Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices

Authors

Daniel J. Bertges, Division of Vascular Surgery, University of Vermont Medical Center, Burlington, Vermont, USA. Electronic address: daniel.bertges@uvmhealth.org.
Jens Eldrup-Jorgensen, Division of Vascular Surgery, Maine Medical Center, Portland, Maine, USA.
Susan Robbins, Division of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.
Henry Ssemaganda, Division of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.
Misti Malone, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Danica Marinac-Dabic, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Joshua Smale, BD Peripheral Intervention, Tempe, Arizona, USA.
Aaron E. Lottes, Weldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana, USA.
Arjun Majithia, Division of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.
Frederic S. Resnic, Division of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.

Document Type

Article

Publication Date

12-13-2021

Journal Title

JACC. Cardiovascular interventions

MeSH Headings

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

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).

First Page

2598

Last Page

2609

Recommended Citation

Bertges DJ, Eldrup-Jorgensen J, Robbins S, et al. Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices. JACC Cardiovasc Interv. 2021;14(23):2598-2609. doi:10.1016/j.jcin.2021.08.058