Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI.

Valgimigli, Marco; Cao, Davide; Angiolillo, Dominick J; Bangalore, Sripal; Bhatt, Deepak L; Ge, Junbo; Hermiller, James; Makkar, Raj R; Neumann, Franz-Josef; Saito, Shigeru; Picon, Hector; Toelg, Ralph; Maksoud, Aziz; Chehab, Bassem M; Choi, James W; Campo, Gianluca; De la Torre Hernandez, Jose M; Kunadian, Vijay; Sardella, Gennaro; Thiele, Holger; ... (2021). Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. Journal of the American College of Cardiology, 78(21), pp. 2060-2072. Elsevier 10.1016/j.jacc.2021.08.074

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BACKGROUND

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown.

OBJECTIVES

The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation.

METHODS

The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI.

RESULTS

A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015).

CONCLUSIONS

Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).

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