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经皮腔内斑块切除术治疗下肢动脉支架内再狭窄的荟萃分析

Meta-analysis of percutaneous transluminal atherectomy in the treatment for in-stent restenosis of lower extremity peripheral artery disease

摘要:

目的 总结经皮腔内斑块切除技术治疗下肢动脉支架内再狭窄(ISR)的安全性和有效性.方法 检索Pubmed、Elsevier、EBSCO、Spring数据库和Cochrane图书馆,纳入经皮腔内斑块切除技术治疗下肢动脉ISR病变文献.根据斑块切除手段的不同将入组病例分为机械斑块切除和激光斑块切除两组进行亚组分析.终点事件包括远端栓塞、严重动脉壁损伤、6个月和12个月一期通畅率及免于靶血管血运重建率(TVR).结果 最终纳入文献9篇,总样本量为620例患者.腔内斑块切除术后远端栓塞发生率为4.2%,95%可信区间(CI)为1.7%~6.7%;严重动脉壁损伤发生率为1.9%(95%CI:0.9%~3.0%);机械斑块切除远端栓塞发生率为2.0%,低于激光斑块切除组的6.8%,差异有统计学意义(Q =21.66,P=0.010).斑块切除术后6个月一期通畅率和免于TVR率分别为63.0% (95% CI:55.5% ~ 70.6%)及80.4%(95% CI:70.5%~ 90.3%),12个月一期通畅率和免于TVR率分别为43.5% (95% CI:32.2% ~54.9%)和58.0% (95% CI:52.1% ~63.9%);机械斑块切除组6个月免于TVR率为77.9%,低于激光斑块切除组的80.8%(Q=13.49,P=0.009).敏感性分析显示研究终点结果稳定;Begg法检验发现12个月免于TVR率存在发表偏倚.对3个随机对照研究进行荟萃分析表明,球囊斑块切除技术与普通球囊6个月免于TVR率差异无统计学意义,优势比为1.34(95% CI:0.86~2.07,P=0.196).结论 激光斑块切除术治疗下肢动脉支架内再狭窄病变能减少中短期的血运再重建发生,但远端栓塞发生率较高.在减少下肢动脉支架内再狭窄病变血运再重建方面,经皮腔内斑块切除技术与普通球囊相比没有优势.

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abstracts:

Objective To evaluate the clinical safety and efficacy of percutaneous transluminal atherectomy for in-stent restenosis (ISR) in patients with low extremity peripheral arterial diseases (PAD).Methods PubMed, Elsevier, EBSCO, Spring databases and Cochrane Library were searched for relevant articles.Based on the different mechanisms of atherectomy, the patients were divided into mechanic atherectomy group and laser atherectomy group.The safety end points included the rate of distal embolism and severe arterial wall injuries.And the efficacy end points included primary patency rate and freedom from target vessel revascularization (TVR-free) 6 months and 12 months after surgery.Results A total of 9 studies and 620 patients (published between 2006 and 2014) were accepted.The rate of distal embolism was 4.2% (95% confidence interval (CI) :1.7%-6.7%), while that of severe arterial wall injuries was 1.9% (95% CI: 0.9%-3.0%), respectively.Laser atherectomy was responsible for more distal embolism (6.8%) compared to mechanic atherectomy (2.0%), which was significantly different (Q =21.66, P=0.010).At 6-month follow-up, primary patency rate and rate of TVR-free were 63.0% (95% CI: 55.5%-70.6%) and 80.4% (95% CI: 70.5%-90.3%) , while at 12-month follow-up were 43.5% (95% CI: 32.2%-54.9%) and 58.0% (95% CI: 52.1%-63.9%), respectively.The free-TVR rate at 6 months follow-up in mechanical atherectomy group was 77.9%, and was inferior to that in laser atherectomy group (80.8%, Q =13.49, P =0.009).Published bias was discovered at the analysis of 12-month TVR-free rate by means of Begg Test (P =0.039).Meta analysis concerned about the 3 randomized controlled trials demonstrated that there was no significant improvement using atherectomy for ISR comparing to standard balloon at 6-month TVR-free rate (OR =1.34, 95% CI: 0.86-2.07, P =0.196).Conclusions To treat ISR lesion in lower extremities, laser atherectomy has a lower free-TVR rate in the middle term follow-up.A higher rate of distal embolism is noted though.On balance, percutaneous transluminal atherectomy demonstrates no significant improvement compared to plain balloon angioplasty for ISR lesions.

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