Background: Randomized controlled trials have reported excess mortality in patients treated with paclitaxel-coated devices versus uncoated devices, while observational studies have reported the opposite. This study aims to determine the underlying factors and cohort differences that may explain these opposite results, with specific focus on sex differences in treatment and outcomes.
Methods: Multicenter health insurance claims data from a large insurance fund, BARMER, were studied. A homogeneous sample of patients with an index of endovascular revascularization for symptomatic peripheral arterial occlusive disease between 2013 and 2017 was included. Adjusted logistic regression and Cox regression models were used to determine the factors predicting allocation to paclitaxel-coated devices and sex-specific 5-year all-cause mortality, respectively.
Results: In total, 13,204 patients (54% females, mean age 74 ± 11 years) were followed for a median of 3.5 years. Females were older (77 vs. 71 years), and had less frequent coronary artery disease (23% vs. 33%), dyslipidemia (44% vs. 50%), and diabetes (29% vs. 41%), as well as being less likely to have a history of smoking (10% vs. 15%) compared with males. Mortality differences were mostly attributable to the female subgroup who were revascularized above the knee (hazard ratio, HR 0.78, 95% CI: 0.64-0.95), while no statistically significant differences were observed in males.
Conclusions: This study found that females treated above the knee benefited from paclitaxel-coated devices, while no differences were found in males. Ongoing and future registries and trials should take sex disparities into account.
Keywords: chronic limb-threatening ischemia; drug-coated balloon; drug-eluting stent; paclitaxel; peripheral arterial occlusive disease.