Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study.

Frigoli, Enrico; Smits, Pieter; Vranckx, Pascal; Ozaki, Yokio; Tijssen, Jan; Jüni, Peter; Morice, Marie-Claude; Onuma, Yoshinobu; Windecker, Stephan; Frenk, Andrè; Spaulding, Christian; Chevalier, Bernard; Barbato, Emanuele; Tonino, Pim; Hildick-Smith, David; Roffi, Marco; Kornowski, Ran; Schultz, Carl; Lesiak, Maciej; Iñiguez, Andrés; ... (2019). Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. American Heart Journal, 209, pp. 97-105. Elsevier 10.1016/j.ahj.2018.10.009

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BACKGROUND The 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. DESIGN MASTER 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. CONCLUSIONS The 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Frigoli, Enrico; Windecker, Stephan; Frenk, André; Moschovitis, Aris; Sunnaker, Mikael Anders and Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0002-8703

Publisher:

Elsevier

Language:

English

Submitter:

Beatrice Minder Wyssmann

Date Deposited:

28 Feb 2019 16:22

Last Modified:

25 Oct 2019 15:32

Publisher DOI:

10.1016/j.ahj.2018.10.009

PubMed ID:

30703644

BORIS DOI:

10.7892/boris.126082

URI:

https://boris.unibe.ch/id/eprint/126082

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