Safety and effectiveness of drug-coated devices in chronic limb-threatening ischaemia: a nationwide analysis

Abstract

Background: Endovascular therapy is a cornerstone for chronic limb-threatening ischaemia (CLTI), yet the optimal device strategy remains uncertain.

Aims: Our objective was to compare the clinical and economic outcomes between plain balloon angioplasty±bare metal stents (PBA±BMS), drug-coated balloons (DCBs)±BMS, and drug-eluting stents (DES) in a national real-world CLTI cohort.

Methods: Medicare beneficiaries aged ≥66 years who underwent femoropopliteal revascularisation for CLTI between 2016 and 2023 were included. Patients were grouped by index device. Outcomes included a composite of all-cause mortality or major amputation, as well as major adverse limb events (MALE) and reintervention. Patients were followed from the index procedure until death, loss to follow-up, or the end of the study period. Time-to-event and cost outcomes were analysed using multivariable Cox and gamma regression models, respectively.

Results: Among 108,304 CLTI patients, 52.5% received PBA±BMS, 30.7% DCBs, and 16.8% DES. At 2 years, the composite outcome occurred in 50.54% (PBA±BMS), 43.08% (DCB±BMS), and 43.71% (DES); at 5 years, it occurred in 75.69%, 71.19%, and 71.71%, respectively. Compared with PBA±BMS, DCB±BMS (hazard ratio [HR] 0.92, 95% confidence interval [CI]: 0.90-0.93) and DES (HR 0.93, 95% CI: 0.92-0.95) were associated with a lower risk of the composite outcome. DCBs were associated with reduced major amputation (HR 0.87, 95% CI: 0.84-0.91), mortality (HR 0.93, 95% CI: 0.91-0.94), MALE (HR 0.96, 95% CI: 0.94-0.98), and reintervention (HR 0.97, 95% CI: 0.96-0.99) compared with PBA±BMS. The proportion of BMS use was 10.1% in the PBA±BMS group and 3.1% in the DCB±BMS group.

Conclusions: In this national CLTI cohort, drug-coated devices were associated with reduced amputation and mortality. Data from this study suggest that DCBs may offer consistent benefit without increased costs.