June 25, 2020

Long-Term Safety of Drug-Coated Devices for Peripheral Revascularization: An Analysis of the Optum Medicare Advantage Cohort

VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, presents the data summary below in conjunction with our Late-Breaking Clinical Trials Livestream on June 25, 2020.

Presenter: Eric Secemsky, MD, MSc

Meta-analyses of randomized trials of paclitaxel-coated peripheral devices found an association with worse long-term survival. To evaluate the safety of these devices, mortality was assessed in patients treated with or without drug-coated devices who were insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population. Patients treated with or without drug-coated devices for femoropopliteal artery revascularization between April 2015 and December 2017 were studied using a sample of de-identified MA claims from Optum’s De-identified Clinformatics® Datamart Database.

All-cause 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. Of 16,796 patients revascularized, 4,427 (26.4%) were treated with drug-coated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. Following revascularization, the median follow-up was 2.66 years (IQR 2.02 – 3.52; longest follow-up 4.75 years).

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).

In this large cohort of MA beneficiaries, there was no evidence of increased long-term mortality following treatment with drug-coated devices. These findings persisted by device type, procedure setting, and patient characteristics. This analysis is the first to involve a MA patient population and contributes to a growing body of real-world data finding no association between drug-eluting devices and harm in routine clinical practice.

About VIVA Physicians

VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by VIVA Physicians have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about VIVA Physicians, visit www.vivaphysicians.org.

SOURCE VIVA Physicians

For further information: press@vivaphysicians.org