Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia
Alik Farber1, Matthew T Menard1, Michael S Conte1
1From the Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine (A.F., M.F.V., J.A. Kalish, J.J.S.), the Division of Vascular and Endovascular Surgery (M.T.M., M.B.S.) and the Department of Medicine (N.K.C.), Brigham and Women's Hospital, Harvard Medical School (M.R.J.), and the Section of Vascular Medicine and Intervention, Massachusetts General Hospital (K.R.), Boston, HealthCore, Watertown (T.H.H., S.F.A., M.J.C., M.O., M.M.), and the Division of Vascular Surgery, UMass Memorial Health, Worcester (A.S.) - all in Massachusetts; the Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco (M.S.C., W.G., P.A.S.), the Division of Vascular Surgery, UC San Diego Health, La Jolla (A.B.), Coastal Cardiology, French Hospital Medical Center, San Luis Obispo (L.C.C.), and the Division of Vascular Surgery and Endovascular Therapy, University of Southern California, Los Angeles (V.L.R.) - all in California; the Department of Interventional Radiology (J.A. Kaufman) and the Division of Vascular Surgery, School of Medicine (A.A.), Oregon Health and Science University, and the Operative Care Division, Portland VA Medical Center (M.C.K.) - all in Portland; the Heart and Vascular Center, Dartmouth Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH (R.J.P., M.A.C., P.P.G.); the Department of Medical Imaging, University of Arizona Health Sciences, Tucson (M.D.D.), and the Division of Vascular Surgery, Peak Heart and Vascular, Glendale (N.G.) - both in Arizona; the National Heart, Lung, and Blood Institute, Bethesda, MD (D.R., G.S.); the Medical Device Innovation Consortium, National Evaluation System for Health Technology Coordinating Center, Arlington, VA (F.S.S.); the Department of Cardiovascular Diseases, Ochsner Clinical School, University of Queensland, Brisbane, Australia (C.J.W.); the Department of Interventional Radiology, Gundersen Health System, La Crosse, WI (E.A.); the Iowa Heart Center, Des Moines (D.K.C.); the Division of Vascular Surgery, Centre Hospitalier Universitaire de Quebec-Université Laval, Quebec City (Y.D.), and Dalhousie University, Division of Cardiac and Vascular Surgery, Department of Surgery, Nova Scotia Health Association, Halifax (C.R.H.) - both in Canada; the Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta (L.F.); the Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland (K.A.G.); the Cardiovascular Section, University of Oklahoma Health Sciences Center, Oklahoma City (B.M.H.); Westchester Medical Center and the Department of Surgery, Section of Vascular Surgery, New York Medical College - both in Valhalla, NY (I.A.L.); the Vascular Medicine Outcomes Program, Yale University, New Haven, CT (C.M.-H.); the Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis (R.M.); and the Department of Vascular Surgery, University of Helsinki, and Helsinki University Hospital - both in Helsinki (M.V.).
Insights
Surgical revascularization is superior to endovascular therapy for patients with chronic limb-threatening ischemia (CLTI) who have a usable great saphenous vein. For CLTI patients without a suitable vein, both strategies showed similar limb outcomes.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Peripheral Artery Disease
Background:
- Chronic limb-threatening ischemia (CLTI) poses a significant risk of amputation.
- Revascularization is crucial for improving limb perfusion in CLTI patients.
- The optimal initial revascularization strategy (endovascular vs. surgical) for CLTI remains uncertain.
Purpose of the Study:
- To compare the effectiveness of endovascular therapy versus surgical revascularization for CLTI.
- To evaluate limb and survival outcomes in patients undergoing different revascularization strategies.
Main Methods:
- An international, randomized trial involving 1830 patients with CLTI and infrainguinal peripheral artery disease.
- Two parallel cohorts: Cohort 1 (usable great saphenous vein) and Cohort 2 (alternative bypass conduit).
- Primary outcome: composite of major adverse limb event (amputation above ankle, major reintervention) or all-cause death.
Main Results:
- In Cohort 1, surgical revascularization significantly reduced the primary outcome compared to endovascular therapy (42.6% vs. 57.4%, HR 0.68).
- In Cohort 2, no significant difference in the primary outcome was observed between surgical and endovascular groups (42.8% vs. 47.7%, HR 0.79).
- Adverse event rates were similar between surgical and endovascular groups in both cohorts.
Conclusions:
- Surgical revascularization is superior for CLTI patients with an adequate great saphenous vein.
- For CLTI patients lacking a suitable saphenous vein conduit, endovascular therapy and surgical revascularization yield similar outcomes.
- The choice of revascularization strategy should consider the availability of a great saphenous vein.
Background:
Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes.
Methods:
In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause.
Results:
In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts.
Conclusions:
Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).
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