Abstract
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.
Highlights
While females were selected for first endovascular interventions at a higher age (77 vs. 71 years, standardized mean differences (SMD) = 0.549), they exhibited a favorable cardiovascular risk profile in terms of coronary artery disease (23% vs. 33%, SMD = 0.241), dyslipidemia (44% vs. 50%, SMD = 0.110), diabetes (29% vs. 41%, SMD = 0.255), and smoking (10% vs. 15%, SMD = 0.149) when compared with their male counterparts
Our design, focusing ther determine mortality the underlying factors were the observed improvement in mor- on first interventions in a cohort which was as homogenous as possible, tality associatedendovascular with the use of paclitaxel-coated devices
Our design, focusing onrevealed first that the mortality differences were mostly attributable to the female subgroup treated endovascular interventions in a cohort which was as homogenous as possible, revealed that above the knee, while statistically significant differences were observed in males
Summary
Occlusive disease (PAOD) [1] This association was later confirmed in a patient-level meta-analysis and a separate meta-analysis concerning amputation-free survival after below-the-knee treatment [2,3]. During this ongoing controversy, multiple studies that used either real-world data from large administrative and clinical registries [4,5,6,7,8,9] or interim analyses from a large RCT [10] were not able to replicate this unsettling safety signal. 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. Results: In total, 13,204 patients (54% females, mean age 74 ± 11 years) were followed for a median of 3.5 years
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