Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis.

Aim: To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS).
Methods and Results: In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT.
Conclusion: In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity.
Clinical Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.
Competing Interests: Conflict of interest: M.V. received an institutional grant from Terumo and consulting fees from Astra Zeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, DORSIA Pharmaceuticals LTD, Vifor, Bristol Myers Squib SA, Biotronik, Boston scientific, Medtronic, Vesalio, Novartis, Chiesi, PhaseBio, ECRI. P.C.S. received institutional grants from Microport, SMT, Daichy Sankyo, and Abbott Vascular; consulting fees from Cavis and Abbott Vascular; honoraria from Abiomed, Terumo, and Abbott Vascular; participated on advisory board of Terumo, Abbott Vascular, and SMI. B.M. received grants from Medtronic and Boston Scientific; Speaker fee from Biotronik, Abbott, Astra Zeneca, Boehringer Ingelheim, and Novartis. T.C. received consulting fees from Medtronic, Abbott vascular, Terumo, and Boston Scientific; honoraria from Medtronic, Abbott vascular, Terumo, and Boston Scientific. F.T.N.M. received consulting fees from Terumo. K.R. received honoraria from Boston Scientific, Terumo, and Astra Zeneca. P.V. received consulting fees from Daiichi Sankyo, Novartis, CSL Behring, and Bayer AG; honoraria from Daiichi Sankyo and Servier; participated on advisory board for Daiichi Sankyo. All other authors declared no conflict of interest.
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