Journal Article

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia

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

2022

Overview

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. 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. 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. 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.).

• Publisher: Massachusetts Medical Society
• Subject: Amputation / Ankle / Cardiology / Cardiology General / Cardiovascular system / Chronic Limb-Threatening Ischemia - surgery / Chronic Limb-Threatening Ischemia - therapy / Clinical trials / Confidence intervals / Endovascular Procedures - adverse effects / Endovascular Procedures - methods / Enrollments / Foot diseases / Gangrene / Heart attacks / Humans / Hypothesis testing / Ischemia / Limb Salvage - adverse effects / Limb Salvage - methods / Patients / Peripheral Arterial and Aortic Disease / Retrospective Studies / Risk Factors / Saphenous Vein - transplantation / Software / Statistical analysis / Surgery / Surgery General / Thrombolysis / Thrombolytic drugs / Treatment Outcome / Vascular diseases / Vascular Surgical Procedures - adverse effects / Vascular Surgical Procedures - methods / Vein & artery diseases