Back to 2026 Abstracts
Impact of Food and Drug Administration Safety Communications on Drug-Coated Device Utilization in Peripheral Artery Disease
Midori White
Johns Hopkins, Baltimore, MD
BackgroundDrug-coated balloons (DCB) and drug-eluting stents (DES) are designed to reduce restenosis in patients with peripheral artery disease. In December 2018, a meta-analysis was published that demonstrated an association between drug-coated device use and mortality. As a result, the U.S. Food and Drug Administration (FDA) issued a safety communication around using DCB or DES in August 2019, which was ultimately reversed in July 2023. We aimed to assess the impact of the initial publication and subsequent FDA communications on drug-coated device utilization in Medicare beneficiaries.
MethodsWe conducted a retrospective study using 100% fee-for-service Medicare claims data from January 1, 2017, through March 31, 2025. We included all adults ≥18 years with claudication or chronic limb-threatening ischemia who underwent a femoropopliteal peripheral vascular intervention (PVI). Patients with acute limb ischemia were excluded. Procedures were classified as plain balloon angioplasty (POBA), bare metal stents (BMS), DCB, or DES using Current Procedural Terminology (CPT) codes. Interrupted time series were used to analyze changes in the proportional utilization of drug-coated technologies (DCB or DES; based on slope) with interruptions at the December 2018 publication, the August 2019 FDA safety communication, and the July 2023 FDA reversal.
ResultsWe identified 329,052 patients who underwent a femoropopliteal PVI (mean age 76.9 ±7.38 years, 57% male, 82% White race). In the initial study period, the use of DCB was significantly increasing each month (P=0.004), while the use of BMS (P=0.009) and POBA (P=0.02) were declining (
Figure). After the meta-analysis publication in December 2018, there was a significant decline in the proportion of DCB utilization (-9.2% per month), with a compensatory increase in both POBA (+6.0% per month) and BMS (+2.5% per month) (all, P<0.001). Following the August 2019 FDA warning, there was a paradoxical increase in the proportion of DCB utilization (+0.86% per month), while POBA (-0.34%) and BMS (-0.62% per month) began declining (all, P<0.001). Similar trends continued after the July 2023 reversal (DCB: +0.56%, POBA: -0.45%, BMS: -0.53% per month; all P<0.004). The proportion use of DES did not significantly change throughout the study period (all slopes P>0.05). The proportional use of DCB recovered back to pre-meta-analysis publication rates by January 2025 (
Figure).
ConclusionDrug-coated balloon utilization among Medicare beneficiaries was most strongly influenced by the December 2018 meta-analysis, rather than subsequent FDA safety communications. While the FDA warning and its reversal were associated with modest directional shifts, practice patterns largely recovered to pre-publication levels over time. These findings highlight the dominant role of scientific publications in shaping physician behavior, even in the setting of regulatory advisories.
Back to 2026 Abstracts
