Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial

Background: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. Methods: In the investigator-initiated, randomized, open-label MASTER DAPT trial, 4579 patients at high bleeding risk were randomized after 1-month dual APT (DAPT) to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis we report outcomes of populations with or without an OAC indication. In the population with an indication, patients changed immediately to single APT (SAPT) for 5 months (abbreviated regimen) or continued ≥ 2 months DAPT and SAPT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to SAPT for 11 months (abbreviated regimen) or continued ≥5 months of DAPT and SAPT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were: net adverse clinical outcomes (NACE; composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium [BARC] 3 or 5 bleeding events); major adverse cardiac and cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 BARC bleeding. Results: NACE or MACE did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; HR, 0.83; 95% CI, 0.60 to 1.15, HR, 0.88; 95% CI, 0.60 to 1.30; respectively) or without OAC indication (n=2913; HR, 1.01; 95% CI, 0.77 to 1.33; HR, 1.06; 95% CI, 0.79 to 1.44; Pinteraction=0.35 and 0.45, respectively). BARC 2, 3 or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83; 95% CI, 0.62 to 1.12) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55; 95% CI, 0.41 to 0.74; Pinteraction=0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in BARC 2 bleedings (HR, 0.48; 95% CI 0.33 to 0.69; Pinteraction=0.021). Conclusions: Rates of NACE and MACCE did not differ with abbreviated APT in high bleeding risk patients with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique identifier:NCT03023020.