Safety of 3-month dual antiplatelet therapy after implantation of ultrathin sirolimus-eluting stents with biodegradable polymer (Orsiro): Results from the SMART-CHOICE trial

SMART-CHOICE Investigators

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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.clini caltr ials.gov; Unique identifier: NCT02079194.

Original languageEnglish
Article numbere018366
Pages (from-to)1-9
Number of pages9
JournalJournal of the American Heart Association
Volume10
Issue number1
DOIs
Publication statusPublished - 2021

Keywords

  • Antiplatelet therapy
  • Coronary artery disease
  • Percutaneous coronary intervention

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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