Efficacy and safety of paclitaxel drug-eluting balloons in femoropopliteal artery disease: a prospective observational study

Mohammed Hidayathulla, Nagesh .


Background: The femoropopliteal artery is most frequently involved artery in peripheral artery disease. To treat femoropopliteal artery disease (FPAD), various revascularization approaches have been available such as simple balloon angioplasty, debulking techniques, stent implantation, and recently the drug-eluting balloon (DEBs). Nowadays, the paclitaxel DEBs have been emerged to treat FPAD with promising outcomes. We therefore evaluate the efficacy and safety of paclitaxel DEBs in patients with lower limb FPAD.

Methods: In total, 25 patients with FPAD were enrolled in the study. All patients underwent peripheral angioplasty using paclitaxel DEBs via antegrade femoral approach or contralateral femoral artery using crossover sheath. Demographics, risk factors, clinical characteristics, and pre- and post-procedure VascuQol-6 score were noted.

Results: Out of 25 patients, the majority of patients (52%) were in the 6th decades of life. The incidence of FPAD was most common in patients with an O +ve blood group. The common risk factors of FPAD, include smoking (88%), diabetes (68%), dyslipidemia (68%), and hypertension (64%). Rest pain (64%) and ulcer (32%) were the most frequent clinical symptoms of FPAD. The percent stenosis was 100% in 17 patients, and 70-99% in 32 patients. A statistically significant difference was found in VascuQol-6 score between pre and post peripheral angioplasty (p<0.001).

Conclusions: We have concluded that the paclitaxel DEBs are safe and efficacious in treating FPAD. Authors recommend that clinician should educate FPAD patients pertaining to modification of controllable risk factors such as cessation of smoking, unhealthy diet, sedentary lifestyle, high blood pressure, and high blood sugar.



Balloon, Paclitaxel, Peripheral artery disease, Revascularization, Risk factors

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