VESS10 - Perioperative Systemic Complications and Adverse Events in the BEST-CLI Trial

Wednesday, June 14, 2023

2:42 PM – 2:53 PM ET

Submitting & Presenting Author(s)

Jeffrey J. Siracuse, MD, MBA

Professor of Surgery and Radiology
Boston University School of Medicine
Boston, Massachusetts

Co-Author(s)

AF

Alik Farber, MD, MBA

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

Matthew T. Menard, MD

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

Co-Author(s)

Michael S. Conte, MD

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

Co-Author(s)

Sharon C. Kiang, MD

Chief, Vascular Surgery Loma Linda VA, Associate Professor of Surgery, Chair-person of IRB
Loma Linda University Medical Center
Loma Linda, California
CO

Cassius I. Ochoa Chaar, MD, MS (he/him/his)

Associate Professor of Surgery
Division of Vascular Surgery and Endovascular Therapy, Yale University School of Medicine
New Haven, Connecticut
NO

Nicholas H. Osborne, MD, MS

Associate Professor
University of Michigan
Ann Arbor, Michigan
NS

Niten Singh, MD

Professor of Surgery
University of Washington
Seattle, Washington
TT

Tze-Woei Tan

Associate Professor
Keck School of Medicine of University of Southern California
Los Angeles, California
MS

Michael B. Strong

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

Raul J. Guzman

Professor of Surgery (Vascular), Surgeon-in-Chief, Vascular Surgery and Endovascular Therapy
Yale School of Medicine
New Haven, Connecticut

Senior Author(s)

KR

Kenneth Rosenfield

Section Head, Vascular Medicine and Intervention, Massachusetts General Hospital
Massachusetts General Hospital
Boston, Massachusetts

Objectives: Perioperative morbidity is a major deciding factor for choosing the revascularization method for chronic limb threatening ischemia (CLTI). Our goal was to assess systemic perioperative complications in the BEST-CLI trial.

Methods: The BEST-CLI trial was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies. There were two Cohorts: Cohort 1 included patients with adequate single segment great saphenous vein (SSGSV), Cohort 2 included those without SSGSV. Data were queried for major adverse cardiovascular events (MACE – composite myocardial infarction, stroke, death), non-serious (non-SAE) and serious adverse events (SAE) 30 days after randomization. Per protocol analysis was used (intervention received without crossover).

Results: There were 1,367 (662 OPEN, 705 ENDO) patients in Cohort 1 and 379 (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality was low in Cohort 1 being 1.5% (OPEN 1.8%; ENDO 1.3%) and Cohort 2 being 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 were 4.98% for OPEN vs. 3.3% for ENDO (P=.12) and Cohort 2 were 4.3% for OPEN and 1.6% for ENDO (P=.16). On multivariable analysis, there was no difference in 30-day MACE for OPEN vs. ENDO for Cohort 1 (HR 1.49, 95% CI .85 – 2.62, P=.17) or Cohort 2 (HR 2.25, 95% CI .49 – 10.4, P=.3).
Acute renal failure was similar by intervention with Cohort 1 being 3.6% for OPEN vs. 2.1% for ENDO (HR 1.6, 95% CI .85 – 3.12, P=.14) and Cohort 2 being 4.2% vs. 1.6% (HR 2.86, 95% CI .75 – 10.8, P=.12). VTE rates were also low with Cohort 1 at 0.7% (OPEN 0.9%; ENDO 0.4%) and Cohort 2 at 0.3% (OPEN 0.5%; ENDO 0%). Patients with non-serious AE in Cohort 1 were 23.4% for OPEN and 17.9% for ENDO (P=.06) and in Cohort 2 were 21.8% for OPEN and 19.9% for ENDO (P=.71). Patients with SAE were Cohort 1 were 35.3% for OPEN and 31.6% for ENDO, P=.57 and Cohort 2 were for 25.5% OPEN and 23.6% for ENDO (P=.72) (Table). Most common etiologies for non-SAE and SAE were infectious, procedural complications, and related to underlying peripheral vascular disease.

Conclusions: Patients with CLTI who were deemed suitable for open lower extremity bypass surgery have similar peri-procedural complications following either OPEN or ENDO revascularization. The choice of revascularization strategy should be based primarily on effectiveness in restoring adequate and durable limb perfusion.