慢性肢体威胁性缺血的手术或血管内治疗。

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

机构信息

From the Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine (A.F., M.F.V., J.A. Kalish, J.J.S.), the Division of Vascular and Endovascular Surgery (M.T.M., M.B.S.) and the Department of Medicine (N.K.C.), Brigham and Women's Hospital, Harvard Medical School (M.R.J.), and the Section of Vascular Medicine and Intervention, Massachusetts General Hospital (K.R.), Boston, HealthCore, Watertown (T.H.H., S.F.A., M.J.C., M.O., M.M.), and the Division of Vascular Surgery, UMass Memorial Health, Worcester (A.S.) - all in Massachusetts; the Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco (M.S.C., W.G., P.A.S.), the Division of Vascular Surgery, UC San Diego Health, La Jolla (A.B.), Coastal Cardiology, French Hospital Medical Center, San Luis Obispo (L.C.C.), and the Division of Vascular Surgery and Endovascular Therapy, University of Southern California, Los Angeles (V.L.R.) - all in California; the Department of Interventional Radiology (J.A. Kaufman) and the Division of Vascular Surgery, School of Medicine (A.A.), Oregon Health and Science University, and the Operative Care Division, Portland VA Medical Center (M.C.K.) - all in Portland; the Heart and Vascular Center, Dartmouth Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH (R.J.P., M.A.C., P.P.G.); the Department of Medical Imaging, University of Arizona Health Sciences, Tucson (M.D.D.), and the Division of Vascular Surgery, Peak Heart and Vascular, Glendale (N.G.) - both in Arizona; the National Heart, Lung, and Blood Institute, Bethesda, MD (D.R., G.S.); the Medical Device Innovation Consortium, National Evaluation System for Health Technology Coordinating Center, Arlington, VA (F.S.S.); the Department of Cardiovascular Diseases, Ochsner Clinical School, University of Queensland, Brisbane, Australia (C.J.W.); the Department of Interventional Radiology, Gundersen Health System, La Crosse, WI (E.A.); the Iowa Heart Center, Des Moines (D.K.C.); the Division of Vascular Surgery, Centre Hospitalier Universitaire de Quebec-Université Laval, Quebec City (Y.D.), and Dalhousie University, Division of Cardiac and Vascular Surgery, Department of Surgery, Nova Scotia Health Association, Halifax (C.R.H.) - both in Canada; the Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta (L.F.); the Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland (K.A.G.); the Cardiovascular Section, University of Oklahoma Health Sciences Center, Oklahoma City (B.M.H.); Westchester Medical Center and the Department of Surgery, Section of Vascular Surgery, New York Medical College - both in Valhalla, NY (I.A.L.); the Vascular Medicine Outcomes Program, Yale University, New Haven, CT (C.M.-H.); the Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis (R.M.); and the Department of Vascular Surgery, University of Helsinki, and Helsinki University Hospital - both in Helsinki (M.V.).

出版信息

N Engl J Med. 2022 Dec 22;387(25):2305-2316. doi: 10.1056/NEJMoa2207899. Epub 2022 Nov 7.

DOI:10.1056/NEJMoa2207899

PMID:36342173

Abstract

BACKGROUND

Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes.

METHODS

In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause.

RESULTS

In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts.

CONCLUSIONS

Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

摘要

背景

患有慢性肢体威胁性缺血（CLTI）的患者需要血运重建以改善肢体灌注，从而降低截肢风险。对于 CLTI，初始策略是采用腔内治疗还是手术血运重建来改善肢体结局尚不确定。

方法

在这项国际性、随机试验中，我们将两条平行队列试验共纳入 1830 例 CLTI 和下肢动脉疾病患者。有一段可用于手术的大隐静脉的患者被分配到队列 1。需要替代旁路移植物的患者被分配到队列 2。主要结局是主要不良肢体事件的复合结局——定义为踝以上截肢或主要肢体再次介入治疗（新旁路移植、移植再修复、血栓切除术或溶栓）或任何原因导致的死亡。

结果

在队列 1 中，中位随访 2.7 年后，手术组 709 例患者中有 302 例（42.6%）和血管腔内组 711 例患者中有 408 例（57.4%）发生主要结局事件（风险比，0.68；95%置信区间[CI]，0.59 至 0.79；P<0.001）。在队列 2 中，手术组 194 例患者中有 83 例（42.8%）和血管腔内组 199 例患者中有 95 例（47.7%）发生主要结局事件（风险比，0.79；95%CI，0.58 至 1.06；P = 0.12），中位随访时间为 1.6 年。两组在两个队列中的不良事件发生率相似。