目的:比较粥样斑块切除术后一年的结果,血管内碎石术与普通球囊血管成形术前应用药物涂层球囊治疗股动脉粥样硬化性疾病。
方法:MEDLINE,EMBASE,和Cochrane图书馆在2023年5月之前进行了随机对照试验的筛选。
方法:这是一项系统综述和网络荟萃分析。纳入标准为跛行患者和危重肢体威胁性缺血患者,所有长度的病变特征,狭窄,钙化,和闭塞。主要结果是在一年时无靶病变再干预。次要结果是救助支架置入率,严重截肢,和一年的全因死亡率。用标准随机效应模型计算汇集点估计值。用混合治疗贝叶斯模型完成进一步的敏感性分析。通过修订的Cochrane偏差风险工具2(RoB2)评估偏差风险,并通过建议分级评估证据的确定性,评估,发展,和评估(等级)框架。
结果:包含549例患者的四个RCT(两项研究评估了定向粥样斑块切除术,一个评估旋转旋磨,包括一项针对普通球囊血管成形术的评估血管内碎石术)。股pop病变的加权平均长度为103.4±6.67mm。混合治疗贝叶斯分析的结果与所有结局的汇总分析一致。靶病变血运重建的自由度没有显着差异(GRADE,高)(RoB2,低),大截肢术(年级,低),或死亡率(等级,中度)。与普通球囊血管成形术相比,血管内碎石术和粥样斑块切除术的支架置入率显著降低(RR0.25,95%CI0.07-0.89)(GRADE,中等)(RoB2,低)。
结论:本综述发现,血管内碎石术或粥样斑块切除术在避免靶病变血运重建方面似乎没有显著的统计学优势,严重截肢,或者一年的死亡率。有证据表明,血管内碎石术和动脉粥样硬化切除术后,救助支架的植入显着减少。
OBJECTIVE: To compare one year outcomes after atherectomy, intravascular lithotripsy vs. plain balloon angioplasty before application of drug coated balloons for treating femoropopliteal atherosclerotic disease.
METHODS: MEDLINE, EMBASE, and Cochrane Library were screened until May 2023 for randomised controlled trials.
METHODS: This was a systematic review and network meta-analysis. The inclusion criteria were patients with claudication and those with critical limb threatening ischaemia with lesion characteristics of all lengths, stenosis, calcification, and occlusions. The primary outcome was freedom from target lesion re-intervention at one year. Secondary outcomes were rate of bailout stenting, major amputation, and all cause mortality at one year. Pooled point estimates were calculated with a standard random effects model. Further sensitivity analyses were completed with a mixed treatment Bayesian model. Risk of bias was assessed by the Revised Cochrane Risk of Bias tool 2 (RoB2) and certainty of evidence assessed via the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework.
RESULTS: Four RCTs comprising 549 patients (two studies evaluating directional atherectomy, one evaluating rotational atherectomy, one evaluating intravascular lithotripsy against plain balloon angioplasty) were included. The weighted mean length of femoropopliteal lesions was 103.4 ± 6.67 mm. Results of the mixed treatment Bayesian analysis were consistent with pooled analysis for all outcomes. There were no significant differences in freedom from target lesion revascularisation (GRADE, high) (RoB2, low), major amputation (GRADE, low), or mortality (GRADE, moderate). Bailout stenting rates were significantly reduced with intravascular lithotripsy and atherectomy compared with plain balloon angioplasty (RR 0.25, 95% CI 0.07 - 0.89) (GRADE, moderate) (RoB2, low).
CONCLUSIONS: This review found that intravascular lithotripsy or atherectomy did not appear to incur a statistically significant advantage in freedom from target lesion revascularisation, major amputation, or mortality rate at one year. There was moderate certainty of evidence that bailout stenting is significantly reduced after vessel preparation with intravascular lithotripsy and atherectomy.