Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia
Authors
Farber, AlikMenard, Matthew T
Conte, Michael S
Kaufman, John A
Powell, Richard J
Choudhry, Niteesh K
Hamza, Taye H
Assmann, Susan F
Creager, Mark A
Cziraky, Mark J
Dake, Michael D
Jaff, Michael R
Reid, Diane
Siami, Flora S
Sopko, George
White, Christopher J
van Over, Max
Strong, Michael B
Villarreal, Maria F
McKean, Michelle
Azene, Ezana
Azarbal, Amir
Barleben, Andrew
Chew, David K
Clavijo, Leonardo C
Douville, Yvan
Findeiss, Laura
Garg, Nitin
Gasper, Warren
Giles, Kristina A
Goodney, Philip P
Hawkins, Beau M
Herman, Christine R
Kalish, Jeffrey A
Koopmann, Matthew C
Laskowski, Igor A
Mena-Hurtado, Carlos
Motaganahalli, Raghu
Rowe, Vincent L
Schanzer, Andres
Schneider, Peter A
Siracuse, Jeffrey J
Venermo, Maarit
Rosenfield, Kenneth
UMass Chan Affiliations
SurgeryDocument Type
Journal ArticlePublication Date
2022-11-07
Metadata
Show full item recordAbstract
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.).Source
Farber A, Menard MT, Conte MS, Kaufman JA, Powell RJ, Choudhry NK, Hamza TH, Assmann SF, Creager MA, Cziraky MJ, Dake MD, Jaff MR, Reid D, Siami FS, Sopko G, White CJ, van Over M, Strong MB, Villarreal MF, McKean M, Azene E, Azarbal A, Barleben A, Chew DK, Clavijo LC, Douville Y, Findeiss L, Garg N, Gasper W, Giles KA, Goodney PP, Hawkins BM, Herman CR, Kalish JA, Koopmann MC, Laskowski IA, Mena-Hurtado C, Motaganahalli R, Rowe VL, Schanzer A, Schneider PA, Siracuse JJ, Venermo M, Rosenfield K; BEST-CLI Investigators. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022 Dec 22;387(25):2305-2316. doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7. PMID: 36342173.DOI
10.1056/NEJMoa2207899Permanent Link to this Item
http://hdl.handle.net/20.500.14038/53234PubMed ID
36342173Rights
Copyright © 2022 Massachusetts Medical Society. Publisher PDF posted after 6 months as allowed by publisher's Author Permissions policy at: https://www.nejm.org/author-center/permissionsae974a485f413a2113503eed53cd6c53
10.1056/NEJMoa2207899