Peripheral artery disease (PAD) was associated with continuous and linearly increasing risk for venous thromboembolism (VTE) after lower extremity revascularization (LER). Low-dose rivaroxaban plus aspirin significantly reduced this risk compared with aspirin alone, according to data from a prespecified secondary analysis of VOYAGER-PAD presented by Connie N. Hess, MD, an interventional cardiology at The University of Colorado, at the American Heart Association Scientific Sessions 2020.
Prior studies have shown that patients with PAD are at risk for arterial thrombosis. VOYAGER-PAD randomly assigned 6,564 patients undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. Clopidogrel was allowed for up to 6 months. The primary endpoint was acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemia stroke or cardiovascular death.
The primary outcome of this secondary analysis was symptomatic VTE with an exploratory outcome of composite acute venous or arterial thrombotic events. The incidence of VTE was 0.42 per 100 patient-years; 66 patients had VTE by efficacy cut-off date. Compared with patients without VTE, those with VTE were older, had higher body weight, more often had renal dysfunction, and lower use of baseline clopidogrel or statin.
The cumulative incidence of VTE was 1.7% in the placebo arm compared with 0.8% in the rivaroxaban arm (HR=0.61; 95% CI, 0.37 to 1.00; P=0.047). This translated to a 39% relative risk reduction associated with rivaroxaban.
“This benefit appears early, persists over time, and is consistent in major subgroups,” Dr. Hess said.
There was no heterogeneity in the effect of rivaroxaban according to age, weight, renal function, coronary artery disease, baseline clopidogrel and baseline statin use.
Looking at the effect of rivaroxaban on the composite endpoint of acute venous and arterial thrombotic events, there was a 25% relative risk reduction associated with rivaroxaban (16.2% vs. 12.2%; HR=0.75; 95% CI, 0.65 to 0.86; P<0.0001).