Rivaroxaban & aspirin benefit PAD patients undergoing lower extremity revascularization: study

Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic peripheral artery disease (PAD). However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking.

A group of researchers randomized patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat.

The Results of the study are as follows:

• Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events.
• In placebo patients, the 3-year cumulative incidence of ALI was 7.8%.
• After multivariable modelling, prior lower extremity revascularization (LER), baseline ABI <0.50, surgical lower extremity revascularization (LER), and longer target lesion length were associated with increased risk of ALI.
• Incident ALI was associated with subsequent all-cause mortality and major amputation
• Rivaroxaban reduced ALI relative to placebo by 33% with benefit starting early benefit was present for severe ALI and regardless of lower extremity revascularization (LER) type or clopidogrel use

Thus, the researchers concluded that after lower extremity revascularization (LER) for symptomatic peripheral artery disease (PAD), ALI is frequent, particularly early after lower extremity revascularization (LER), and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after lower extremity revascularization (LER), including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.

Reference:

Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD by Connie N. Hess et al. published in the Circulation.

https://doi.org/10.1161/CIRCULATIONAHA.121.055146