One month of dual antiplatelet therapy (DAPT) following stent implantation in high bleeding risk patients preserves ischaemic benefits and reduces bleeding risk. That’s according to the findings of the MASTER DAPT trial, which were presented at at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30 August, virtual), and published in the New England Journal of Medicine.
Principal investigator, Marco Valgimigli of the Cardiocentro Ticino Foundation, Lugano, Switzerland, said: “One month of DAPT after PCI in high bleeding risk patients maintained the ischaemic benefits of therapy while reducing the risk of bleeding. Unlike other studies, we did not exclude patients with acute coronary syndrome or limit the number, location, or complexity of the treated lesions.
“Our results can therefore inform treatment decisions on DAPT at one month after PCI in patients at high risk for bleeding without postprocedural ischaemic events, including those with clinical or angiographic high ischaemic risk features.”
Trial data showed that abbreviated DAPT was noninferior to standard DAPT in terms of net adverse clinical events and major adverse cardiac and cerebral events, and superior in terms of major or clinically relevant non-major bleeding.
The MASTER DAPT trial was conducted in patients at high risk for bleeding who had undergone biodegradable polymer sirolimus-eluting stent implantation.
The objective was to assess whether one month of DAPT preserved the benefit in relation to cardiovascular events, while mitigating bleeding outcomes, compared with longer treatment durations. This was a noninferiority study with sequential superiority testing.
Participants were randomised 1:1 to receive open-label abbreviated or standard DAPT. A total of 4,579 patients in 30 countries were randomised to abbreviated or standard DAPT at a median of 34 days after PCI. The mean age was 76 years, 69.3% were men, 36.2% were receiving concomitant oral anticoagulation, and 48.3% underwent PCI for acute coronary syndrome. There was a mean of 2.1 high bleeding risk criteria per patient.
Net adverse clinical events occurred in 165 (7.5%) patients in the abbreviated DAPT group and 172 (7.7%) patients in the standard DAPT group (hazard ratio [HR] 0.97; 95% confidence interval [CI]; 0.78–1.20) in the per-protocol population, for a difference in risk of −0.23 percentage points (95% CI −1.80 to 1.33; p<0.001 for noninferiority).
A total of 133 (6.1%) patients in the abbreviated DAPT group had a major adverse cardiac or cerebral event versus 132 (5.9%) patients in the standard DAPT group (HR 1.02; 95% CI 0.80–1.30) in the per-protocol population, for a difference in risk of 0.11 percentage points (95% CI −1.29 to 1.51; p=0.0014 for noninferiority).
Major or clinically relevant non-major bleeding was lower in the abbreviated versus standard DAPT group (148 [6.5%] versus 211 [9.4%]; HR 0.68; 95% CI 0.55–0.84; p<0.001 for superiority) in the intention-to-treat population, for a difference in risk of −2.82 percentage points (95% CI −4.40 to –1.24).