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  • Frigoli, EnricoUniv Bern, Clin Trials Unit, Bern, Switzerland (author)

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

  • Article/chapterEnglish2019

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  • MOSBY-ELSEVIER,2019
  • electronicrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:uu-380473
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-380473URI
  • https://doi.org/10.1016/j.ahj.2018.10.009DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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 antipkitelet 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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  • Smits, PieterMaasstad Hosp, Dept Cardiol, Rotterdam, Netherlands (author)
  • Vranckx, PascalJessa Ziekenhuis, Hartcentrum Hasselt, Dept Cardiol & Crit Care Med, Hasselt, Belgium;Hasselt Univ, Fac Med & Life Sci, Hasselt, Belgium (author)
  • Ozaki, YokioFujita Hlth Univ, Sch Med, Dept Cardiol, Toyoake, Aichi, Japan (author)
  • Tijssen, JanUniv Amsterdam, Acad Med Ctr, AMC Heartctr, Amsterdam, Netherlands (author)
  • Juni, PeterUniv Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada (author)
  • Morice, Marie-ClaudeCERC, Massy, France (author)
  • Onuma, YoshinobuErasmus MC, Thorax Ctr, Rotterdam, Netherlands (author)
  • Windecker, StephanBern Univ Hosp, Dept Cardiol, Bern, Switzerland (author)
  • Frenk, AndreBern Univ Hosp, Dept Cardiol, Bern, Switzerland (author)
  • Spaulding, ChristianParis Descartes Univ, Hop Europeen Georges Pompidou, AP HP, INSERM,U 970,Sudden Death Expert Ctr,Cardiol Dept, Paris, France (author)
  • Chevalier, BernardRamsay Gen Sante, Intervent Cardiol Dept, Inst Cardiovasc Paris Sud, Massy, France (author)
  • Barbato, EmanueleCardiovasc Res Ctr Aalst, Aalst, Belgium;Univ Federico II Naples, Dept Adv Biomed Sci, Div Cardiol, Naples, Italy (author)
  • Tonino, PimCatharina Hosp, Dept Cardiol, Eindhoven, Netherlands (author)
  • Hildick-Smith, DavidBrighton & Sussex Univ Hosp NHSTrust, Brighton, E Sussex, England (author)
  • Roffi, MarcoGeneva Univ Hosp, Div Cardiol, Geneva, Switzerland (author)
  • Kornowski, RanTel Aviv Univ, Sackler Sch Med, Rabin Med Ctr, Tel Aviv, Israel (author)
  • Schultz, CarlUniv Western Australia, Royal Perth Hosp Campus, Dept Cardiol, Perth, WA, Australia (author)
  • Lesiak, MaciejUniv Med Sci, Dept Cardiol 1, Poznan, Poland (author)
  • Iniguez, AndresHosp Alvaro Cunqueiro, Vigo, Spain (author)
  • Colombo, AntonioIRCCS San Raffaele Sci Inst, Unit Cardiovasc Intervent, Milan, Italy (author)
  • Alasnag, MirvatKing Fahad Armed Forces Hosp, Dept Cardiol, Jeddah, Saudi Arabia (author)
  • Mullasari, AjitMadras Med Mission, Chennai, Tamil Nadu, India (author)
  • James, Stefan K,1964-Uppsala universitet,Kardiologi(Swepub:uu)stjam367 (author)
  • Stankovic, GoranUniv Belgrade, Clin Ctr Serbia, Dept Cardiol, Belgrade, Serbia;Univ Belgrade, Fac Med, Belgrade, Serbia (author)
  • Ong, Paul J. L.Tan Tock Seng Hosp, Singapore, Singapore (author)
  • Rodriguez, Alfredo E.Otamendi Hosp, Buenos Aires Sch Med, Cardiac Unit, Cardiovasc Res Ctr CECI, Buenos Aires, DF, Argentina (author)
  • Mahfoud, FelixSaarland Univ Hosp, Homburg, Germany (author)
  • Bartunek, JozefBern Univ Hosp, Dept Cardiol, Bern, Switzerland (author)
  • Moschovitis, ArisBern Univ Hosp, Dept Cardiol, Bern, Switzerland (author)
  • Laanmets, PeepNorth Estonia Med Ctr Fdn, Tallinn, Estonia (author)
  • Leonardi, SergioFdn IRCCS Policlin San Matteo, Pavia, Italy (author)
  • Heg, DikUniv Bern, Clin Trials Unit, Bern, Switzerland (author)
  • Sunnaker, MikaelUniv Bern, Clin Trials Unit, Bern, Switzerland (author)
  • Valgimigli, MarcoBern Univ Hosp, Dept Cardiol, Bern, Switzerland (author)
  • Univ Bern, Clin Trials Unit, Bern, SwitzerlandMaasstad Hosp, Dept Cardiol, Rotterdam, Netherlands (creator_code:org_t)

Related titles

  • In:American Heart Journal: MOSBY-ELSEVIER209, s. 97-1050002-87031097-6744

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