TY - JOUR
T1 - Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia
AU - Farber, Alik
AU - Menard, Matthew T.
AU - Conte, Michael S.
AU - Kaufman, John A.
AU - Powell, Richard J.
AU - Choudhry, Niteesh K.
AU - Hamza, Taye H.
AU - Assmann, Susan F.
AU - Creager, Mark A.
AU - Cziraky, Mark J.
AU - Dake, Michael D.
AU - Jaff, Michael R.
AU - Reid, Diane
AU - Siami, Flora S.
AU - Sopko, George
AU - White, Christopher J.
AU - Van Over, Max
AU - Strong, Michael B.
AU - Villarreal, Maria F.
AU - Mckean, Michelle
AU - Azene, Ezana
AU - Azarbal, Amir
AU - Barleben, Andrew
AU - Chew, David K.
AU - Clavijo, Leonardo C.
AU - Douville, Yvan
AU - Findeiss, Laura
AU - Garg, Nitin
AU - Gasper, Warren
AU - Giles, Kristina A.
AU - Goodney, Philip P.
AU - Hawkins, Beau M.
AU - Herman, Christine R.
AU - Kalish, Jeffrey A.
AU - Koopmann, Matthew C.
AU - Laskowski, Igor A.
AU - Mena-Hurtado, Carlos
AU - Motaganahalli, Raghu
AU - Rowe, Vincent L.
AU - Schanzer, Andres
AU - Schneider, Peter A.
AU - Siracuse, Jeffrey J.
AU - Venermo, Maarit
AU - Rosenfield, Kenneth
N1 - Publisher Copyright:
© 2022 Massachusetts Medical Society.
PY - 2022/12/22
Y1 - 2022/12/22
N2 - 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.)
AB - 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.)
KW - Cardiology
KW - Cardiology General
KW - Peripheral Arterial and Aortic Disease
KW - Surgery
KW - Surgery General
UR - http://www.scopus.com/inward/record.url?scp=85142419872&partnerID=8YFLogxK
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U2 - 10.1056/NEJMoa2207899
DO - 10.1056/NEJMoa2207899
M3 - Article
AN - SCOPUS:85142419872
SN - 0028-4793
VL - 387
SP - 2305
EP - 2316
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 25
ER -