A New Strategy for Discontinuation of Dual Antiplatelet Therapy: The RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation)

• Published in: Journal of the American College of Cardiology Vol. 60; no. 15; pp. 1340 - 1348
• Main Authors: KIM, Byeong-Keuk, HONG, Myeong-Ki, LEE, Seung-Hwan, YOON, Jung-Han, HONG, Bum-Kee, KWON, Hyuck-Moon, JANG, Yangsoo, SHIN, Dong-Ho, NAM, Chung-Mo, KIM, Jung-Sun, KO, Young-Guk, CHOI, Donghoon, KANG, Tae-Soo, PARK, Byoung-Eun, KANG, Woong-Chol
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier 09-10-2012
• Subjects: Angioplasty, Balloon, Coronary; Biological and medical sciences; Cardiology. Vascular system; Coronary Angiography; Coronary Stenosis - diagnostic imaging; Coronary Stenosis - drug therapy; Coronary Stenosis - surgery; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Platelet Aggregation Inhibitors - therapeutic use; Practice Guidelines as Topic; Prospective Studies; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Sirolimus - analogs & derivatives; Sirolimus - pharmacology; Time Factors; Treatment Outcome; Withholding Treatment - standards; Instrumentation therapy; Implantation; Zotarolimus; Antiplatelet agent; Chemotherapy; Treatment; Efficiency; Complication; Strategy; Circulatory system; Safety; Cardiology; Drug eluting stent
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2012.06.043

The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation.
There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation.
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.
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).
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).