Safety of 3-Month Dual Antiplatelet Therapy After Implantation of Ultrathin Sirolimus-Eluting Stents With Biodegradable Polymer (Orsiro): Results From the SMART-CHOICE Trial

• Published in: Journal of the American Heart Association Vol. 10; no. 1; p. e018366
• Main Authors: Yun, Kyeong Ho, Lee, Seung-Yul, Cho, Byung Ryul, Jang, Woo Jin, Song, Young Bin, Oh, Ju-Hyeon, Chun, Woo Jung, Park, Yong Hwan, Im, Eul-Soon, Jeong, Jin-Ok, Oh, Seok Kyu, Cho, Deok-Kyu, Lee, Jong-Young, Koh, Young-Youp, Bae, Jang-Whan, Choi, Jae Woong, Lee, Wang Soo, Yoon, Hyuck Jun, Lee, Seung Uk, Cho, Jang Hyun, Choi, Woong Gil, Rha, Seung-Woon, Lee, Joo Myung, Park, Taek Kyu, Yang, Jeong Hoon, Choi, Jin-Ho, Choi, Seung-Hyuck, Lee, Sang Hoon, Gwon, Hyeon-Cheol, Hahn, Joo-Yong
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 05.01.2021; Wiley
• Subjects: antiplatelet therapy; coronary artery disease; Original Research; percutaneous coronary intervention; coronary artery disease; percutaneous coronary intervention; antiplatelet therapy
• ISSN: 2047-9980; 2047-9980
• DOI: 10.1161/JAHA.120.018366

Background This study sought to investigate the safety of 3-month dual antiplatelet therapy (DAPT) in patients receiving ultrathin sirolimus-eluting stents with biodegradable polymer (Orsiro). Methods and Results The SMART-CHOICE (Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Anti- platelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents) randomized trial compared 3-month DAPT followed by P2Y12 inhibitor monotherapy with 12-month DAPT in 2993 patients undergoing percutaneous coronary intervention. The present analysis was a prespecified subgroup analysis for patients receiving Orsiro stents. As a post hoc analysis, comparisons between Orsiro and everolimus-eluting stents were also done among patients receiving 3-month DAPT. Of 972 patients receiving Orsiro stents, 481 patients were randomly assigned to 3-month DAPT and 491 to 12-month DAPT. At 12 months, the target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization, occurred in 8 patients (1.7%) in the 3-month DAPT group and in 14 patients (2.9%) in the 12-month DAPT group (hazard ratio [HR], 0.58; 95% CI, 0.24-1.39; =0.22). In whole population who were randomly assigned to receive 3-month DAPT (n=1495), there was no significant difference in the target vessel failure between the Orsiro group and the everolimus-eluting stent group (n=1014) (1.7% versus 1.8%; HR, 0.96; 95% CI, 0.41-2.22; =0.92). Conclusions In patients receiving Orsiro stents, clinical outcomes at 1 year were similar between the 3-month DAPT followed by P2Y12 inhibitor monotherapy and 12-month DAPT strategies. With 3-month DAPT, there was no significant difference in target vessel failure between Orsiro and everolimus-eluting stents. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02079194.