Patients with symptomatic lower extremity perip[heral artery disease (LE-PAD) are at a higher risk of major cardiovascular events. However, the information on what the clinical features of symptomatic LE-PAD forecast about major vascular events is not known. This study aims to evaluate the risk of major cardiovascular events and the response to treatment with rivaroxaban and aspirin.

This subanalysis of a large, placebo-controlled, double-blind, randomized clinical trial included a total of 4,129 patients with symptomatic LE-PAD. The patients were randomly assigned to receive either low-dose rivaroxaban and aspirin or aspirin alone. The primary outcomes of the study were 30-month incidence risk of myocardial infarction, cardiovascular death & stroke, bleeding, and major adverse limb events (MALE).

The 30-month risk of MALE was 22.6% in patients with prior amputation and 17.6% with Fontaine 3 or 4 symptoms, and 11.8% with previous peripheral artery revascularization. Besides, the risk of incidence of MALE was 14.1% in patients with kidney dysfunction, 13.5% in those with heart failure, and 12.8% in those with polyvascular disease.

 The research concluded that patients with LE-PAD and hgih-risk comorbidities or high-risk limb presentations were at a higher risk of incident major vascular events.