VOYAGER PAD trial aimed to determine if adding rivaroxaban to aspirin would affect outcomes in patients with peripheral arterial disease undergoing stenting. The trial seems to follow the lead of the COMPASS trial that showed better cardiovascular outcomes with addition of rivaroxaban to aspirin in patients with stable CAD.
The authors of the VOYAGER PAD trial randomly assigned 6,564 peripheral arterial disease patients who had undergone lower-extremity stenting to take rivaroxaban 2.5 mg BID + aspirin or a placebo and aspirin. A total of 3,286 patients were assigned to the rivaroxaban group and 3,278 were assigned to the placebo group.
Patients were included in the study if they were ≥ 50 years of age with lower extremity symptomatic peripheral arterial disease proven with imaging or symptoms or abnormal ankle-brachial index. Patients were randomized after successful lower extremity revascularization.
The primary outcome (composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction (MI), ischemic stroke or cardiovascular death) occurred in 17.3% patients in the rivaroxaban group, compared with 19.9% patients in the placebo group (hazard ratio [HR], 0.85; 95% CI, 0.76-0.96; p =0.009). The absolute risk reduction was 1.5% at six months, 2.0% at one year and 2.6% at three years. TIMI major bleeding occurred in 2.7% patients in the rivaroxaban group and 1.9% in the placebo group (HR, 1.43; 95% CI, 0.97-2.10, p=0.07). The secondary safety outcome – defined as International Society on Thrombosis and Haemostasis major bleeding – occurred in 5.9% and 4.1% of the rivaroxaban and placebo groups, respectively (HR, 1.42; 95% CI, 1.10-1.84; p=0.007).
The COMPASS and the VOYAGER PAD trials are large size break-through trials for stable ischemic heart disease and peripheral arterial disease respectively. We now know that factor Xa inhibitor like rivaroxaban even in low dose of 2.5 mg BID can play a huge role in improving CV outcomes in this patient population.