Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization Insights From VOYAGER PAD

BACKGROUND Paclitaxel drug-coated devices (DCDs) were developed to improve tower extremity revascutarization (LER) patency in peripheral artery disease (PAD) but have been associated with tong-term mortality. OBJECTIVES This study assessed DCD safety and effectiveness in LER for PAD. METHODS VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models. RESULTS Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% 0: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (P-interaction = 0.88) and safety of rivaroxaban with respect to bleeding (P-in(teraction) 0.57) were observed. CONCLUSIONS In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (C) 2021 by the American College of Cardiology Foundation.

Automated summary

The study found that the use of paclitaxel drug-coated devices in patients undergoing peripheral artery disease lower extremity revascularization was not associated with mortality or major adverse limb events, but was associated with a persistent reduction in unplanned index limb revascularization.