Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal interventions.

Autor:	Giles KA; Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME. Electronic address: Kristina.Giles@MaineHealth.org., Farber A; Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA., Menard MT; Division of Vascular and Endovascular Surgery, Brigham and Woman's Hospital, Boston, MA., Conte MS; Division of Vascular and Endovascular Surgery, University of California San Francisco., Nolan BW; Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME., Siracuse JJ; Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA., Strong MB; Brigham and Woman's Hospital, Boston, MA., Doros G; Department of Biostatistics, Boston University, School of Public Health, Boston, MA., Venermo M; Department of Vascular Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Azene E; Department of Interventional Radiology, Gundersen Health System, La Crosse, WI., Rosenfield K; Vascular Medicine and Intervention, Massachusetts General Hospital, Boston, MA., Powell RJ; Heart and Vascular Center, Dartmouth Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH.
Jazyk:	angličtina
Zdroj:	Journal of vascular surgery [J Vasc Surg] 2024 Nov; Vol. 80 (5), pp. 1515-1524. Date of Electronic Publication: 2024 Jun 21.
DOI:	10.1016/j.jvs.2024.05.049
Abstrakt:	Objective: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. Methods: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. Results: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12). Conclusions: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes. (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu