Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD), College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia.
Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD), College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Department of Vascular and Endovascular Surgery, Townsville University Hospital, Townsville, Queensland, Australia.
Eur J Vasc Endovasc Surg. 2024 Aug;68(2):246-254. doi: 10.1016/j.ejvs.2024.05.014. Epub 2024 May 14.
The aim of this study was to compare the efficacy of different endovascular revascularisation procedures for treating chronic limb threatening ischaemia (CLTI) using network meta-analysis (NMA).
The databases PubMed and Cochrane Central Register for Controlled Trials were searched on 14 March 2023.
A NMA of randomised controlled trials (RCTs) reporting the efficacy of different endovascular revascularisation techniques for treating CLTI was performed according to PRISMA guidelines. The primary and secondary outcomes were major amputation and death, respectively. Random effects models were developed and the results were presented using surface under the cumulative ranking curve plots and forest plots. A p value of ≤ .050 was considered statistically significant. The Cochrane collaborative tool was used to assess risk of bias.
A total of 2 655 participants of whom 94.8% had CLTI were included. Eleven trials compared plain balloon angioplasty (PBA) vs. drug coated balloon (DCB) angioplasty (n = 1 771), five trials compared bare metal stent (BMS) vs. drug coated stent (DCS) (n = 466), three trials compared atherectomy vs. DCB (n = 194), two trials compared PBA vs. BMS (n = 70), one trial compared PBA vs. atherectomy (n = 50), and one trial compared BMS vs. DCB (n = 104). None of the revascularisation strategies significantly reduced the risk of major amputation or death compared with PBA. Using the network estimates, GRADE certainty of evidence for improvement in major amputation outcomes for DCB was moderate, for atherectomy and BMS was low, and for DCS was very low compared with PBA. Risk of bias was low in 16 trials, of some concerns in six trials, and high in one trial, respectively.
There is no current evidence from RCTs to reliably conclude that BMS, DCB, DCS, or atherectomy are superior to PBA in preventing major amputation and death in patients with CLTI. Larger comparative RCTs are needed to identify the best endovascular revascularisation strategy.
本研究旨在通过网络荟萃分析（NMA）比较不同血管内血运重建术治疗慢性肢体严重缺血（CLTI）的疗效。
2023 年 3 月 14 日检索了 PubMed 和 Cochrane 对照试验中心注册库数据库。
根据 PRISMA 指南，对报告不同血管内血运重建技术治疗 CLTI 疗效的随机对照试验（RCT）进行 NMA。主要和次要结局分别为主要截肢和死亡。采用随机效应模型进行分析，并通过累积排序曲线下面积和森林图展示结果。p 值≤0.050 被认为具有统计学意义。采用 Cochrane 协作工具评估偏倚风险。
共纳入 2655 名患者，其中 94.8%患有 CLTI。11 项试验比较了单纯球囊血管成形术（PBA）与药物涂层球囊（DCB）血管成形术（n=1771），5 项试验比较了裸金属支架（BMS）与药物涂层支架（DCS）（n=466），3 项试验比较了旋切术与 DCB（n=194），2 项试验比较了 PBA 与 BMS（n=70），1 项试验比较了 PBA 与旋切术（n=50），1 项试验比较了 BMS 与 DCB（n=104）。与 PBA 相比，任何血管重建策略均不能显著降低主要截肢或死亡的风险。使用网络估计值，与 PBA 相比，DCB 改善主要截肢结局的证据质量为中级，旋切术和 BMS 为低级，DCS 为极低级。16 项试验的偏倚风险较低，6 项试验的偏倚风险为中度，1 项试验的偏倚风险为高度。
目前尚无 RCT 证据可靠地表明 BMS、DCB、DCS 或旋切术在预防 CLTI 患者的主要截肢和死亡方面优于 PBA。需要更大规模的比较 RCT 来确定最佳的血管内血运重建策略。
