Department of Vascular Surgery, Northwest Clinics, Alkmaar, the Netherlands -
Department of Surgery, Changi General Hospital, Singapore, Singapore.
Int Angiol. 2021 Feb;40(1):42-51. doi: 10.23736/S0392-9590.20.04462-4. Epub 2020 Oct 21.
Different types of bioresorbable vascular scaffolds (BVSs) have been developed and used in below-the-knee (BTK) arterial diseases. This is the first study reviewing and analyzing the literature on BVS treatment for BTK arterial disease.
MEDLINE, Embase, and Cochrane were searched for studies published until October 21, 2019. The search, study selection, quality assessment, and data extraction were performed by 2 authors independently. Articles that studied the treatment of BTK arterial disease by using BVSs were eligible. Exclusion criteria were studies with a variant design (e.g. case reports <5 patients), non-BTK indications for BVS use, and nonhuman studies. Primary endpoint was 12-month primary patency. Secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, and amputation-free survival (AFS). Study quality was assessed by the Methodological Index for Non-randomized Studies score.
Five studies representing 155 patients with 160 treated limbs met the inclusion criteria. Pooled 12-month primary patency per limb was 90% (143/160; 95% confidence interval [CI]: 0.84-0.95), freedom from CD-TLR 96% (124/130; 95% CI: 0.91-0.99), limb salvage rate 97% (156/160; 95% CI: 0.94-1.00), survival rate 90% (112/125; 95% CI: 0.82-0.96), and AFS rate 89% (110/125; 95% CI: 0.81-0.94). Subgroup analyses of included Absorb BVS studies showed similar results. All studies were assessed as moderate quality.
This meta-analysis of case series showed good 12-month patency and clinical results with BVSs for BTK arterial disease, even in patients with multimorbidity and short but complex lesions. These results encourage a revival of this scaffold.
不同类型的生物可吸收血管支架（BVS）已被开发并用于膝下（BTK）动脉疾病。这是第一项综述和分析 BVS 治疗 BTK 动脉疾病文献的研究。
截至 2019 年 10 月 21 日，通过 MEDLINE、Embase 和 Cochrane 检索发表的研究。由 2 位作者独立进行检索、研究选择、质量评估和数据提取。研究 BVS 治疗 BTK 动脉疾病的文章符合入选标准。排除标准为设计变异（例如，<5 例患者的病例报告）、BVS 使用的非 BTK 适应证以及非人体研究。主要终点为 12 个月时的初始通畅率。次要终点为 12 个月时免于临床驱动的靶病变血运重建（CD-TLR）、肢体存活率、生存率和免于截肢的生存率（AFS）。研究质量通过非随机研究方法学指数进行评估。
符合纳入标准的 5 项研究共纳入 155 例患者的 160 条治疗肢体。每条肢体的 12 个月初始通畅率为 90%（143/160；95%置信区间 [CI]：0.84-0.95），免于 CD-TLR 为 96%（124/130；95% CI：0.91-0.99），肢体存活率为 97%（156/160；95% CI：0.94-1.00），生存率为 90%（112/125；95% CI：0.82-0.96），AFS 率为 89%（110/125；95% CI：0.81-0.94）。纳入的 Absorb BVS 研究的亚组分析显示出相似的结果。所有研究的质量均为中等。
这项 BTK 动脉疾病 BVS 治疗的病例系列荟萃分析显示，即使在合并多种疾病且病变较短但复杂的患者中，12 个月时的通畅率和临床结果也较好。这些结果鼓励重新使用这种支架。
