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.
| Original language | English |
|---|---|
| Journal | American Heart Journal |
| Volume | 163 |
| Issue number | 6 |
| Pages (from-to) | 938-945 |
| Number of pages | 8 |
| ISSN | 0002-8703 |
| DOIs | |
| Publication status | Published - 01.01.2012 |
Funding
The IABP-SHOCK II Steering Committee is chaired by Holger Thiele, MD, of the University of Leipzig—Heart Center, Leipzig, Germany; co-chaired by Gerhard Schuler, MD, University of Leipzig—Heart Center, Leipzig, Germany; Uwe Zeymer, Institut für Herzinfarktforschung, Ludwigshafen, Germany; and Karl Werdan, MD, Martin-Luther University Halle-Wittenberg, Halle, Germany. The Steering Committee is responsible for the scientific content of the protocol and oversees the trial operations and will prepare the primary manuscript and other publications arising from the IABP-SHOCK II trial. Each participating center has a coordinator with extensive clinical trial experience. All trial-related processes will follow the standard operating procedures of the Institut für Herzinfarktforschung, which is an independent clinical research organization providing biometry, study coordination, monitoring, and data management. Central monitoring will include a timely query management process based on consistency and plausibility checks automatically generated from the database, combined with a dunning process for missing documentation and a reminder system in advance for upcoming visits. Monitoring on site of all centers includes initiation, regular visits, and close out. During recruitment and follow-up, the centers will be visited regularly. Scope of these visits is to check adherence to Good Clinical Practice and trial protocol. The focus of the visits will be on the verification of informed consent documents, eligibility criteria, key primary and secondary end points, and safety aspects for all patients. The trial will be monitored by an independent DSMB. This committee is chaired by Johannes Haerting, PhD, as independent statistician, Halle, Germany. Other DSMB members are Kurt Huber, MD, Vienna, Austria; Ferenc Follath, MD, Zurich, Switzerland; and Bernhard Maisch, MD, Marburg, Germany. The CEC will adjudicate all clinical end points. The trial follows a standard study organization with Steering Committee, DSMB, and CEC. The IABP-SHOCK II trial is an investigator-initiated trial that is supported by the German Research Foundation, the German Heart Research Foundation, the German Cardiac Society, the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte, and the University of Leipzig—Heart Center. It is performed under the patronage of the German Heart Research Foundation and the German Cardiac Society. Furthermore, it is supported by unrestricted grants from Maquet Cardiopulmonary AG, Hirrlingen, Germany, and Teleflex Medical, Everett, MA. Participating centers are provided with intraaortic balloons free of charge and a modest case fee per included patient. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents. The aforementioned foundations and organizations as well as Maquet Cardiopulmonary and Teleflex Medical have no influence on the study design, data collection, data analysis, and final drafting of this article.
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Research Areas and Centers
- Academic Focus: Center for Brain, Behavior and Metabolism (CBBM)
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