High-risk patients with symptomatic peripheral artery disease (PAD) of the legs are less likely to experience major vascular events if they are treated with a combination of rivaroxaban and aspirin versus aspirin alone, a secondary analysis of clinical trial results suggests.

The subanalysis was of a previously reported subgroup of patients with symptomatic lower extremity PAD enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies Study (COMPASS), which included 602 centres in 33 countries from 2013-20 and was funded by Bayer AG.

The 4129 patients in COMPASS were randomised to three groups: rivaroxaban 2.5mg twice a day plus aspirin 81mg; rivaroxaban 5mg twice a day; or aspirin 81mg once a day.

The 30-month incidence of a major vascular event (MI, stroke or cardiovascular death or a major adverse limb event including major amputation), was found to be greater than 10% in patients with certain comorbidities — baseline kidney dysfunction, heart failure, diabetes, and polyvascular disease — which the authors then classified as ‘high-risk comorbidities’.