Impacts of Rivaroxaban on Functional Outcomes in Patients with Lower-extremity Peripheral Artery Disease Following Endovascular Revascularization: A Randomized Double-blinded Controlled Trial.

Abstract

Background: Rivaroxaban (RIVA) is a medication with anti-inflammatory and anticoagulant properties that may slow the progression of peripheral artery disease (PAD). This trial evaluated the effects of RIVA on functional outcomes in patients with lower extremity PAD (LEPAD) following endovascular revascularization.

Methods: A six-month, double-blind, randomized controlled trial was conducted at Golestan Hospital (Ahvaz, Iran) and enrolled patients with LEPAD who had undergone endovascular revascularization within the previous 10 days. Clinical and demographic data were collected from the participants. Participants were randomly assigned to receive either RIVA (2.5 mg twice daily) plus aspirin (80 mg once daily) or clopidogrel (CLOP; 75 mg once daily) plus aspirin (80 mg once daily) for six months.

Results: The trial enrolled 104 patients with LEPAD. A total of 53 participants were assigned to the RIVA group, while 51 were assigned to the CLOP group. Among the patients, 73 were men, and 41 were women, with a mean age of 68 years. After six months, the RIVA group demonstrated significantly greater improvements in functional outcomes, pain, and claudication symptoms compared to the CLOP group. Notable between-group differences included improvements in the six-minute walk test (6MWT) distance (63.67 ± 1.34 m; p < 0.05), anklebrachial index (ABI) (0.10 ± 0.03; p < 0.05), and toe-brachial index (TBI) (0.08 ± 0.02; p < 0.05).

Conclusion: RIVA was more effective than CLOP in improving functional outcomes, reducing claudication, and alleviating pain in patients with LEPAD.

Clinical trial registration number: This trial was registered at irct.behdasht.gov.ir as IRCT20231117060086N1.