Rivaroxaban effective in treating VTE in symptomatic peripheral artery disease after lower extremity

A new cohort study found that 6564 patients undergoing lower extremity revascularization for peripheral arterial disease, the 3-year rate of venous thromboembolism (VTE) in patients receiving placebo was 1.66%, and low-dose rivaroxaban plus aspirin was associated with reduced risk for venous thromboembolism.

Previous studies have observed an association between the burden of atherosclerotic vascular disease and the risk of venous thromboembolism (VTE). The association is not known in peripheral artery disease (PAD) after lower extremity revascularization (LER).

The study was a global, multicenter cohort study that used data from the Vascular Outcomes Study of ASA (acetylsalicylic acid) Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD (VOYAGER PAD) randomized clinical trial, which enrolled patients from 2015 to 2018 with median follow-up of 28 months. Participants included patients with peripheral artery disease undergoing lower extremity revascularization. Patients with an indication for therapeutic anticoagulation were excluded. Data were analyzed from September 2020 to September 2021.

Randomization to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily; short-term clopidogrel was used at the discretion of the treating physician.

Among 6564 patients, 66 patients had at least 1 venous thromboembolism. The 3-year rate of venous thromboembolism in patients receiving placebo was 1.7%. hypertension was 2.11, prior amputation 2.07, and older age 1.81 were associated with increased risk of venous thromboembolism. venous thromboembolism was associated with risk of subsequent mortality of 7.22. Compared with aspirin alone, rivaroxaban plus aspirin was associated with lower venous thromboembolism risk of 0.61 with benefit apparent early and sustained over time. This association was not modified by use of clopidogrel at randomization without clopidogrel: 0.55 with clopidogrel 0.69.

Researchers conclude this study there was continuous risk for venous thromboembolism after lower extremity revascularization in patients with peripheral arterial disease. Low-dose rivaroxaban plus aspirin was associated with lower venous thromboembolism risk compared with aspirin alone, with benefits apparent early and continued over time.

Reference: Hess CN, Szarek M, Anand SS, et al. Rivaroxaban and Risk of Venous Thromboembolism in Patients With Symptomatic Peripheral Artery Disease After Lower Extremity Revascularization. JAMA Netw Open. 2022;5(6):e2215580; doi:10.1001/jamanetworkopen.2022.15580.