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ESC2017重磅研究万众瞩目:RE-DUALPCI研究 房颤患者冠脉介入术后抗凝策略将有重大突破?

2017-08-15 文韬 中国循环杂志

2周后,2017年欧洲心脏病学会(ESC)年会就要召开了,会上将要公布一项万众瞩目的研究:RE-DUALPCI?,该研究的目的是,对于房颤患者,在冠状动脉介入治疗(PCI)术后比较达比加群联合P2Y12抑制剂双抗,是否优于华法林联合双联抗血小板治疗?

2周后,2017年欧洲心脏病学会(ESC)年会就要召开了,会上将要公布一项万众瞩目的研究:RE-DUALPCI?,该研究的目的是,对于房颤患者,在冠状动脉介入治疗(PCI)术后比较达比加群联合P2Y12抑制剂双抗,是否优于华法林联合双联抗血小板治疗?

房颤PCI患者抗凝面临困境

对于接受PCI的患者而言,如果同时有房颤,术后的抗凝就成了问题。因为PCI术后要求使用双联抗血小板治疗,脑卒中高危房颤则需要使用华法林或新型抗凝药物抗凝。同时使用多种抗栓药物就有出血的风险。

之前国内外多项指南的相关推荐,多为华法林与抗血小板药物的双联、三联抗栓治疗。但近年来,随着新型抗凝药物的经验积累,关于新型抗凝药物与华法林用于PCI术后的疗效与安全性比较,已有多项大型随机对照试验。

之前的PIONEER AF-PCI研究发现,利伐沙班在心血管事件减少方面未优于华法林,而是减少了TIMI 大出血/小出血和需要临床关注的出血事件。但其使用的利伐沙班剂量(2.5 mg BID与15/10 mg QD)并未被批准用于房颤患者卒中预防

2016年欧洲心律协会(EHRA)相关指南指出,在房颤伴冠心病患者中,新型抗凝药物似乎优于华法林。

在这种情况下,RE-DUAL PCI?研究能否成功突围就成了令人瞩目的焦点。

RE-DUAL PCI研究设计

RE-DUAL PCI研究是一项在2502例非瓣膜性房颤冠脉介入患者中进行的全球、事件-驱动、临床Ⅲb期、前瞻性、随机、开放标签,盲终点(PROBE)的活性对照研究,旨在验证达比加群在这类患者中的安全性和疗效。

研究中,受试者被随机分为3组(每组834例),分别接受达比加群(150 mg BID)加一种抗血小板药物 (P2Y12抑制剂)、达比加群(110 mg BID)加一种抗血小板药物(P2Y12抑制剂)和华法林加二联抗血小板药物(阿司匹林+P2Y12抑制剂)治疗。

试验主要终点是评估至首次发生国际血栓与止血学会(ISTH)定义的大出血事件,或主要的临床相关非大出血事件(CRNM)发生的时间。

次要终点评估至首次事件(死亡、血栓事件)发生的时间,包括全因死亡(心血管、非心血管或原因不明)、 心肌梗死、卒中/全身性栓塞、计划外血运重建(经皮冠状动脉介入治疗/冠状动脉旁路移植术)。

哈佛大学Christopher Cannon教授是该研究的首席研究者,称该研究将会为接受PCI治疗的房颤患者带来福音。

另外还有两项研究也在进行,分别是AUGUSTUS ACS/PCI(阿哌沙班vs华法林)和ENTRUST-AF-PCI(依度沙班vs华法林)。


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    2017-09-18 jiekemin
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    2017-08-17 xxxx1054
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