In patients at high risk for bleeding, discontinuation of dual antiplatelet therapy (DAPT) at one month after implantation of a biodegradable-polymer sirolimus-eluting coronary stent was noninferior to the standard therapy in terms of net adverse clinical events and major adverse cardiac or cerebral events, according to findings from MASTER-DAPT presented at ESC Congress 2021 and published in the New England Journal of Medicine. Additionally, researchers noted that abbreviated DAPT therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.

Patients with an acute or chronic coronary syndrome who underwent successful PCI of all coronary artery stenoses and fulfilled one or more high bleeding risk criteria were considered candidates for the trial. A total of 4,579 patients from 30 countries who were free from ischemic and bleeding events and who adhered to a DAPT regimen were screened for inclusion 30 to 44 days after PCI and randomly assigned to discontinue DAPT immediately or continue DAPT therapy for at least two additional months, per standard therapy. The mean patient age was 76 years and 69.3 were men. The three ranked primary outcomes were net adverse clinical events, major adverse cardiac or cerebral events, and major or clinically relevant nonmajor bleeding. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population.

Overall findings found 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 nonmajor bleeding. Net adverse clinical events occurred in 7.5% of patients in the abbreviated DAPT group (n=165) and 7.7% of patients in the standard DAPT group (n=172). In the intention-to-treat population, major or clinically relevant nonmajor bleeding was lower in the abbreviated DAPT group (6.5%) compared with the standard DAPT group (9.5%), for a difference in risk of −2.82 percentage points.

"One month of DAPT after PCI in high bleeding risk patients maintained the ischemic benefits of therapy while reducing the risk of bleeding," said principal investigator Marco Valgimigli, MD. "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 ischemic events, including those with clinical or angiographic high ischemic risk features." However, Valgimigli and colleagues caution that the results may not extend to patients who are not at high risk for bleeding or who receive other stent types.

In a related NEJM editorial, E. Magnus Ohman, MD, FACC, writes, "The findings of Valgimigli and colleagues are important and move us toward a shorter and simpler antithrombotic strategy after PCI. Concomitant shorter antiplatelet monotherapy in the context of chronic disease after the implantation of a drug-eluting stent represents a major shift. This news is welcome for patients at high risk for bleeding after stent placement."

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS

Keywords: ESC Congress, ESC21, Acute Coronary Syndrome, Stents, Hemorrhage, ACC International

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