Mok Michelle Kam Yan, Wu Iris Ho Ching, Yau Kenneth Hong Kit, Chan Yiu Che
Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
Division of Vascular & Endovascular Surgery, Department of Surgery, University of Hong Kong Medical Centre, Hong Kong SAR, China.
J Endovasc Ther. 2025 Feb 14:15266028251315442. doi: 10.1177/15266028251315442.
Limus-based balloons, stents, and scaffolds are alternatives to paclitaxel-coated devices in peripheral endovascular treatment. This study aims to review contemporary evidence on the efficacy and safety of limus-coated devices in the treatment of lower extremity peripheral arterial disease (PAD).
A systematic literature review was performed using PubMed, Web of Sciences, OvidSP, and EMBASE, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Efficacy endpoints were primary patency (PP), freedom from clinically driven target lesion revascularization (CD-TLR) and Rutherford-Becker improvement; safety endpoints included target limb amputation and all-cause mortality.
From a primary search of 453 articles between 27th June 2002 to 15th September 2024, 30 publications, among which were 27 prospective trials, 10 multicenter studies and 11 double-arm studies, with 2325 patients were analyzed. The numbers for above-the-knee (ATK) limus-balloons, stents, scaffolds and below-the-knee (BTK) limus-balloons, stents, scaffolds were 76, 333, 35, 55, 1445, 381 respectively. With a mean 12-month follow-up, PP for ATK lesions was 86.50% for sirolimus-coated balloons (SCB), 86.80% for sirolimus-eluting stents (SES), 72.60% for everolimus-eluting stents (EES), 86.20% for everolimus bioresorbable vascular scaffold (EBVS); whereas PP for BTK lesions was 72.60%, 73.20%, 71.60 and 83.80% respectively. Absence of CD TLR for ATK lesions was 96.50%, 95.50%, 87.60%, 89.20% respectively; meanwhile 84.90%, 75.80%, 87.70%, 94.30% for BTK lesions respectively. Rutherford-Becker improvement with 86.70%, 84.50%, 79.80 and 90.80% were seen in ATK lesions respectively, similarly, 76.50%, 81.90%, 79.50%, 92.30% respectively were observed in BTK lesions. Efficacy and clinical outcomes of SES, EES and EBVS in BTK lesions were significantly superior, where vascular complications had no proven significant difference regardless of lesion locations nor device types.
Limus-coated/eluting balloons, stents, and scaffolds are safe adjuncts and potentially superior alternative in endovascular treatment for lower extremity PAD, especially well proven in BTK lesions. However, more statistically significant evidence is recommended to validate the long-term efficacy on ATK lesions and overall use of non-SES devices regardless of locations.
Limus (siro-, zotaro-, evero-, bio-, amphi-, tacrolimus) have potent antiproliferative effects in atherosclerosis. This systematic review analyzes evidence for the efficacy and safety of limus devices (balloons, stents, and scaffolds) in the treatment of femoropopliteal and below-the-knee PAD. There were 5 single-arm studies with 309 patients on femoropopliteal disease, and 11 studies with 679 patients on below-the knee (BTK) diseases. The overall primary patency rate, significant freedom from target lesion revascularization and improvement in Rutherford-Becker classification were high. Certain limus devices have shown to be superior to non-limus devices. Limus scaffolds are new developments with promising short-term results.
在周围血管腔内治疗中，基于雷帕霉素的球囊、支架和支架植入物是紫杉醇涂层器械的替代方案。本研究旨在综述有关雷帕霉素涂层器械治疗下肢外周动脉疾病（PAD）疗效和安全性的当代证据。
根据系统评价和荟萃分析的首选报告项目（PRISMA）声明，使用PubMed、Web of Sciences、OvidSP和EMBASE进行系统文献综述。疗效终点为主要通畅率（PP）、免于临床驱动的靶病变血运重建（CD-TLR）和卢瑟福-贝克尔分级改善；安全终点包括靶肢体截肢和全因死亡率。
在对2002年6月27日至2024年9月15日期间的453篇文章进行初步检索后，分析了30篇出版物，其中包括27项前瞻性试验、10项多中心研究和11项双臂研究，共2325例患者。膝上（ATK）雷帕霉素球囊、支架、支架植入物以及膝下（BTK）雷帕霉素球囊、支架、支架植入物的数量分别为76、333、35、55、1445、381。平均随访12个月时，ATK病变的PP在西罗莫司涂层球囊（SCB）中为86.50%，西罗莫司洗脱支架（SES）中为86.80%，依维莫司洗脱支架（EES）中为72.60%，依维莫司生物可吸收血管支架（EBVS）中为86.20%；而BTK病变的PP分别为72.60%、73.20%、71.60%和83.80%。ATK病变中无CD TLR的比例分别为96.50%、95.50%、87.60%、89.20%；同时，BTK病变中分别为84.90%、75.80%、87.70%、94.30%。ATK病变中卢瑟福-贝克尔分级改善的比例分别为86.70%、84.50%、79.80%和90.80%，同样，BTK病变中分别观察到76.50%、81.90%、79.50%、92.30%。SES、EES和EBVS在BTK病变中的疗效和临床结局显著更优，无论病变部位或器械类型，血管并发症均无经证实的显著差异。
雷帕霉素涂层/洗脱球囊、支架和支架植入物是下肢PAD血管腔内治疗中的安全辅助手段，且可能是更优的替代方案，尤其在BTK病变中得到充分证实。然而，建议有更多具有统计学意义的证据来验证其对ATK病变的长期疗效以及非SES器械在所有部位的整体应用效果。
雷帕霉素（西罗莫司、佐他莫司、依维莫司、生物雷帕霉素、两性霉素、他克莫司）在动脉粥样硬化中具有强大的抗增殖作用。本系统评价分析了雷帕霉素器械（球囊、支架和支架植入物）治疗股腘动脉和膝下PAD疗效和安全性的证据。有5项单臂研究共309例患者涉及股腘动脉疾病，11项研究共679例患者涉及膝下（BTK）疾病。总体主要通畅率、免于靶病变血运重建的显著比例以及卢瑟福-贝克尔分级改善情况均较高。某些雷帕霉素器械已显示优于非雷帕霉素器械。雷帕霉素支架是具有良好短期效果的新进展。
