Among 341 consecutive patients with chronic limb-threatening ischemia (CLTI) undergoing infrainguinal endovascular therapy, drug-coated device use was associated with an 86% higher rate of wound healing (HR 1.86; 95% CI 1.14–3.02) after inverse-probability-weighted multivariable adjustment, with no significant difference in major amputation, target lesion revascularization, or all-cause mortality compared to uncoated devices. Exploratory analysis signaled particularly favorable wound-healing outcomes with sirolimus-coated balloons and comparable mortality between paclitaxel-coated and uncoated devices.
The paclitaxel safety controversy — ignited by a 2018 meta-analysis linking the drug to excess late mortality in peripheral arterial disease — has cast a long shadow over drug-coated technology. This single-center real-world cohort provides reassuring mortality data for paclitaxel and introduces sirolimus-coated balloons as a potentially superior alternative, consistent with sirolimus's more favorable systemic toxicity profile seen in coronary and renal-transplant contexts. Wound healing, often underused as an endpoint in vascular trials, is arguably the most patient-relevant outcome in CLTI, where tissue loss drives amputation decisions. Limitations are significant: 341 patients from one center limits generalizability, the observational design cannot exclude residual confounding despite statistical weighting, and follow-up appears limited to one year. Crucially, this is a preprint posted on medRxiv and has not yet been peer-reviewed — findings, particularly the exploratory sirolimus signal, should be treated as hypothesis-generating. Larger randomized trials directly comparing sirolimus- versus paclitaxel-coated devices with wound healing as a primary endpoint are urgently needed.
