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| Turkish Society of Cardiology Young Cardiologists Bulletin Year: 4 Number: 1 / 2021 |
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Reviwer: Dr. Örsan Deniz URGUN Name of the Study : Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices: SAFE-PAD Study Published in Congress: ACC 2021 Full Text Link: http://europepmc.org/article/MED/33993204#free-full-text Background: Drug-coated devices used during femoropopliteal endovascular therapy have been associated with increased mortality, and these data were limited to small-scale studies. Objective : Evaluation of the safety of drug-coated devices used in femoropopliteal endovascular therapy. Method: The study is a retrospective cohort. 168553 patients over 66 years of age with a mean age of 77 who received femoropopliteal endovascular treatment were followed for an average of 2.72 years. 70584 patients (41.9%) had a drug-eluting device, 44.9% were women, 51% had Diabetes Mellitus, 49% had cigarettes, 45.7% had critical extremity ischemia, and 7.9% had amputation. The primary outcome was all-cause death. Secondary outcomes included repeated hospitalization, repeated lower extremity revascularization, and lower extremity amputation. Results: The cumulative incidence of all-cause mortality was 53.8% for drug-eluting devices and 55.1% for non-drug-eluting devices ([HR], 0.95; 95% CI, 0.94-0.97; noninferiority P?<001). Conclusion: During the follow-up period, drug-eluting devices were found to be non-inferior compared to non-drug-eluting devices, this result did not change in balloon technique or other subgroups. Interpretation: Peripheral arterial disease and lower extremity ischemia are conditions that increase mortality and morbidity, and endovascular method is a treatment option.
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