November 7, 2020

Drug-Coated Devices & Limb Outcomes After Endovascular Peripheral Artery Revascularizations: Insights from VOYAGER

Presented by Connie N. Hess, MD, MHS

Endovascular lower extremity revascularization (LER) is used to treat symptomatic peripheral artery disease (PAD) but is limited by restenosis. Although paclitaxel drug-coated devices (DCD) improve patency, they have been associated with long-term mortality. Recent data from VOYAGER PAD, a trial demonstrating benefit of rivaroxaban plus aspirin versus aspirin alone in reducing severe cardiovascular and limb outcomes after lower extremity revascularization for PAD, showed no association between DCD use and mortality. Given the absence of a safety signal, the current analysis examined the potential benefit of DCD versus non-DCD treatment for reducing limb outcomes.

The co-primary outcomes for this analysis 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. Use of DCD was associated with a significant 16% reduction in relative risk of clinically-driven unplanned index limb revascularization (HR 0.84, 95% CI 0.76-0.92) but was not associated with a reduction in MALE (hazard ratio [HR] 1.08, 95% confidence interval [CI] 0.90-1.30). Rivaroxaban plus aspirin also reduces the risk of unplanned index limb revascularization, in addition to 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.

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