Ramesh Prasana, Zghouzi Mohamed, Bista Roshan, Patel Neel N, Ezenna Chidubem, Paul Timir K, Nanjundappa Aravinda
UMass Chan - Baystate Medical Center, Springfield, MA, United States of America.
Ascension Saint Thomas Hospital, Nashville, TN, United States of America.
Cardiovasc Revasc Med. 2025 Jun;75:107-115. doi: 10.1016/j.carrev.2025.02.017. Epub 2025 Mar 6.
Chronic Limb Threat Ischemia (CLTI) is a severe form of peripheral arterial disease characterized by various symptoms including nonhealing wounds, ulcers and gangrene ultimately leading to a possible amputation. Therefore, revascularization either through endovascular intervention (EVI) or surgical bypass (SB) is an important step in management. Literature review of various studies including Randomized clinical trials (RCTs), Meta-analysis and observational studies show varied results with some studies suggesting better outcomes with EVI while majority of the others favors superiority of SB. Our Systematic review and meta-analysis aims to ascertain underlying differences between the approaches.
We performed a Meta-analysis of observational studies and RCTs following the PRISMA guidelines. We searched Pubmed, and Cochrane databases. After removing duplicates and studies that did not meet the inclusion criteria, 9 studies were included which comprised of 4 RCTs and 5 observational studies. Outcomes measured include limb salvage, amputation free survival and Mortality. Random effects were applied to calculate Odds ratio (OR) and 95 % confidence Intervals (CI).
A total of 6375 patients from 9 studies were included. The pooled analysis from the meta-analysis comparing Endovascular intervention vs Surgical Bypass showed no statistically significant difference between the outcomes. The Pooled OR was 0.990(95%CI 0.913-1.073). Additionally the heterogeneity among the studies was moderate (i = 34.7 %) suggesting some variability in the study results but not enough to conclude a significant difference. Additionally subgroup analysis was performed for above-knee and infra popliteal interventions which yielded statistically similar results.
Based on the results above, neither endovascular intervention nor bypass surgery showed superiority over the other for outcomes such as limb salvage, mortality and amputation free survival. Therefore, effectiveness of both interventions for revascularization is comparable.
慢性肢体威胁性缺血（CLTI）是外周动脉疾病的一种严重形式，其特征包括多种症状，如伤口不愈合、溃疡和坏疽，最终可能导致截肢。因此，通过血管内介入治疗（EVI）或外科旁路手术（SB）进行血运重建是治疗的重要步骤。对包括随机临床试验（RCT）、荟萃分析和观察性研究在内的各种研究的文献综述显示结果各异，一些研究表明EVI有更好的结果，而其他大多数研究则支持SB的优越性。我们的系统评价和荟萃分析旨在确定这两种方法之间的潜在差异。
我们按照PRISMA指南对观察性研究和RCT进行了荟萃分析。我们检索了PubMed和Cochrane数据库。在去除重复项和不符合纳入标准的研究后，纳入了9项研究，其中包括4项RCT和5项观察性研究。测量的结果包括肢体挽救、无截肢生存和死亡率。应用随机效应计算比值比（OR）和95%置信区间（CI）。
9项研究共纳入6375例患者。比较血管内介入治疗与外科旁路手术的荟萃分析汇总分析显示，结果之间无统计学显著差异。汇总OR为0.990（95%CI 0.913 - 1.073）。此外，研究之间的异质性为中度（I = 34.7%），表明研究结果存在一定变异性，但不足以得出显著差异的结论。此外，还对膝上和膝下干预进行了亚组分析，结果在统计学上相似。
基于上述结果，在肢体挽救、死亡率和无截肢生存等结果方面，血管内介入治疗和旁路手术均未显示出优于对方。因此，两种干预措施进行血运重建的有效性相当。
