Outcomes of Endovascular-First Versus Bypass-First Approach for Patients With Chronic Limb-Threatening Ischemia Using a Medicare-Linked Database

Abstract

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 (EVF) approach. However, it remains unknown whether the 2 treatment modalities have similar durability in today's real-world setting. The aim of the present study was to compare the midterm outcomes of the EVF and bypass-first (BF) 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 2 groups: EVF and BF. The main end points 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 5,166 patients (30%). The median follow-up was 33 months (interquartile range [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<0.001), freedom from reintervention (72% vs. 68%; P < 0.001), AFS (66.9% vs. 56.3%; P < 0.001), and freedom from ACM (75.7% vs. 66.1%; P < 0.001). 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. 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.