XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Chronic Total Occlusion of Coronary Artery Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis
Interventions:	Drug: placebo + aspirin Drug: clopidogrel + aspirin OR prasugrel + aspirin Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Additional 3000 patients were enrolled in the second enrollment phase and had completed phase I at 1 year. In phase II, 870 patients from these were transferred to AV-DAPT cohort and followed from 1 year to 33 months, and the remaining who did not participate in AV-DAPT cohort will be followed for the first year only.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outcome measures of participants of XIENCE V USA trial of phase I followed up until 1 year from index procedure are available in the study with ID NCT00676520. Outcome measures of participants belonging to XIENCE V USA long-term follow-up cohort of phase II (followed up from year 1 to year 5) are available in the study with ID NCT01120379.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Outcome measures of participants of XIENCE V USA trial of phase I followed up until 1 year from index procedure are available in the study with ID NCT00676520.

Outcome measures of participants belonging to XIENCE V USA long-term follow-up cohort of phase II (followed up from year 1 to year 5) are available in the study with ID NCT01120379.

Reporting Groups

	Description
Second Enrollment Phase of XIENCE V® USA	Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.

Description

Second Enrollment Phase of XIENCE V® USA

Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.

Participant Flow: Overall Study

	Second Enrollment Phase of XIENCE V® USA
STARTED	2997
COMPLETED	2960
NOT COMPLETED	37
Withdrawal by Subject	18
Lost to Follow-up	2
Death	16
Physician Decision	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics are provided for 2997 patients recruited in the second enrollment phase.

Reporting Groups

	Description
Second Enrollment Phase of XIENCE V® USA	Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.

Description

Second Enrollment Phase of XIENCE V® USA

Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.

Baseline Measures

	Second Enrollment Phase of XIENCE V® USA
Number of Participants [units: participants]	2997
Age [units: years] Mean (Standard Deviation)	64.27 (10.39)
Age, Customized [units: participants]
< 65 years	1587
>= 65 to < 75 years	922
>= 75 years	488
Gender [units: participants]
Female	870
Male	2127
Race/Ethnicity, Customized ^[1] [units: participants]
American Indian or Alaskan Native	23
Asian	49
Black or African Heritage	231
Native Hawaiian or Pacific Islander	7
White	2577
Hispanic or Latino	117
Other	15

[1]	Patient may be counted in more than one category

Outcome Measures

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1. Primary:

Incidence of Composite of All Death, MI and Stroke (Defined as MACE) [ Time Frame: 12-33 months post-stent ]

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2. Primary:

Incidence of ARC Definite or Probable ST [ Time Frame: 12-33 months post-stent ]

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3. Primary:

Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) [ Time Frame: 12-33 months post-stent ]

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4. Secondary:

MACE for ITT Population [ Time Frame: 12 through 30 months ]

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5. Secondary:

ST for ITT Population [ Time Frame: 12 through 30 months ]

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6. Secondary:

Major Bleeding for ITT Population [ Time Frame: 12 through 30 months ]

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7. Secondary:

MACE for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]

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8. Secondary:

ST for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]

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9. Secondary:

Major Bleeding for Treatment Population [ Time Frame: 12 through 30 months and 12 through 33 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The participants enrolled in this study will be followed by Abbott Vacular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the outcomes.

More Information

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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.

The agreement is:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI 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
e-mail: david.rutledge@av.abbott.com

Responsible Party:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT01106534 History of Changes
Other Study ID Numbers:	06-374C
Study First Received:	April 16, 2010
Results First Received:	July 31, 2015
Last Updated:	May 12, 2016
Health Authority:	United States: Food and Drug Administration

XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)