Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices
JACC. Cardiovascular interventions
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
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).
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