Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial

Michael S Conte; Ezana Azene; Gheorghe Doros; Warren J Gasper; Taye Hamza; Vikram S Kashyap; Randy Guzman; Carlos Mena-Hurtado; Matthew T Menard; Kenneth Rosenfield; Vincent L Rowe; Michael Strong; Alik Farber

doi:10.1016/j.jvs.2024.02.005

Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial

J Vasc Surg. 2024 Feb 17:S0741-5214(24)00308-2. doi: 10.1016/j.jvs.2024.02.005. Online ahead of print.

Authors

Affiliations

¹ Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA. Electronic address: michael.conte2@ucsf.edu.
² Department of Interventional Radiology, Gundersen Health System, La Crosse, WI.
³ Boston University School of Public Health, Boston, MA.
⁴ Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA.
⁵ HealthCore, Inc, Watertown, MA.
⁶ Frederik Meijer Heart and Vascular Institute, Corewell Health, Grand Rapids, MI.
⁷ Section of Vascular Surgery, Hospital St. Boniface, Winnipeg, Manitoba, Canada.
⁸ Vascular Medicine Outcomes Program, Yale University, New Haven, CI.
⁹ Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
¹⁰ Section of Vascular Medicine and Intervention, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
¹¹ Division of Vascular Surgery and Endovascular Therapy, University of California, Los Angeles, CA.
¹² Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA.

PMID: 38368997
DOI: 10.1016/j.jvs.2024.02.005

Abstract

Objectives: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints.

Methods: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models.

Results: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial.

Conclusions: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.

Keywords: Chronic limb-threatening ischemia; Critical limb ischemia; Endovascular; Lower extremity bypass; Peripheral artery disease; Revascularization.