Division of Vascular Surgery, Northwell Health, Glen Cove, NY, USA.
Division of Vascular Surgery, Lenox Hill Hospital, New York, NY, USA.
Vascular. 2023 Dec;31(6):1117-1123. doi: 10.1177/17085381221107749. Epub 2022 Jun 14.
The optimal management for revascularization after critical limb ischemia (CLI) is controversial due to limited studies comparing long-term results of endovascular and open techniques. This study compares long-term outcomes after initial management of CLI via lower extremity bypass (LEB) and percutaneous vascular intervention (PVI).
This retrospective cohort study investigates outcomes of patients who underwent endovascular or open surgical management for CLI at a single institution from 2013-2018. All patients with diagnosis of CLI were included and separated based on initial therapy of PVI or LEB. Demographic, procedural, and follow-up data were assessed. Primary endpoints included major adverse limb events (MALE), specifically the need for major amputation and reintervention. Secondary endpoints included mortality at 30 days and one year. A multivariable Cox Proportional Hazard regression model was used to assess the relationship between Surgery group and time to MALE/death while controlling for confounding variables.
This study identified 338 patients with an initial diagnosis of CLI who underwent either LEB ( = 108, 32%) or PVI ( = 230, 68%). The average age was 71.4, 54.4% were male, 30% were African American, 53.6% were diabetic, and 93.2% had hypertension. Patients who underwent LEB were more predominantly smokers ( = .003) and less predominantly on dialysis at time of surgery ( = .01). Re-intervention rates in the bypass group (11%) were not significantly different than the PVI group (9%; = .95). In the bypass group, 20 (19%) patients had a major amputation with a median time of 189.5 days compared to 23 (10%) patients at a median time of 113 days in the PVI group; however, this difference was not significant ( = .16). There was no significant difference in 1-year mortality between the LEB (2%) and PVI group (4%; = .2). The cumulative incidence of MALE/death at 30 days was 4.0% in the bypass group and 3.7% in the PVI group ( = .2). Incidences of MALE/death were 21.1% and 48.5% in the bypass group and 19.7 and 45.9% in the PVI group at one and 2 years, respectively. Intervention type was not found to be significantly associated with MALE/death after controlling for possible confounders (HR = 0.82, = .43).
In the initial management of CLI, there is no significant difference in long-term outcomes in terms of major amputation, need for reintervention, limb-salvage, and 1-year mortality.
由于比较血管内和开放技术长期结果的研究有限，因此临界肢体缺血（CLI）后血运重建的最佳治疗方法存在争议。本研究比较了下肢旁路（LEB）和经皮血管介入（PVI）初次治疗 CLI 的长期结果。
本回顾性队列研究调查了 2013 年至 2018 年在一家机构接受血管内或开放手术治疗 CLI 的患者的结局。所有诊断为 CLI 的患者均被纳入，并根据初始 PVI 或 LEB 治疗进行分组。评估了人口统计学、程序和随访数据。主要终点包括主要肢体不良事件（MALE），特别是需要进行主要截肢和再干预。次要终点包括 30 天和 1 年的死亡率。使用多变量 Cox 比例风险回归模型来评估手术组与 MALE/死亡之间的关系，同时控制混杂变量。
本研究确定了 338 名初始诊断为 CLI 的患者，其中 108 名（32%）接受了 LEB，230 名（68%）接受了 PVI。平均年龄为 71.4 岁，54.4%为男性，30%为非裔美国人，53.6%为糖尿病患者，93.2%患有高血压。接受 LEB 的患者中吸烟者居多（ =.003），手术时接受透析治疗者较少（ =.01）。旁路组的再干预率（11%）与 PVI 组（9%）无显著差异（ =.95）。在旁路组中，20 名（19%）患者进行了主要截肢，中位时间为 189.5 天，而 PVI 组中 23 名（10%）患者的中位时间为 113 天；然而，这一差异无统计学意义（ =.16）。旁路组和 PVI 组 1 年死亡率分别为 2%和 4%（ =.2）。旁路组和 PVI 组 30 天的 MALE/死亡累积发生率分别为 4.0%和 3.7%（ =.2）。旁路组和 PVI 组 1 年和 2 年的 MALE/死亡率分别为 21.1%和 48.5%，19.7%和 45.9%。在控制可能的混杂因素后，干预类型与 MALE/死亡无显著相关性（HR = 0.82， =.43）。
在 CLI 的初始治疗中，在主要截肢、需要再干预、肢体挽救和 1 年死亡率方面，长期结果无显著差异。
