Highlights from

ACC 2020

Together with World Congress of Cardiology

Virtual 28 - 30 March 2020

Rivaroxaban and aspirin effective and safe for PAD patients

Results from the VOYAGER-PAD trial showed that rivaroxaban 5 mg (2.5 mg twice daily) + aspirin significantly reduces the risk of ischaemic events patients with symptomatic peripheral artery disease (PAD) after peripheral artery revascularisation [1]. Despite a numerical increase in thrombolysis in myocardial infarction (TIMI) major bleeding and significantly increased International Society on Thrombosis and Haemostasis (ISTH) major bleeding, no excess was observed in intracranial or fatal bleeding.

The multicentre, randomised, double-blind VOYAGER-PAD trial was presented by Prof. Marc Bonaca (University of Colorado, USA), and simultaneously published in the New England Journal of Medicine. The trial enrolled 6,564 participants from 34 countries with moderate-to severe-symptomatic PAD in the lower extremities. Of these participants, 65% underwent endovascular revascularisation within 10 days before starting study treatment. The remaining 35% had undergone surgical revascularisation. Patients received either rivaroxaban 2.5 mg twice daily added to low-dose aspirin (n=3,286) or aspirin + placebo (n=3,278). The primary endpoint was a composite of acute myocardial infarction (MI), ischaemic stroke, cardiovascular death, acute limb ischaemia, or major amputation. Median follow-up was 28 months.

The primary endpoint was reached by 17.3% of patients who received rivaroxaban + aspirin and 19.9% of those on aspirin + placebo (HR 0.85; 95% CI 0.76-0.96; P=0.0085). Patients on rivaroxaban + aspirin had a statistically significant 15% relative risk reduction. This endpoint was primarily driven by a reduction in acute limb ischaemia. Regarding safety, the rate of TIMI major bleeds was 2.7% for patients treated with rivaroxaban versus 1.9% for patients on placebo (HR 1.43: 95% CI 0.97-2.10; P=0.0695). Although this result did not reach statistical significance, it did demonstrate a small but important increased risk for bleeding events of this combined regimen. Despite bleeding events being more common in the patients receiving rivaroxaban, the rate of ischaemic events prevented by rivaroxaban + aspirin exceeded the excess bleeding rate by 3- to 6-fold (depending on the definition of the bleeding episodes).

  1. Bonaca M, et al. Rivaroxaban For Prevention Of Cardiovascular And Limb Events After Lower Extremity Revascularization: Primary Results Of The VOYAGER PAD Randomized Trial. Abstract 402-10. ACC/WCC 28-30 March 2020.
  2. Bonaca M, et al. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020; DOI: 10.1056/NEJMoa2000052.

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