Author + information
- Received April 2, 2012
- Revision received June 9, 2012
- Accepted June 12, 2012
- Published online October 9, 2012.
- Byeong-Keuk Kim, MD⁎,
- Myeong-Ki Hong, MD⁎,†,⁎ (, )
- Dong-Ho Shin, MD, MPH⁎,
- Chung-Mo Nam, PhD‡,
- Jung-Sun Kim, MD⁎,
- Young-Guk Ko, MD⁎,
- Donghoon Choi, MD⁎,
- Tae-Soo Kang, MD§,
- Byoung-Eun Park, MD§,
- Woong-Chol Kang, MD∥,
- Seung-Hwan Lee, MD¶,
- Jung-Han Yoon, MD¶,
- Bum-Kee Hong, MD#,
- Hyuck-Moon Kwon, MD#,
- Yangsoo Jang, MD⁎,†,
- RESET Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Myeong-Ki Hong, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu, Seoul 120-752, Republic of Korea
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)
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 other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 2, 2012.
- Revision received June 9, 2012.
- Accepted June 12, 2012.
- American College of Cardiology Foundation