Tirziu Daniela, Saleh Amr, Huang Haocheng, Akhlaghi Narjes, Breen Thomas J, Parikh Sahil A, Rosenfield Kenneth, Armstrong Ehrin J, Geraghty Patrick J, Brodmann Marianne, Adams George L, Snyder Daniel, Zilinyi Robert S, Altin S Elissa, Parise Helen, Lansky Alexandra J
Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
J Endovasc Ther. 2025 Jun 30:15266028251344809. doi: 10.1177/15266028251344809.
Endovascular revascularization of below-the-knee lesions is a crucial treatment for patients with chronic limb-threatening ischemia (CLTI). However, the optimal approach to revascularizing infrapopliteal arteries remains uncertain. This study aims to compare the safety and efficacy outcomes of various endovascular treatment modalities for infrapopliteal artery disease and provide an evidence-based update through a network meta-analysis.
We performed a systematic literature search in MEDLINE, EMBASE, and the Cochrane Database for randomized controlled trials published between January 01, 2005, and January 12, 2025. The study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was prospectively registered in PROSPERO database (CRD42022323480). The primary safety outcome was major adverse events defined as a composite of all-cause death, major amputation, and any re-intervention of the target limb at 30 days. The primary efficacy outcomes included freedom from composite of major amputation, target lesion occlusion, and clinically driven target lesion revascularization (CD-TLR) and primary patency defined as freedom from binary restenosis and CD-TLR at 6 months. The network meta-analysis was conducted in the frequentist framework using random effects model and conventional percutaneous transluminal angioplasty (PTA) as the reference intervention. Treatment effects were reported as odds ratio (OR) with 95% confidence interval (CI) compared with conventional PTA and interventions were ranked using P-scores.
Twenty-three studies including 3091 patients treated with PTA, paclitaxel drug-coated balloons (DCB), drug-eluting stents (DES), bare metal stents (BMS), bioresorbable vascular scaffold (BVS), and atherectomy were included. There were no significant differences in the primary safety outcome between different treatment modalities. At 6 months, DCB, atherectomy with DCB, and DES produced the largest benefit for primary efficacy outcomes. DCB (OR, 3.68; 95% CI, 1.37-9.92) had a higher freedom from the primary composite, and atherectomy with DCB (OR, 7.65; 95% CI, 1.03-56.98) and DES (OR, 5.48; 95% CI, 1.54-19.49) had higher primary patency compared with PTA. At 12 months, the benefit of atherectomy with DCB was sustained for primary patency, and BVS was ranked first for freedom from the primary composite. There was no benefit of BMS compared with PTA at any timepoint.
This network meta-analysis evaluating 7 endovascular treatment modalities provides evidence of improved efficacy outcomes with DCB, atherectomy with DCB, DES, and BVS compared with PTA for treating infrapopliteal lesions in patients with CLTI.Clinical ImpactLocal antiproliferative drug delivery, whether by balloon-expandable sirolimus/everolimus DES or paclitaxel DCB or everolimus BVS, is necessary to improve patency and efficacy outcomes for the treatment of infrapopliteal artery disease. Furthermore, combining atherectomy with drug delivery shows promising potential. Emerging endovascular targeted drug delivery therapies with limus-based DCB or scaffolds promise to provide greater drug transfer efficiency and a more effective therapeutic alternative that overcomes the limitations of metallic stents in one of the most challenging vascular beds.
膝下病变的血管内血运重建是治疗慢性肢体威胁性缺血（CLTI）患者的关键方法。然而，腘下动脉血运重建的最佳方法仍不确定。本研究旨在比较腘下动脉疾病各种血管内治疗方式的安全性和疗效结果，并通过网络荟萃分析提供基于证据的更新。
我们在MEDLINE、EMBASE和Cochrane数据库中对2005年1月1日至2025年1月12日发表的随机对照试验进行了系统文献检索。该研究按照系统评价和荟萃分析的首选报告项目（PRISMA）指南进行，并在PROSPERO数据库（CRD42022323480）中进行了前瞻性注册。主要安全结局是主要不良事件，定义为30天时全因死亡、大截肢和目标肢体的任何再次干预的综合结果。主要疗效结局包括免于大截肢、目标病变闭塞和临床驱动的目标病变血运重建（CD-TLR）的综合结果，以及6个月时定义为免于二元再狭窄和CD-TLR的原发性通畅。网络荟萃分析在频率学派框架内使用随机效应模型进行，以传统经皮腔内血管成形术（PTA）作为参考干预。治疗效果以与传统PTA相比的比值比（OR）和95%置信区间（CI）报告，并使用P值对干预措施进行排名。
纳入了23项研究，共3091例接受PTA、紫杉醇药物涂层球囊（DCB）、药物洗脱支架（DES）、裸金属支架（BMS）、生物可吸收血管支架（BVS）和旋切术治疗的患者。不同治疗方式之间的主要安全结局没有显著差异。在6个月时，DCB、DCB联合旋切术和DES在主要疗效结局方面产生了最大益处。与PTA相比，DCB（OR，3.68；95%CI，1.37-9.92）在免于主要综合结局方面更高，DCB联合旋切术（OR，7.65；95%CI，1.03-56.98）和DES（OR，5.48；95%CI，1.54-19.49）的原发性通畅率更高。在12个月时，DCB联合旋切术在原发性通畅方面的益处持续存在，BVS在免于主要综合结局方面排名第一。在任何时间点，BMS与PTA相比均无益处。
这项评估7种血管内治疗方式的网络荟萃分析提供了证据，表明与PTA相比，DCB、DCB联合旋切术、DES和BVS在治疗CLTI患者的腘下病变方面疗效结局有所改善。临床影响局部抗增殖药物递送，无论是通过球囊扩张式西罗莫司/依维莫司DES、紫杉醇DCB还是依维莫司BVS，对于改善腘下动脉疾病治疗的通畅性和疗效结局都是必要的。此外，将旋切术与药物递送相结合显示出有希望的潜力。基于雷帕霉素的DCB或支架等新兴的血管内靶向药物递送疗法有望提供更高的药物传递效率，并提供一种更有效的治疗选择，克服金属支架在最具挑战性的血管床之一中的局限性。
