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).

• Authors: Daniel J Bertges, Jens Eldrup-Jorgensen, Susan Robbins, Henry Ssemaganda, Misti Malone, Danica Marinac-Dabic, Joshua Smale, Aaron E Lottes, Arjun Majithia, Frederic S Resnic, Society for Vascular Surgery Vascular Quality Initiative
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 14 Issue 23 Pg. 2598-2609 (12 13 2021) ISSN: 1876-7605 [Electronic] United States
• PMID: 34887051 (Publication Type: Journal Article, Meta-Analysis, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright © 2021 American College of Cardiology Foundation. All rights reserved.

Chemical References

• Cardiovascular Agents
• Paclitaxel

Topics

• Angioplasty, Balloon
• Cardiovascular Agents
• Cohort Studies
• Drug-Eluting Stents
• Femoral Artery (diagnostic imaging, surgery)
• Humans
• Multicenter Studies as Topic
• Paclitaxel
• Peripheral Arterial Disease (drug therapy, therapy)
• Popliteal Artery (diagnostic imaging, surgery)
• Prospective Studies
• Treatment Outcome
• Vascular Patency