Rivaroxaban protects limbs and ischaemic events in CAD-PAD patients

A new subanalysis from the VOYAGER PAD trial showed that rivaroxaban significantly reduced the risk of adverse limb ischaemia and cardiovascular events in patients with coronary artery disease (CAD) concomitant to symptomatic peripheral artery disease (PAD) after peripheral artery revascularisation [1]. Safety in the CAD subgroup of patients in this trial was also favourable.

Initial results from the multicentre, randomised, double-blind VOYAGER PAD trial (n=6,564) were recently published in the New England Journal of Medicine [2]. The subanalysis presented at the ESC Congress 2020 by Prof. William Hiatt (University of Colorado, USA) focused on the patients with concomitant CAD (n=2,067). Patient characteristic analysis revealed that the subgroup of patients who had CAD were more likely to have concomitant carotid disease and heart failure, were older, and were more burdened with cardiovascular risk factors, including hypertension, diabetes, and hyperlipidaemia. The primary endpoint of the subanalysis was a composite of acute limb ischaemia, major amputation of vascular aetiology, acute myocardial infarction, ischaemic stroke, and cardiovascular death.

At 3 years, the primary endpoint for CAD patients was met (see Figure). Among those with PAD and CAD, the endpoint occurred in 24.3% in the placebo arm versus 18.9% of those in the rivaroxaban arm (HR 0.78; 95% CI 0.64-0.95). In patients with PAD only, the endpoint occurred in 17.9% in the placebo arm versus 16.1% in the rivaroxaban arm (HR 0.89; 95% CI 0.77-1.04).

Figure: Primary endpoint with rivaroxaban with and without CAD [1]



Regarding safety, the rate of TIMI major bleeding was increased in patients with and without CAD randomised to rivaroxaban versus placebo, but rates of intracranial haemorrhage or fatal bleeding occurred in less than 1% in each group.

In conclusion, Prof. Hiatt noted, “The efficacy and safety of rivaroxaban in PAD are consistent regardless of CAD, with no significant interactions. However, the absolute benefits of rivaroxaban appear greater in those with CAD, particularly for myocardial infarction and ischaemic stroke.”

 

1. 
   
   1. Hiatt W, et al. VOYAGER PAD and concomitant coronary artery disease. Hotline session. ESC Congress 2020, 30 Aug.
   2. Bonaca MP, et al. N Engl J Med. 2020; DOI: 10.1056/NEJMoa2000052.

 



Posted on 5 November, 2020