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房颤患者支架置入术后使用泰毕全双联治疗大出血发生率低

来源:勃林格殷格翰  发布日期: 2017-08-28 16:24 

-- RE-DUAL PCI?显示,与华法林三联治疗相比,泰毕全双联治疗大幅度降低出血并发症
-- RE-DUAL PCI?中使用的两种剂量的泰毕全?均已获批用于房颤卒中预防
-- 研究结果作为“最新突破”在2017欧洲心脏年会发布,并同时发表在《新英格兰杂志》

德国殷格翰2017年8月28日电 /美通社/ -- RE-DUAL PCI?试验探索在行经皮冠状动脉介入(PCI)并行支架置入治疗的非瓣膜性房颤患者中使用泰毕全®(达比加群酯)联合一种P2Y12受体抑制剂进行双联治疗(无阿司匹林)。结果表明:泰毕全®双联治疗组大出血和临床相关非大出血事件的发生率显著低于华法林三联治疗组1,2。泰毕全® 110 mg和150 mg双联治疗组的主要安全性终点风险分别比华法林三联治疗组降低48%和28%(相对差异),总血栓栓塞事件的发生率相似。这两种泰毕全®剂量都已获得全球诸多监管机构的批准,用于非瓣膜性房颤患者的卒中预防。RE-DUAL PCI?试验结果已于今日在2017欧洲心脏病学会年会1上公布,并同时发表在《新英格兰医学杂志》2。

在长期口服抗凝药物以降低房颤相关卒中风险的所有房颤患者中,约20%~30%伴发冠状动脉疾病,而且可能需要采取经皮冠脉介入治疗,以改善冠脉血流及心肌灌注3。对于这类患者,当前的强化抗栓治疗方法,即华法林和两种抗血小板药联合的三联治疗。该治疗方案与这类患者较高的大出血发生率相关4-7。RE-DUAL PCI? 试验探讨了一种替代治疗策略:泰毕全®和一种非阿司匹林抗血小板药的双联治疗方案。

RE-DUAL PCI? 主要研究者兼Baim临床研究所心血管代谢试验组执行总监 Christopher Cannon 教授说:“医生在治疗经皮冠状动脉介入伴支架置入术后的房颤患者时,必须权衡疗效及出血风险。既往我们缺少非维生素K口服抗凝剂用于此类患者的专门数据;而现在我们有了RE-DUAL PCI?试验中达比加群双联治疗方案令人鼓舞的结果,可以肯定的是此项结果必将获得正在治疗此类患者并且寻求最佳抗栓方案的医生欢迎。”

研究结果如下1,2:

- 主要终点(大出血和临床相关的非大出血事件)发生率:

泰毕全® 110 mg双联治疗组为15.4%,华法林三联治疗组为26.9%,相对风险降低48% 泰毕全® 150 mg双联治疗组为20.2%,华法林三联治疗组为25.7%,相对风险降低28% 两个剂量的泰毕全®双联治疗组大出血(采用ISTH*或TIMI*的大出血定义单独分析)和总出血发生率均低于华法林三联治疗组 关键次要终点(死亡、心肌梗死、卒中、全身性栓塞和计划外血运重建复合终点):
- 观察到的事件发生率相似:泰毕全®150 mg双联治疗组为13.7%,华法林三联治疗组为13.4%

勃林格殷格翰心血管治疗领域医学副总裁 Jorg Kreuzer 教授说:“我们在RE-DUAL PCI?试验中观测到的结果再一次有力地证实了泰毕全®对房颤患者和其治疗医生的益处。结合其他近期公布的数据来看,如导管消融RE-CIRCUIT?研究数据、‘真实世界研究’中的证据、或紧急情况下的RE-VERSE AD? 研究结果,泰毕全®的获益被反复证实,这些数据着实描绘了令人振奋的前景。8-18

*ISTH,国际血栓与止血学会  
**TIMI,心肌梗死溶栓 

有关RE-DUAL PCI?

RE-DUAL PCI? 在PCI伴支架置入的房颤患者中比较了达比加群酯+一种抗血小板的双联治疗(不含阿司匹林)和华法林+两种抗血小板药物的三联治疗。1,2,19

RE-DUAL PCI? 在全球41个国家的414个研究中心随机入组了2,725例行PCI伴支架置入(择期或因为急性冠状动脉综合征)的成年非瓣膜房颤患者。

此研究的主要目的是比较110 mg或150 mg达比加群酯(每日二次)+氯吡格雷或替格瑞洛双联抗血栓疗法和华法林+氯吡格雷或替格瑞洛+阿司匹林≤100 mg(每日一次)三联抗血栓疗法1,2,19

此项研究为期30个月,旨在检验主要安全性终点的非劣效性。安全性终点定义为至首次发生ISTH定义大出血事件或具有临床意义的非大出血事件的时间。关键血栓性终点的非劣效检验为至死亡、首次血栓形成事件(心肌梗死、卒中或全身性栓塞)和计划外血运重建时间复合终点1,2,19

关于经皮冠状动脉介入(PCI

PCI是一种介入治疗方法,利用支架扩张冠状动脉疾病患者闭塞的冠脉,目的是恢复或改善心肌灌注20。欧洲大约有200万房颤患者伴发冠状动脉疾病,可能需要接受此手术。

PCI伴支架置入后的房颤患者因血栓导致的严重并发症风险增加,这些严重并发症包括卒中、全身性栓塞、心肌梗死、支架内血栓形成,甚至可能导致死亡21,22。抗栓治疗可降低这类患者出现血栓及其后果的风险。

这些患者需要接受抗血小板治疗降低支架内血栓形成和心肌梗死的风险,同时需要接受抗凝治疗降低卒中风险。截至目前,双联抗血小板治疗与抗凝治疗联合可导致频繁的出血并发症,仍然是该领域的一个重大挑战,因而如何解决这一难题也成为该领域的研究热点。  

关于泰毕全®(达比加群酯)

2013年2月泰毕全®获得中国食品药品监督管理局颁发的进口药品注册许可证,被批准用于成人非瓣膜性心房颤动患者的卒中和全身性栓塞预防,并正式在中国大陆地区上市。2017年泰毕全®被纳入中国国家医保目录。

泰毕全®在全球范围内所有获批适应症的临床使用经验已经超过790万患者年。泰毕全®的上市时间已超过8年,并已在超过一百个国家获批。23

泰毕全®是一种直接凝血酶抑制剂(DTI),是首个获得广泛注册批准的新一代口服抗凝药物。直接凝血酶抑制剂通过特异性阻断凝血酶活性而发挥强效抗凝疗效,凝血酶是血栓形成过程中起核心作用的酶17。与作用多个凝血因子的维生素K拮抗剂不同,达比加群可提供有效的、可预测的、可重复的抗凝效果,同时较少发生药物相互作用,无药物食物相互作用,无需进行常规凝血功能监测或强制性剂量调整24-26

泰毕全®是唯一一种具有已获准逆转剂的非维生素K拮抗剂类口服抗凝血药。依达赛珠单抗已在欧盟和美国获准,用于接受泰毕全®治疗、需要在急诊操作/急诊手术前或出现危及生命的或未控制的出血时迅速逆转泰毕全®抗凝效应的成人患者27,28。依达赛珠单抗目前尚未在中国大陆获批。  

参考文献

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