The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

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

DOI: 10.4244/EIJ-D-20-01018

1. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Bolton, MA, 
2. Harvard Medical School, Boston, MA, USA
3. Division of Cardiology, Department of Medicine; Beth Israel Deaconess Medical Center, Boston, MA, USA
4. Medtronic, Minneapolis, MN, USA
5. CPC Clinical Research, Denver, CO, USA
6. Division of Cardiology, Department of Medicine; University of Colorado Anschutz Medical Campus, Denver, CO, USA

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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.

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