한빛사논문
- 조회334
Jung-Kyu Han, MD1,2*; Doyeon Hwang, MD1*; Seokhun Yang, MD1; Sang-Hyeon Park, MD1; Jeehoon Kang, MD1; Han-Mo Yang, MD1,2; Kyung Woo Park, MD1,2; Hyun-Jae Kang, MD1,2; Bon-Kwon Koo, MD1,2; Seung-Ho Hur, MD3; Weon Kim, MD4; Seok Yeon Kim, MD5; Sang-Hyun Park, MD6; Seung Hwan Han, MD7; Sang-Hyun Kim, MD8; Sanghoon Shin, MD9; Yong Hoon Kim, MD10; Kyungil Park, MD11; Namho Lee, MD12; Seung Jin Lee, MD13; Jin Won Kim, MD14; Hyo-Soo Kim, MD1,2
1Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea;
2Department of Internal Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea;
3Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea;
4Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea;
5Department of Internal Medicine, Cardiovascular Center, Seoul Medical Center, Seoul, Republic of Korea;
6Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Republic of Korea;
7Division of Cardiology, Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Republic of Korea;
8Division of Cardiology, Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea;
9Department of Cardiology, Seoul Hospital, Ewha Womans University College of Medicine, Seoul, Republic of Korea;
10Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Republic of Korea;
11Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea;
12Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea;
13Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea;
14Cardiovascular Center, Guro Hospital Korea University, Seoul, Republic of Korea
*J-K. Han and D. Hwang contributed equally.
Address for Correspondence: Hyo-Soo Kim, MD, PhD
Abstract
Background: Limited data are available on short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) using third-generation drug-eluting stents (DES) with ultrathin struts and advanced polymer technology. We investigated whether 3-6 month DAPT was non-inferior to 12 month one after implantation of DES with ultrathin struts and advanced polymer technology.
Methods: We performed an open-label, randomized trial at 37 centers in South Korea. We enrolled patients undergoing PCI using the Orsiro biodegradable-polymer sirolimus-eluting stents (SES) or the Coroflex ISAR polymer-free SES. Patients with ST-segment elevation myocardial infarction were excluded. Patients were randomized to receive either 3-6 month or 12 month DAPT after PCI. The choice of antiplatelet medications was at the physician's discretion. The primary outcome was a net adverse clinical event (NACE), a composite of cardiac death, target vessel myocardial infarction (TVMI), clinically driven target lesion revascularization (CD-TLR), stent thrombosis, or major bleeding, defined as Bleeding Academic Research Consortium type 3 or 5 at 12 months. The major secondary outcomes were target lesion failure (TLF), a composite of cardiac death, TVMI, CD-TLR, and major bleeding.
Results: A total of 2,013 patients (mean age 65.7±10.5, 1,487 male [73.9%], 1,110 [55.1%] presented with acute coronary syndrome) were randomized to 3-6 month DAPT (n=1,002) or 12 month DAPT (n=1,011). The primary outcome occurred in 37 (3.7%) patients in the 3-6 month DAPT group and 41 (4.1%) in the 12 month DAPT group. The non-inferiority of the 3-6 month DAPT group to the 12 month DAPT group was met (absolute risk difference, -0.4% [1-sided 95% confidence interval (CI), -∞% to 1.1%; P<0.001 for non-inferiority]). There were no significant differences in TLF (hazard ratio [HR] 0.98, 95% CI 0.56-1.71, P=0.94) or major bleeding (HR 0.82, 95% CI 0.41-1.61, P=0.56) between the two groups. Across various subgroups, the treatment effect of 3-6 month DAPT was consistent for NACE.
Conclusions: Among patients undergoing PCI using third-generation DES, 3-6 month DAPT was non-inferior to 12 month DAPT for NACE. Further research is needed to generalize this finding to other populations and to determine the ideal regimen for 3-6 month DAPT.
논문정보
- Research article
- 2023년 03월 (BRIC 등록일 2023-03-08)
- 국내 연구진
- 의약학 > 응용의학
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