SS08 - Females Have Better Amputation-Free Survival Compared to Males in the BEST-CLI Trial: Appropriate Management of Females May Eliminate Sex Disparities in Outcomes of Infrainguinal Revascularization

Thursday, June 20, 2024

8:23 AM – 8:34 AM CT

Location: West Building, Level 3, Skyline Ballroom W375ab

Submitting & Presenting Author(s)

Katharine L. McGinigle, MD

Associate Professor
University of North Carolina at Chapel Hill, Department of Surgery, Division of Vascular Surgery
Chapel Hill, North Carolina

Co-Author(s)

GD

Gheorghe Doros

Boston University, School of Public Health, Boston, MA USA
Olamide Alabi, MD

Associate Professor Surgery
Division of Vascular Surgery and Endovascular Therapy, Emory School of Medicine
Atlanta, Georgia
Benjamin S. Brooke, MD, PhD

Chief, Division of Vascular Surgery
University of Utah Health
Salt Lake City, Utah
Charles J. Bailey, MD

Assistant Professor of Surgery; Director, Limb Preservation-Peripheral Arterial Disease Program
University of South Florida
Tampa, Florida
MM

Mahmoud Malas

Professor & Chief , Vascular & Endovascular Surgery
University of California San Diego, Division of Vascular and Endovascular Surgery
San Diego, California
AV

Agelilki G. Vouyouka

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

Jade S. Hiramoto

Associate Professor in Residence
University of California, San Francisco
San Francisco, California
Kristofer M. Charlton-Ouw

University of Texas Health Science Center Houston - McGovern Medical School
Houston, Texas
MS

Michael B. Strong

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

Kenneth Rosenfield

Section Head, Vascular Medicine and Intervention, Massachusetts General Hospital
Section of Vascular Medicine and Intervention Massachusetts General Hospital, Harvard Medical School, Boston, MA
Boston, Massachusetts
Matthew T. Menard, MD

Associate Professor of Surgery
Brigham and Women's Hospital
Boston, Massachusetts
AF

Alik Farber, MD, MBA

Chief, Division of vascular and Endovascular Surgery
Boston Medical Center
WESTON, Massachusetts

Senior Author(s)

KG

Kristina A. Giles

Division Chief
Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME, USA
Portland, Maine

Objectives: Female patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We compared outcomes after open and endovascular revascularization in the Best Endovascular versus best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and examined outcomes of each revascularization type in an all-female cohort.

Methods: In a secondary analysis of the intention to treat BEST-CLI Trial data, patients with chronic limb threatening ischemia (CLTI) undergoing open surgical (with or without adequate conduit) and endovascular treatment were stratified by sex. Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable Cox regression were performed to determine the association between female sex and randomized treatment and the outcomes at one year.

Results: Among 1830 patients, females were significantly underrepresented, comprising only 28% (n=519) of the cohort. Overall, the characteristics of females enrolled in the trial were similar to the whole cohort, with some differences: compared to males, females were more likely to have rest pain alone (72% vs 60%, p <.0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%, p = .01). Females were less likely to have an adequate single segment greater saphenous vein (SSGSV) available (82% vs 89%, p = .01). Controlled for baseline clinical factors, at one year, females had significantly lower rates of major limb amputation compared to males (HR .70, p = .023), which drove better amputation- and MALE- free survival rates (Table 1). In the all-female cohort, results paralleled the overall trial; open surgical bypass had significantly better outcomes compared to endovascular therapy (Table 2). Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared to females undergoing open surgical revascularization (24.8% vs. 10.5%, p < .001).

Conclusions: The primary results of the BEST-CLI trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, are generalizable to female patients. Female patients enrolled in BEST-CLI had better amputation-free survival at one year compared to male patients. These findings suggest that in treating female CLTI patients considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially eliminate sex disparities.