Objective

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.

Methods

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 I² < 50%; otherwise, the random effects model was used. Subgroup and sensitivity analyses were performed to further analyse the results.

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; I² = 0; high quality), reduced bailout stenting (RR 0.15, 95% CI 0.07–0.32, p < .001; I² = 16%; high quality), and flow limiting dissection (RR 0.24, 95% CI 0.13–0.47, p < .001; I² = 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.

Conclusion

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.

中文翻译：

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斑块切除术联合球囊血管成形术与单独球囊血管成形术治疗新股腘动脉疾病：随机对照试验的系统评价和荟萃分析

目标

尚未确定旋切术治疗股腘动脉疾病的疗效和成本效益。进行系统回顾和荟萃分析比较动脉斑块旋切术与球囊成形术（BA）和BA单独患者合并的疗效和安全性从头FP速记闭塞病变。

方法

Cochrane 图书馆、Medline 和 Embase 用于搜索评估从开始到 2020 年 7 月在 FP 动脉疾病中斑块切除术联合 BA 与单独 BA 的结果的研究。 纳入研究的方法学质量通过 Cochrane 偏倚风险评估工具。建议分级评估、制定和评估 (GRADE) 框架用于评估每个结果的证据水平。当I ² < 50%时，选择固定效应模型合并数据；否则，使用随机效应模型。进行亚组和敏感性分析以进一步分析结果。

结果

包括四项 RCT。荟萃分析表明，旋切术联合 BA 与提高技术成功率相关（风险比 [RR] 0.22，95% 置信区间 [CI] 0.13-0.38，p < .001；I ² = 0；高质量），减少救助支架（RR 0.15，95% CI 0.07–0.32，p  < .001；I ²  = 16%；高质量）和限流夹层（RR 0.24，95% CI 0.13–0.47，p  < .001；I ²  = 0；高质量）。随访一年后，靶病变血运重建 (TLR)、主要通畅率、死亡率、主要不良事件 (MAE) 或踝臂指数 (ABI) 无统计学差异。

结论

与单独使用 BA 相比，旋切术联合 BA 可能不会改善初始通畅率、TLR、死亡率或 ABI，但可能会减少对紧急支架置入的需求和限流夹层的发生率，并提高 FP 动脉疾病的技术成功率。需要更多的研究来进一步证实这一结论。