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.
Absorbable Implants
/ adverse effects
Aged, 80 and over
Coronary Artery Disease
/ surgery
Drug-Eluting Stents
/ adverse effects
Dual Anti-Platelet Therapy
/ methods
Female
Humans
Immunosuppressive Agents
/ pharmacology
Male
Percutaneous Coronary Intervention
/ adverse effects
Polymers
Postoperative Hemorrhage
/ etiology
Sirolimus
/ pharmacology
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
03 2019
03 2019
Historique:
received:
18
05
2018
accepted:
28
10
2018
pubmed:
1
2
2019
medline:
24
12
2019
entrez:
1
2
2019
Statut:
ppublish
Résumé
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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 30703644
pii: S0002-8703(18)30305-3
doi: 10.1016/j.ahj.2018.10.009
pii:
doi:
Substances chimiques
Immunosuppressive Agents
0
Polymers
0
Sirolimus
W36ZG6FT64
Banques de données
ClinicalTrials.gov
['NCT03023020']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
97-105Informations de copyright
Copyright © 2018 Elsevier Inc. All rights reserved.