Mortality After Paclitaxel Coated Balloon Angioplasty and Stenting of Superficial Femoral and Popliteal Artery in the Vascular Quality Initiative.

BACKGROUND

To compare mortality after treatment of superficial femoral-popliteal artery disease with paclitaxel and nonpaclitaxel devices using a multicenter vascular registry.

METHODS

Patients (N=8376) undergoing endovascular treatment of superficial femoral-popliteal artery disease in the Society for Vascular Surgery Vascular Quality Initiative were studied from October 2016 to December 2017. One-year mortality was compared between 3 groups; plain balloon angioplasty (N=2104) versus paclitaxel-coated balloon angioplasty (N=3543), bare-metal stenting (N= 2045) versus paclitaxel-eluting stents (N=684), and combined paclitaxel versus nonpaclitaxel devices. Mortality rates with hazard ratios (HR) and 95% CI were compared in unadjusted and propensity-matched cohorts and illustrated by Kaplan-Meier analysis with subgroup analysis for intermittent claudication, chronic limb-threatening ischemia, and secondary interventions.

RESULTS

In propensity-matched analyses, mortality was similar after plain balloon angioplasty (12.6%) and paclitaxel-coated balloon angioplasty (9.6%; HR=0.84 [95% CI, 0.66-1.06],

CONCLUSIONS

At 1 year, mortality was similar if not lower after treatment of femoral-popliteal occlusive disease with paclitaxel versus nonpaclitaxel devices. This work highlights the potential use of the Society for Vascular Surgery Vascular Quality Initiative for surveillance of the safety of new peripheral arterial devices.