Takeaway
- In patients with peripheral artery disease (PAD) who had undergone lower-extremity revascularisation, rivaroxaban plus aspirin significantly reduced the incidence of major adverse limb and cardiovascular (CV) events vs aspirin alone.
Why this matters
- Findings provide evidence of an antithrombotic regimen that effectively lowers risk, and although bleeding rates were higher, the overall risk-benefit was quite favourable.
Study design
- In this VOYAGER PAD trial, 6564 patients with PAD who underwent revascularisation were randomly assigned to receive either rivaroxaban (2.5 mg twice daily) plus aspirin (n=3286) or placebo plus aspirin (n=3278).
- Primary efficacy outcome: composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischaemic stroke, or death from CV causes.
- Funding: Bayer and Janssen Pharmaceuticals.
Key results
- The primary efficacy outcome occurred in 508 patients in the rivaroxaban group vs 584 in the placebo group (Kaplan–Meier [K-M] estimate of the incidences at 3 years: 17.3% vs 19.9%; HR, 0.85; 95% CI, 0.76-0.96).
- The principal safety outcome of major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification occurred in 62 patients in the rivaroxaban group vs 44 patients in the placebo group (K-M estimate at 3 years: 2.65% vs 1.87%; HR, 1.43; 95% CI, 0.97-2.10).
- Secondary safety outcome defined as International Society on Thrombosis and Haemostasis major bleeding occurred in 140 patients in the rivaroxaban group vs 100 patients in the placebo group (K-M estimate at 3 years: 5.94% vs 4.06%; HR, 1.42; 95% CI, 1.10-1.84).
Limitations
- Percentage of patients who discontinued treatment was higher.
Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Mátyás L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N. Engl. J. Med.2020 Mar 28 [Epub ahead of print]. doi: 10.1056/NEJMoa2000052. PMID: 32222135. View abstract.
This clinical summary first appeared on Univadis from Medscape.
