Insights from the prospective multicentre observational study evaluating acute lower limb ischemia on the influence of patient characteristics on treatment strategy selection and outcomes

Abstract

Objective: Acute lower limb ischemia (ALI) is a vascular emergency requiring prompt intervention to prevent limb loss and mortality. Treatment strategies have evolved from open surgical revascularization (OSR) and thrombolysis-dominated endovascular therapy (EVT) with advanced thrombectomy devices and hybrid approaches, yet optimal management remains debated. PROMOTE-ALI (Prospective Multicentre Observational Study Evaluating Acute Lower Limb Ischaemia) evaluates contemporary treatment practices, factors influencing modality selection, and short-term outcomes in ALI across Europe.

Methods: The PROMOTE-ALI registry included patients from December 1, 2021, to August 31, 2023. The primary end point was identifying preoperative predictors influencing treatment choice. Secondary end points included 30-day and 90-day amputation-free survival (AFS), freedom from target limb reintervention, clinical outcomes, complications, and survival. Predictors of treatment were analyzed with generalized linear mixed model with random intercept for inclusion site. Kaplan-Meier analysis evaluated the probability for AFS, freedom from major amputation, and survival.

Results: Among 705 cases, OSR (55.7%) was the predominant treatment, followed by hybrid (20.9%) and EVT (19.1%). Completion angiography was performed in 50.1% of OSR cases, significantly reducing reintervention rates (6.16% vs 13.52%; P = .02). EVT and hybrid therapy were favored in patients with peripheral artery disease (60.0% and 60.5% vs 46.3% OSR; P = .05 and P = .03) and prior ipsilateral revascularizations (57.8% and 48.3% vs 32.1%; P < .001 and P < .02). OSR was preferred in patients with cardiac dysrhythmia (38.4% vs 16.3% EVT and 13.6% hybrid; P = .004 and P = .002). EVT patients had higher reintervention (32.6%) and bleeding rates (5.2%) compared with OSR (8.9%, 1.0%) and hybrid therapy (15.0%, 1.4%; P < .001 and P = .01).

Conclusions: This study highlights evolving ALI treatment patterns in Europe. Patient characteristics, disease etiology, and procedural factors significantly influence ALI treatment selection. Although OSR remains essential, hybrid techniques address complex lesions, and EVT is preferred in failed prior revascularizations, although with higher reintervention risks. Comparable AFS across modalities underscores the importance of individualized approaches and refinement of treatment protocols to optimize outcomes.

Keywords: Acute limb ischemia; Amputation-free survival; Endovascular; Hybrid; Limb salvage; Open surgery.