Marc Bonaca, MD, explains the value of new assessments made in the pivotal peripheral artery disease clinical trial.
Sub-analysis data from the 2020 VOYAGER PAD study showed rivaroxaban plus aspirin was associated with a 15% reduction in total major adverse limb and cardiovascular events among patients with peripheral arterial disease (PAD) who had recently underwent revascularization.
The findings, presented at the American College of Cardiology (ACC) 2021 Scientific Sessions, additionally show an 18% reduction in total events (HR, 0.82; 95% CI, 0.76 – 0.96; P = .0085) with rivaroxaban plus aspirin versus placebo and aspirin. The reduction was a difference of 124 total events avoided among the 3286 patients treated with the therapy.
This interpretation of first and total event reduction, investigators suggested, may be a “useful metric” in quantifying rivaroxaban’s use in this patient population.
Another expert went as far to say it should supplant the more frequently used metric of “time to first event” in understanding PAD clinical benefit.
In an interview with HCPLive during ACC 2021, VOYAGER PAD study author Marc Bonaca, MD, executive director of CPC Clinical Research, discussed the new sub-analysis findings. Bonaca also explained why time to first event is a metric which results in investigators “missing 80% of the benefit of the drug” from when VOYAGER PAD was presented last year.
“I think from the patient’s perspective, time to first event doesn’t really describe their experience,” Bonaca said. “As we turn more to hear the patient’s voice and patient-reported outcomes, looking at total events is an important metric—and also to make sure the therapy we are using have consistent benefit across multiple events.”
The findings from the original VOYAGER PAD trial, and their implication on the state of PAD care and research, were featured in the newest episode of the Heart Trials podcast series, featuring author Manesh Patel, MD, and his Duke University colleague Schuyler Jones, MD.
The study, “Reductions In Total Ischemic Events With Rivaroxaban In Patients With Symptomatic Pad After Revascularization: The VOYAGER PAD Trial,” was presented at ACC 2021.