摘要
Objective: A summary level meta-analysis showed an increased mortality rate beyond the first year following revascularisation with paclitaxel coated devices (PCDs) in patients with peripheral artery disease. However, these findings remain controversial. This study aimed to provide a real world analysis on the safety of PCDs. Methods: An exhaustive nationwide retrospective cohort study was conducted using administrative medical data from the National Health Insurance Research Database in Taiwan. A total of 19 612 patients receiving endovascular lower limb revascularisation from May 2016 to December 2019 were analysed. All cause death, limb outcome, and cardiovascular (CV) outcome in the propensity matched cohort were assessed. Limb outcome was the composite of new onset chronic limb threatening ischaemia or amputation. Cardiovascular outcomes included CV death, non-fatal ischaemic stroke, non-fatal myocardial infarction, or heart failure (HF) hospitalisation. Results: Over a median of 14.2 months, all cause death occurred in 535 of 2 205 patients (24.3%) receiving PCDs and 1 398 of 4 410 (31.7%) receiving non-PCDs (subdistribution hazard ratio [sHR] 0.71, 95% confidence interval [CI] 0.64 – 0.78). The composite limb outcome occurred in 622 patients (28.2%) in the PCD group and in 1 174 patients (26.6%) in the non-PCD group (sHR 0.98, 95% CI 0.89 – 1.08). The composite CV outcome was less frequent in patients receiving PCD (20.1%) than control (23.3 %) (sHR 0.79, 95% CI 0.71 – 0.88). Conclusion: In patients having endovascular revascularisation, exposure to a PCD was associated with lower risk of all cause death and composite CV outcome. There was no difference in composite limb outcome.