SS06 - The Impact of Revascularization Strategy on Clinical Failure, Hemodynamic Failure and Chronic Limb-Threatening Ischemia Symptoms in the BEST-CLI Trial

Thursday, June 15, 2023

8:11 AM – 8:22 AM ET

Presenting Author only(s)

MM

Matthew T. Menard, MD

Associate Professor of Surgery
Brigham and Women's Hospital / Harvard Medical School
Boston, Massachusetts

Submitting Author only(s)

MS

Michael B. Strong

BEST-CLI Senior National Trial Manager
Brigham and Women's Hospital
Boston, Massachusetts

Co-Author(s)

AF

Alik Farber, MD, MBA

Professor of Surgery and Radiology
Boston University, Chobanian & Avedisian School of Medicine
Boston, Massachusetts
TH

Taye Hamza

Principal HealthCore Statistician
HealthCore
Watertown, Massachusetts
KR

Kenneth Rosenfield

Section Head, Vascular Medicine and Intervention, Massachusetts General Hospital
Massachusetts General Hospital
Boston, Massachusetts
Emiliano Chisci, MD

Vascular Surgeon
San Giovanni di Dio Hospital - USL CENTRO
Florence, Toscana, Italy
LC

Leonardo Clavijo
Michael D. Dake, MD

Senior Vice President for Health
University of Arizona College of Medicine
Tucson, Arizona
BH

Beau Hawkins
Ahmed Kayssi, MD

Associate Scientist
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Katharine L. McGinigle, MD

Associate Professor
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina
Peter A. Schneider, MD

Vascular Surgeon
University of California San Francisco
San Francisco, California

Senior Author(s)

Michael S. Conte, MD

Professor and Chief, Division of Vascular and Endovascular Surgery
University of California San Francisco
San Francisco, California

Objectives: Sustained clinical and hemodynamic benefit following revascularization for chronic limb threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI following endovascular (ENDO) vs bypass (OPEN) revascularization in the BEST-CLI trial.

Methods: As planned secondary analyses of the BEST-CLI trial, we examined the rates of A) clinical failure (a composite of all cause death, above ankle amputation, major reintervention, and degradation of WIfI stage); B) hemodynamic failure (a composite of above ankle amputation, major and minor reintervention to maintain index limb patency, failure to initially increase or a subsequent decrease in ankle brachial index of 0.15 or toe brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion); C) time to resolution of presenting CLTI symptoms; and D) incidence of recurrent CLTI. Time-to-event analyses were by intention-to-treat assignment in both trial cohorts (cohort 1: suitable single segment great saphenous vein [SSGSV], N=1434; cohort 2: lacking suitable SSGSV, N= 396) and multivariate stratified Cox regression models were created.

Results: In cohort 1, there was a significant difference in time to clinical failure (Figure 1, log-rank p< 0.001), hemodynamic failure (log-rank p< 0.001), and resolution of presenting symptoms (log-rank p=0.009) in favor of OPEN. In cohort 2, there was a significantly lower rate of hemodynamic failure (log-rank p=0.006) favoring OPEN, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis revealed that assignment to OPEN was associated with significantly lower risk of clinical and hemodynamic failure in both cohorts, and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1 (Table 1), including after adjustment for key baseline patient covariates (end stage renal disease (ESRD), prior revascularization, smoking, diabetes, age>80, WIfI stage, tissue loss, infrapopliteal disease). Factors independently associated with clinical failure included age>80 in cohort 1 and ESRD across both cohorts. ESRD was associated with hemodynamic failure in cohort 1. Factors associated with slower resolution of presenting symptoms included diabetes in cohort 1 and WIfI stage in cohort 2.

Conclusions: Durable clinical and hemodynamic benefit following revascularization for CLTI is important to avoid persistent and recurrent CLTI, reinterventions and limb loss. Initial treatment with open surgical bypass, particularly with available saphenous vein, is associated with improved clinical and hemodynamic outcomes and enhanced resolution of CLTI symptoms.