Division of Vascular and Endovascular Surgery, Department of Surgery, University of Virginia Health System, Charlottesville, VA.
Division of Vascular Surgery, Department of Surgery, The University of Tokyo, Tokyo, Japan.
Ann Surg. 2023 Aug 1;278(2):172-178. doi: 10.1097/SLA.0000000000005793. Epub 2023 Jan 3.
The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients with intermittent claudication (IC).
Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy.
Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. MEDLINE, Web of Science, and Google Scholar were searched aided by a health sciences librarian through August 16, 2022. Randomized control trials (RCTs) comparing invasive (endovascular or surgical revascularization) and noninvasive treatment (exercise and/or medical treatment) were included. PROSPERO registration was completed (CRD42022352831).
A total of 9 RCTs comprising 1477 patients (invasive, 765 patients; noninvasive, 712 patients) were eligible. During a mean of 3.6-year follow-up, progression to CLTI after invasive [5 (2-8) per 1000 person-years] and noninvasive treatment [6 (3-10) per 1000 person-years] were not statistically different [rate ratio (RR): 0.77; 95% CI, 0.35-1.69; P =0.51, I2 =0%]. Incidence of amputation (RR: 1.69; 95% CI, 0.54-5.26; P =0.36, I2 =0%) and all-cause mortality (hazard ratio: 1.26; 95% CI, 0.91-1.74; P =0.16, I2 =0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR: 4.15; 95% CI, 2.80-6.16; P <0.00001, I2 =83%). The results were not changed by fixed effect or random-effects models, nor by sensitivity analysis.
Although there is equivalent risk of progression to CLTI, major amputation and all-cause mortality compared with noninvasive treatment, invasive treatment for patients with IC led to significantly more revascularization procedures and should be used selectively in patients with major lifestyle limitation. Guideline recommendation of noninvasive treatment for first-line IC therapy is supported.
分析间歇性跛行(IC)患者经血管内或手术血运重建与非侵入性治疗后进展为慢性肢体威胁性缺血(CLTI)、截肢和随后干预的风险。
关于每种治疗策略后肢体不良结局的证据存在冲突。
遵循系统评价和荟萃分析的首选报告项目指南。在卫生科学图书馆员的协助下,检索了 MEDLINE、Web of Science 和 Google Scholar,检索时间截至 2022 年 8 月 16 日。纳入比较侵入性(血管内或手术血运重建)和非侵入性治疗(运动和/或药物治疗)的随机对照试验(RCT)。已完成 PROSPERO 注册(CRD42022352831)。
共有 9 项 RCT 纳入了 1477 名患者(介入组 765 名,非介入组 712 名)。在平均 3.6 年的随访中,介入治疗后进展为 CLTI 的比例为[5(2-8)/1000 人年],非介入治疗后为[6(3-10)/1000 人年],两组间无统计学差异[风险比(RR):0.77;95%置信区间,0.35-1.69;P=0.51,I2=0%]。截肢(RR:1.69;95%置信区间,0.54-5.26;P=0.36,I2=0%)和全因死亡率(风险比:1.26;95%置信区间,0.91-1.74;P=0.16,I2=0%)也无差异。然而,介入治疗组进行了更多的血运重建[RR:4.15;95%置信区间,2.80-6.16;P<0.00001,I2=83%]。固定效应或随机效应模型、敏感性分析的结果均未改变。
尽管与非侵入性治疗相比,进展为 CLTI、主要截肢和全因死亡率的风险相当,但 IC 患者的侵入性治疗导致了更多的血运重建手术,应选择性地用于有严重生活方式限制的患者。支持将非侵入性治疗作为 IC 一线治疗的指南推荐。