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November 7, 2020

Analysis of VOYAGER PAD Trial Supports “Pharmaco-Invasive” Approach to PAD Treatment

November 7, 2020—Connie N. Hess, MD, presented findings from an analysis of data from the VOYAGER PAD trial that examined the potential benefit of drug-coated devices (DCDs) versus non-DCD treatment for reducing limb outcomes after endovascular peripheral artery revascularization.

The investigation was conducted in light of the absence of a safety signal in another recent analysis of the trial data showing no association between DCD use and mortality. Endovascular lower extremity revascularization is used to treat symptomatic peripheral artery disease (PAD) but is limited by restenosis and paclitaxel DCDs, which improve patency but have been associated with long-term mortality.

The data were presented by Dr. Hess in a late-breaking clinical trials session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6-8, 2020.

The VOYAGER PAD trial demonstrated the benefit of rivaroxaban plus aspirin versus aspirin alone in reducing severe cardiovascular and limb outcomes after lower extremity revascularization for PAD. The 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.

In the analysis presented at VIVA 2020, the coprimary outcomes were unplanned index limb revascularization and major adverse limb events (MALE; defined as acute limb ischemia or major amputation of vascular cause). As DCD use was not randomized, inverse probability treatment weighting was used to account for known confounders.

The investigators found that use of DCD was associated with a significant 16% reduction in relative risk of clinically driven unplanned index limb revascularization (hazard ratio [HR], 0.84; 95% CI, 0.76-0.92) but was not associated with a reduction in MALE (HR, 1.08; 95% CI, 0.90-1.30). The findings show that rivaroxaban plus aspirin also reduces the risk of unplanned index limb revascularization, in addition to the risk of major adverse events of the heart, limb, and brain, irrespective of device type.

These observations suggest that a “pharmaco-invasive” approach in PAD combining innovative devices with effective medical therapy may optimize outcomes in PAD, concluded Dr. Hess at VIVA 2020.

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