No Evidence for Increased Mortality With Drug-Coated Devices Observed in Medicare Database Analysis


Submitted on Tue, 02/19/2019 - 16:31

After analyzing data from Centers for Medicare and Medicaid Services beneficiaries, researchers found no evidence of increased all-cause mortality for patients who underwent femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

The investigators undertook this study after the recent meta-analysis by Katsanos et al raised concerns about femoropopliteal artery revascularization with paclitaxel drug-coated devices being linked with increased long-term all-cause mortality compared with non-drug-coated devices.

The current study was a retrospective cohort study that included 16,560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. Data were included from throughout the United States and drew from multiple centers.

Patients included in the study had a mean age of 79.2 years. Of the patients 7,734 were men, 12,232 were white, 8,222 currently or had previously used tobacco, 9,817 had diabetes, and 8,450 had critical limb ischemia (CLI).

There were 5,989 participants treated with drug-coated devices, and patients were followed for a median of 389 days. “Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007),” the researchers wrote.

When treatment was stratified by using a DCB alone or DES with or without DCB, the investigators noted similar survival trends. Multivariable adjustment was performed, and this showed that drug-coated devices were not linked with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These results were also seen in patients with CLI, patients without CLI, patients treated with DCB alone, and patients treated with DES with or without DCB.

The authors acknowledged strengths and limitations to the study. “The strengths of using these data include ICD-10-PCS claims codes specific for femoropopliteal artery revascularization and the availability of time-to-event mortality data, which allowed for the use of survival analysis methods,” they stated. Additionally, the study was powered to examine sub-groups such as patients with CLI. Several limitations to the study were also noted, including a follow-up period that was less than the 5 years in the Katsanos study.

“Further review of patient-level trial data and real-world registries will be valuable in providing greater evidence of the safety of drug-coated devices used for peripheral artery revascularization,” the authors concluded.


Secemsky EA, Kundi H, Weinberg I, et al. Association of survival with femoropopliteal artery revascularization with drug-coated devices. JAMA Cardiol. 2019 Feb 12. doi: 10.1001/jamacardio.2019.0325. [Epub ahead of print]