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

Connie N. Hess, Manesh R. Patel, Rupert M. Bauersachs, Sonia S. Anand, E. Sebastian Debus, Mark R. Nehler, Fabrizio Fanelli, Robert W. Yeh, Eric A. Secemsky, Joshua A. Beckman, Laura Mauri, Nicholas Govsyeyev, Warren H. Capell, Taylor Brackin, Scott D. Berkowitz, Eva Muehlhofer, Lloyd P. Haskell, William R. Hiatt, Marc P. Bonaca

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Background: Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-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% CI: 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 (Pinteraction = 0.88) and safety of rivaroxaban with respect to bleeding (Pinteraction = 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.

Original languageEnglish (US)
Pages (from-to)1768-1778
Number of pages11
JournalJournal of the American College of Cardiology
Volume78
Issue number18
DOIs
StatePublished - Nov 2 2021
Externally publishedYes

Keywords

  • outcomes
  • peripheral artery disease
  • revascularization

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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