Enrico Frigoli1, Pieter Smits2, Pascal Vranckx3, Yokio Ozaki4, Jan Tijssen5, Peter Jüni6, Marie-Claude Morice7, Yoshinobu Onuma8, Stephan Windecker9, Andrè Frenk9, Christian Spaulding10, Bernard Chevalier11, Emanuele Barbato12, Pim Tonino13, David Hildick-Smith14, Marco Roffi15, Ran Kornowski16, Carl Schultz17, Maciej Lesiak18, Andrés Iñiguez19, Antonio Colombo20, Mirvat Alasnag21, Ajit Mullasari22, Stefan James23, Goran Stankovic24, Paul J L Ong25, Alfredo E Rodriguez26, Felix Mahfoud27, Jozef Bartunek28, Aris Moschovitis9, Peep Laanmets29, Sergio Leonardi30, Dik Heg1, Mikael Sunnåker1, Marco Valgimigli31. 1. Clinical Trials Unit, University of Bern, Bern, Switzerland. 2. Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands. 3. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium. 4. Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan. 5. AMC Heartcenter, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 6. University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada. 7. Cardiovascular European Research Center (CERC), Massy, France. 8. Thorax Center, Erasmus Medical Center, Rotterdam, the Netherlands. 9. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 10. Cardiology department, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, Sudden Death Expert Center, INSERM U 970, Paris Descartes Université, Paris, France. 11. Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France. 12. Cardiovascular Research Center Aalst, Aalst, Belgium; Division of Cardiology, Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy. 13. Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands. 14. Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom. 15. Division of Cardiology, Geneva University Hospitals, Geneva, Switzerland. 16. Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. 17. Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia. 18. 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland. 19. Hospital Alvaro Cunqueiro, Vigo, Spain. 20. Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy. 21. Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia. 22. Madras Medical Mission, Chennai, India. 23. Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. 24. Department of Cardiology, Clinical Center of Serbia, and Faculty of medicine, University of Belgrade, Belgrade, Serbia. 25. Tan Tock Seng Hospital, Singapore, Singapore. 26. Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (CECI), Buenos Aires, Argentina. 27. Saarland University Hospital, Homburg, Germany. 28. Cardiovascular Research Center Aalst, Aalst, Belgium. 29. North-Estonia Medical Centre Foundation, Tallinn, Estonia. 30. Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 31. Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.
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.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.
RCT Entities:
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.
Authors: Giuseppe Gargiulo; Christopher P Cannon; Charles Michael Gibson; Renato D Lopes; Pascal Vranckx; Marco Valgimigli Journal: Eur Heart J Cardiovasc Pharmacother Date: 2021-05-23
Authors: Davide Capodanno; Deepak L Bhatt; C Michael Gibson; Stefan James; Takeshi Kimura; Roxana Mehran; Sunil V Rao; Philippe Gabriel Steg; Philip Urban; Marco Valgimigli; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2021-08-23 Impact factor: 32.419
Authors: David E Kandzari; Ajay J Kirtane; Stephan Windecker; Azeem Latib; Elvin Kedhi; Roxana Mehran; Matthew J Price; Alexandre Abizaid; Daniel I Simon; Stephen G Worthley; Azfar Zaman; James W Choi; Ronald Caputo; Mihir Kanitkar; Brent McLaurin; Srinivasa Potluri; Timothy Smith; Douglas Spriggs; Thaddeus Tolleson; Tamim Nazif; Maria Parke; Lilian C Lee; Te-Hsin Lung; Gregg W Stone Journal: Circ Cardiovasc Interv Date: 2020-11-10 Impact factor: 6.546
Authors: Pieter C Smits; Enrico Frigoli; Jan Tijssen; Peter Jüni; Pascal Vranckx; Yukio Ozaki; Marie-Claude Morice; Bernard Chevalier; Yoshinobu Onuma; Stephan Windecker; Pim A L Tonino; Marco Roffi; Maciej Lesiak; Felix Mahfoud; Jozef Bartunek; David Hildick-Smith; Antonio Colombo; Goran Stankovic; Andrés Iñiguez; Carl Schultz; Ran Kornowski; Paul J L Ong; Mirvat Alasnag; Alfredo E Rodriguez; Aris Moschovitis; Peep Laanmets; Dik Heg; Marco Valgimigli Journal: Circulation Date: 2021-08-29 Impact factor: 29.690