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

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 & 15 others 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, Marco Valgimigli

Research output: Contribution to journalArticle

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Abstract

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.gov NCT03023020) 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.

Original languageEnglish
Pages (from-to)97-105
Number of pages9
JournalAmerican Heart Journal
Volume209
DOIs
Publication statusPublished - Mar 1 2019

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Stents
Polymers
Hemorrhage
Sirolimus
Therapeutics
Randomized Controlled Trials
Group Psychotherapy
Cardiology
Sample Size
Coronary Artery Disease
Research Personnel
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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; Colombo, Antonio; Alasnag, Mirvat; Mullasari, Ajit; James, Stefan; Stankovic, Goran; Ong, Paul J.L.; Rodriguez, Alfredo E.; Mahfoud, Felix; Bartunek, Jozef; Moschovitis, Aris; Laanmets, Peep; Leonardi, Sergio; Heg, Dik; Sunnåker, Mikael; Valgimigli, Marco.

In: American Heart Journal, Vol. 209, 01.03.2019, p. 97-105.

Research output: Contribution to journalArticle

Frigoli, E, Smits, P, Vranckx, P, Ozaki, Y, Tijssen, J, Jüni, P, Morice, MC, Onuma, Y, Windecker, S, Frenk, A, Spaulding, C, Chevalier, B, Barbato, E, Tonino, P, Hildick-Smith, D, Roffi, M, Kornowski, R, Schultz, C, Lesiak, M, Iñiguez, A, Colombo, A, Alasnag, M, Mullasari, A, James, S, Stankovic, G, Ong, PJL, Rodriguez, AE, Mahfoud, F, Bartunek, J, Moschovitis, A, Laanmets, P, Leonardi, S, Heg, D, Sunnåker, M & Valgimigli, M 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, vol. 209, pp. 97-105. https://doi.org/10.1016/j.ahj.2018.10.009
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 ; Colombo, Antonio ; Alasnag, Mirvat ; Mullasari, Ajit ; James, Stefan ; Stankovic, Goran ; Ong, Paul J.L. ; Rodriguez, Alfredo E. ; Mahfoud, Felix ; Bartunek, Jozef ; Moschovitis, Aris ; Laanmets, Peep ; Leonardi, Sergio ; Heg, Dik ; Sunnåker, Mikael ; Valgimigli, Marco. / 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. In: American Heart Journal. 2019 ; Vol. 209. pp. 97-105.
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abstract = "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.gov NCT03023020) 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.",
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AU - Frigoli, Enrico

AU - Smits, Pieter

AU - Vranckx, Pascal

AU - Ozaki, Yokio

AU - Tijssen, Jan

AU - Jüni, Peter

AU - Morice, Marie Claude

AU - Onuma, Yoshinobu

AU - Windecker, Stephan

AU - Frenk, Andrè

AU - Spaulding, Christian

AU - Chevalier, Bernard

AU - Barbato, Emanuele

AU - Tonino, Pim

AU - Hildick-Smith, David

AU - Roffi, Marco

AU - Kornowski, Ran

AU - Schultz, Carl

AU - Lesiak, Maciej

AU - Iñiguez, Andrés

AU - Colombo, Antonio

AU - Alasnag, Mirvat

AU - Mullasari, Ajit

AU - James, Stefan

AU - Stankovic, Goran

AU - Ong, Paul J.L.

AU - Rodriguez, Alfredo E.

AU - Mahfoud, Felix

AU - Bartunek, Jozef

AU - Moschovitis, Aris

AU - Laanmets, Peep

AU - Leonardi, Sergio

AU - Heg, Dik

AU - Sunnåker, Mikael

AU - Valgimigli, Marco

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