MASTER DAPT: results just published
31.08.2021 – Results of a global trial on dual antiplatelet therapy after percutaneous coronary artery intervention were published in The New England Journal of Medicine on 28th of August 2021.
The trial studied a population of high-bleeding risk patients needing dual antiplatelet therapy (DAPT) after coronary artery stent implantation. For this population, the optimal duration of DAPT had remained unclear. The specific challenge is the trade-off between ischemic and bleeding risk associated with this therapy. Therefore, one month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, patients were randomly to discontinue DAPT (so called abbreviated therapy) or to continue it for at least two additional months (so called standard therapy). The three ranked primary outcomes were 1) net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), 2) major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and 3) major or clinically relevant nonmajor bleeding. Cumulative incidences of these endpoints were assessed 335 days after randomization. The first two outcomes were assessed for non-inferiority (showing that the abbreviated therapy is not worse than the standard therapy) and the third outcome for superiority (showing that the abbreviated therapy reduces risk of bleeding). The results confirmed non-inferiority for the first two outcomes and superiority in the third outcome, i.e. major and nonmajor clinically relevant bleeding were reduced in the patients in the abbreviated therapy group compared to the standard therapy group while maintaining cardiovascular safety. The MASTER DAPT was a large trial run in 140 different hospitals across Europe, Asia and Australia. CTU Bern provided the electronic case report form and trial database (Data Management), data checks (Central Data Monitoring) and performed the statistical analysis (Statistics and Methodology).