Use of paclitaxel-coated balloons in clinical setting is not associated with increased mortality compared with plain balloon angioplasty in femoropopliteal lesions.

Objective: To investigate mortality and causes of death associated with the use of paclitaxel-coated balloon (PCB) compared with plain balloon (PB) angioplasty in the treatment of femoropopliteal artery lesions in real-world clinical setting.

Methods: This retrospective, single-center study included patients who underwent percutaneous femoropopliteal artery angioplasty without stenting between years 2014 and 2020. Patients were stratified into PCB and PB groups according to the index procedure. Those who had undergone any prior or subsequent intervention using drug-eluting technology were excluded from the PB group. Long-term survival was estimated up to 5 years using the Kaplan-Meier method, and risk factors for all-cause mortality were assessed in a multivariable analysis. Causes of death were retrieved from a national registry.

Results: The study included 139 patients treated with PB and 190 with PCB. Patients treated with PCB had a higher prevalence of chronic pulmonary disease (27% vs 17%; P = .02) and were less often on anticoagulant therapy (34% vs 48%; P = .01) compared with patients in the PB group. Those treated with PB were more likely to have chronic limb-threatening ischemia (CLTI; 82% vs 72%; P = .04). Ipsilateral perioperative amputation rate was significantly higher in the PB group (7% vs 1%; P = .01). There were no major differences in other 30-day outcomes between the groups and no differences in the rates of reinterventions and ipsilateral amputations during a mean follow-up time of 2.7 ± 1.9 years. Survival at 1 year in the PCB group was 83% ± 3% compared with 73% ± 4% in the PB group (P = .0001). The 5-year survival estimates were 56% ± 5% and 37% ± 5%, respectively. PCB use was independently associated with decreased risk of mortality (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.50-0.97). Independent risk factors for increased mortality were age (HR, 1.04 per year; 95% CI, 1.02-1.06), cardiac insufficiency (HR, 1.60; 95% CI, 1.12-2.27), chronic renal insufficiency (HR, 2.04; 95% CI, 1.47-2.85), anticoagulation therapy (HR, 1.65, 95% CI, 1.16-2.34), and CLTI (HR, 2.85; 95% CI, 1.51-5.39). In the PCB group, 63% of deaths were due to cardiovascular causes compared with 42% in the PB group (P < .01).

Conclusions: The use of PCB is safe, and there is no concern of increased mortality after the procedure based on the 5-year survival estimates.