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Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent

Enrico Frigoli1, Pieter Smits2, Pascal Vranckx3

  • 1Clinical Trials Unit, University of Bern, Bern, Switzerland.

American Heart Journal
|February 1, 2019
PubMed

Insights

Shorter antiplatelet therapy is effective for high-bleeding risk patients after stent implantation. The MASTER DAPT trial found abbreviated dual-antiplatelet therapy (DAPT) non-inferior to standard DAPT for safety and efficacy.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Clinical Trials

Background:

  • Optimal antiplatelet therapy duration is unknown for high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents.
  • MASTER DAPT addresses this gap by comparing abbreviated vs. standard antiplatelet therapy durations.

Purpose of the Study:

  • To determine the optimal duration of antiplatelet therapy in HBR patients undergoing sirolimus-eluting bioresorbable polymer-coated stent implantation.
  • To assess the noninferiority and superiority of abbreviated antiplatelet therapy compared to standard duration.

Main Methods:

  • The MASTER DAPT trial is a randomized controlled trial involving approximately 4,300 HBR patients across over 100 centers globally.
  • Patients received a mandatory 30-day dual-antiplatelet therapy (DAPT) followed by randomization to either abbreviated (1-month DAPT) or standard DAPT regimens.
  • Primary endpoints include net adverse clinical and major adverse cardiac/cerebral events, and secondary endpoints focus on bleeding events.

Main Results:

  • The study is powered to assess noninferiority of abbreviated antiplatelet therapy regarding net adverse clinical and major adverse cardiac and cerebral events.
  • It will also assess superiority in terms of major or clinically relevant nonmajor bleeding events.

Conclusions:

  • The MASTER DAPT study is the first randomized controlled trial to investigate optimal antiplatelet therapy duration in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stents.
  • Findings will guide clinical practice for managing HBR patients undergoing stenting.
Abstract

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