A New Strategy for Discontinuation of Dual Antiplatelet Therapy

OBJECTIVES: The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. BACKGROUND: There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation. METHODS: We randomly assigned 2, 117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n=1, 059) versus 12-month DAPT following the other DES implantation (standard therapy, n=1, 058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target revascularization, or bleeding) at 1 year. RESULTS: The primary endpoint occurred in 40 (4. 7%) patients assigned to E-ZES+3-month DAPT compared with 41 (4. 7%) patients assigned to the standard therapy (difference: 0. 0%; 95% confidence interval CI: -2. 5 to 2. 5; p=0. 84; p<0. 001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0. 8% and 1. 3%, respectively (difference: -0. 5%; 95% CI: -1. 5 to 0. 5; p=0. 48). The rates of stent thrombosis were 0. 2% and 0. 3%, respectively (difference: -0. 1%; 95% CI: -0. 5 to 0. 3; p=0. 65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3. 9% and 3. 7%, respectively (difference: 0. 2%; 95% CI: -2. 3 to 2. 6; p=0. 70). CONCLUSIONS: E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation RESET; NCT01145079).