SS15 - Female Gender is Associated with Lower Quality of Life in Patients with Chronic Limb Threatening Ischemia as Determined by Review of BEST-CLI Patients

Saturday, June 18, 2022

8:11 AM – 8:22 AM EDT

Presenting Author only(s)

RP

Richard J. Powell, MD

Professor of Surgery
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire

Video

Co-Author(s)

KG

Kristina A. Giles

Maine Medical Center
Portland, Maine
Jeffrey J. Siracuse, MD, MBA

Associate Professor
Boston Medical Center
Boston, Massachusetts
VR

Vincent L. Rowe, MD

Professor of Clinical Surgery
Keck School of Medicine of University of Southern California
Los Angeles, California
Michael S. Conte, MD

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

Chris White

Professor, System Chairman for Cardiovascular Disease
John Ochsner Heart & Vascular Institute
NC

Niteesh Choudhry

Professor
Harvard Medical School

Submitting Author only(s)

MS

Michael Strong

Brigham and Women's Hospital
Boston, Massachusetts

Co-Author(s)

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
Matthew T. Menard, MD

Brigham and Women's Hospital
Lincoln, Massachusetts

Senior Author(s)

AF

Alik Farber, MD, MBA

Chief of Vascular and Endovascular Surgery
Boston University
Boston, Massachusetts

Objectives: There is limited evidence regarding the role of health-related quality of life (HRQOL) measures in patients with chronic limb threatening ischemia (CLI). The Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial is an ongoing, NIH-sponsored, multicenter, randomized controlled trial comparing revascularization strategies in patients with CLI. BEST-CLI baseline HRQOL measures were evaluated for patient-specific variables that were associated with poor HRQOL and then compared with relevant published measures.

Methods: The VascQOL (Vascular Quality of Life Questionnaire), EQ-5D (EuroQoL 5D), and SF-12 Index physical component (PCS) and mental component (MCS) scores were aggregated from questionnaires completed by trial subjects at baseline visits. Overall scores from each instrument were separated by cohort (Cohort 1: subjects with available single-segment great saphenous vein; Cohort 2: subjects without such conduit). Multivariable linear regression models were fit to determine which baseline characteristics were associated with QOL in each cohort.

Results: 1830 subjects were randomized into BEST-CLI (Cohort 1: 1434, Cohort 2: 396) (Table 1). 94.9%, 95.8%, and 95.8% of subjects completed the VascQOL, EQ5D, and SF-12 instruments at baseline. Overall VascQOL, EQ-5D, and SF-12 scores were consistent across both cohorts (Table 2). In VascQOL, female gender, current or past smoking, opioid use and non-independent ambulation predicted lower QoL scores in both cohorts. Overall, VascQol scores were similar to those of participants in the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) [(3.07(1.2)) vs 2.9(1.1)), P=.07]. In EQ5D, no variables independently predicted lower QoL scores. In SF-12, only female gender independently predicted lower QoL scores in both cohorts. The mean (standard deviation) SF 12 PCS for all patients in the study was 33.0(8.5) and for MCS was 46.4(12.0). These are significantly lower than the national SF 12 scores for US population over 60 y/o which is PCS of 46.5(11.4) and MCS of 52.9 (8.7). In fact, BEST-CLI SF12 scores are similar to a population of patients with cancer and 3-4 additional chronic conditions (PCS 34.8, MCS 48.66).

Conclusions: Patients with CLI entering the BEST-CLI trial have very low HRQOL scores comparable to patients suffering from other chronic conditions characterized by physical limitation and chronic pain. While current smoking and opioid use predicted lower QOL in CLI patients, only female gender was associated with lower quality of life in multiple QOL measurement tools.