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Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial

  • 주제(키워드) coronary artery disease , drug-eluting stents , dual-antiplatelet therapy , duration of therapy , randomized controlled trial
  • 주제(기타) Cardiac & Cardiovascular Systems
  • 설명문(일반) [Jin, Uram; Seo, Kyoung-Woo; Yang, Hyoung-Mo; Lim, Hong-Seok; Choi, Byoung-Joo; Choi, So-Yeon; Shin, Joon-Han; Tahk, Seung-Jea; Yoo, Sang-Yong; Yoon, Myeong-Ho] Ajou Univ, Dept Cardiol, Sch Med, 164 Worldcup Ro, Suwon 16499, South Korea; Univ Ulsan, Coll Med, Div Cardiol, Dept Internal Med,Gangneung Asan Hosp, Kangnung, South Korea; [Rha, Seung Woon] Korea Univ, Cardiovasc Ctr, Guro Hosp, Seoul, South Korea; [Chung, Woo-Young] Seoul Natl Univ, Boramae Med Ctr, Dept Internal Med, Seoul, South Korea; [Chung, Woo-Young] Seoul Natl Univ, Coll Med, Seoul, South Korea; [Kim, Chi-Hoon] Sejong Gen Hosp, Sejong Heart Inst, Bucheon, South Korea; [Won, Ki-Bum] Univ Ulsan, Ulsan Univ Hosp, Dept Cardiol, Coll Med, Ulsan, South Korea; [Pyun, Wook Bum] Ewha Womans Univ, Dept Internal Med, Div Cardiol, Med Ctr, Seoul, South Korea; [Jang, Jae Sik] Inje Univ, Dept Internal Med, Div Cardiol, Busan Paik Hosp, Busan, South Korea; [Lee, Sung Yun] Inje Univ, Dept Internal Med, Div Cardiol, Ilsan Paik Hosp, Goyang, South Korea; [Hong, Young Joon] Chonnam Natl Univ Hosp, Dept Internal Med, Div Cardiol, Gwangju, South Korea; [Kim, Moo Hyun] Dong A Univ Hosp, Dept Cardiol, Busan, South Korea; [Hong, Soon Jun] Korea Univ, Coll Med, Dept Cardiol, Cardiovasc Ctr,Anam Hosp, Seoul, South Korea; [Choi, Yun-Seok; Cho, Eun Joo] Catholic Univ Korea, Coll Med, Youido St Marys Hosp, Div Cardiol,Dept Internal Med, Seoul, South Korea; [Kim, Hee-Yeol] Catholic Univ Korea, Coll Med, Dept Cardiol, Bucheon St Marys Hosp, Bucheon, South Korea; [Choi, Rak Kyeong] Mediplex Sejong Hosp, Div Cardiol, Cardiovasc Ctr, Incheon, South Korea; [Kang, Woong Chol] Gachon Univ, Gil Med Ctr, Dept Cardiol, Incheon, South Korea
  • 등재 SCIE, SCOPUS
  • 발행기관 H M P COMMUNICATIONS
  • 발행년도 2022
  • 총서유형 Journal
  • URI http://www.dcollection.net/handler/ewha/000000203132
  • 본문언어 영어
  • PubMed https://pubmed.ncbi.nlm.nih.gov/35863061

초록/요약

Background. The optimal duration of dual-antiplatelet therapy (DAPT) after implantation of a drug-eluting stent (DES), especially recently developed polymer-free DESs, is unknown. This study examined the efficacy and safety of 3- versus 6-month DAPT in patients implanted with Coroflex ISAR polymer-free DESs. Methods. Between May 2015 and August 2020, 488 patients who underwent Coroflex ISAR stent implantation were enrolled in the study and randomly assigned to the 3-month (n=244) or 6-month (n=244) DAPT group. Results. At 1 year, the primary endpoint (composite of cardiovascular death, myocardial infarction, target vessel revascularization, and Bleeding Academic Research Consortium [BARC] type 2-5 bleeding) occurred in 9 (3.7%) patients in the 3-month DAPT group and in 7 (2.9%) patients in the 6-month DAPT group (hazard ratio, 1.31; P=.60). There was no difference between the 3- and 6-month DAPT groups in either BARC type 2-5 bleeding (1.6% vs 0.8%; hazard ratio, 2.00; P=.42) or any bleeding (2.9% vs 3.3%; hazard ratio, 0.87; P=.80). Conclusion. Compared with 6 months of DAPT, 3 months of DAPT did not increase the risk of primary endpoint 1 year after Coroflex ISAR stent implantation, although it should be noted that the trial has limited power to see differences due to low event rate and low recruitment rate.

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