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

Authors
 Kyeong Ho Yun  ;  Seung-Yul Lee  ;  Byung Ryul Cho  ;  Woo Jin Jang  ;  Young Bin Song  ;  Ju-Hyeon Oh  ;  Woo Jung Chun  ;  Yong Hwan Park  ;  Eul-Soon Im  ;  Jin-Ok Jeong  ;  Seok Kyu Oh  ;  Deok-Kyu Cho  ;  Jong-Young Lee  ;  Young-Youp Koh  ;  Jang-Whan Bae  ;  Jae Woong Choi  ;  Wang Soo Lee  ;  Hyuck Jun Yoon  ;  Seung Uk Lee  ;  Jang Hyun Cho  ;  Woong Gil Choi  ;  Seung-Woon Rha  ;  Joo Myung Lee  ;  Taek Kyu Park  ;  Jeong Hoon Yang  ;  Jin-Ho Choi  ;  Seung-Hyuck Choi  ;  Sang Hoon Lee  ;  Hyeon-Cheol Gwon  ;  Joo-Yong Hahn 
Citation
 JOURNAL OF THE AMERICAN HEART ASSOCIATION, Vol.10(1) : e018366, 2021-01 
Journal Title
JOURNAL OF THE AMERICAN HEART ASSOCIATION
Issue Date
2021-01
MeSH
Aged ; Aspirin* / administration & dosage ; Aspirin* / adverse effects ; Biodegradable Plastics / pharmacology* ; Clopidogrel* / administration & dosage ; Clopidogrel* / adverse effects ; Coronary Artery Disease / surgery* ; Coronary Restenosis* / diagnosis ; Coronary Restenosis* / etiology ; Coronary Restenosis* / mortality ; Drug-Eluting Stents / adverse effects* ; Dual Anti-Platelet Therapy / methods ; Female ; Humans ; Immunosuppressive Agents / pharmacology ; Male ; Outcome and Process Assessment, Health Care ; Percutaneous Coronary Intervention* / adverse effects ; Percutaneous Coronary Intervention* / instrumentation ; Percutaneous Coronary Intervention* / methods ; Platelet Aggregation Inhibitors / administration & dosage ; Platelet Aggregation Inhibitors / adverse effects ; Purinergic P2Y Receptor Antagonists / administration & dosage ; Purinergic P2Y Receptor Antagonists / adverse effects ; Sirolimus / pharmacology*
Keywords
antiplatelet therapy ; coronary artery disease ; percutaneous coronary intervention
Abstract
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; P=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; P=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.
DOI
10.1161/JAHA.120.018366
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Deok Kyu(조덕규)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/191064

https://www.ahajournals.org/doi/10.1161/JAHA.120.018366
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