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Sapien瓣膜的研究达到了安全终点和疗效终点，但患者卒中风险增加

2012-07-09 邓涛 牛津期刊

Sapien瓣膜安全终点疗效终点卒中风险
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       华盛顿——周一，FDA评审员说针对高危严重主动脉狭窄患者经导管植入Sapien瓣膜的研究结束。研究达到了安全终点和疗效终点，但同时显示患者卒中风险增加。Edwards Lifesciences公司制造的瓣膜将在周三接受FDA循环系统咨询委员会的评审。评审主要内容为此器械能不能适用于高危患者，即那些有指征行主动脉瓣换瓣术，但开

       华盛顿——周一，FDA评审员说针对高危严重主动脉狭窄患者经导管植入Sapien瓣膜的研究结束。研究达到了安全终点和疗效终点，但同时显示患者卒中风险增加。Edwards Lifesciences公司制造的瓣膜将在周三接受FDA循环系统咨询委员会的评审。评审主要内容为此器械能不能适用于高危患者，即那些有指征行主动脉瓣换瓣术，但开胸手术预计死亡率大于15%的患者。
       Sapien在2011年被核准适用于不能耐受手术的患者。但Edwards公司希望能将适应症扩大至“高危手术患者”，这将使这一器械能用于更多病人的治疗。此前的核准是基于公司发起的PARTNER研究中的群体A。PARTNER研究是首个比较经导管主动脉瓣置换和外科手术主动脉瓣置换的研究。专家小组将审阅此项研究中的“群体B”，这部分高危患者行经导管主动脉瓣置换术后一年生存率同外科手术主动脉瓣置换术后几乎相同。

       PARTNER研究入选了699名高龄高危严重主动脉瓣狭窄患者，随机分配之TAVI组（n＝348）及外科手术组。将近三分之二TAVI组患者为股动脉径路即瓣膜通过股动脉进入人体，103患者为经心尖路径即瓣膜之间经皮进入左室心尖部。一年内死亡率在Sapien组和对照组基本相同。经股动脉Sapien植入组的一年死亡率为24.2％，而外科手术组为26.8％；经心尖区植入Sapien组一年死亡率为22.2％而开胸手术组为26.4％。FDA官员说，尽管组间死亡率相似，但TAVI组患者术后30天内发生卒中风险是外科手术组的两倍。经心尖区径路的患者早期卒中的发生率更高。“这一器械的神经系统不良反应仍是一个需要考虑的重要的安全因素。应该考虑在总体的安全性和有效性评价中。”FDA官员评价说。

       FDA官员同时注意到PARTNER研究中显示的性别差异及主动脉瓣反流的情况。女性对此植入器械的反应似乎要好于男性。术后发生主动脉瓣反流似乎与死亡率之间存在相关性。

       周三的小组讨论将关注多方面的安全性和有效性，并对Sapein是否安全、有效进行投票，讨论其获益是否大于风险。FDA不一定必须遵循从专家委员会的意见，但他们通常会听取专家意见。

相关原文链接：Direct transapical aortic valve implantation: a modified transcatheter approach avoiding balloon predilatation

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    2012-09-30 zz70

    #SAP#

    0

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    2012-09-01 lizhou0204

    #Sapien#

    0

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    2012-07-11 wmr111

    #卒中风险#

    0

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    2012-07-11 12498e5fm17(暂无昵称)

    #瓣膜#

    0