Hot Line - Abbreviated DAPT after stent implantation has benefits for high bleeding-risk patients

28 Aug 2021

There is currently no evidence-based recommendation for the duration of dual antiplatelet therapy (DAPT) following stent implantation in patients at a high risk of bleeding. Guideline recommendations for shortened DAPT duration in these types of patients, irrespective of clinical presentation, are based on expert opinion.^1,2

In a Hot Line session today, Professor Marco Valgimigli (Cardiocentro Ticino Foundation, Lugano, Switzerland) presented results from the investigator-initiated, open-label MASTER DAPT trial comparing an abbreviated vs. a standard duration of antiplatelet therapy after bioresorbable polymer-coated sirolimus-eluting stent implantation in patients with acute or chronic coronary syndrome who fulfilled one or more high bleeding-risk criteria.

Following a mandatory 30-day DAPT run-in phase after percutaneous coronary intervention (PCI), eligible patients who were free from ischaemic and bleeding events were randomised 1:1 to receive abbreviated or standard DAPT. Abbreviated treatment comprised single antiplatelet therapy until study completion, except for patients receiving clinically indicated oral anticoagulation, who continued single antiplatelet therapy up to 6 months after PCI. Standard treatment comprised DAPT continuation for at least 5 additional months (6 months after PCI) or, for those receiving clinically indicated oral anticoagulation, for at least 2 additional months (3 months after PCI) and with continuation thereafter of single antiplatelet therapy.

This was a noninferiority study with sequential superiority testing. The three ranked coprimary outcomes were: 1) net adverse clinical events (the composite of all-cause death, myocardial infarction [MI], stroke, and major or clinically relevant non-major bleeding); 2) major adverse cardiac and cerebrovascular events (MACCE, the composite of all-cause death, MI and stroke); and 3) major or clinically relevant non-major bleeding occurring between randomisation and 335 days, defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding.

A total of 4,579 patients from 30 countries were randomised 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 (ACS). There was a mean of 2.1 high bleeding-risk criteria per patient.

Abbreviated DAPT was noninferior to standard DAPT in terms of net adverse clinical events and MACCE. Net adverse clinical events occurred in 7.5% of patients in the abbreviated DAPT group and 7.7% of patients in the standard DAPT group (hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.78 to 1.20), for a risk difference of −0.23 percentage points (95% CI −1.80 to 1.33; p<0.001 for noninferiority). MACCE occurred in 6.1% of patients in the abbreviated DAPT group and 5.9% of patients in the standard DAPT group (HR 1.02; 95% CI 0.80 to 1.30), for a risk difference of 0.11 percentage points (95% CI −1.29 to 1.51; p=0.0014 for noninferiority).

Abbreviated DAPT was superior to standard DAPT in terms of major or clinically relevant non-major bleeding events (6.5% vs. 9.4%, respectively; HR 0.68; 95% CI 0.55 to 0.84; p<0.001 for superiority), with a risk difference of −2.82 percentage points (95% CI −4.40 to –1.24).

The finding that 1 month of DAPT after PCI maintained the ischaemic benefits of therapy while reducing the risk of bleeding is notable. Prof. Valgimigli commented, “Unlike other studies, we did not exclude patients with ACS or limit the number, location or complexity of the treated lesions. Our results can therefore inform treatment decisions on DAPT at 1 month after PCI in patients at high risk for bleeding without post-procedural ischaemic events, including those with clinical or angiographic high ischaemic risk features.”

 

Missed the session? Watch it on demand:

https://digital-congress.escardio.org/ESC-Congress/sessions/2829-hot-line-master-dapt