Assessment of 2-Year Mortality With Use of Drug-Coated Devices in Femoropopliteal Disease: A Real-World Experience From the Bronx, New York

Abstract

The use of drug-coated devices (DCD) in peripheral arterial disease (PAD) intervention continues to remain controversial after a recent meta-analysis raised concerns of higher late mortality outcome with the use of these devices. Given this, there is need for more data with regards to the late mortality outcome with DCD use. We sought to assess the 2-year mortality outcome in patients with PAD treated with DCD in an inner-city public hospital that mainly serves patients of lower socio-economic status.

Methods: This was an observational study of consecutive patients with femoropopliteal arterial disease who had revascularization procedures from 2014 to 2018 at Jacobi Medical Center and were followed for 2 years. Patients were classified into DCD and non-drug-coated (nDCD) groups based on the device used at the index procedure. The primary endpoint was 2-year mortality. Propensity cohort matching was applied. A multivariate Cox regression model was used to identify baseline variables associated with 2-year mortality.

Results: 152 patients were included in this analysis (DCD group = 83, nDCD group =69). No significant difference in mortality between the two groups was identified at 2 years after propensity score matching with replacement (DCD: HR 0.72; 95% CI 0.30-1.71; p = 0.457). Patients that had revascularization because of intermittent claudication had lower mortality at 2 years compared to patients with critical limb ischemia as procedure indication (HR 0.18; 95% CI 0.04-0.82; p = 0.026).

Conclusions: This propensity score matched study revealed no difference in 2-year mortality between patients treated with DCD compared to patients treated with nDCD.

Keywords: Bronx; Drug-coated devices; Endovascular therapy; Mortality; New York; Observational study; Paclitaxel-coated devices; Peripheral arterial disease.