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October 18, 2020

Subgroup Analysis of VOYAGER PAD Trial Finds No Mortality Risk or Benefit Associated with Drug-Coated Devices in PAD Treatment

October 18, 2020—A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a drug-coated device was used.

VOYAGER PAD was a double-blind, placebo-controlled trial of PAD patients undergoing lower-extremity revascularization randomized to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. Clopidogrel was allowed per operator discretion.

The subgroup analysis findings were reported by Connie N. Hess, MD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.

The background of the analysis is that paclitaxel-coated devices improve patency of lower extremity revascularization in patients with PAD; however, the meta-analysis of randomized trials by Konstantinos Katsanos, MD, et al, which was published in December 2018 in Journal of the American Heart Association, reported increased long-term mortality compared with non–drug-coated devices, leading to warnings from regulatory agencies about the use of drug-coated device in patients with PAD.

In March 2020, the primary results of VOYAGER PAD were presented by Marc P. Bonaca, MD, at the virtual American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) and published by Dr. Bonaca, et al in The New England Journal of Medicine (2020; 382:1994-2004). Those findings demonstrated that rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone.

In the analysis presented at TCT Connect, investigators examined the long-term safety of drug-coated devices and evaluated whether rivaroxaban 2.5 mg twice daily plus low-dose aspirin versus low-dose aspirin alone on the primary efficacy endpoint was consistent with versus without drug-coated device use.

For this analysis, the primary outcome was all-cause mortality, which was a prespecified secondary outcome in VOYAGER PAD. Deaths were prospectively collected and adjudicated. Device type was collected at enrollment in patients undergoing endovascular lower-extremity revascularization.

As summarized in the TCT Connect announcement, this analysis included the 4,316 patients (66% of the 6,564 randomized patients) who underwent endovascular index lower-extremity revascularization. Median follow-up was 31 months (IQR 25, 37). Complete ascertainment of vital status was available for 99.6% of patients.

During the qualifying endovascular revascularization, a drug-coated device was used for 31% (n = 1,358) of patients. Patients receiving drug-coated devices more frequently had previous endovascular lower-extremity revascularization, had higher baseline use of dual antiplatelet therapy and statins, and were more often treated for claudication than non–drug-coated device patients.

In the unweighted analysis, the investigators observed lower associated mortality among patients receiving drug-coated versus non–drug coated devices (2.9 vs 3.9 per 100 patient-years; 3.5-year Kaplan-Meier cumulative incidence of 10.2% vs 13.8%).

After weighting, there was no association between use of drug-coated devices and mortality (3.5-year cumulative incidence, 12.1% vs. 12.6%; hazard ration, 0.95; 95% CI, 0.83-1.09; P = .49). The benefit of rivaroxaban 2.5 mg twice daily with aspirin compared to aspirin alone on reducing ischemic limb and cardiovascular outcomes was also consistent regardless of whether a drug-coated device was used.

Dr. Hess, who is Associate Professor of Medicine (Cardiology) at the University of Colorado School of Medicine in Aurora, Colorado, commented in the TCT Connect press release, “Inverse probability treatment weighting successfully adjusted for known confounders and showed no mortality risk or benefit associated with drug-coated devices, including in subgroups by device type. This analysis from VOYAGER PAD addresses many of the limitations of currently available data regarding mortality and paclitaxel and adds to the literature examining the safety of drug-coated devices.”

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