한빛사논문
- 조회633
Hyo-Soo Kim, MD1,*; Jeehoon Kang, MD1,*; Doyeon Hwang, MD1; Jung-Kyu Han, MD1; Han-Mo Yang, MD1; Hyun-Jae Kang, MD1; Bon-Kwon Koo, MD1; Seok Yeon Kim, MD2; Keun-Ho Park, MD3; Seung-Woon Rha, MD4; Won-Yong Shin, MD5; Hong-Seok Lim, MD6; Kyungil Park, MD7; Kyung Woo Park, MD1; on behalf of the HOST-REDUCE-POLYTECH-ACS Randomized Clinical Trial Investigators†
1Seoul National University Hospital, Seoul, Republic of Korea; 2Seoul Medical Center, Seoul,
Republic of Korea; 3Chosun University Hospital, Gwangju, Republic of Korea; 4Korea University Guro Hospital, Seoul, Republic of Korea; 5Soon Chun Hyang University Cheonan Hospital, Cheonan, Republic of Korea; 6Ajou University School of Medicine, Suwon, Republic of Korea; 7Dong-A University Hospital, Busan, South Korea.
* HSK and JK equally contributed
† All investigators of the HOST-REDUCE-POLYTECH-ACS trial are listed in the appendix
Address for correspondence : : Kyung Woo Park, MD, PhD, MBA, Professor, Department of Internal Medicine Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul 03080, Korea
Abstract
Background: Large scale randomized comparison of drug-eluting stents (DES) based on durable polymer (DP) versus biodegradable polymer (BP) technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study sought to prove the non-inferiority of the DP-DES compared with the BP-DES in such patients.
Methods: The HOST-REDUCE-POLYTECH-ACS trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, non-inferiority trial which compared the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary endpoint was patient oriented composite outcome (POCO, a composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization) at 12 months. The key secondary endpoint was device oriented composite outcome (DOCO; a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.
Results: A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, POCO occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (Absolute risk difference: -1.2%, Pnon-inferiority<0.001). The key secondary endpoint, DOCO, occurred less frequently in the DP-DES group (DP-DES vs. BP-DES: 2.6% vs. 3.9%, HR 0.67, 95% CI 0.46-0.98, p=0.038), mostly due to a reduction in target lesion revascularization. The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively).
Conclusions: In ACS patients receiving percutaneous coronary intervention (PCI), DP-DES was non-inferior to BP-DES with regard to POCO at 12 months after index PCI.
Key Words: Biodegradable polymer; Durable polymer; Acute coronary syndrome; Patient oriented composite outcome; Device oriented composite outcome; Stent thrombosis
논문정보
- Research article
- 2020년 11월 (BRIC 등록일 2020-11-25)
- 국내 연구진
- 의약학 > 응용의학
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