Department of Vascular Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine, Shanghai, China.
Department of Vascular Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine, Shanghai, China; Vascular Centre of Shanghai JiaoTong University, Shanghai, China.
Eur J Vasc Endovasc Surg. 2021 Jul;62(1):65-73. doi: 10.1016/j.ejvs.2021.02.012. Epub 2021 Jun 8.
The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were performed to compare the efficacy and safety between atherectomy combined with balloon angioplasty (BA) and BA alone for patients with de novo FP steno-occlusive lesions.
The Cochrane Library, Medline, and Embase were used to search for studies evaluating outcomes of atherectomy combined with BA compared with BA alone in FP arterial diseases from inception to July 2020. The methodological quality of the included studies was evaluated with the Cochrane Risk of Bias Tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to assess the level of evidence for each outcome. The fixed effects model was chosen to combine the data when I < 50%; otherwise, the random effects model was used. Subgroup and sensitivity analyses were performed to further analyse the results.
Four RCTs were included. The meta-analysis showed that atherectomy combined with BA was associated with improved technical success rate (risk ratio [RR] 0.22, 95% confidence interval [CI] 0.13-0.38, p < .001; I = 0; high quality), reduced bailout stenting (RR 0.15, 95% CI 0.07-0.32, p < .001; I = 16%; high quality), and flow limiting dissection (RR 0.24, 95% CI 0.13-0.47, p < .001; I = 0; high quality). No statistically significant difference was found in target lesion revascularisation (TLR), primary patency, mortality, major adverse event (MAE), or ankle brachial index (ABI) after one year follow up.
Compared with BA alone, atherectomy combined with BA may not improve primary patency, TLR, mortality rate, or ABI, but may reduce the need for bailout stenting and the incidence of flow limiting dissection and increase the technical success rate in FP arterial diseases. More studies are warranted to further confirm the conclusion.
腔内斑块旋切术治疗股腘动脉（FP）疾病的疗效和成本效益尚未确定。本系统评价和荟萃分析旨在比较腔内斑块旋切术联合球囊血管成形术（BA）与单纯 BA 治疗新发 FP 狭窄闭塞性病变患者的疗效和安全性。
检索 Cochrane 图书馆、Medline 和 Embase 数据库，以评估从成立到 2020 年 7 月腔内斑块旋切术联合 BA 与单纯 BA 治疗 FP 动脉疾病的研究结果。采用 Cochrane 偏倚风险工具评估纳入研究的方法学质量。采用推荐评估、制定与评价（GRADE）框架对每个结局的证据水平进行评估。当 I²<50%时，选择固定效应模型合并数据；否则，使用随机效应模型。进一步进行亚组分析和敏感性分析以分析结果。
纳入 4 项 RCT。荟萃分析结果显示，腔内斑块旋切术联合 BA 治疗可提高技术成功率（风险比 [RR] 0.22，95%置信区间 [CI] 0.13-0.38，p<.001；I²=0；高质量），降低紧急支架置入率（RR 0.15，95%CI 0.07-0.32，p<.001；I²=16%；高质量）和血流受限性夹层发生率（RR 0.24，95%CI 0.13-0.47，p<.001；I²=0；高质量）。在 1 年随访时，TLR、一期通畅率、死亡率、主要不良事件（MAE）或踝肱指数（ABI）均无统计学差异。
与单纯 BA 相比，腔内斑块旋切术联合 BA 可能不会改善 FP 动脉疾病的一期通畅率、TLR、死亡率或 ABI，但可能减少紧急支架置入的需要，并降低血流受限性夹层的发生率，提高技术成功率。需要更多的研究来进一步证实这一结论。
