Rivaroxaban used in combination with aspirin in patients with peripheral artery disease (PAD) undergoing peripheral arterial revascularization helped avoid 4.4 primary vascular events and 12.5 total vascular events for every 100 patients, according to study results published in the Journal of the American College of Cardiology.

The investigators of this multinational study sought to evaluate the efficacy of low-dose rivaroxaban in 6564 patients with PAD undergoing lower extremity revascularization and to characterize the total burden of vascular events in this population. Participants were randomly assigned to treatment with 2.5 mg of rivaroxaban twice daily or placebo; all patients received 100 mg of aspirin daily.

The primary endpoint was time to first major adverse limb or cardiovascular event (acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death). The investigators considered both first and subsequent primary endpoint events, along with other vascular events such as peripheral revascularizations and venous thromboembolism.


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Patients were followed for a median of 2.5 years. A total of 4714 vascular events were reported in the study, of which 1614 were primary endpoint events; peripheral revascularization was the most common type of event observed (64%). The total number of first events was 2301, including 872 that were reported as first primary endpoint events and 1429 that were other vascular endpoints. A total of 1092 participants experienced more than one vascular event; 60% of second events were reported by participants whose first event was peripheral revascularization.

Overall, the rivaroxaban group reported fewer events vs the placebo group: 342 fewer total vascular events (2186 vs 2528 total events), including 61 fewer first vascular events (1120 vs 1181) and 281 fewer subsequent vascular events.

First events alone reflect an absolute reduction of 18% associated with rivaroxaban treatment.

The cumulative incidence for vascular events over 3 years in the placebo group was 30.3 primary endpoint events and 88.4 total vascular events per 100 patients. For rivaroxaban, the cumulative incidence was reduced by 4.4 primary endpoint events and 12.5 total vascular events per 100 patients. This translates to a 14% reduction for primary endpoint events (hazard ratio [HR], 0.86; 95% CI, 0.75-0.98; P =.02) and total vascular events (HR, 0.86; 95% CI, 0.79-0.95; P =.003).

Researchers revealed an even more robust benefit of rivaroxaban vs placebo in terms of event reduction after sensitivity analyses in which rivaroxaban exposure was treated as a time-varying covariate.

A limitation to the study was that more patients in the rivaroxaban group than the placebo group terminated treatment prematurely, potentially underestimating the effects of therapy. Because the primary efficacy outcome was time to first event, the current study findings are considered complimentary.

According to the researchers, patients with PAD undergoing peripheral arterial revascularization are at high risk for major adverse events. Rivaroxaban significantly reduced the total burden of vascular events (including first events) by 14% among this patient population.

The investigators suggested that the reduction of total vascular events in this setting may be a useful metric for rivaroxaban in measuring treatment efficacy.

Disclosure: This research was funded by Bayer and Janssen. Please see the original reference for a full list of disclosures.

Reference

Bauersachs RM, Szarek M, Brodmann M, et al; VOYAGER PAD Committees and Investigators. Total ischemic event reduction with rivaroxaban after peripheral arterial revascularization in the VOYAGER PAD trial.. J Am Coll Cardiol. Published online May 7, 2021. doi:10.1016/j.jacc.2021.05.003