XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

Conditions

Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia, Vascular Disease

Keywords

drug eluting stents, Stents, Angioplasty, Stent thrombosis, antiplatelet treatment

Brief summary

XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are * To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and * To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Detailed description

This prospective, multi-center, randomized, double-blind AV-DAPT study cohort is designed to collect data to support the FDA DAPT initiative. The protocol for AV-DAPT cohort is designed according to the HCRI-DAPT (NCT00977938) study protocol, Study IDE # G080186. A total 8040 patients (5034 in initial enrollment phase and additional \ 3000 patients in the second enrollment phase) enrolled in the XIENCE V USA (NCT00676520) had completed Phase I and were evaluated at 1 year. These patients were transferred to the following cohorts in Phase II and followed-up for 1-5 years: The long-term follow-up cohort of phase II (NCT01120379) consisted of 5020 patients from the first enrollment phase who were not transferred to the HCRI- DAPT study and remained in the study beyond 1 year. Patients from the additional 3000 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. The remaining patients from the additional 3000 patients who did not participate in AV-DAPT cohort will be followed for the first year only. A study completion form will be filled out and the patients will not be followed beyond their 1 year visit. The participants enrolled in this study will be followed by Abbott Vascular 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 study outcomes.

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Interventions

DRUGplacebo + aspirin

This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

DRUGclopidogrel + aspirin OR prasugrel + aspirin

This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

DEVICEXIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients who are enrolled into the XIENCE V USA Study Phase I * The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

Exclusion criteria

* The inability to obtain an informed consent is an exclusion criterion. Patients must meet the following criteria to be eligible for randomization in the study: * Patient is 12 Month Clear: 12-Month Clear patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - severe or moderate by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of 12 Month Clear. * Patient is DAPT Compliant: During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered clear. * Patient completes 1 year visit within ± 30 days window. Patients will be excluded from randomization if any of the following criteria are met: * Pregnant women. * Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged. * PCI or cardiac surgery between 6 weeks post index procedure and randomization. * Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization. * Current medical condition with a life expectancy of less than 3 years. * Patients on warfarin or similar anticoagulant therapy.

Design outcomes

Primary

Measure	Time frame
Incidence of Composite of All Death, MI and Stroke (Defined as MACE)	12-33 months post-stent
Incidence of ARC Definite or Probable ST	12-33 months post-stent
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)	12-33 months post-stent

Secondary

Measure	Time frame
MACE for Treatment Population	12 through 30 months and 12 through 33 months
MACE for ITT Population	12 through 30 months
Major Bleeding for Treatment Population	12 through 30 months and 12 through 33 months
ST for Treatment Population	12 through 30 months and 12 through 33 months
ST for ITT Population	12 through 30 months
Major Bleeding for ITT Population	12 through 30 months

Countries

United States

Participant flow

Recruitment details

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

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.

Participants by arm

Arm	Count
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.	2,997
Total	2,997

Arm

Count

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.

2,997

Total

2,997

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	16
Overall Study	Lost to Follow-up	2
Overall Study	Physician Decision	1
Overall Study	Withdrawal by Subject	18

Baseline characteristics

Characteristic	Second Enrollment Phase of XIENCE V® USA
Age, Continuous	64.27 years STANDARD_DEVIATION 10.39
Age, Customized >= 65 to < 75 years	922 participants
Age, Customized < 65 years	1587 participants
Age, Customized >= 75 years	488 participants
Race/Ethnicity, Customized American Indian or Alaskan Native	23 participants
Race/Ethnicity, Customized Asian	49 participants
Race/Ethnicity, Customized Black or African Heritage	231 participants
Race/Ethnicity, Customized Hispanic or Latino	117 participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	7 participants
Race/Ethnicity, Customized Other	15 participants
Race/Ethnicity, Customized White	2577 participants
Sex: Female, Male Female	870 Participants
Sex: Female, Male Male	2127 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0