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. 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 suprainguinal 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). The EVF approach was applied to 12,062 patients (70%) and the BF approach to 5166 patients (30%). The median follow-up was 32 months (interquartile range, 14-48 months). 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], 1.05; 95% confidence interval [CI], 0.96-1.16; P = .25), reintervention (aHR, 0.92; 95% CI, 0.84-1.003; P = .06), AFS (aHR, 0.96; 95% CI, 0.91-1.015; P = .16), and ACM (aHR, 0.94; 95% CI, 0.89-1.004; P = .06) was not observed (Table). 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.TableMain outcomes stratified by treatment strategy2-Year outcomeEVF (n = 12,062; 70%)BF (n = 5166; 30%)P valueaHR (95% CI)P valueAmputation-free survival, %56.3066.87<.0010.96 (0.91-1.015).16Limb salvage, %82.1086.40<.0011.05 (0.96-1.16).25Freedom from reintervention, %68.0072.00<.0010.92 (0.840-1.003).06Freedom from all-cause mortality, %75.7066.10<.0010.94 (0.89-1.004).06aHR, Adjusted hazard ratio; BF, bypass first; CI, confidence interval; EVF, endovascular first. Open table in a new tab
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