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心肌梗死合并心源性休克的主动脉内球囊支持
Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock


Holger Thiele ... 心脑血管疾病 • 2012.10.04
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摘要


背景

在当前的国际指南中,主动脉内球囊反搏被认为是急性心肌梗死合并心源性休克的I类推荐治疗。然而,该推荐的证据主要基于注册数据,缺乏随机临床研究的数据。

 

方法

在这项随机、前瞻性、开放标签、多中心试验中,我们将600名急性心肌梗死合并心源性休克患者随机分配入主动脉内球囊反搏组(IABP组,301名患者)或非主动脉内球囊反搏组(对照组,299名患者)。所有患者均预期接受早期血运重建(通过经皮冠状动脉介入或旁路手术)并接受可获得的最佳医学治疗。主要终点为30天全因死亡率。安全性评估包括大出血、外周缺血性并发症、脓毒症和卒中。

 

结果

共有300名IABP组患者以及298名对照组患者被纳入主要终点分析。在30天时,119名(39.7%)IABP组患者以及123名对照组(41.3%)患者死亡(IABP的相对危险,0.96;95%可信区间,0.79~1.17;P=0.69)。在次要终点或治疗过程指标(包括至血流动力学稳定的时间、重症监护室的住院时间、血清乳酸水平、儿茶酚胺治疗的剂量和持续时间以及肾功能)方面也无显著差异。IABP组与对照组相比在大出血发生率(3.3%对4.4%,P=0.51)、外周缺血并发症(4.3%对3.4%,P=0.53)、脓毒症(15.7%对20.5%,P=0.15)和卒中发生率(0.7%对1.7%,P=0.28)方面也无显著差异。

 

结论

主动脉内球囊反搏不能显著降低计划早期血运重建的急性心肌梗死合并心源性休克患者的30天死亡率(德国研究基金会[German Research Foundation]等赞助;IABP-SHOCK Ⅱ在ClinicalTrials.org注册号NCT00491036)。





作者信息

Holger Thiele, M.D., Uwe Zeymer, M.D., Franz-Josef Neumann, M.D., Miroslaw Ferenc, M.D., Hans-Georg Olbrich, M.D., Jörg Hausleiter, M.D., Gert Richardt, M.D., Marcus Hennersdorf, M.D., Klaus Empen, M.D., Georg Fuernau, M.D., Steffen Desch, M.D., Ingo Eitel, M.D., Rainer Hambrecht, M.D., Jörg Fuhrmann, M.D., Michael Böhm, M.D., Henning Ebelt, M.D., Steffen Schneider, Ph.D., Gerhard Schuler, M.D., and Karl Werdan, M.D., forthe IABP-SHOCK II Trial Investigators*
From the University of Leipzig–Heart Center, Leipzig (H.T., G.F., S.D., I.E., G.S.), Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Ludwigshafen (U.Z., S.S.), Heart Center Bad Krozingen, Bad Krozingen (F.-J.N., M.F.), Asklepios Clinic Langen-Seligenstadt, Langen (H.-G.O.), German Heart Center Munich, Munich (J.H.), Heart Center–Segeberger Kliniken, Bad Segeberg (G.R.), SLK Kliniken Heilbronn, Heilbronn (M.H.), Ernst-Moritz-Arndt University Greifswald, Greifswald (K.E.), Klinikum Links der Weser, Bremen (R.H.), Zentralklinik Bad Berka, Bad Berka (J.F.), University Clinic of Saarland, Homburg/Saar (M.B.), and Martin-Luther University Halle-Wittenberg, Halle (H.E., K.W.) — all in Germany. Address reprint requests to Dr. Thiele at the University of Leipzig–Heart Center, Department of Internal Medicine/Cardiology, Strümpellstr. 39, 04289 Leipzig, Germany, or at thielh@medizin.uni-leipzig.de. *Investigators in the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial are listed in the Supplementary Appendix, available at NEJM.org.

 

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