Abbreviated Dual Antiplatelet Therapy in Patients With High Bleeding Risk Undergoing PCI of Bifurcation Lesions: A Prespecified Substudy of the MASTER DAPT Trial.

BACKGROUND

Coronary stenting of bifurcation lesions has been associated with an increased risk of thrombotic events. However, the optimal duration of dual antiplatelet therapy (DAPT) after treatment of bifurcations, particularly among patients with high bleeding risk, is unknown. We aimed to evaluate the safety and efficacy of abbreviated DAPT in patients with high bleeding risk undergoing percutaneous coronary intervention (PCI) of bifurcation lesions.

METHODS

The MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen) randomized patients with high bleeding risk who were free from ischemic or bleeding events after 1 month of PCI to discontinue DAPT (abbreviated regimen) or continue DAPT for a minimum of 2 additional months (standard regimen). Coprimary outcomes were net adverse clinical outcomes events, major adverse cardiac and cerebral events, and BARC (Bleeding Academic Research Consortium) type 2, 3, or 5 bleeding at 335 days after randomization. This prespecified substudy evaluates the outcomes of abbreviated versus standard DAPT according to treatment of bifurcation lesions.

RESULTS

Of the 4579 patients randomized, 976 (21.2%) underwent bifurcation PCI. Net adverse clinical event and major adverse cardiac and cerebral events did not differ between abbreviated and standard DAPT in both patients with (hazard ratio [HR], 0.98 [95% CI, 0.73-1.17] and HR, 0.92 [95% CI, 0.63-1.54], respectively) and without bifurcation PCI (HR, 1.14 [95% CI, 0.67-1.93] and HR, 0.96 [95% CI, 0.74-1.25]; P interaction=0.803 and 0.563, respectively). Abbreviated DAPT consistently reduced BARC 2, 3, or 5 bleeding in patients with (HR, 0.83 [95% CI, 0.53-1.30]) or without (HR, 0.65 [95% CI, 0.51-0.82]) bifurcation (P interaction=0.321).

CONCLUSIONS

Among patients with high bleeding risk with or without bifurcation PCI, abbreviated DAPT was associated with lower bleeding risk without an excess of ischemic or net adverse events compared with standard DAPT.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.