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

Published:April 06, 2022DOI:https://doi.org/10.1016/j.avsg.2022.03.040

      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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      References

        • Shu J.
        • Santulli G.
        Update on peripheral artery disease: epidemiology and evidence-based facts.
        Atherosclerosis. 2018; 275: 379-381
        • Conte M.S.
        • Pomposelli F.B.
        • Clair D.G.
        • et al.
        Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.
        J Vasc Surg. 2015; 61: 2S-41S.e1
        • Teraa M.
        • Conte M.S.
        • Moll F.L.
        • et al.
        Critical limb ischemia: current trends and future directions.
        J Am Heart Assoc. 2016; 5: e002938
        • Reinecke H.
        • Unrath M.
        • Freisinger E.
        • et al.
        Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence.
        Eur Heart J. 2015; 36: 932-938
        • Shah D.M.
        • Darling R.C.
        • Chang B.B.
        • et al.
        Long-term results of in situ saphenous vein bypass. Analysis of 2058 cases.
        Ann Surg. 1995; 222 (discussion 446–448): 438-446
        • Reifsnyder T.
        • Arhuidese I.J.
        • Hicks C.W.
        • et al.
        Contemporary outcomes for autogenous infrainguinal bypass in the endovascular era.
        J Ann Vasc Surg. 2015; 29: 619-625
        • Cassese S.
        • Byrne R.A.
        Endovascular stenting in femoropopliteal arteries.
        Lancet. 2018; 392: 1491-1493
        • Gerhard-Herman M.D.
        • Gornik H.L.
        • Barrett C.
        • et al.
        2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines.
        J Am Coll Cardiol. 2017; 69: e71-e126
        • Kudo T.
        • Chandra F.A.
        • Ahn S.S.
        The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience.
        J Vasc Surg. 2005; 41: 423-435
        • Timaran C.H.
        • Stevens S.L.
        • Freeman M.B.
        • et al.
        Predictors for adverse outcome after iliac angioplasty and stenting for limb-threatening ischemia.
        J Vasc Surg. 2002; 36: 507-513
        • Malas M.B.
        • Enwerem N.
        • Qazi U.
        • et al.
        Comparison of surgical bypass with angioplasty and stenting of superficial femoral artery disease.
        J Vasc Surg. 2014; 59: 129-135
        • Siracuse J.J.
        • Menard M.T.
        • Eslami M.H.
        • et al.
        Comparison of open and endovascular treatment of patients with critical limb ischemia in the Vascular Quality Initiative.
        J Vasc Surg. 2016; 63: 958-965
        • Adam D.J.
        • Beard J.D.
        • Cleveland T.
        • et al.
        Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial.
        Lancet. 2005; 366: 1925-1934
        • Menard M.T.
        • Farber A.
        • Assmann S.F.
        • et al.
        Design and rationale of the best endovascular versus best surgical therapy for patients with critical limb ischemia (BEST-CLI) trial.
        J Am Heart Assoc. 2016; 5: e003219
        • Klaphake S.
        • de Leur K.
        • Mulder P.G.
        • et al.
        Life expectancy and outcome of different treatment strategies for critical limb ischemia in the elderly patients.
        Ann Vasc Surg. 2018; 46: 241-248
        • Bradbury A.W.
        • Adam D.J.
        • Bell J.
        • et al.
        Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy.
        J Vasc Surg. 2010; 51: 5S-17S
        • Jones W.S.
        • Dolor R.J.
        • Hasselblad V.
        • et al.
        Comparative effectiveness of endovascular and surgical revascularization for patients with peripheral artery disease and critical limb ischemia: systematic review of revascularization in critical limb ischemia.
        Am Heart J. 2014; 167: 489-498
        • Lin J.H.
        • Brunson A.
        • Romano P.S.
        • et al.
        Endovascular-first treatment is associated with improved amputation-free survival in patients with critical limb ischemia.
        Circ Cardiovasc Qual Outcomes. 2019; 12: e005273
        • Scali S.T.
        • Rzucidlo E.M.
        • Bjerke A.A.
        • et al.
        Long-term results of open and endovascular revascularization of superficial femoral artery occlusive disease.
        J Vasc Surg. 2011; 54: 714-721
        • Acin F.
        • De Haro J.
        • Bleda S.
        • et al.
        Primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis of randomized controlled trials.
        J Endovasc Ther. 2012; 19: 585-595
        • Bisdas T.
        • Borowski M.
        • Stavroulakis K.
        • et al.
        Endovascular therapy versus bypass surgery as first-line treatment strategies for critical limb ischemia: results of the interim analysis of the CRITISCH registry.
        JACC Cardiovasc Intervent. 2016; 9: 2557-2565