Diamantopoulos A, Katsanos K
Department of Interventional Radiology Guy's and St. Thomas' NHS Foundation Trust London, UK -
J Cardiovasc Surg (Torino). 2014 Oct;55(5):655-65. Epub 2014 Jul 10.
A systematic review was performed to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing debulking atherectomy versus balloon angioplasty for treatment of femoropopliteal artery occlusive disease. PubMed (MEDLINE), EMBASE, AMED, Scopus, online content and meeting abstracts were searched in May 2014 for eligible RCTs following the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Pooled risks were calculated with a random effects model to account for clinical and conceptual heterogeneity. Sensitivity analysis was employed to test the robustness of the results. Six RCTs comprising 287 patients (328 lesions) treated with either debulking atherectomy or balloon angioplasty for femoropopliteal artery disease were analyzed and synthesized. Technical success was similar between the atherectomy and the angioplasty group (93.6% vs. 96.2%, RR: 0.99. 95%CI: 0.95-1.03, P=0.57, I(2)=0%). Need for bail-out stenting and distal arterial embolization were largely similar between atherectomy and balloon angioplasty alone. After a median follow-up of 9 months the 2 groups showed similar primary patency (RR: 0.90, 95%CI: 0.56-1.46, P=0.68, I(2)=69%). Only 2 low-quality studies reported amputation and mortality rates, both of which were found significantly less in the atherectomy arms. Analysis of a limited body of low quality evidence with high risk of bias showed that debulking atherectomy of the femoropopliteal artery does not seem to confer any procedural advantage or improvement of clinical outcomes over balloon angioplasty alone.
进行了一项系统评价，以对评估斑块旋切术与球囊血管成形术治疗股腘动脉闭塞性疾病的随机对照试验（RCT）进行定性分析和定量数据综合。2014年5月，按照PRISMA选择流程在PubMed（MEDLINE）、EMBASE、AMED、Scopus、在线内容和会议摘要中检索符合条件的RCT。使用Cochrane协作工具评估偏倚风险。采用随机效应模型计算合并风险，以考虑临床和概念上的异质性。进行敏感性分析以检验结果的稳健性。分析并综合了6项RCT，共287例患者（328处病变），这些患者接受了斑块旋切术或球囊血管成形术治疗股腘动脉疾病。旋切术组和血管成形术组的技术成功率相似（93.6%对96.2%，RR：0.99，95%CI：0.95 - 1.03，P = 0.57，I² = 0%）。单纯旋切术和球囊血管成形术之间，补救性支架置入需求和远端动脉栓塞情况基本相似。中位随访9个月后，两组的主要通畅率相似（RR：0.90，95%CI：0.56 - 1.46，P = 0.68，I² = 69%）。只有2项低质量研究报告了截肢率和死亡率，两者在旋切术组均显著更低。对一组存在高偏倚风险的有限低质量证据的分析表明，股腘动脉斑块旋切术与单纯球囊血管成形术相比，似乎并未带来任何手术优势或改善临床结局。
