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

Peripheral interventions

Long-term safety of drug-coated devices for peripheral revascularisation

EuroIntervention 2021;17:590-598. DOI: 10.4244/EIJ-D-20-01018

1. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Bolton, MA, USA; 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

Background: Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival.

Aims: We aimed to assess long-term mortality in patients treated with drug-coated versus non-drug-coated devices who are insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population. We analysed data from an MA administrative claims data source that includes both inpatient and outpatient femoropopliteal artery revascularisation procedures.

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 up to 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 to non-drug-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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