2 years]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

18. Number of Participants With Myocardial Infarctions (MI) [From 2 years to 3 years]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

19. Number of Participants With Target Lesion Revascularization (TLR) [Post Procedure to 1 Year]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

20. Number of Participants With Target Lesion Revascularization (TLR) [From 1 year to 2 years]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

21. Number of Participants With Target Lesion Revascularization (TLR) [From 2 years to 3 years]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.

22. Number of Participants With Target Vessel Revascularization (TVR) [Post Procedure to 1 Year]

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

23. Number of Participants With Target Vessel Revascularization (TVR) [From 1 Year to 2 Years]

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

24. Number of Participants With Target Vessel Revascularization (TVR) [From 2 Years to 3 Years]

    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

25. Number of Participants With Cardiac Death and All MI [Post Procedure to 1 Year]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

26. Number of Participants With Cardiac Death and All MI [From 1 Year to 2 Years]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

27. Number of Participants With Cardiac Death and All MI [From 2 Years to 3 Years]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

28. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [Post Procedure to 1 Year]

29. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [From 1 Year to 2 Years]

30. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) [From 2 Years to 3 Years]

31. Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [Post Procedure to 1 Year]

32. Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [From 1 Year to 2 Years]

33. Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR [From 2 Years to 3 Years]

34. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [Post Procedure to 1 Year]

35. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [From 1 Year to 2 Years]

36. Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) [From 2 Years to 3 Years]

37. Number of Participants With All Deaths and All MI [Post Procedure to 1 Year]

38. Number of Participants With All Deaths and All MI [From 1 Year to 2 Years]

39. Number of Participants With All Deaths and All MI [From 2 Years to 3 Years]

40. Number of Participants With All Deaths, All MI and All Revascularization [Post Procedure to 1 Year]

41. Number of Participants With All Deaths, All MI and All Revascularization [From 1 Year to 2 Years]

42. Number of Participants With All Deaths, All MI and All Revascularization [From 2 Years to 3 Years]

43. Number of Participants With All Deaths, TVMI and TLR [Post Procedure to 1 Year]

44. Number of Participants With All Deaths, TVMI and TLR [From 1 Year to 2 Years]

45. Number of Participants With All Deaths, TVMI and TLR [From 2 Years to 3 Years]

46. Number of Participants With All Deaths, TVMI and CI-TLR [Post Procedure to 1 Year]

47. Number of Participants With All Deaths, TVMI and CI-TLR [From 1 Year to 2 Years]

48. Number of Participants With All Deaths, TVMI and CI-TLR [From 2 Years to 3 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Exclusion Criteria:

• Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 104727	Aichi		Japan
2	Site Reference ID/Investigator# 113428	Aichi		Japan
3	Site Reference ID/Investigator# 115745	Aichi		Japan
4	Site Reference ID/Investigator# 104424	Chiba		Japan
5	Site Reference ID/Investigator# 113645	Chiba		Japan
6	Site Reference ID/Investigator# 105015	Ehime		Japan
7	Site Reference ID/Investigator# 105148	Fukuoka		Japan
8	Site Reference ID/Investigator# 105177	Fukuoka		Japan
9	Site Reference ID/Investigator# 104677	Gifu		Japan
10	Site Reference ID/Investigator# 104365	Gunma		Japan
11	Site Reference ID/Investigator# 105038	Hiroshima		Japan
12	Site Reference ID/Investigator# 105043	Hiroshima		Japan
13	Site Reference ID/Investigator# 104236	Hokkaido		Japan
14	Site Reference ID/Investigator# 105963	Hyogo		Japan
15	Site Reference ID/Investigator# 104326	Ibaraki		Japan
16	Site Reference ID/Investigator# 104606	Ishikawa		Japan
17	Site Reference ID/Investigator# 104607	Ishikawa		Japan
18	Site Reference ID/Investigator# 104528	Kanagawa		Japan
19	Site Reference ID/Investigator# 104536	Kanagawa		Japan
20	Site Reference ID/Investigator#104563	Kanagawa		Japan
21	Site Reference ID/Investigator# 104837	Kyoto		Japan
22	Site Reference ID/Investigator# 104838	Kyoto		Japan
23	Site Reference ID/Investigator# 104843	Kyoto		Japan
24	Site Reference ID/Investigator# 104844	Kyoto		Japan
25	Site Reference ID/Investigator# 104850	Kyoto		Japan
26	Site Reference ID/Investigator# 104658	Nagano		Japan
27	Site Reference ID/Investigator# 104990	Nara		Japan
28	Site Reference ID/Investigator# 105027	Okayama		Japan
29	Site Reference ID/Investigator# 105296	Okinawa		Japan
30	Site Reference ID/Investigator# 104864	Osaka		Japan
31	Site Reference ID/Investigator# 104898	Osaka		Japan
32	Site Reference ID/Investigator# 104906	Osaka		Japan
33	Site Reference ID/Investigator# 114863	Osaka		Japan
34	Site Reference ID/Investigator# 104407	Saitama		Japan
35	Site Reference ID/Investigator# 106044	Saitama		Japan
36	Site Reference ID/Investigator# 104697	Shizuoka		Japan
37	Site Reference ID/Investigator# 104356	Tochigi		Japan
38	Site Reference ID/Investigator# 105092	Tokushima		Japan
39	Site Reference ID/Investigator# 104448	Tokyo		Japan
40	Site Reference ID/Investigator# 104454	Tokyo		Japan
41	Site Reference ID/Investigator# 104473	Tokyo		Japan
42	Site Reference ID/Investigator# 104497	Tokyo		Japan
43	Site Reference ID/Investigator# 104510	Tokyo		Japan
44	Site Reference ID/Investigator# 104514	Tokyo		Japan
45	Site Reference ID/Investigator#104481	Tokyo		Japan
46	Site Reference ID/Investigator # 104285	Yamagata		Japan
47	Site Reference ID/Investigator# 104294	Yamagata		Japan

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Gary Thompson, Abbott Medical Devices

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01086228
• Other Study ID Numbers: 09-384
• First Posted: Mar 15, 2010
• Last Update Posted: Feb 19, 2018
• Last Verified: Aug 1, 2017

• 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 2010 patients were registered. Of which 1 patient was excluded from this analysis. Therefore, 2009 patients (1,159 patients treated with XIENCE V; 850 patients treated with PROMUS) were included in the analysis.
Pre-assignment Detail	Study has excluded those patients who were treated with stents other than CoCr-EES (XIENCE V or PROMUS), or underwent concomitant treatment of a graft vessel. Patients were invited to enroll in the study after apparently successful per-cutaneous coronary intervention (PCI).

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Period Title: 8 Month Follow-up
STARTED	2009
COMPLETED	1938
NOT COMPLETED	71
Period Title: 8 Month Follow-up
STARTED	1938
COMPLETED	1894
NOT COMPLETED	44
Period Title: 8 Month Follow-up
STARTED	1894
COMPLETED	1834
NOT COMPLETED	60
Period Title: 8 Month Follow-up
STARTED	1834
COMPLETED	1767
NOT COMPLETED	67
Period Title: 8 Month Follow-up
STARTED	1767
COMPLETED	1664
NOT COMPLETED	103
Period Title: 8 Month Follow-up
STARTED	1664
COMPLETED	1012
NOT COMPLETED	652

Baseline Characteristics

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Overall Participants	2009
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	70.0 (10.1)
Sex: Female, Male (Count of Participants)
Female	481 23.9%
Male	1528 76.1%
Region of Enrollment (participants) [Number]
Japan	2009 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Description	Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	2009
Definite Stent Thrombosis	6 0.3%
Probable Stent Thrombosis	2 0.1%
Possible Stent Thrombosis	6 0.3%

2. Primary Outcome

Title	Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Description	Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1894
Definite Stent Thrombosis	0 0%
Probable Stent Thrombosis	0 0%
Possible Stent Thrombosis	5 0.2%

3. Primary Outcome

Title	Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Description	Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time Frame	From 2 years to 3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1834
Definite Stent Thrombosis	0 0%
Probable Stent Thrombosis	0 0%
Possible Stent Thrombosis	4 0.2%

4. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Time Frame	From post-procedure to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	2009
Abnormal Non-Cardiac Lab Value/Test	13 0.6%
Allergic Reaction	10 0.5%
Bleeding	32 1.6%
Cardiac	3 0.1%
Cancer/Tumor	0 0%
Gastro-intestinal	4 0.2%
General/Musculoskeletal/Connective	7 0.3%
Genito-urinary and renal disorder	0 0%
Neurological/Psychiatric disorders	3 0.1%
Vascular	4 0.2%

5. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Time Frame	From 1 year to 2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1894
Abnormal Non-Cardiac Lab Value/Test	2 0.1%
Allergic Reaction	0 0%
Bleeding	5 0.2%
Cardiac	0 0%
Cancer/Tumor	1 0%
Gastro-intestinal	0 0%
General/Musculoskeletal/Connective	0 0%
Genito-urinary and renal disorder	1 0%
Neurological/Psychiatric disorders	0 0%
Vascular	0 0%

6. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Time Frame	From 2 years to 3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1834
Abnormal Non-Cardiac Lab Value/Test	2 0.1%
Allergic Reaction	0 0%
Bleeding	3 0.1%
Cardiac	1 0%
Cancer/Tumor	0 0%
Gastro-intestinal	0 0%
General/Musculoskeletal/Connective	0 0%
Genito-urinary and renal disorder	0 0%
Neurological/Psychiatric disorders	1 0%
Vascular	0 0%

7. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Time Frame	From 3 years to 4 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1767
Abnormal Non-Cardiac Lab Value/Test	0 0%
Allergic Reaction	0 0%
Bleeding	9 0.4%
Cardiac	0 0%
Cancer/Tumor	0 0%
Gastro-intestinal	0 0%
General/Musculoskeletal/Connective	1 0%
Genito-urinary and renal disorder	0 0%
Neurological/Psychiatric disorders	1 0%
Vascular	2 0.1%

8. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Time Frame	From 4 years to 5 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1664
Abnormal Non-Cardiac Lab Value/Test	0 0%
Allergic Reaction	0 0%
Bleeding	3 0.1%
Cardiac	0 0%
Cancer/Tumor	0 0%
Gastro-intestinal	2 0.1%
General/Musculoskeletal/Connective	2 0.1%
Genito-urinary and renal disorder	1 0%
Neurological/Psychiatric disorders	1 0%
Vascular	0 0%

9. Secondary Outcome

Title	Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1548
Measure lesions	1850
Mean (Standard Deviation) [Percent Diameter stenosis]	69.6 (15.4)

10. Secondary Outcome

Title	Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame	On day 0 after procedure

Outcome Measure Data

Analysis Population Description

Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1548
Measure lesions	1850
Mean (Standard Deviation) [Percent Diameter stenosis]	23.6 (10.7)

11. Secondary Outcome

Title	Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame	At 8 months

Outcome Measure Data

Analysis Population Description

Eight-month follow-up angiograms for 1,309 lesions in 1,085 patients were assessed by the core laboratory.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1085
Measure lesions	1309
Mean (Standard Deviation) [Percent Diameter stenosis]	26.1 (14.5)

12. Secondary Outcome

Title	Acute Gain
Description	The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time Frame	On day 0 after procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1548
Measure lesions	1850
In-stent (n=1845 lesions)	1.769
In-segment (n=1846 lesions)	1.409

13. Secondary Outcome

Title	Late Loss
Description	Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].
Time Frame	On day 0 after procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1548
Measure lesions	1850
In-stent (n=1303 lesions)	0.219
Proximal (n=1086 lesions)	0.152
Distal (n=1298 lesions)	0.034
In-segment (n=1308 lesions)	0.128

14. Secondary Outcome

Title	Net Gain
Description	Net Gain = Acute Gain - Late Loss, paired analysis only.
Time Frame	On day 0 after procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1548
Measure lesions	1850
In-stent (n=1300 lesions)	1.536
In-segment (n=1305 lesions)	1.269

15. Secondary Outcome

Title	Acute Success
Description	Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met: Stent was successfully delivered to the intended location Stent was successfully deployed at the intended location Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure.
Time Frame	On day 0 (Immediately post-index procedure)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	2009
Measure stents	3104
Success	99.94
Unknown	0.06

16. Secondary Outcome

Title	Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	47 2.3%

17. Secondary Outcome

Title	Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 1 to 2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	80 4%

18. Secondary Outcome

Title	Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 2 years to 3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	109 5.4%

19. Secondary Outcome

Title	Number of Participants With Myocardial Infarctions (MI)
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	17 0.8%

20. Secondary Outcome

Title	Number of Participants With Myocardial Infarctions (MI)
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	From 1 year to 2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	30 1.5%

21. Secondary Outcome

Title	Number of Participants With Myocardial Infarctions (MI)
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	From 2 years to 3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	33 1.6%

22. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	72 3.6%

23. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame	From 1 year to 2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	92 4.6%

24. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time Frame	From 2 years to 3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	104 5.2%

25. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	113 5.6%

26. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	146 7.3%

27. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TVR)
Description	Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	168 8.4%

28. Secondary Outcome

Title	Number of Participants With Cardiac Death and All MI
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	31 1.5%

29. Secondary Outcome

Title	Number of Participants With Cardiac Death and All MI
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	51 2.5%

30. Secondary Outcome

Title	Number of Participants With Cardiac Death and All MI
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	56 2.8%

31. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	87 4.3%

32. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	120 6%

33. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	133 6.6%

34. Secondary Outcome

Title	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	96 4.8%

35. Secondary Outcome

Title	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	125 6.2%

36. Secondary Outcome

Title	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	140 7%

37. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	122 6.1%

38. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	163 8.1%

39. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	184 9.2%

40. Secondary Outcome

Title	Number of Participants With All Deaths and All MI
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	61 3%

41. Secondary Outcome

Title	Number of Participants With All Deaths and All MI
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	105 5.2%

42. Secondary Outcome

Title	Number of Participants With All Deaths and All MI
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	134 6.7%

43. Secondary Outcome

Title	Number of Participants With All Deaths, All MI and All Revascularization
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	345 17.2%

44. Secondary Outcome

Title	Number of Participants With All Deaths, All MI and All Revascularization
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	449 22.3%

45. Secondary Outcome

Title	Number of Participants With All Deaths, All MI and All Revascularization
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	508 25.3%

46. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and TLR
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	126 6.3%

47. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and TLR
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	176 8.8%

48. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and TLR
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	214 10.7%

49. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and CI-TLR
Time Frame	Post Procedure to 1 Year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1948
Number [participants]	113 5.6%

50. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and CI-TLR
Time Frame	From 1 Year to 2 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1921
Number [participants]	161 8%

51. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and CI-TLR
Time Frame	From 2 Years to 3 Years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Measure Participants	1890
Number [participants]	196 9.8%

Adverse Events

Time Frame	5 years
Arm/Group Title	XIENCE V / PROMUS Stent
Arm/Group Description	Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
All Cause Mortality
	XIENCE V / PROMUS Stent
	Affected / at Risk (%)	# Events
Total	184/2009 (9.2%)
Serious Adverse Events
	XIENCE V / PROMUS Stent
	Affected / at Risk (%)	# Events
Total	910/2009 (45.3%)
Blood and lymphatic system disorders
Mild: bleeding that is not moderate nor severe	19/2009 (0.9%)
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise	21/2009 (1%)
Severe/Life Threatening (either intracranial hemorrhage or bleeding that causes hemodynamic compromi	19/2009 (0.9%)
Cardiac disorders
Abnormal stress test	9/2009 (0.4%)
Acute coronary syndrome	18/2009 (0.9%)
Angina-equivalent symptoms	108/2009 (5.4%)
Arrhythmia of unknown reason	2/2009 (0.1%)
Atrial arrhythmia	16/2009 (0.8%)
Cardiac arrest	7/2009 (0.3%)
Cardiac: other	3/2009 (0.1%)
Cardiomyopathy	3/2009 (0.1%)
Cardiopulmonary arrest	9/2009 (0.4%)
Conduction disorder	17/2009 (0.8%)
Elevated cardiac enzymes	4/2009 (0.2%)
Heart failure	86/2009 (4.3%)
Hypertension	2/2009 (0.1%)
Hypotension	3/2009 (0.1%)
Myocardial infarction	11/2009 (0.5%)
Palpitation	4/2009 (0.2%)
Pericardial effusion	1/2009 (0%)
Restenosis	158/2009 (7.9%)
Stenosis	244/2009 (12.1%)
Stent Thrombosis	6/2009 (0.3%)
Tachycardia	3/2009 (0.1%)
Tamponade	1/2009 (0%)
Valve disorder	10/2009 (0.5%)
Ventricular arrhythmia	14/2009 (0.7%)
Gastrointestinal disorders
Biliary/liver disorder	26/2009 (1.3%)
Gastroesophageal reflux disease, diarrhea, nausea	21/2009 (1%)
Other gastro-intestinal symptoms	28/2009 (1.4%)
Pancreatic disorder	4/2009 (0.2%)
General disorders
Abnormal Lab Test (Non-cardiac):Abnormal CBC with differentials	4/2009 (0.2%)
Abnormal Lab Test (Non-cardiac):Abnormal liver enzymes	1/2009 (0%)
Abnormal Lab Test (Non-cardiac):Abnormal other	5/2009 (0.2%)
Contusion	3/2009 (0.1%)
Death of unknown reason	23/2009 (1.1%)
Eye/ear/nose/throat disorder	23/2009 (1.1%)
Fall	2/2009 (0.1%)
Fever	3/2009 (0.1%)
Non cardiac chest pain	0/2009 (0%)
General/Musculoskeletal/ Connective: Other	29/2009 (1.4%)
Outcome to Death	138/2009 (6.9%)
Weakness/fatigue	3/2009 (0.1%)
Immune system disorders
Allergic Reaction to antiplatelet Agent	1/2009 (0%)
Allergic Reaction to contrast	3/2009 (0.1%)
Infections and infestations
Local infection	26/2009 (1.3%)
Systemic infection	16/2009 (0.8%)
Wound infection/abnormal healing	6/2009 (0.3%)
Metabolism and nutrition disorders
Diabetes mellitus	9/2009 (0.4%)
Hyper/hypoglycemia	1/2009 (0%)
Thyroid disorder	2/2009 (0.1%)
Musculoskeletal and connective tissue disorders
Ache/ myalgia/ pain	3/2009 (0.1%)
Bone or joint injury/disorder	42/2009 (2.1%)
Edema	3/2009 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign	15/2009 (0.7%)
Cancer and tumour: other	2/2009 (0.1%)
Malignant	100/2009 (5%)
Nervous system disorders
Dizziness	7/2009 (0.3%)
Headache/migraine	1/2009 (0%)
Nerve/Psychiatric Disorders : Other	9/2009 (0.4%)
Neuropathy	2/2009 (0.1%)
Sleep disorder	2/2009 (0.1%)
Stroke/CVA	36/2009 (1.8%)
Syncope/fainting	8/2009 (0.4%)
Renal and urinary disorders
Genito-urinary and renal disorder	40/2009 (2%)
Respiratory, thoracic and mediastinal disorders
Asthma	2/2009 (0.1%)
Chronic Obstructive Pulmonary Disease (COPD)	3/2009 (0.1%)
Interstitial pneumonia	8/2009 (0.4%)
Pleural effusion	4/2009 (0.2%)
Pneumonia	50/2009 (2.5%)
Respiratory System: other	9/2009 (0.4%)
Respiratory insufficiency/failure	5/2009 (0.2%)
Upper respiratory tract infection	1/2009 (0%)
Skin and subcutaneous tissue disorders
Rash/Urticaria	2/2009 (0.1%)
skin/subcutaneous disorder: other	4/2009 (0.2%)
Vascular disorders
Abrupt closure	1/2009 (0%)
Aneurysm	15/2009 (0.7%)
Dissection	2/2009 (0.1%)
Embolism	4/2009 (0.2%)
Hematoma	7/2009 (0.3%)
Ischemia	10/2009 (0.5%)
No/slow reflow	2/2009 (0.1%)
Occlusion	14/2009 (0.7%)
Perforation	3/2009 (0.1%)
Peripheral arterial disease	35/2009 (1.7%)
Peripheral vascular disease (PVD)	0/2009 (0%)
Spasm	1/2009 (0%)
Thrombosis - non stent	6/2009 (0.3%)
Vascular: other	17/2009 (0.8%)
Other (Not Including Serious) Adverse Events
	XIENCE V / PROMUS Stent
	Affected / at Risk (%)	# Events
Total	116/2009 (5.8%)
Blood and lymphatic system disorders
Mild: bleeding that is not moderate nor severe	1/2009 (0%)
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise	1/2009 (0%)
Cardiac disorders
Abnormal stress test	1/2009 (0%)
Acute coronary syndrome	3/2009 (0.1%)
Angina-equivalent symptoms	23/2009 (1.1%)
Arrhythmia of unknown reason	1/2009 (0%)
Cardiopulmonary arrest	6/2009 (0.3%)
Conduction disorder	1/2009 (0%)
Elevated cardiac enzymes	1/2009 (0%)
Heart failure	6/2009 (0.3%)
Myocardial infarction	2/2009 (0.1%)
Palpitation	1/2009 (0%)
Restenosis	44/2009 (2.2%)
Stenosis	20/2009 (1%)
Stent Thrombosis	2/2009 (0.1%)
Tachycardia	2/2009 (0.1%)
Ventricular arrhythmia	6/2009 (0.3%)
Gastrointestinal disorders
Biliary/liver disorder	1/2009 (0%)
Gastro-intestinal disorder (e.g. GERD, diarrhea, nausea)	1/2009 (0%)
General disorders
Non cardiac chest pain	0/2009 (0%)
General/Musculoskeletal/ Connective : Other	4/2009 (0.2%)
Immune system disorders
Allergic Reaction:To antiplatelet Agent	1/2009 (0%)
Infections and infestations
Wound infection/abnormal healing	1/2009 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	1/2009 (0%)
Hyper/hypoglycemia	1/2009 (0%)
Musculoskeletal and connective tissue disorders
Bone or joint injury/disorder	4/2009 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign	1/2009 (0%)
Malignant	2/2009 (0.1%)
Nervous system disorders
Nerve/psychiatric disorders : Other	1/2009 (0%)
Renal and urinary disorders
Genito-urinary and renal disorder	1/2009 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/2009 (0%)
Respiratory/Pulmonary disorders : Other	1/2009 (0%)
Vascular disorders
Dissection	1/2009 (0%)
Ischemia	4/2009 (0.2%)
Jailing of side branch	1/2009 (0%)
No/slow reflow	1/2009 (0%)
Perforation	1/2009 (0%)
Peripheral artery disease (PAD)	2/2009 (0.1%)
Spasm	2/2009 (0.1%)
Thrombosis - non stent	1/2009 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.