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Published on: September 22, 2020
Outcomes of Endovascular-First Versus Bypass-First Approach for Patients With Chronic Limb-Threatening Ischemia Using
Asma Mathlouthi1, Nadin Elsayed1, Omar Al-Nouri1
1Division of Vascular and Endovascular Surgery, University of California San Diego, La Jolla, CA.
Insights
The endovascular-first (EVF) approach for chronic limb-threatening ischemia (CLTI) shows similar limb salvage and survival rates compared to bypass-first (BF) strategies. This large real-world analysis supports EVF as a non-inferior treatment option for CLTI patients.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Public Health
Background:
- Chronic limb-threatening ischemia (CLTI) is a growing concern, leading to limb loss, disability, and increased cardiovascular mortality.
- Endovascular-first (EVF) approaches have gained popularity due to their less invasive nature, with previous studies suggesting comparable effectiveness to open repair.
- The long-term durability of EVF versus bypass-first (BF) strategies in real-world CLTI patient populations remains under investigation.
Purpose of the Study:
- To compare the midterm outcomes of endovascular-first (EVF) and bypass-first (BF) revascularization strategies in patients with chronic limb-threatening ischemia (CLTI).
- To evaluate the durability and effectiveness of EVF versus BF approaches in a large, real-world patient cohort.
Main Methods:
- A retrospective analysis of patients undergoing limb revascularization between 2010 and 2016 was conducted using the Vascular Quality Initiative Medicare-linked database.
- Patients were stratified into EVF and BF groups, excluding those with prior revascularization or hybrid/suprainguinal procedures.
- Primary endpoints included 2-year limb salvage, freedom from reintervention, amputation-free survival (AFS), and freedom from all-cause mortality (ACM).
Main Results:
- The EVF group comprised 12,062 patients (70%), while the BF group included 5,166 patients (30%), with a median follow-up of 33 months.
- Patients in the EVF group were generally older with more comorbidities and tissue loss.
- At 2 years, the BF group demonstrated higher unadjusted rates for limb salvage (86.4% vs. 82.1%), freedom from reintervention (72% vs. 68%), AFS (66.9% vs. 56.3%), and freedom from ACM (75.7% vs. 66.1%). However, after adjusting for confounders, no significant differences were observed between the groups for these outcomes.
Conclusions:
- This large real-world study indicates that the endovascular-first (EVF) approach is non-inferior to the bypass-first (BF) strategy for patients with chronic limb-threatening ischemia (CLTI).
- The EVF strategy demonstrated comparable limb salvage, durability, amputation-free survival, and all-cause mortality rates to the BF approach.
- Further level 1 evidence is warranted to definitively establish the role of revascularization strategy in managing complex CLTI patients.
Background:
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.
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 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).
Results:
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.
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.
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