Following lower limb revascularization, optimal medical therapy includes antiplatelet agents, high-intensity statins, and control of cardiovascular risk factors. Recent studies such as COMPASS and VOYAGER-PAD demonstrated that the addition of low-dose rivaroxaban (2.5 mg twice daily) to antiplatelet therapy reduces cardiovascular events and adverse limb events, although at the cost of an increased risk of bleeding.
However, the degree of adoption of this strategy and its impact in real-world clinical practice were not well established. The aim of this study was to evaluate the utilization, effectiveness, and safety of low-dose rivaroxaban after peripheral endovascular interventions in patients with PAD in a real-world clinical setting.
A retrospective cohort study was conducted in the United States, identifying adults aged 40 to 90 years with PAD who underwent peripheral endovascular intervention between 2017 and 2024. Patients who received low-dose rivaroxaban within 30 days after the procedure were analyzed, and adherence during the first year was assessed (patients were considered adherent if they had ≥80% medication coverage).
Patients receiving therapeutic anticoagulation or other doses of rivaroxaban were excluded. The primary endpoint was the occurrence of major adverse limb events (MALE), defined as major amputation, reintervention, or thrombotic events in the treated limb, while the safety endpoint was the occurrence of bleeding events classified according to ISTH criteria.
A total of 88,792 patients were included between 2017 and 2024. Only 1,285 (1.5%) received low-dose rivaroxaban after the procedure, and among them, only 547 (42.6%) maintained ≥80% adherence during the first year. The median age was 65 years (IQR 59–75), and approximately 62% were male. Patients treated with rivaroxaban had a higher prevalence of diabetes (53.1% vs 45.0%), obesity (20.9% vs 10.5%), smoking (31.3% vs 21.3%), hypertension (75.1% vs 67.5%), and hyperlipidemia (70.6% vs 57.6%). A total of 10.9% of procedures were performed for chronic limb-threatening ischemia and 89.1% for claudication.
The treated territories were femoropopliteal in 40.7%, aortoiliac in 33.3%, and tibial in 26%. The study does not provide information regarding procedural technical characteristics, such as the type of device used, the use of stents or drug-coated balloons, or the length of the treated lesions.
Significant Reduction in Major Amputation Risk with Low-Dose Rivaroxaban After Peripheral Revascularization
The use of rivaroxaban was associated with a reduction in the risk of major amputation at one year (HR 0.66; 95% CI 0.50–0.87; p=0.004). The benefit was more pronounced among patients adherent to therapy, who showed a 70% reduction in the risk of major amputation (p=0.03). Regarding the composite endpoint of MALE, overall rivaroxaban use showed a trend toward reduction (HR 0.76; 95% CI 0.55–1.06; p=0.11), while adherent patients experienced a 62% reduction (HR 0.38; 95% CI 0.13–1.12; p=0.08). Furthermore, the combination of rivaroxaban with P2Y12 inhibitors was associated with a 68% reduction in the risk of MALE (HR 0.32; 95% CI 0.10–1.02; p=0.054).
Regarding safety, patients treated with rivaroxaban had a higher incidence of bleeding during follow-up (20.3% vs 11.2%; p<0.001), although major bleeding events were infrequent (1.01% vs 0.53%; p=0.034).
Conclusion: Rivaroxaban After Peripheral Angioplasty: Lower Limb Events with a Moderate Increase in Bleeding Risk
The use of low-dose rivaroxaban after peripheral endovascular interventions remains infrequent (only 1.5% of patients). However, when prescribed and maintained with adequate adherence, it is associated with a significant reduction in the risk of major amputation and adverse limb events. This benefit is achieved at the expense of an increase in bleeding complications, generally of low severity, highlighting the need for careful patient selection considering the balance between thrombotic and bleeding risk.
Original Title: Effectiveness and Safety of Rivaroxaban following Peripheral Arterial Endovascular Revascularization in Real World Practice.
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