Drug-Coated Devices, Wound Healing, and Mortality After Endovascular Therapy for Chronic Limb-Threatening Ischemia

Background

The clinical benefit and safety of drug-coated devices in chronic limb-threatening ischemia remain debated, particularly after recent randomized evidence questioning paclitaxel-coated technologies. We evaluated wound healing, limb outcomes, and mortality after infrainguinal endovascular therapy with uncoated, paclitaxel-coated, and sirolimus-coated devices.

Methods

Consecutive patients with chronic limb-threatening ischemia undergoing successful infrainguinal endovascular therapy in a prospective single-center service evaluation were analyzed. The primary exposure was use of any drug-coated device during the index procedure. Inverse probability of treatment weighting and multivariable Cox models were used to adjust for baseline differences. Exploratory analyses compared paclitaxel-coated, sirolimus-coated, and uncoated devices.

Results

Among 341 patients, 244 (71.6%) received at least one drug-coated device. After weighting, drug-coated device use was associated with more frequent wound healing, whereas major amputation, clinically driven target lesion revascularization, major adverse limb events, and death did not differ significantly between groups. In weighted multivariable models, drug-coated device use remained associated with wound healing (HR, 1.86; 95% CI, 1.14–3.02), but not with mortality or major limb events. Exploratory drug-specific analyses suggested the highest wound-healing rates among patients treated with sirolimus-coated devices, while mortality was comparable between paclitaxel-coated and uncoated devices.

Conclusion

In this real-world cohort of patients with chronic limb-threatening ischemia undergoing infrainguinal endovascular therapy, drug-coated device use was not associated with increased adjusted 1-year mortality and was associated with improved wound healing. Exploratory analyses suggested favourable wound-healing outcomes with sirolimus-coated balloons, with a lower observed mortality signal that warrants confirmation in larger comparative studies.

What is Known

• Drug-coated devices are widely used in endovascular therapy to prevent restenosis, but their clinical benefit in patients with chronic limb-threatening ischemia remains uncertain.

• Recent randomized evidence has questioned the effectiveness of paclitaxel-coated devices in chronic limb-threatening ischemia and has raised ongoing concerns regarding long-term mortality.

What the Study Adds

• In a real-world cohort of patients with chronic limb-threatening ischemia undergoing infrainguinal endovascular therapy, drug-coated device use was not associated with increased adjusted 1-year mortality and was associated with improved wound healing.

• Wound healing may be a clinically sensitive, patient-relevant endpoint for evaluating endovascular strategies in CLTI.

• Exploratory drug-specific analyses suggested favourable outcomes with sirolimus-coated devices, supporting dedicated comparative studies of limus-based technologies in CLTI.