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

Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease

Young‐Youp Koh¹  Jang‐Whan Bae²  Jin‐Ok Jeong³  Wang Soo Lee⁴  Eul‐Soon Im⁵  Jae Woong Choi⁶  Jong‐Young Lee⁷  Byung Ryul Cho⁸  Hyuck Jun Yoon⁹  Woong Gil Choi^1,10  Seung‐Woon Rha^1,11  Seung Uk Lee^1,12  Seok Kyu Oh^1,13  Seung‐Yul Lee^1,13  Kyeong Ho Yun^1,13  Jang Hyun Cho^1,14  Woo Jin Jang^1,15  Ju‐Hyeon Oh^1,15  Yong Hwan Park^1,15  Woo Jung Chun^1,15  Young Bin Song^1,16  Hyeon‐Cheol Gwon^1,16  Sang Hoon Lee^1,16  Joo‐Yong Hahn^1,16  Seung‐Hyuck Choi^1,16  Jin‐Ho Choi^1,16  Taek Kyu Park^1,16  Joo Myung Lee^1,16  Jeong Hoon Yang^1,16  Deok‐Kyu Cho^1,17 

[1] Chosun University Hospital Gwangju Korea;Chungbuk National University Hospital Cheongju Korea;Chungnam National University Hospital Daejeon Korea;Chung‐Ang University Hospital Seoul Korea;Dongsuwon General Hospital Suwon Korea;Eulji General Hospital Seoul Korea;Kangbuk Samsung Hospital Sungkyunkwan University School of Medicine Seoul Korea;Kangwon National University Hospital Chuncheon Korea;Keimyung University Dongsan Medical Center Daegu Korea;Konkuk University Chungju Hospital Chungju Korea;Korea University Guro Hospital Seoul Korea;Kwangju Christian Hospital Gwangju Korea;Regional Cardiocerebrovascular Center Wonkwang University Hospital Iksan Korea;Saint Carollo Hospital Suncheon Korea;Samsung Changwon Hospital Sungkyunkwan University School of Medicine Changwon Korea;Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea;Yongin Severance Hospital Yongin Korea;

关键词: antiplatelet therapy;    coronary artery disease;    percutaneous coronary intervention;   

DOI  :  10.1161/JAHA.120.018366

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown