ACC 2014：CoreValve“创造历史”

2014-04-04 王娣中国医学论坛报

在2011年ACC年会上占尽风光的PARTNER试验将当时问世不足10年的经导管主动脉瓣置换(TAVR)技术推到聚光灯下，并使EdwardsSapien瓣膜(球囊扩张置入)一举获得美国食品与药物管理局(FDA)批准，而欧洲临床常用的另一种人工瓣膜CoreValve(自膨胀置入)则在今年会议上等来了机会。 CoreValveU.S.Pivo-talTrial包括两项研究，分别在外科换瓣手术(S

在2011年ACC年会上占尽风光的PARTNER试验将当时问世不足10年的经导管主动脉瓣置换(TAVR)技术推到聚光灯下，并使EdwardsSapien瓣膜(球囊扩张置入)一举获得美国食品与药物管理局(FDA)批准，而欧洲临床常用的另一种人工瓣膜CoreValve(自膨胀置入)则在今年会议上等来了机会。

CoreValveU.S.Pivo-talTrial包括两项研究，分别在外科换瓣手术(SAVR)“极高风险(extremerisk)”和“高风险(highrisk)”的严重主动脉瓣狭窄(AS)患者中验证CoreValve瓣膜TAVR的疗效和安全性。前者是一项前瞻性非随机纵向研究，在去年美国经导管心血管治疗(TCT)会议上公布结果并推动美国FDA批准了CoreValve在该人群中的使用;后者是一项严格的前瞻性随机对照试验，在3月29日开幕式后揭晓。

Adams 教授

主要研究者之一、西奈山医学中心亚当斯(Adams)教授介绍，来自美国45个中心的747例患者随机接受TAVR(390例)或SAVR(357例)，主要终点结果(12个月全因死亡率TAVR组14.2%对SAVR组19.1%，优效性检验P=0.04)表明TAVR显著优于SAVR。他提到，这是该领域第一项在特定人群中显示出TAVR优于SAVR的前瞻性随机试验，特别在SAVR组患者预后显著好于预期的情况下，TAVR仍然更胜一筹，令人惊喜。

尽管Adams再三强调该试验与PARTNER试验不具备直接可比性，但这种比较几乎不可避免。PARTNERA试验主要研究者之一马克(MichaelMack)在现场评论中提出了3点质疑：

1.入选人群该试验入选标准为外科手术后30天死亡风险≥15%，实际入选患者平均风险约为7%，更像一个中等风险而非高风险人群;Adams在总结中也提及研究人群风险低于预期、或外科手术“表现太好”。

2.分析方法用AT(astreated，定义为随机后实际“进入手术室”的患者)而不是ITT(意向性治疗)模型分析，从而“丢失”了48例患者(AT模型TAVR组390例，SAVR组357例;ITT模型TAVR组394例，SAVR组401例)，加上1年内失访的23例，共71例患者转归信息缺失;Adams则称在同期发表于《新英格兰医学杂志》(NEJM)的论文中两种分析方法都有描述且结果相似。

3.新置入起搏器风险高CoreValve瓣膜导致高达25%的患者面临新置入起搏器的风险。

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2014-09-25 12498f1em08(暂无昵称)

#valve#

38 0
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2014-05-02 hunizi005

#CoreValve#

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2014-04-06 12498568m50暂无昵称

#ACC#

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2014-04-06 cathymary

#历史#

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2014-04-06 docwu2019

#CORE#

32 0

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