Endovascular Revascularization Incorporating Infrapopliteal Coronary Drug-Eluting Stents Improves Clinical Outcomes in Patients with Critical Limb Ischemia and Tissue Loss

Background: Critical limb ischemia (CLI) involving infrapopliteal arterial atherosclerosis and tissue loss remains a formidable clinical scenario with significant morbidity and mortality. Despite level IA evidence, tibial revascularization with coronary drug-eluting stents (DES) remains a seldom-used technique in the United States due, in part, to lack of a Food and Drug Administration-approved indication and dedicated stent technology for infrapopliteal application. Furthermore, follow-up data beyond 1 year remain scarce, and further evidence for improvement in clinical outcomes using this technique is needed. Herein, we present our multi-institutional experience with endovascular revascularization of patients with CLI and tissue loss using coronary DES for infrapopliteal lesions of appropriate dimensions and the Wound, Ischemia, and foot Infection (WIfI) score as supportive evidence for improvement in clinical outcomes. Methods: In this retrospective study, 40 sequential tibial revascularization procedures performed in 32 patients with CLI were reviewed. Outcomes including changes in WIfI scores, patency rates, freedom from major amputation, target lesion recurrence, and all-cause mortality were analyzed. Average follow-up duration was 19.3 months (interquartile range: 7-27.1 months). Results: Freedom from major amputation was 88.6%. One-year primary patency was 90.3%. Mean ankle-brachial indices increased after revascularization (0.57 +/- 0.26 to 0.97 +/- 0.26; P = 0.03). All components of the WIfI score significantly improved after revascularization (W: 1.9 to 1.1, P = 0.03; I: 2.0 to 0.6, P = 0.001; and fI: 1.5 to 0.8, P = 0.01). WIfI risk of major amputation score before revascularization was 3.58 +/- 0.75 (high risk), which was reduced to 2.04 +/- 1.31 (low risk; P < 0.001). One-year survival rate was 90.6%. Conclusions: Coronary DES continue to demonstrate promising primary patency and limb salvage rates in appropriately selected patients undergoing multilevel endovascular revascularization for CLI and tissue loss. In addition to its value as a predictor for major amputation and revascularization benefit, the WIfI score can also serve as a multicomponent tool for objective assessment of outcomes after revascularization.