In one of the latest sub-analyses from the VOYAGER PAD trial, investigators found that rivaroxaban plus aspirin versus aspirin alone in the high-risk population of patients with critical limb-threatening ischemia (CLTI) undergoing lower-extremity revascularization reduced the risk of a first major adverse limb or cardiovascular event as well as unplanned revascularization at three years.
The data was presented by Marc Bonaca, MD, a cardiologist at the University of Colorado Anschutz School of Medicine, at the American Heart Association’s virtual Scientific Sessions 2020, Nov. 13–17.
More than one in four of CLTI patients will experience a first major adverse limb or cardiovascular event and 23% will require an unplanned revascularization at three years, Bonaca et al told attendees, and rivaroxaban 2.5mg twice daily plus aspirin versus aspirin alone reduced the risk of these outcomes consistently in those with and without CLTI. “However, due to their risk profile, the absolute benefits are particularly important in those with [CLTI],” they revealed.
A total of 6,564 were randomized to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100mg daily. The indication for lower-extremity revascularization was collected at randomization, the authors note.
The primary endpoint was a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or cardiovascular death. Unplanned index limb revascularization was a prespecified secondary outcome.
Of the total, some 1,533 patients underwent revascularization for CLTI. Patients with CLTI versus those without had a higher rate of the primary endpoint at three years (26.9% vs. 17.8%). The benefit of rivaroxaban was consistent in those with CLTI (hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.69–1.05) and without (HR 0.86, 95% CI 0.74–0.99). Unplanned index limb revascularization was significantly reduced in those with CLTI (HR 0.78; p=0.0376). Bleeding was increased with no heterogeneity based on CLTI.