LAUSR

OBJECTIVE Chronic limb-threatening ischemia (CLTI) has been increasing in prevalence and remains a significant cause of limb loss and disability and a strong predictor of cardiovascular mortality. Previous studies have demonstrated that endovascular and open repair are similarly effective. These findings led to a significant increase in the adoption of the less-invasive endovascular-first approach. However, it remains unknown whether the two treatment modalities have similar durability in today's real-world setting. The aim of the present study was to compare the mid-term outcomes of the endovascular-first and bypass-first strategies in patients with CLTI. METHODS We identified all patients who had undergone limb revascularization from January 2010 to December 2016 in the Vascular Quality Initiative-Medicare-linked database. Patients with a history of previous revascularization and those who had undergone hybrid or supra-inguinal procedures were excluded from the present study. The remaining patients were divided into two groups: endovascular-first (EVF) or bypass-first (BF). The main endpoints were 2-year limb salvage, freedom from reintervention, amputation-free survival (AFS), and freedom from all-cause mortality (ACM). RESULTS The EVF approach was applied to 12,062 patients (70%) and the BF approach to 5166 patients (30%). The median follow-up was 33 months (IQR 14-49). Patients in the EVF group were older and had more comorbidities and tissue loss. At 2 years, the BF group had achieved greater rates of limb salvage (86.4% vs 82.1%; P < .001), freedom from reintervention (72% vs 68%; P < .001), AFS (66.9% vs 56.3%; P < .001), and freedom from ACM (75.7% vs 66.1%; P < .001; Fig). After adjusting for potential confounders, an effect of the treatment strategy on limb salvage (adjusted hazard ratio [aHR], 1.03; 95% confidence interval [CI], 0.93-1.16; P=0.55), reintervention (aHR, 0.95; 95% CI, 0.89-1.019, P=0.06), AFS (aHR, 0.94; 95% CI, 0.89-1.007; P=0.08), and ACM (aHR, 0.93; 95% CI, 0.87-1.001, P=0.055) was not observed (Table). CONCLUSIONS The present study is the largest real-word analysis showing the noninferiority of the EVF approach in patients with CLTI, with similar limb salvage, durability, AFS, and ACM compared with the BF approach. However, level 1 evidence on the role of the revascularization strategy in these challenging patients is needed.