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\vessel 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)
Bibliographical noteFunding Information:
This study was supported by the Cardiovascular Research Center, Seoul, Korea, Medtronic Inc., and grants from the Korea Healthcare Technology R&D Project, Ministry for Health, Welfare & Family Affairs , Republic of Korea (No. A085012 and A102064 ), and the Korea Health 21 R&D Project, Ministry of Health & Welfare , Republic of Korea (No. A085136 ). Dr. Myeong-Ki Hong has received research grants from Medtronic and the Cardiovascular Research Centers , Seoul, Korea. Dr. Jang is a consultant to and has received research funds from Medtronic.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine