• Enrico Frigoli, Pieter Smits, Pascal Vranckx, Yokio Ozaki, Jan Tijssen, Peter Jüni, Marie-Claude Morice, Yoshinobu Onuma, Stephan Windecker, Andrè Frenk, Christian Spaulding, Bernard Chevalier, Emanuele Barbato, Pim Tonino, David Hildick-Smith, Marco Roffi, Ran Kornowski, Carl Schultz, Maciej Lesiak, Andrés Iñiguez, Antonio Colombo, Mirvat Alasnag, Ajit Mullasari, Stefan James, Goran Stankovic, Paul J L Ong, Alfredo E Rodriguez, Felix Mahfoud, Jozef Bartunek, Aris Moschovitis, Peep Laanmets, Sergio Leonardi, Dik Heg, Mikael Sunnåker, and Marco Valgimigli.
• Clinical Trials Unit, University of Bern, Bern, Switzerland.
• Am. Heart J. 2019 Mar 1; 209: 97-105.

BackgroundThe optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear.DesignMASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee.ConclusionsThe MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.Copyright © 2018 Elsevier Inc. All rights reserved.

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