Reduction of Major Amputations after Surgery versus Endovascular Intervention: The BEST-CLI Randomised Trial.

Autor: Venermo MA; Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, Finland. Electronic address: Maarit.venermo@hus.fi., Farber A; Division of Vascular and Endovascular Surgery, Boston Medical Centre, Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA., Schanzer A; Division of Vascular Surgery, UMass Chan Medical School, Worcester, MA, USA., Menard MT; Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Rosenfield K; Section of Vascular Medicine and Intervention, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Dosluoglu H; Vascular Surgery, Jacobs School of Medicine and Biomedical Sciences, SUNY at Buffalo, Buffalo, NY, USA., Goodney PP; Heart and Vascular Centre, Dartmouth Hitchcock Medical Centre, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA., Abou-Zamzam AM; Division of Vascular Surgery, Loma Linda University Medical Centre, Loma Linda, CA, USA., Motaganahalli R; Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, IN, USA., Doros G; Boston University, School of Public Health, Boston, MA, USA., Creager MA; Heart and Vascular Centre, Dartmouth Hitchcock Medical Centre, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.
Jazyk: angličtina
Zdroj: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery [Eur J Vasc Endovasc Surg] 2024 Jun 24. Date of Electronic Publication: 2024 Jun 24.
DOI: 10.1016/j.ejvs.2024.06.018
Abstrakt: Objective: BEST-CLI, an international randomised trial, compared an initial strategy of bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated.
Methods: A total of 1 830 patients were randomised to receive surgical or endovascular treatment in two parallel cohorts: patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434) were assigned to cohort 1; and patients without adequate SSGSV (n = 396) were assigned to cohort 2. Differences in time to first event and number of amputations were evaluated.
Results: In cohort 1, there were 410 (45.6%) total amputation events in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during a mean follow up of 2.7 years. Approximately one in three patients underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical group and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (74/718) of patients in the surgical group and 14.9% (107/716) in the endovascular group (p = .008). In cohort 2, there were 199 amputation events in 132 patients (33.3%) during a mean follow up of 1.6 years: 95 (47.7%) in the surgical group vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (30/197) of patients in the surgical group and 14.1% (28/199) in the endovascular group (p = .74).
Conclusion: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations, mainly due to a decrease in major amputations subsequent to minor amputations.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE