• American heart journal · Dec 2016

    Randomized Controlled Trial Multicenter Study

    Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.

    • Joo Myung Lee, Deok-Kyu Cho, Joo-Yong Hahn, Young Bin Song, Taek Kyu Park, Ju-Hyeon Oh, Jin Bae Lee, Joon-Hyung Doh, Sang-Hyun Kim, Jeong Hoon Yang, Jin-Ho Choi, Seung-Hyuck Choi, Sang Hoon Lee, and Hyeon-Cheol Gwon.
    • Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
    • Am. Heart J. 2016 Dec 1; 182: 1-8.

    Background And RationaleDual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population.Study DesignThe SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5.ConclusionsThe SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation.Copyright © 2016 Elsevier Inc. All rights reserved.

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