Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices

Abstract

Objectives: This study sought to determine the safety and efficacy of paclitaxel (PTX) devices in the treatment of peripheral artery disease involving the femoropopliteal artery.

Background: A meta-analysis of PTX devices for the treatment of femoropopliteal artery disease reported a mortality signal.

Methods: This was a multicenter cohort study using an integrated clinical data surveillance system to conduct a prospective, propensity score-matched survival analysis of 2,456 patients in the Society for Vascular Surgery Vascular Quality Initiative from January 2017 to May 2020. The study compared PTX drug-coated balloon angioplasty versus percutaneous transluminal balloon angioplasty, PTX drug-eluting stents versus bare-metal stents, and any PTX device versus any non-PTX device. The primary outcome was 2-year survival. Secondary endpoints were successful ambulation and interventional success.

Results: Treatment with any PTX device versus any non-PTX device was associated with increased 2-year survival (89.5% vs 86.7%; HR: 0.79; 95% CI: 0.72-0.87; P = 0.004), improved interventional success (81.6% vs 77.6%; HR: 0.82; 95% CI: 0.74-0.91; P < 0.001), and higher rates of independent ambulation at 1 year (86.0% vs 83.4%; HR: 0.85; 95% CI: 0.79-0.91; P = 0.008). Treatment with PTX drug-coated balloon angioplasty was associated with improved survival at 2 years (88.9% vs 85.7%; HR: 0.77; 95% CI: 0.70-0.86; P = 0.005), while PTX drug-eluting stent therapy was associated with similar survival compared with bare-metal stent therapy (91.3% vs 89.6%; HR: 0.84; 95% CI: 0.70-1.01; P = 0.36).

Conclusions: In this prospective, active surveillance of a national clinical registry, PTX-containing devices were associated with increased survival at 2 years and improved clinical outcomes at 1 year. (VQI DELTA Paclitaxel Device Safety Analysis [VQI-PTX]; NCT04110288).

Keywords: drug-coated balloon; drug-eluting stent(s); mortality; paclitaxel; registry.

Conflict of interest statement

Funding Support and Author Disclosures This research was supported through U.S. Food and Drug Administration research grant 1U01FD004963-01: Active Surveillance of Cardiovascular Devices: The Multi-Registry DELTA Network. Mr Smale is an employee of BD Peripheral Intervention. Dr Lottes was an employee of Cook Medical during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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