TY - JOUR
T1 - 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
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
N1 - Funding Information:
Dr Roffi reports institutional research grants from Terumo, Abbott Vascular, Medtronic, Boston Scientific, and Biotronik, outside the submitted work.
Funding Information:
Dr Windecker reports grants from Biotronik, grants from Boston Scientific, grants from St Jude Medical, grants from Abbott, grants from Amgen Inc, grants from Terumo Inc, and grants from Symetis SA, outside the submitted work.
Funding Information:
This study is an investigator-driven clinical trial sponsored by European Cardiovascular Research Institute and supported by an unrestricted research grant from TERUMO Corporation, Tokyo, Japan. The Executive Committee (ExC) is responsible for scientific content and oversight of the study and oversees publication. The Steering Committee is comprised of the ExC and national/regional lead investigators. The Operational Committee is responsible for executing and implementing study procedures under the supervision of the ExC. The Data Monitoring Committee is an independent, multidisciplinary board composed of 3 members who are not directly involved in the conduct of the trial and is responsible for ensuring the safety of the patients participating in the clinical study. The Data Monitoring Committee members will seriously consider recommending early termination of the trial when the abbreviated DAPT regimen would show a statistically significant increased rate of (cardiovascular) mortality or of MACCE, provided the latter is not counterbalanced by a reciprocal reduction in the rate of major bleeding. An independent, multidisciplinary, and blinded CEC is responsible for the adjudication of all investigator-reported as well as electronically triggered potential end points events from the electronic case report form. Independent study monitoring and site management are performed by Cardiovascular European Research Center (Massy, France), Cardialysis (Rotterdam, the Netherlands), and CV Quest (Tokyo, Japan). Data management, central data review, and statistical analyses will be conducted by an independent academic Clinical Trial Unit located in Bern, Switzerland. The first study patient was randomized in April 2016, and enrolment is projected to reach completion by Q4 2019. At 10th December 2018, 2,196 patients were randomized, and their distribution according to each HBR criterion is shown in Figure 3 .
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2019/3
Y1 - 2019/3
N2 - 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.
AB - 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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U2 - 10.1016/j.ahj.2018.10.009
DO - 10.1016/j.ahj.2018.10.009
M3 - Article
C2 - 30703644
AN - SCOPUS:85060520985
VL - 209
SP - 97
EP - 105
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -