Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

Alik Farber, Matthew T. Menard, Michael S. Conte, John A. Kaufman, Richard J. Powell, Niteesh K. Choudhry, Taye H. Hamza, Susan F. Assmann, Mark A. Creager, Mark J. Cziraky, Michael D. Dake, Michael R. Jaff, Diane Reid, Flora S. Siami, George Sopko, Christopher J. White, Max Van Over, Michael B. Strong, Maria F. Villarreal, Michelle MckeanEzana Azene, Amir Azarbal, Andrew Barleben, David K. Chew, Leonardo C. Clavijo, Yvan Douville, Laura Findeiss, Nitin Garg, Warren Gasper, Kristina A. Giles, Philip P. Goodney, Beau M. Hawkins, Christine R. Herman, Jeffrey A. Kalish, Matthew C. Koopmann, Igor A. Laskowski, Carlos Mena-Hurtado, Raghu Motaganahalli, Vincent L. Rowe, Andres Schanzer, Peter A. Schneider, Jeffrey J. Siracuse, Maarit Venermo, Kenneth Rosenfield

Research output: Contribution to journalArticlepeer-review

205 Scopus citations

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)2305-2316
Number of pages12
JournalNew England Journal of Medicine
Volume387
Issue number25
DOIs
StatePublished - Dec 22 2022
Externally publishedYes

Keywords

  • Cardiology
  • Cardiology General
  • Peripheral Arterial and Aortic Disease
  • Surgery
  • Surgery General

ASJC Scopus subject areas

  • General Medicine

Fingerprint

Dive into the research topics of 'Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia'. Together they form a unique fingerprint.

Cite this