VOYAGER PAD: Treatment effect of rivaroxaban in PAD strongest in concomitant CAD
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Among patients with peripheral artery disease who underwent revascularization, those with concomitant clinical evidence of CAD received greater absolute benefit of reduced risk for MACE from taking low-dose rivaroxaban than those with PAD without CAD.
According to new data from the VOYAGER PAD trial, in patients with PAD with and without CAD, low-dose rivaroxaban conferred reduced risk for CV and limb events, with no statistical interactions.
As Healio previously reported, in the main results of VOYAGER PAD, in which all patients were also given aspirin, during a median of 28 months, those assigned rivaroxaban (Xarelto, Janssen/Bayer) 2.5 mg twice daily had a 15% reduced risk for the primary endpoint of acute limb ischemia, major amputation for vascular cause, MI, ischemic stroke or CV death, although a higher rate of bleeding, compared with those assigned placebo. William R. Hiatt, MD, professor of medicine at the University of Colorado School of Medicine and senior clinician scientist at CPC Clinical Research, presented an analysis of the results at the European Society of Cardiology Congress stratified by whether patients also had CAD.
Hiatt said those with and without CAD had reduced risk for the primary endpoint if assigned rivaroxaban, but the risk reduction was greater in those who had CAD (absolute risk reduction, 5.4%; HR = 0.78; 95% CI, 0.64-0.95) than in those who did not (absolute risk reduction, 1.8%; HR = 0.89; 95% CI, 0.77-1.04; P for interaction = .29).
The treatment effect of rivaroxaban did not differ between those with CAD and those without it for all components of the primary endpoint and all prespecified secondary endpoints, including all-cause mortality (P for interaction > .1 for all), he said, noting the same was true for all bleeding endpoints (P for interaction > .1 for all).
In the cohort, “patients with PAD and coronary disease appear to have higher rates of myocardial infarction and ischemic stroke relative to those with PAD without coronary disease,” Hiatt said during the presentation. “In contrast, patients with PAD who do not have coronary disease have higher rates of adverse limb events relative to myocardial infarction and ischemic stroke.”
He noted that: “The efficacy and safety of rivaroxaban in PAD are consistent regardless of coronary disease, with no significant interactions. However, the absolute benefits of rivaroxaban appear greater in those with CAD, particularly for myocardial infarction and ischemic stroke.”
Hiatt concluded that: “A strategy of rivaroxaban 2.5 mg twice daily vs. aspirin alone reduces the risk of ischemic events of the limb, brain and heart, but also increases bleeding, with an overall favorable net benefit in patients with lower-extremity symptomatic PAD after revascularization. In particular, the benefits of this strategy for myocardial infarction and ischemic stroke are robust, particularly in patients with PAD and CAD, and are consistent with the data from COMPASS. In those without known coronary disease, the benefits appear to be driven by reductions in severe limb events. These findings suggest heterogeneity of prognostic events in lower-extremity PAD patients and may support shared decision-making with patients.”
The trial included 6,564 patients. Those with CAD were older (median age, 68 years vs. 66 years) and were less likely to be women (22% vs. 28%) compared with those without CAD, Hiatt said.
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Hiatt WR, et al. Late-breaking science in peripheral vascular and cerebrovascular disease. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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