Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: Design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial

Holger Thiele*, Gerhard Schuler, Franz Josef Neumann, Jörg Hausleiter, Hans Georg Olbrich, Bettina Schwarz, Marcus Hennersdorf, Klaus Empen, Georg Fuernau, Steffen Desch, Suzanne De Waha, Ingo Eitel, Rainer Hambrecht, Michael Böhm, Volkhard Kurowski, Bernward Lauer, Hans Heinrich Minden, Hans Reiner Figulla, Rüdiger C. Braun-Dullaeus, Ruth H. StrasserKristin Rochor, Sebastian K.G. Maier, Helge Möllmann, Steffen Schneider, Henning Ebelt, Karl Werdan, Uwe Zeymer

*Korrespondierende/r Autor/-in für diese Arbeit
79 Zitate (Scopus)

Abstract

Background: In current guidelines, intraaortic balloon pumping (IABP) is considered a class 1 indication in cardiogenic shock complicating acute myocardial infarction. However, evidence is mainly based on retrospective or prospective registries with a lack of randomized clinical trials. Therefore, IABP is currently only used in 20% to 40% of cardiogenic shock cases. The hypothesis of this trial is that IABP in addition to early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting will improve clinical outcome of patients in cardiogenic shock. Study Design: The IABP-SHOCK II study is a 600-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of IABP versus optimal medical therapy on the background of early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of IABP-SHOCK II is 30-day all-cause mortality. Secondary outcome measures, such as hemodynamic, laboratory, and clinical parameters, will serve as surrogate end points for prognosis. Furthermore, an intermediate and long-term follow-up at 6 and 12 months will be performed. Safety will be assessed, by the GUSTO bleeding definition, peripheral ischemic complications, sepsis, and stroke. Conclusions: The IABP-SHOCK II trial addresses important questions regarding the efficacy and safety of IABP in addition to early revascularization in patients with cardiogenic shock complicating myocardial infarction.

OriginalspracheEnglisch
ZeitschriftAmerican Heart Journal
Jahrgang163
Ausgabenummer6
Seiten (von - bis)938-945
Seitenumfang8
ISSN0002-8703
DOIs
PublikationsstatusVeröffentlicht - 01.01.2012

Strategische Forschungsbereiche und Zentren

  • Forschungsschwerpunkt: Gehirn, Hormone, Verhalten - Center for Brain, Behavior and Metabolism (CBBM)

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