Johnson & Johnson announced a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® (rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery. These data were featured in an oral presentation today at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia (Abstract #906-04). The PIONEER AF-PCI exploratory trial enrolled 2,124 patients with nonvalvular AF undergoing PCI, of whom 729 (34.3%) were elderly.

Patients were randomized to either rivaroxaban- or warfarin-based antithrombotic regimens. The data analysis demonstrated a reduced rate of CSB among both elderly (=75 years) and non-elderly (<75) patients with nonvalvular AF undergoing PCI treated with XARELTO® compared to warfarin. Elderly patients treated with XARELTO® had a lower rate of CSB at 12 months compared to those treated with warfarin (21.3% vs 31.4%; hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.46-0.88; P=0.005; number needed to treat [NNT]=10).

The reduction in CSB was consistent among non-elderly patients treated with XARELTO® compared to warfarin (15.3% vs 24.6%; HR, 0.58; 95% CI, 0.45-0.75; P<0.001; NNT=11; interaction P=0.676). The analysis also showed XARELTO® treatment was associated with a lower risk of NACE or rehospitalization in both elderly (HR, 0.77; 95% CI, 0.62-0.96) and non-elderly patients (HR, 0.69; 95% CI, 0.58-0.82; interaction P=0.435), primarily driven by a lower risk of CSB. In addition, the rates of major bleeding were lower in patients treated with XARELTO® compared to warfarin in both elderly (3.7% vs 5.2%; HR, 0.71; 95% CI, 0.33-1.55) and non-elderly (1.1% vs 2.5%; HR, 0.45; 95% CI, 0.18-1.10) patients.

Patients treated with XARELTO® also experienced lower rates of minor bleeding compared to warfarin in both elderly (1.4% vs 3.8%; HR, 0.36; 95% CI, 0.12-1.07) and non-elderly (1.0% vs 1.4%; HR, 0.67; 95% CI, 0.23-1.92) patients.