Rivaroxaban reduces ischaemic events in patients with PAD
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Patients with PAD who are treated with revascularization for limb symptoms have a 4-fold increased risk of subsequent vascular complications compared with patients who have never undergone revascularization. The previously published COMPASS trial showed that in a population of patients with chronic and stable PAD, rivaroxaban added to aspirin therapy significantly reduced the risk of ischaemic events compared with aspirin therapy alone. The VOYAGAER PAD investigators thus sought to determine the safety and efficacy of adding this anticoagulant to aspirin to lower ischaemic risk in patients with PAD after revascularization.

The investigators randomly assigned 3,286 patients to rivaroxaban (2.5 mg twice daily) plus aspirin and 3,278 patients to placebo plus aspirin. At a median follow-up of 28 months, the incidence of the primary end point (a composite of acute limb ischaemia, major amputation for vascular causes, myocardial infarction, ischaemic stroke or cardiovascular death) was 17.3% in the rivaroxaban group and 19.9% in the aspirin group.

The benefit of rivaroxaban was consistent across all subgroups, occurred early (from 3 months) and continued to accrue over time. Importantly, the principal safety outcome of TIMI major bleeding was not significantly different between the two treatment groups, but the incidence of the secondary safety outcome of ISTH major bleeding was greater in the rivaroxaban group. Overall, the investigators estimated that for every 10,000 patients treated for 1 year, the addition of rivaroxaban to aspirin therapy will prevent 181 ischaemic events at the expense of 29 TIMI major bleeding events.

These results extend and complement the observations in the COMPASS trial, which showed reductions in ischaemic risk … in a broad population of patients with chronic [PAD],” summarize the investigators.

Source: https://www.nature.com/articles/s41569-020-0385-9