背景:血管内治疗(ET)对于股pop周围动脉疾病(FP-PAD)的结果仍不理想。西洛他唑治疗可以改善FP-PADET后的通畅率并减少主要的不良肢体事件。我们的目标是分析已发表的评估ET后使用西洛他唑治疗FP-PAD的研究。
方法:我们搜索了MEDLINE,EMBASE,和CENTRAL用于评估FP-PADET后西洛他唑治疗的随机和观察性研究。我们只纳入了调整混杂变量的观察性研究。我们分别分析了观察性和随机研究,并通过估计I2统计量来探索异质性。如果I2统计量较低,则选择固定效应模型。如果在真实零假设下观察到组间差异的双侧概率小于5%,我们认为这种差异具有统计学意义。
结果:我们筛选了2,171项研究,并在我们的分析中纳入了26篇论文(5项随机研究和21项观察性研究)。所有随机研究均为开放标签。在随机研究中,使用西洛他唑治疗的患者发生再狭窄的几率较低(合并比值比(pOR)=0.28,95%置信区间(CI)0.18~0.43,p<0.01,I2=0%).西洛他唑治疗的患者靶病变血运重建(TLR)的几率也较低(pOR=0.35,95%CI0.22至0.65,p<0.01,I2=0%)。在观察性研究中,我们还确定了西洛他唑的围介入治疗与较低再狭窄率之间的关联(合并风险比(pHR)=0.57,95%CI0.51至0.65,p<0.01,I2=34%),TLR(pHR=0.53,95%CI0.36至0.79,p<0.01,I2=0%),截肢(pHR=0.54,95%CI0.32~0.90,p=0.02,I2=30%)。
结论:在随机开放标签研究中,ET治疗FP-PAD后西洛他唑的围介入治疗降低了再狭窄和TLR的几率(1A级)。同样,在对混杂因素进行调整的观察性研究中,围介入西洛他唑治疗与较低的再狭窄率相关,TLR,截肢(2A级)。
BACKGROUND: Endovascular therapy (ET) outcomes for femoropopliteal peripheral arterial disease (FP-PAD) remain suboptimal. Cilostazol therapy may improve patency rates and decrease major adverse limb events after ET for FP-PAD. Our goal is to analyze published studies evaluating the use of cilostazol after ET for FP-PAD.
METHODS: We searched MEDLINE, EMBASE, and CENTRAL for randomized and observational studies evaluating cilostazol therapy after ET for FP-PAD. We only included observational studies adjusting for confounding variables. We analyzed observational and randomized studies separately and explored heterogeneity by estimating an I2 statistic. A fixed-effects model was chosen if the I2 statistic was low. If the two-sided probability of observing the difference between groups under a true null hypothesis was less than 5%, we considered this difference statistically significant.
RESULTS: We screened 2,171 studies and included 26 papers in our analysis (5 randomized and 21 observational studies). All randomized studies were open label. In randomized studies, the odds of restenosis were lower in patients treated with cilostazol (pooled odds ratio (pOR) = 0.28, 95% confidence interval (CI) 0.18 to 0.43, p < 0.01, I2 = 0%). The odds of target lesion revascularization (TLR) were also lower in patients treated with cilostazol (pOR = 0.35, 95% CI 0.22 to 0.65, p < 0.01, I2 = 0%). In observational studies, we also identified associations between peri-interventional treatment with cilostazol and lower rates of restenosis (pooled hazard ratio (pHR) = 0.57, 95% CI 0.51 to 0.65, p <0.01, I2 = 34%), TLR (pHR = 0.53, 95% CI 0.36 to 0.79, p <0.01, I2 = 0%), and amputation (pHR = 0.54, 95% CI 0.32 to 0.90, p = 0.02, I2 = 30%).
CONCLUSIONS: In randomized open label studies, peri-interventional treatment with cilostazol after ET for FP-PAD lowered the odds of restenosis and TLR (Level 1A). Similarly, in observational studies that adjusted for confounding, peri-interventional cilostazol therapy was associated with lower rates of restenosis, TLR, and amputation (Level 2A).