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

• ClinicalTrials.gov Identifier: NCT01086228
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Results First Posted: February 19, 2018
• Last Update Posted: February 19, 2018
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Conditions: Angina; Chronic Coronary Occlusion; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis
• Intervention: Device: XIENCE V / PROMUS stent
• Enrollment: 2010

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 Details	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 [1]
Completed	1938
Not Completed	71
[1] Analysis population
Period Title: 1-year Follow-up
Started	1938
Completed	1894
Not Completed	44
Period Title: 2-year Follow-up
Started	1894
Completed	1834
Not Completed	60
Period Title: 3-year Follow-up
Started	1834
Completed	1767
Not Completed	67
Period Title: 4-year Follow-up
Started	1767
Completed	1664
Not Completed	103
Period Title: 5-year 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 Number of Baseline Participants		2009
Baseline Analysis Population Description		Baseline characteristics were analyzed for 2,009 patients (XIENCE V:1,159 ; PROMUS : 850).
Age, Continuous; Median (Standard Deviation); Unit of measure: Years
	Number Analyzed	2009 participants
		70.0 (10.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2009 participants
	Female	481 23.9%
	Male	1528 76.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Japan	Number Analyzed	2009 participants
		2009

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.
Overall Number of Participants Analyzed	2009
Measure Type: Number; Unit of Measure: participants
Definite Stent Thrombosis	6
Probable Stent Thrombosis	2
Possible Stent Thrombosis	6

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.
Overall Number of Participants Analyzed	1894
Measure Type: Number; Unit of Measure: participants
Definite Stent Thrombosis	0
Probable Stent Thrombosis	0
Possible Stent Thrombosis	5

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.
Overall Number of Participants Analyzed	1834
Measure Type: Number; Unit of Measure: participants
Definite Stent Thrombosis	0
Probable Stent Thrombosis	0
Possible Stent Thrombosis	4

4. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	2009
Measure Type: Number; Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test	13
Allergic Reaction	10
Bleeding	32
Cardiac	3
Cancer/Tumor	0
Gastro-intestinal	4
General/Musculoskeletal/Connective	7
Genito-urinary and renal disorder	0
Neurological/Psychiatric disorders	3
Vascular	4

5. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1894
Measure Type: Number; Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test	2
Allergic Reaction	0
Bleeding	5
Cardiac	0
Cancer/Tumor	1
Gastro-intestinal	0
General/Musculoskeletal/Connective	0
Genito-urinary and renal disorder	1
Neurological/Psychiatric disorders	0
Vascular	0

6. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1834
Measure Type: Number; Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test	2
Allergic Reaction	0
Bleeding	3
Cardiac	1
Cancer/Tumor	0
Gastro-intestinal	0
General/Musculoskeletal/Connective	0
Genito-urinary and renal disorder	0
Neurological/Psychiatric disorders	1
Vascular	0

7. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1767
Measure Type: Number; Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test	0
Allergic Reaction	0
Bleeding	9
Cardiac	0
Cancer/Tumor	0
Gastro-intestinal	0
General/Musculoskeletal/Connective	1
Genito-urinary and renal disorder	0
Neurological/Psychiatric disorders	1
Vascular	2

8. Secondary Outcome

Title	Number of Participants With Adverse Events Related to Anti-platelet Medication
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1664
Measure Type: Number; Unit of Measure: participants
Abnormal Non-Cardiac Lab Value/Test	0
Allergic Reaction	0
Bleeding	3
Cardiac	0
Cancer/Tumor	0
Gastro-intestinal	2
General/Musculoskeletal/Connective	2
Genito-urinary and renal disorder	1
Neurological/Psychiatric disorders	1
Vascular	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.
Overall Number of Participants Analyzed	1548
Overall Number of Units Analyzed; Type of Units Analyzed: Lesions	1850
Mean (Standard Deviation); Unit of Measure: 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.
Overall Number of Participants Analyzed	1548
Overall Number of Units Analyzed; Type of Units Analyzed: Lesions	1850
Mean (Standard Deviation); Unit of Measure: 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.
Overall Number of Participants Analyzed	1085
Overall Number of Units Analyzed; Type of Units Analyzed: Lesions	1309
Mean (Standard Deviation); Unit of Measure: 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.
Overall Number of Participants Analyzed	1548
Overall Number of Units Analyzed; Type of Units Analyzed: Lesions	1850
Mean (95% Confidence Interval); Unit of Measure: millimeters
In-stent (n=1845 lesions)	1.769; (1.744 to 1.794)
In-segment (n=1846 lesions)	1.409; (1.383 to 1.436)

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.
Overall Number of Participants Analyzed	1548
Overall Number of Units Analyzed; Type of Units Analyzed: Lesions	1850
Mean (95% Confidence Interval); Unit of Measure: millimeters
In-stent (n=1303 lesions)	0.219; (0.196 to 0.243)
Proximal (n=1086 lesions)	0.152; (0.125 to 0.178)
Distal (n=1298 lesions)	0.034; (0.012 to 0.055)
In-segment (n=1308 lesions)	0.128; (0.099 to 0.157)

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.
Overall Number of Participants Analyzed	1548
Overall Number of Units Analyzed; Type of Units Analyzed: Lesions	1850
Mean (95% Confidence Interval); Unit of Measure: millimeters
In-stent (n=1300 lesions)	1.536; (1.504 to 1.568)
In-segment (n=1305 lesions)	1.269; (1.235 to 1.302)

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.
Overall Number of Participants Analyzed	2009
Overall Number of Units Analyzed; Type of Units Analyzed: Stents	3104
Measure Type: Number; Unit of Measure: percentage of stents
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	47

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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	80

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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	109

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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	17

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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	30

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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	33

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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	72

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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	92

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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	104

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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	113

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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	146

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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	168

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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	31

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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	51

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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	56

31. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	87

32. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	120

33. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	133

34. Secondary Outcome

Title	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	96

35. Secondary Outcome

Title	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	125

36. Secondary Outcome

Title	Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	140

37. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	122

38. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	163

39. Secondary Outcome

Title	Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	184

40. Secondary Outcome

Title	Number of Participants With All Deaths and All MI
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	61

41. Secondary Outcome

Title	Number of Participants With All Deaths and All MI
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	105

42. Secondary Outcome

Title	Number of Participants With All Deaths and All MI
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	134

43. Secondary Outcome

Title	Number of Participants With All Deaths, All MI and All Revascularization
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	345

44. Secondary Outcome

Title	Number of Participants With All Deaths, All MI and All Revascularization
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	449

45. Secondary Outcome

Title	Number of Participants With All Deaths, All MI and All Revascularization
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	508

46. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	126

47. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	176

48. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	214

49. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and CI-TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1948
Measure Type: Number; Unit of Measure: participants
	113

50. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and CI-TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1921
Measure Type: Number; Unit of Measure: participants
	161

51. Secondary Outcome

Title	Number of Participants With All Deaths, TVMI and CI-TLR
Description	[Not Specified]
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.
Overall Number of Participants Analyzed	1890
Measure Type: Number; Unit of Measure: participants
	196

Adverse Events

Time Frame	5 years
Adverse Event Reporting 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.
All-Cause Mortality
	XIENCE V / PROMUS Stent
	Affected / at Risk (%)
Total	184/2009 (9.16%)
Serious Adverse Events
	XIENCE V / PROMUS Stent
	Affected / at Risk (%)
Total	910/2009 (45.30%)
Blood and lymphatic system disorders
Mild: bleeding that is not moderate nor severe † 1	19/2009 (0.95%)
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise † 1	21/2009 (1.05%)
Severe/Life Threatening (either intracranial hemorrhage or bleeding that causes hemodynamic compromi † 1	19/2009 (0.95%)
Cardiac disorders
Abnormal stress test † 1	9/2009 (0.45%)
Acute coronary syndrome † 1	18/2009 (0.90%)
Angina-equivalent symptoms † 1	108/2009 (5.38%)
Arrhythmia of unknown reason † 1	2/2009 (0.10%)
Atrial arrhythmia † 1	16/2009 (0.80%)
Cardiac arrest † 1	7/2009 (0.35%)
Cardiac: other † 1	3/2009 (0.15%)
Cardiomyopathy † 1	3/2009 (0.15%)
Cardiopulmonary arrest † 1	9/2009 (0.45%)
Conduction disorder † 1	17/2009 (0.85%)
Elevated cardiac enzymes † 1	4/2009 (0.20%)
Heart failure † 1	86/2009 (4.28%)
Hypertension † 1	2/2009 (0.10%)
Hypotension † 1	3/2009 (0.15%)
Myocardial infarction † 1	11/2009 (0.55%)
Palpitation † 1	4/2009 (0.20%)
Pericardial effusion † 1	1/2009 (0.05%)
Restenosis † 1	158/2009 (7.86%)
Stenosis † 1	244/2009 (12.15%)
Stent Thrombosis † 1	6/2009 (0.30%)
Tachycardia † 1	3/2009 (0.15%)
Tamponade † 1	1/2009 (0.05%)
Valve disorder † 1	10/2009 (0.50%)
Ventricular arrhythmia † 1	14/2009 (0.70%)
Gastrointestinal disorders
Biliary/liver disorder † 1	26/2009 (1.29%)
Gastroesophageal reflux disease, diarrhea, nausea † 1	21/2009 (1.05%)
Other gastro-intestinal symptoms † 1	28/2009 (1.39%)
Pancreatic disorder † 1	4/2009 (0.20%)
General disorders
Abnormal Lab Test (Non-cardiac):Abnormal CBC with differentials † 1	4/2009 (0.20%)
Abnormal Lab Test (Non-cardiac):Abnormal liver enzymes † 1	1/2009 (0.05%)
Abnormal Lab Test (Non-cardiac):Abnormal other † 1	5/2009 (0.25%)
Contusion † 1	3/2009 (0.15%)
Death of unknown reason † 1	23/2009 (1.14%)
Eye/ear/nose/throat disorder † 1	23/2009 (1.14%)
Fall † 1	2/2009 (0.10%)
Fever † 1	3/2009 (0.15%)
Non cardiac chest pain † 1	0/2009 (0.00%)
General/Musculoskeletal/ Connective: Other † 1	29/2009 (1.44%)
Outcome to Death † 1	138/2009 (6.87%)
Weakness/fatigue † 1	3/2009 (0.15%)
Immune system disorders
Allergic Reaction to antiplatelet Agent † 1	1/2009 (0.05%)
Allergic Reaction to contrast † 1	3/2009 (0.15%)
Infections and infestations
Local infection † 1	26/2009 (1.29%)
Systemic infection † 1	16/2009 (0.80%)
Wound infection/abnormal healing † 1	6/2009 (0.30%)
Metabolism and nutrition disorders
Diabetes mellitus † 1	9/2009 (0.45%)
Hyper/hypoglycemia † 1	1/2009 (0.05%)
Thyroid disorder † 1	2/2009 (0.10%)
Musculoskeletal and connective tissue disorders
Ache/ myalgia/ pain † 1	3/2009 (0.15%)
Bone or joint injury/disorder † 1	42/2009 (2.09%)
Edema † 1	3/2009 (0.15%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign † 1	15/2009 (0.75%)
Cancer and tumour: other † 1	2/2009 (0.10%)
Malignant † 1	100/2009 (4.98%)
Nervous system disorders
Dizziness † 1	7/2009 (0.35%)
Headache/migraine † 1	1/2009 (0.05%)
Nerve/Psychiatric Disorders : Other † 1	9/2009 (0.45%)
Neuropathy † 1	2/2009 (0.10%)
Sleep disorder † 1	2/2009 (0.10%)
Stroke/CVA † 1	36/2009 (1.79%)
Syncope/fainting † 1	8/2009 (0.40%)
Renal and urinary disorders
Genito-urinary and renal disorder † 1	40/2009 (1.99%)
Respiratory, thoracic and mediastinal disorders
Asthma † 1	2/2009 (0.10%)
Chronic Obstructive Pulmonary Disease (COPD) † 1	3/2009 (0.15%)
Interstitial pneumonia † 1	8/2009 (0.40%)
Pleural effusion † 1	4/2009 (0.20%)
Pneumonia † 1	50/2009 (2.49%)
Respiratory System: other † 1	9/2009 (0.45%)
Respiratory insufficiency/failure † 1	5/2009 (0.25%)
Upper respiratory tract infection † 1	1/2009 (0.05%)
Skin and subcutaneous tissue disorders
Rash/Urticaria † 1	2/2009 (0.10%)
skin/subcutaneous disorder: other † 1	4/2009 (0.20%)
Vascular disorders
Abrupt closure † 1	1/2009 (0.05%)
Aneurysm † 1	15/2009 (0.75%)
Dissection † 1	2/2009 (0.10%)
Embolism † 1	4/2009 (0.20%)
Hematoma † 1	7/2009 (0.35%)
Ischemia † 1	10/2009 (0.50%)
No/slow reflow † 1	2/2009 (0.10%)
Occlusion † 1	14/2009 (0.70%)
Perforation † 1	3/2009 (0.15%)
Peripheral arterial disease † 1	35/2009 (1.74%)
Peripheral vascular disease (PVD) † 1	0/2009 (0.00%)
Spasm † 1	1/2009 (0.05%)
Thrombosis - non stent † 1	6/2009 (0.30%)
Vascular: other † 1	17/2009 (0.85%)
1 Term from vocabulary, Abbott Categories; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	XIENCE V / PROMUS Stent
	Affected / at Risk (%)
Total	116/2009 (5.77%)
Blood and lymphatic system disorders
Mild: bleeding that is not moderate nor severe † 1 [1]	1/2009 (0.05%)
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise † 1 [1]	1/2009 (0.05%)
Cardiac disorders
Abnormal stress test † 1	1/2009 (0.05%)
Acute coronary syndrome † 1	3/2009 (0.15%)
Angina-equivalent symptoms † 1	23/2009 (1.14%)
Arrhythmia of unknown reason † 1	1/2009 (0.05%)
Cardiopulmonary arrest † 1	6/2009 (0.30%)
Conduction disorder † 1	1/2009 (0.05%)
Elevated cardiac enzymes † 1	1/2009 (0.05%)
Heart failure † 1	6/2009 (0.30%)
Myocardial infarction † 1	2/2009 (0.10%)
Palpitation † 1	1/2009 (0.05%)
Restenosis † 1	44/2009 (2.19%)
Stenosis † 1	20/2009 (1.00%)
Stent Thrombosis † 1	2/2009 (0.10%)
Tachycardia † 1	2/2009 (0.10%)
Ventricular arrhythmia † 1	6/2009 (0.30%)
Gastrointestinal disorders
Biliary/liver disorder † 1	1/2009 (0.05%)
Gastro-intestinal disorder (e.g. GERD, diarrhea, nausea) † 1	1/2009 (0.05%)
General disorders
Non cardiac chest pain † 1	0/2009 (0.00%)
General/Musculoskeletal/ Connective : Other † 1 [2]	4/2009 (0.20%)
Immune system disorders
Allergic Reaction:To antiplatelet Agent † 1 [3]	1/2009 (0.05%)
Infections and infestations
Wound infection/abnormal healing † 1	1/2009 (0.05%)
Metabolism and nutrition disorders
Diabetes mellitus † 1 [4]	1/2009 (0.05%)
Hyper/hypoglycemia † 1 [4]	1/2009 (0.05%)
Musculoskeletal and connective tissue disorders
Bone or joint injury/disorder † 1 [5]	4/2009 (0.20%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign † 1 [6]	1/2009 (0.05%)
Malignant † 1 [6]	2/2009 (0.10%)
Nervous system disorders
Nerve/psychiatric disorders : Other † 1	1/2009 (0.05%)
Renal and urinary disorders
Genito-urinary and renal disorder † 1	1/2009 (0.05%)
Respiratory, thoracic and mediastinal disorders
Asthma † 1	0/2009 (0.00%)
Respiratory/Pulmonary disorders : Other † 1	1/2009 (0.05%)
Vascular disorders
Dissection † 1	1/2009 (0.05%)
Ischemia † 1	4/2009 (0.20%)
Jailing of side branch † 1	1/2009 (0.05%)
No/slow reflow † 1	1/2009 (0.05%)
Perforation † 1	1/2009 (0.05%)
Peripheral artery disease (PAD) † 1	2/2009 (0.10%)
Spasm † 1	2/2009 (0.10%)
Thrombosis - non stent † 1	1/2009 (0.05%)
1 Term from vocabulary, Abbott Categories; † Indicates events were collected by systematic assessment; [1] Bleeding; [2] Except bone or joint injury/disorder and Non cardiac chest pain.; [3] Allergic Reaction; [4] Metabolism/endocrine; [5] Systemic/musculoskeletal/connective tissue disorder; [6] Cancer and Tumor

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.

Results Point of Contact

• Name/Title: David R Rutledge
• Organization: Abbott Vascular
• Phone: (408) 845-3820
• EMail: david.rutledge@av.abbott.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Aoki J, Kozuma K, Awata M, Nanasato M, Shiode N, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/PROMUS PMS Investigators. Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan. Cardiovasc Interv Ther. 2019 Jan;34(1):40-46. doi: 10.1007/s12928-018-0515-z. Epub 2018 Feb 26.

Shiode N, Kozuma K, Aoki J, Awata M, Nanasato M, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/Promus PMS Investigators. The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study. Cardiovasc Interv Ther. 2018 Oct;33(4):313-320. doi: 10.1007/s12928-017-0484-7. Epub 2017 Jul 19.

Aoki J, Kozuma K, Awata M, Nanasato M, Shiode N, Tanabe K, Yamaguchi J, Kusano H, Nie H, Kimura T; XIEVCE V/PROMUS PMS Investigators. Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan. Circ J. 2016;80(4):906-12. doi: 10.1253/circj.CJ-15-1181. Epub 2016 Jan 27.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01086228
• Other Study ID Numbers: 09-384
• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Results First Submitted: February 13, 2017
• Results First Posted: February 19, 2018
• Last Update Posted: February 19, 2018