Long-Term Safety of Drug-Coated Devices for Peripheral Revascularisation

BACKGROUND: Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival. We assessed long-term mortality in patients treated with drug-coated devices insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population. METHODS: Patients treated with or without drug-coated devices for femoropopliteal artery revascularisation from 4/2015–12/2017 were studied using Optum’s De-identified Clinformatics® Datamart Database. Mortality was assessed through December 2019 using Kaplan Meier cumulative mortality curves and Cox-proportional hazard models. Inverse probability of treatment weighting was used to adjust for differences between groups. RESULTS: Of 16,796 patients revascularised, 4,427 (26.4%) were treated with drug-coated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. The median follow-up was 2.66 years (IQR 2.02–3.52). Treatment with drug-coated devices was associated with similar long-term mortality as nondrug-coated devices (adjusted HR 1.03; 95%CI=0.96–1.10; P=0.39). Results were comparable for patients treated with balloons alone (adjusted HR 1.00; 95%CI=0.92–1.08; P=0.96) or stents (adjusted HR 1.02; 95%CI=0.88–1.18; P=0.78). These findings did not differ based on treatment setting, disease severity, age, sex or comorbidity burden (interaction P>0.05 for all). CONCLUSIONS: In this large cohort, there was no evidence of increased long-term mortality following treatment with drug-coated devices. CONDENSED ABSTRACT: Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival. To further evaluate device safety, Medicare Advantage claims data from 4/2015–12/2017 were used to identify patients treated with drug-coated and nondrug-coated devices. Inverse probability of treatment weighting was used for adjustment. Of 16,796 patients, 26.4% were treated with drug-coated devices. Median follow-up was 2.66 years (IQR 2.02 – 3.52). Treatment with drug-coated devices was associated with similar risk of long-term mortality as nondrug-coated devices (HR 1.03; 95%CI=0.96–1.10; P=0.39). In this large cohort, there was no evidence of increased long-term mortality following treatment with drug-coated devices.