Effectiveness and safety of rivaroxaban following peripheral arterial endovascular revascularization in real-world practice.

Abstract

The VOYAGER PAD clinical trial demonstrated that low-dose rivaroxaban (LDR; 2.5 mg twice daily) reduces major adverse limb events (MALE) at the expense of increased bleeding rates in patients undergoing lower extremity revascularization for peripheral artery disease (PAD). However, it is unclear whether LDR therapy is associated with similar outcomes in real-world practice. This retrospective cohort study was designed to evaluate the effectiveness and safety of LDR therapy following peripheral vascular intervention (PVI) for patients with PAD. The Merative MarketScan database was used to identify patients 40 to 90 years old who underwent lower extremity PVI between 2017 and 2024. Pharmacy claims were used to identify LDR use within 30 days post-PVI and patient adherence to therapy within 1 year while excluding those receiving therapeutic anticoagulation. For patients prescribed LDR, the proportion of days covered (PDC) was determined and those greater or equal to 80% of PDC were classified as adherent. After performing a propensity-subclass weighted analysis on the use of LDR, we used Cox proportional hazards models to estimate the risk-adjusted incidence of MALE and bleeding complications following PVI. We identified 88,792 patients, of which 1285 (1.5%) were prescribed LDR within 30 days post-PVI. However, only 547 of these patients (43%) were adherent to LDR within the year after revascularization. After propensity weighted analysis, patients on LDR were well-matched to those not on therapy based on age, sex, comorbidities, and demographics. Although non-adherent patients had no significant improvement in MALE outcomes, those adherent to LDR therapy had a 70% lower likelihood of major amputation at 1 year after revascularization (hazard ratio, 0.30; 95% confidence interval, 0.10-0.91; P = .03). There was an increased likelihood of experiencing a bleeding complication (hazard ratio, 1.85; 95% confidence interval, 1.24-2.76; P = .002) associated with LDR use relative to the non-LDR control group. Following the publication of VOYAGER PAD, the use of LDR remains low, and patient adherence is variable. However, clinical outcomes in real-world practice are similar if adherence to LDR is maintained following PVI. Further work is needed to define the optimal patients with PAD who should receive LDR following revascularization.