Department of Vascular Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Vascular. 2021 Dec;29(6):883-896. doi: 10.1177/1708538120985732. Epub 2021 Jan 21.
To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions.
This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted.
Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34-0.71, < 0.001). There was no significant difference between two groups in terms of distal embolization (RR: 2.06, 95%CI: 0.51-8.38, = 0.31), perforation (RR: 2.04, 95%CI: 0.43-9.71, = 0.37), hematoma (RR: 1.75, 95%CI: 0.43-7.09, = 0.43), primary patency at 12 months (1.09, 95%CI: 0.98-1.21, = 0.12), target lesion revascularization at 12 months (RR: 0.68, 95%CI: 0.41-1.14, = 0.15), leg amputations at 12 months (RR: 0.54, 95%CI: 0.13-2.23, = 0.39), mortality at 12 months (RR: 2.18, 95%CI: 0.71-6.64, = 0.17). Sensitivity analysis had no effect on our findings.
The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.
比较旋切术联合药物涂层球囊与单纯药物涂层球囊治疗股腘动脉病变的安全性和有效性。
本系统评价和荟萃分析按照 PRISMA 的要求进行和报告。从 2000 年 1 月到 2020 年 6 月，检索 EMBASE、MEDLINE 和 Cochrane 图书馆，以确定合格的文献。使用改良的 Downs 和 Black 清单评估纳入研究的质量。结局指标包括紧急支架置入、远端栓塞、穿孔、血肿、12 个月时的初始通畅率、12 个月时的靶病变血运重建、12 个月时的截肢率和 12 个月时的死亡率。我们使用 DerSimonian 和 Laird 随机效应模型，对每项研究的风险比（RR）和 95%置信区间（CI）进行汇总，以获得主要结局的总体估计值。进行了亚组分析和敏感性分析。
纳入了 6 项研究（2 项随机对照试验和 4 项回顾性队列研究），共 470 例患者。旋切术联合药物涂层球囊组的紧急支架置入率较低（RR：0.49，95%CI：0.34-0.71， < 0.001）。两组在远端栓塞（RR：2.06，95%CI：0.51-8.38， = 0.31）、穿孔（RR：2.04，95%CI：0.43-9.71， = 0.37）、血肿（RR：1.75，95%CI：0.43-7.09， = 0.43）、12 个月时的初始通畅率（RR：1.09，95%CI：0.98-1.21， = 0.12）、12 个月时的靶病变血运重建率（RR：0.68，95%CI：0.41-1.14， = 0.15）、12 个月时的截肢率（RR：0.54，95%CI：0.13-2.23， = 0.39）和 12 个月时的死亡率（RR：2.18，95%CI：0.71-6.64， = 0.17）方面无显著差异。敏感性分析对我们的发现没有影响。
旋切术联合药物涂层球囊治疗股腘动脉病变安全有效，与单纯药物涂层球囊相比，紧急支架置入的发生率较低。
