XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

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.