Int J Cardiol:多种药物洗脱支架致支架血栓的荟萃分析

2014-05-08 rayliu88 dxy

支架血栓是行PCI治疗的潜在致死并发症之一。第一代的耐用药物洗脱支架已经明确与迟发或者超迟发支架血栓有关,可能继发于耐用多聚物诱导的炎症反应有关。第二代的药物洗脱支架含有生物相容性多聚物,其可降低血栓的发生率。第三代的药物洗脱支架NOBORI™为可降解生物相容性支架,因其在2007年的临床试验取得的成果,现同时作为一种抗增生药物广泛地被亚洲和欧洲国家所认可。 然而四项无限制患者的试验则出现了

支架血栓是行PCI治疗的潜在致死并发症之一。第一代的耐用药物洗脱支架已经明确与迟发或者超迟发支架血栓有关,可能继发于耐用多聚物诱导的炎症反应有关。第二代的药物洗脱支架含有生物相容性多聚物,其可降低血栓的发生率。第三代的药物洗脱支架NOBORI™为可降解生物相容性支架,因其在2007年的临床试验取得的成果,现同时作为一种抗增生药物广泛地被亚洲和欧洲国家所认可。

然而四项无限制患者的试验则出现了相互冲突的结果,一项试验通过使用依维莫司洗脱与Biolimus A9洗脱支架的比较表明:NOBORI™并不比XIENCE-V/PROMUS(一种第二代耐用依维莫司洗脱支架)差。

在SORT-OUT V试验表明NOBORI™比Cypher™(一种第一代耐用西罗莫斯洗脱支架)差,在为期9个月的周期中,设置了第一终点事件,由安全性(心源性死亡,心肌梗死,明确的支架血栓)和有效性(目标血管的再通)组成。根据近期试验的冲突证据,一篇近日由国内专家张瑶俊等人近日发表在Int J Cardiol上对所有NOBORI™试验做的一项荟萃分析来调查其使用的安全性。

通过网上辅助参考资料上的方法,这项荟萃分析设置三个终点事件:1.明确的或可能的支架血栓(通过学术研究协会分类明确);2.心肌梗死(包括Q波和非Q波型心肌梗死);3.死亡。NOBORI™支架迄今为止已用在7个临床试验中,其患者的相关危险性通过联合效应模型和Mantel–Haenszel方法进行分析计算的。

通过这项荟萃分析得到使用NOBORI™支架出现支架血栓或致心肌梗死的风险与第二代药物洗脱支架的相似。

近期两项全面网络的荟萃分析提出,可生物降解洗脱支架与第二代洗脱支架对比有更高的致支架血栓和致心肌梗死率,有趣的是,这两项研究中的生物降解多聚洗脱支架多是Biomatrix™ and NOBORI™。

然而,Biomatrix™ 和NOBORI™的区别是NOBORI™有超薄、非降解的聚对二甲苯涂层。虽然OCT资料表明Biomatrix™能延迟早期血管愈合的可能,可是支架血栓与心肌梗死的原因是多因素导致的,这些结果的冲突原因仍有待进一步研究。


原始出处:

Zhang YJ1, Ye F2, Iqbal J3, Dong SJ4, Bourantas CV3, Tian NL2, Serruys PW3, Chen SL5.NOBORI™ biodegradable-polymer biolimus-eluting stent versus durable-polymer drug-eluting stents: A meta-analysis.Int J Cardiol. 2014 Mar 29. pii: S0167-5273(14)00603-2. doi: 10.1016/j.ijcard.2014.03.167. [Epub ahead of print]

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