Objectives: To assess 24-month outcome differences based on sex in symptomatic femoro-popliteal arterial disease of patients treated with drug-coated balloon (DCB).
Background: Peripheral artery disease affects over 12 million people in the United States. Drug-coated balloons have shown to be effective in treating patients with symptomatic femoropopliteal arterial occlusive disease. Debate remains regarding its safety and efficacy in female gender. We investigated the differential treatment effect between genders.
Methods: Patients (93 females and 102 males) with symptomatic femoropopliteal arterial disease treated with DCB from November 2014 to November 2015 were included in this retrospective study. We compared the resting ankle-brachial indices (ABIs) and peak systolic velocities (PSVs) by arterial duplex between the male and female patients at 6, 12, and 24 months postintervention.
Results: Females had significantly smaller vessels (4.70 ± 0.9, P = .02) and higher body mass index (BMI; 30.0 ± 3.7, P = .002) than males. Females had significantly decreased ABI and PSV at the 6-month (ABI: 0.90 ± 0.15, P = .05 and PSV: 188.30 ± 103.1, P = .02), 12-month (ABI: 0.86 ± 0.15, P < .0001 and PSV: 219.10 ± 100.10, P = .001), and at 24-month (ABI: 0.84 ± 0.2, P = .0001 and PSV: 251.0 ± 135.9, P < .0001) intervals when compared to males. Females had increased clinically driven target lesion revascularization (TLR) at 6 months (females = 8 vs males = 4, P = .22), 12 months (females = 12 vs males = 4, P = .02), and 24 months (females = 14 vs males = 6, P = .03). In simple logistic regression analysis, BMI, age, reference vessel diameter (RVD), and gender were strongly associated with target lesion restenosis. The final model included the above and it produced the following odds ratios (ORs): BMI (OR = 1.07, 95% confidence interval [CI]: 0.98-1.2), age (OR: 1.0, CI: 0.96-1.03), RVD (OR: 1.6, CI: 1.02-2.4), and gender (OR: 3.5, CI: 1.6-7.8).
Conclusion: Females treated with DCBs have significantly decreased ABI, PSVs, and an increased rate of TLR than their male counterparts.
Keywords: drug-coated balloon; female; gender; restenosis; superficial femoral artery.