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Circ Cardiovasc Interv:冠心病患者PCI后比伐卢定抗凝治疗 真实世界研究证据(EVENT和EUROVISION注册研究)

2014-06-02 MedSci MedSci原创

EVENT注册研究的一项分析显示,行PCI的稳定型缺血性心脏病(IHD)或非ST抬高型急性冠脉综合征(NSTE-ACS)患者使用比伐卢定与肝素相比可减少一半的出血风险。在2014年ACC年会上刚刚发布了HEAT-PPCI试验结果,EVENT注册研究的发表无疑又把我们带回了一个老问题,抗凝用新药还是老药更好?哪些患者适合新药/老药?Sripal Bangalore博士(纽约大学医学院)指出,对于IH

EVENT注册研究的一项分析显示,行PCI的稳定型缺血性心脏病(IHD)或非ST抬高型急性冠脉综合征(NSTE-ACS)患者使用比伐卢定与肝素相比可减少一半的出血风险。

在2014年ACC年会上刚刚发布了HEAT-PPCI试验结果,EVENT注册研究的发表无疑又把我们带回了一个老问题,抗凝用新药还是老药更好?哪些患者适合新药/老药?

Sripal Bangalore博士(纽约大学医学院)指出,对于IHD或NSTE-ACS患者的抗凝治疗,不同的文献存在很大差距。但目前还没有大量能够解决这一问题的随机对照试验。在临床实践中,IHD或NSTE-ACS患者使用比伐卢定在减少出血事件方面的获益是否与急性心肌梗死试验中的相当,是否优于肝素?这个问题一直未得到很好的解决。

在针对NSTEMI 患者的ACUITY和PROTECT TIMI 30试验中,比伐卢定可以减少出血事件,但对照组是肝素+ GPIIb/IIIa抑制剂。REPLACE-2试验中,对于直接和择期PCI患者,比伐卢定可显著减少主要出血事件,对照组同样是肝素+ GPIIb/IIIa抑制剂。

比伐卢定在真实世界的数据

EVENT注册研究中,Bangalore博士等分析了住院出血事件、住院缺血事件(死亡/心梗)和死亡/心梗/计划外PCI血运重建(12个月)数据。在2004年7月至2007年6月之间共在50多个研究中心纳入超过10000例患者。在倾向得分匹配后,有1036例NSTE-ACS患者和2062例IHD患者进入分析。

在NSTE-ACS和IHD患者中,比伐卢定组出血事件较对照组低50%,住院和12个月缺血事件均无增加。两组支架内血栓形成发生率无差异。

EVENT注册研究分析的主要结果

Bangalore说,对于NSTE-ACS和稳定型IHD队列,我们的关键研究结果与除HEAT-PPCI试验之外的其他随机试验结果一致。与肝素相比,比伐卢定显著减少出血事件,同时没有发现缺血事件的增加,特别是1年支架内血栓形成发生率。

值得注意的是,EVENT分析中100%的患者接受了经股PCI,患者抗血小板药物均选用的是氯吡格雷。这可能是本研究与HEAT-PPCI试验结果不同的部分原因。同时也说明,尽管有很多新药出现,但在全球范围内,氯吡格雷依然是主要的抗血小板药物。对于PCI患者如果使用氯吡格雷最好选用比伐卢定进行抗凝治疗,特别是那些出血风险很高的患者。

同时,研究者指出,PCI术后抗凝方面还有许多悬而未决的问题,仍需要进一步研究。


另外一项注册研究EUROVISION,来自于5个国家,58个中心,2018例患者,也显示了比伐卢定能降低心肌缺血事件,而且显示出很好的安全性。

参考文献:

Hamon M, Nienaber CA, Galli S, Huber K, Lipiecki J, Hill JM, Amabile N, Bernstein D, Deliargyris E, Lafont A, Steg PG. Bivalirudin in percutaneous coronary intervention: the EUROpean BiValIrudin UtiliSatION in Practice (EUROVISION) Registry. Int J Cardiol. 2014 May 1;173(2):290-4.

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    2015-03-03 quxin068
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    2014-11-05 lhlxtx
  5. [GetPortalCommentsPageByObjectIdResponse(id=1764746, encodeId=759a1e6474631, content=<a href='/topic/show?id=c73964968de' target=_blank style='color:#2F92EE;'>#注册研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64968, encryptionId=c73964968de, topicName=注册研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=510b37798730, createdName=dlwang_26703139, createdTime=Sat May 09 03:21:00 CST 2015, time=2015-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1667766, encodeId=40b6166e76697, content=<a href='/topic/show?id=676c636260c' target=_blank style='color:#2F92EE;'>#比伐卢定#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63626, encryptionId=676c636260c, topicName=比伐卢定)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a96426178489, createdName=Luyuxie_18, createdTime=Fri Jan 16 12:21:00 CST 2015, time=2015-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1938380, encodeId=5bca19383809a, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Tue Mar 03 01:21:00 CST 2015, time=2015-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2052356, encodeId=a15c2052356c8, content=<a href='/topic/show?id=aeece1137b' target=_blank style='color:#2F92EE;'>#event#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7113, encryptionId=aeece1137b, topicName=event)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e12358, createdName=lhlxtx, createdTime=Wed Nov 05 03:21:00 CST 2014, time=2014-11-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295144, encodeId=80b8129514489, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Wed Jun 04 09:21:00 CST 2014, time=2014-06-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1447665, encodeId=70d5144e66558, content=<a href='/topic/show?id=523a3082670' target=_blank style='color:#2F92EE;'>#冠心病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30826, encryptionId=523a3082670, topicName=冠心病患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=99445365987, createdName=liubm557, createdTime=Wed Jun 04 09:21:00 CST 2014, time=2014-06-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1556706, encodeId=1b781556e0620, content=<a href='/topic/show?id=e4016495635' target=_blank style='color:#2F92EE;'>#注册#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64956, encryptionId=e4016495635, topicName=注册)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c52c14833361, createdName=zhyy93, createdTime=Wed Jun 04 09:21:00 CST 2014, time=2014-06-04, status=1, ipAttribution=)]
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    2014-06-04 zhyy93

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