P3590Rivaroxaban strategies improve the number of days patients remain out of the hospital and event free: A PIONEER substudy

Abstract

Background: Combined anticoagulant/antiplatelet therapy in patients with atrial fibrillation (AF) undergoing coronary stenting (PCI) is associated with increased bleeding and cardiovascular events. An outcome relevant to patients is event‐free days out of hospital. Purpose: To assess whether rivaroxaban (R) treatment strategies improve out‐ofhospital adverse event‐free duration compared with a standard warfarin regimen in patients with AF who undergo PCI. Methods: In the PIONEER AF‐PCI trial, patients with AF undergoing PCI were randomized 1:1:1 to (1) 15 mg/d R + P2Y12 inhibitor (15 mg R n=669), (2) 2.5 mg bid R + dual‐antiplatelet therapy (DAPT) (2.5 mg R n=668); or (3) vitamin K antagonist warfarin (VKA) + DAPT (n=654), and followed for 1 year. We collected the days out of the hospital free of any adverse event that was severe enough to prompt hospitalization. The adverse event that prompted a hospitalization had to have resolved even though the patient was out of the hospital to be counted as an event‐free day. The figure compares the cumulative distribution of eventfree days and median number of event‐free days (non‐parametric Kruskal‐Wallis test). The proportion of subjects exceeding a given duration of adverse event free days (AEFD) was compared using the Wilcoxon test. Results: The 2.5 mg R + DAPT strategy was associated with greater median outof‐ hospital event‐free days compared to VKA (p<0.0001). For any AEFD on the X axis, the proportion of subjects exceeding that time was significantly different across strata overall (p<0.0001; Figure). The proportion of subjects in the 2.5mg R + DAPT arm was significantly higher than the proportion in the VKA + DAPT group (p<0.0001). 89% of subjects in the 2.5 mg R + DAPT arm experienced >100 days of AEFD vs only 81% in the VKA + DAPT arm. Likewise, 81% of subjects in the 2.5 mg R + DAPT arm exhibited >300 days of AEFD vs only 74% in the VKA + DAPT arm. There was no statistical difference comparing the 15 mg R + P2Y12 to the VKA + DAPT group (p=0.47). Conclusions: Among patients with AF undergoing PCI, a rivaroxaban‐based strategy increased event‐free days out of hospital compared with a VKA + DAPT strategy, a patient‐centered outcome that should be considered in the assessment of net clinical benefit.