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

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, SMART‐CHOICE Investigators [Link], Dong-Bin Kim, Sang Cheol Cho, Sun-Ho Hwang, Dong Woon Jeon, Jae Kean Ryu, Moo-Hyun Kim, In-Ho Chae, Sang-Hyun Kim, Hack-Lyoung Kim, Dong Kyu Jin, Il Woo Suh, Jong Seon Park, Eun-Seok Shin, Shin-Jae Kim, Sang-Sig Cheong, Kyeong Ho, Sung Yun Lee, Jong-Young Lee, Jei Keon Chae, Yong Mo Yang, Jin-Ok Jeong, Jang-Whan Bae, Joon-Hyouk Choi, 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, SMART‐CHOICE Investigators [Link], Dong-Bin Kim, Sang Cheol Cho, Sun-Ho Hwang, Dong Woon Jeon, Jae Kean Ryu, Moo-Hyun Kim, In-Ho Chae, Sang-Hyun Kim, Hack-Lyoung Kim, Dong Kyu Jin, Il Woo Suh, Jong Seon Park, Eun-Seok Shin, Shin-Jae Kim, Sang-Sig Cheong, Kyeong Ho, Sung Yun Lee, Jong-Young Lee, Jei Keon Chae, Yong Mo Yang, Jin-Ok Jeong, Jang-Whan Bae, Joon-Hyouk Choi

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.

Keywords: antiplatelet therapy; coronary artery disease; percutaneous coronary intervention.

Conflict of interest statement

Dr Hahn has received grants from Abbott Vascular, Boston Scientific, Biotronik, Daiichi Sankyo, and Medtronic; and speaker's fees from AstraZeneca, Daiichi Sankyo, and Sanofi‐Aventis. Dr Gwon has received research grants from Abbott Vascular, Boston Scientific, and Medtronic; and speaker's fees from Abbott Vascular, Boston Scientific, and Medtronic. The remaining authors have no disclosures to report.

Figures

Figure 1. Participants' flow.
Figure 1. Participants' flow.
DAPT indicates dual antiplatelet therapy.
Figure 2. Time‐to‐event curves for target vessel…
Figure 2. Time‐to‐event curves for target vessel failure (A) and net adverse clinical event (B) between 3‐month (line) and 12‐month (dotted line) dual antiplatelet therapy.
HR indicates hazard ratio.
Figure 3. Time‐to‐event curves for target vessel…
Figure 3. Time‐to‐event curves for target vessel failure between Orsiro stents (line) and everolimus‐eluting stents (EES; dotted lines).
HR indicates hazard ratio. (A), Orsiro versus EES; (B), Orsiro versus Promus/Synergy versus Xience.

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