VESS17 - Contemporary Outcomes of Lower Extremity Vein Bypass for Chronic Limb-Threatening Ischemia: A Post Hoc Comparison of BEST-CLI and PREVENT III Multicenter Prospective Randomized Controlled Trials

Wednesday, June 4, 2025

3:50 PM - 4:01 PM CT

Location: Morial CC, Second Floor, Room 228-230

Submitting & Presenting Author(s)

Mohamad A. Hussain, MD, PhD

Vascular & Endovascular Surgeon, Assistant Professor of Surgery
Brigham and Women's Hospital, Harvard Medical School
Boston, Massachusetts

Slides

Co-Author(s)

Matthew T. Menard, MD

Professor of Surgery
Division of Vascular and Endovascular Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
Lincoln, Massachusetts
Michael S. Conte, MD

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

Ageliki G. Vouyouka

Professor of Surgery and Radiology
The Icahn School of Medicine at Mount Sinai
New York, New York
GD

Gheorghe Doros

Professor of Biostatistics
Boston University, School of Public Health, Boston, MA USA
MS

Michael B. Strong

Senior National Trial Manager
Division of Vascular and Endovascular Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
Boston, Massachusetts
Jeffrey A. Kalish

Associate Professor of Surgery and Radiology
Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA, USA
Boston, Massachusetts
DC

David Chew
WG

Warren J. Gasper, MD

Chief, Vascular Surgery Section
San Francisco VA Health Care System
San Francisco, California
TT

Tze-Woei Tan

Associate Professor of Surgery
University of Southern California
Los Angeles, California
R. Clement Darling, III, MD

Division Chief
Albany Medical Center Hospital
Albany, New York
GL

Glenn LaMuraglia

Massachusetts General Hospital
Boston, Massachusetts
KR

Kenneth Rosenfield

Section Head for Vascular Medicine and Intervention
Massachusetts General Hospital, Harvard Medical School, Boston, MA
Boston, Massachusetts
AF

Alik Farber, MD, MBA

Professor of Surgery
Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA, USA
Boston, Massachusetts

Senior Author(s)

Andres Schanzer, MD (he/him/his)

Professor
UMass Chan Medical School
Worcester, Massachusetts

Objectives: BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with Chronic Limb-Threatening Ischemia [CLTI]) trial demonstrated superiority of vein bypass over endovascular treatment for patients with CLTI who were candidates for both treatment strategies. However, with the rise of endovascular techniques and the subsequent decline in the number of vein bypass procedures being performed, concerns have emerged regarding the continued ability to perform surgical bypass safely and effectively. This study aimed to evaluate whether outcomes after lower extremity vein bypass for CLTI have improved over the past two decades by comparing data from two major randomized controlled trials: BEST-CLI and PREVENT III (Project or Ex-Vivo vein graft Engineering via Transfection III).

Methods: This post hoc comparative analysis included patients with CLTI who underwent lower extremity vein bypass in the multicenter, prospective BEST-CLI (2014–2019) and PREVENT III (2001–2003) trials. The primary outcome was a composite of major adverse limb event (MALE) or death at 1 year. Secondary outcomes included perioperative (30-day) rates of major adverse cardiovascular (MACE) and limb events. Multivariable Cox and logistic regression models were used to compare outcomes between the two cohorts.

Results: In total, 2114 patients underwent vein bypass for CLTI (710 BEST-CLI and 1404 PREVENT III). Mean (SD) age was 67.9 (11.0) years; 32.8% were female. Patients in BEST-CLI had higher use of aspirin (66.6% vs. 60.7%; p=0.0074), statins (71.5% vs. 44.3%; p< 0.0001), and single segment great saphenous vein (86.9% vs. 80.6%; p=0.0003). The primary endpoint of 1-year MALE or death was lower in BEST-CLI (21.0%) compared with PREVENT III (37.8%) (adjusted HR, 0.50; 95% CI, 0.40-0.62; p< 0.0001; Fig 1) – this observation was consistent across predefined subgroups (Fig 2). Major re-interventions (new bypass, surgical revision, thrombectomy, or endovascular intervention for graft occlusion) at 1 year were also lower in BEST-CLI (7.2% vs. 18.4%; adjusted HR, 0.40; 95% CI, 0.28-0.57; p< 0.0001), although rates of any re-interventions were similar (25.8% vs. 29.3%; adjusted HR, 0.90; 95% CI, 0.72-1.14; p=0.39). Perioperative major cardiovascular and limb events were significantly lower in BEST-CLI: MACE (4.1% vs. 7.8%; adjusted OR, 0.47; 95% CI, 0.28-0.79; p=0.005) and MALE (2.7% vs. 6.3%; OR, 0.44; 95% CI, 0.24-0.82; p=0.009).

Conclusions: Over the past 10 to 15 years, outcomes following lower extremity vein bypass for CLTI have significantly improved, as evidenced by the BEST-CLI and PREVENT III trials. These advances reflect broader progress in cardiovascular risk management, surgical techniques, and postoperative care for CLTI patients.