Your browser doesn't support javascript.
loading
Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.
Menard, Matthew T; Farber, Alik; Powell, Richard J; Rosenfield, Kenneth; Conte, Michael S; Hamza, Taye H; Kaufman, John A; Cziraky, Mark J; Creager, Mark A; Dake, Michael D; Jaff, Michael R; Reid, Diane; Sopko, George; White, Christopher J; Strong, Michael B; van Over, Max; Chisci, Emiliano; Goodney, Philip P; Gray, Bruce; Kayssi, Ahmed; Siracuse, Jeffrey J; Choudhry, Niteesh K.
Afiliación
  • Menard MT; Division of Vascular and Endovascular Surgery (M.T.M., M.B.S.), Harvard Medical School, Boston, MA.
  • Farber A; Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, MA (A.F., J.J.S.).
  • Powell RJ; Division of Vascular and Endovascular Surgery, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.P., M.A.C., P.P.G.).
  • Rosenfield K; Brigham and Women's Hospital, Section of Vascular Medicine and Intervention, Massachusetts General Hospital (K.R.), Harvard Medical School, Boston, MA.
  • Conte MS; Division of Vascular and Endovascular Surgery, University of California, San Francisco (M.S.C.).
  • Hamza TH; HealthCore, Inc, Watertown, MA (T.H.H., M.J.C., M.v.O.).
  • Kaufman JA; Department of Interventional Radiology, Human Performance Laboratory, Oregon Health and Science University, Portland (J.A.K.).
  • Cziraky MJ; HealthCore, Inc, Watertown, MA (T.H.H., M.J.C., M.v.O.).
  • Creager MA; Division of Vascular and Endovascular Surgery, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.P., M.A.C., P.P.G.).
  • Dake MD; Department of Medical Imaging, University of Arizona Health System, University of Arizona, Tucson (M.D.D.).
  • Jaff MR; Professor of Medicine, Harvard Medical School (retired), Cambridge, MA (M.R.J.).
  • Reid D; National Heart, Lung & Blood Institute, Division of Cardiovascular Sciences, National Institutes of Health, Bethesda, MD (D.R., G.S.).
  • Sopko G; National Heart, Lung & Blood Institute, Division of Cardiovascular Sciences, National Institutes of Health, Bethesda, MD (D.R., G.S.).
  • White CJ; Department of Cardiovascular Diseases, The Ochsner Clinical School, University of Queensland, Australia (C.J.W.).
  • Strong MB; Division of Vascular and Endovascular Surgery (M.T.M., M.B.S.), Harvard Medical School, Boston, MA.
  • van Over M; HealthCore, Inc, Watertown, MA (T.H.H., M.J.C., M.v.O.).
  • Chisci E; Division of Vascular Surgery, Ospedale San Giovanni di Dio, Florence, Italy (E.C.).
  • Goodney PP; Division of Vascular and Endovascular Surgery, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.P., M.A.C., P.P.G.).
  • Gray B; Division of Vascular Medicine, Prisma Health, Greenville, SC (B.G.).
  • Kayssi A; Division of Vascular Surgery, University of Toronto, Canada (A.K.).
  • Siracuse JJ; Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, MA (A.F., J.J.S.).
  • Choudhry NK; Department of Medicine (N.K.C.), Harvard Medical School, Boston, MA.
Circulation ; 149(16): 1241-1253, 2024 Apr 16.
Article en En | MEDLINE | ID: mdl-38597097
ABSTRACT

BACKGROUND:

In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL).

METHODS:

Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression.

RESULTS:

A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure.

CONCLUSIONS:

Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.
Asunto(s)
Palabras clave

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Isquemia Crónica que Amenaza las Extremidades Límite: Humans Idioma: En Revista: Circulation Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Isquemia Crónica que Amenaza las Extremidades Límite: Humans Idioma: En Revista: Circulation Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos