Dual antiplatelet
therapy (
DAPT) is key for the prevention of recurrent ischemic events after
percutaneous coronary intervention (PCI); however, it increases the risk of
bleeding complications. While new generation
drug-eluting stents have been shown superior to bare-
metal stents after a short
DAPT course, the optimal
DAPT duration in patients at high
bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short
DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month
DAPT durations in HBR patients undergoing PCI with the XIENCE
stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued
DAPT at 3 months if they were free from
myocardial infarction (MI), repeat coronary revascularization,
stroke, or
stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue
DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short
DAPT regimen will be non-inferior to a conventional
DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short
DAPT Program will provide insights into the safety and efficacy of 2 abbreviated
DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE
stent.