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
- Authors
- 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; Rha, Seung Woon; Chung, Woo-Young; Kim, Chi-Hoon; Won, Ki-Bum; Pyun, Wook Bum; Jang, Jae Sik; Lee, Sung Yun; Hong, Young Joon; Kim, Moo Hyun; Hong, Soon Jun; Choi, Yun-Seok; Kim, Hee-Yeol; Choi, Rak Kyeong; Kang, Woong Chol; Cho, Eun Joo; Yoon, Myeong-Ho
- Issue Date
- Sep-2022
- Publisher
- H M P COMMUNICATIONS
- Keywords
- coronary artery disease; drug-eluting stents; dual-antiplatelet therapy; duration of therapy; randomized controlled trial
- Citation
- JOURNAL OF INVASIVE CARDIOLOGY, v.34, no.9, pp.E653 - E659
- Journal Title
- JOURNAL OF INVASIVE CARDIOLOGY
- Volume
- 34
- Number
- 9
- Start Page
- E653
- End Page
- E659
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/86667
- ISSN
- 1042-3931
- Abstract
- 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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