Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial
Uram Jin, Kyoung-Woo Seo, Hyoung-Mo Yang, Hong-Seok Lim, Byoung-Joo Choi, So-Yeon Choi, Joon-Han Shin, Seung-Jea Tahk, Sang-Yong Yoo, Seung Woon Rha, Woo-Young Chung, Chi-Hoon Kim, Ki-Bum Won, Wook Bum Pyun, Jae Sik Jang, Sung Yun Lee, Young Joon Hong, Moo Hyun Kim, Soon Jun Hong, Yun-Seok Choi, Hee-Yeol Kim, Rak Kyeong Choi, Woong Chol Kang, Eun Joo Cho, Myeong-Ho Yoon, Uram Jin, Kyoung-Woo Seo, Hyoung-Mo Yang, Hong-Seok Lim, Byoung-Joo Choi, So-Yeon Choi, Joon-Han Shin, Seung-Jea Tahk, Sang-Yong Yoo, Seung Woon Rha, Woo-Young Chung, Chi-Hoon Kim, Ki-Bum Won, Wook Bum Pyun, Jae Sik Jang, Sung Yun Lee, Young Joon Hong, Moo Hyun Kim, Soon Jun Hong, Yun-Seok Choi, Hee-Yeol Kim, Rak Kyeong Choi, Woong Chol Kang, Eun Joo Cho, Myeong-Ho Yoon
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.
Trial registration: ClinicalTrials.gov NCT02609698.
Keywords: coronary artery disease; drug-eluting stents; dual-antiplatelet therapy; duration of therapy; randomized controlled trial.
Source: PubMed