Document Detail


Intraaortic balloon support for myocardial infarction with cardiogenic shock.
MedLine Citation:
PMID:  22920912     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials.
METHODS: In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke.
RESULTS: A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P=0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P=0.51), peripheral ischemic complications (4.3% and 3.4%, P=0.53), sepsis (15.7% and 20.5%, P=0.15), and stroke (0.7% and 1.7%, P=0.28).
CONCLUSIONS: The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.).
Authors:
Holger Thiele; Uwe Zeymer; Franz-Josef Neumann; Miroslaw Ferenc; Hans-Georg Olbrich; Jörg Hausleiter; Gert Richardt; Marcus Hennersdorf; Klaus Empen; Georg Fuernau; Steffen Desch; Ingo Eitel; Rainer Hambrecht; Jörg Fuhrmann; Michael Böhm; Henning Ebelt; Steffen Schneider; Gerhard Schuler; Karl Werdan;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-08-26
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-04     Completed Date:  2012-10-16     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1287-96     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00491036
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Balloon, Coronary
Coronary Artery Bypass
Female
Humans
Intention to Treat Analysis
Intra-Aortic Balloon Pumping*
Male
Middle Aged
Myocardial Infarction / complications*,  therapy
Practice Guidelines as Topic
Prospective Studies
Shock, Cardiogenic / etiology,  mortality,  therapy*
Stents / adverse effects
Survival Rate
Treatment Failure
Investigator
Investigator/Affiliation:
Gerhard Schuler / ; Karl Werdan / ; Uwe Zeymer / ; Holger Thiele / ; Uwe Zeymer / ; Karin Vonderschmitt / ; Sonja Frey / ; Beate Messemer / ; Zehra Alkisoglu / ; Karin Vonderschmitt / ; Steffen Schneider / ; Taoufik Ourrak / ; Johannes Haerting / ; Kurt Huber / ; Bernhard Maisch / ; Ferenc Follath / ; Holger Thiele / ; Steffen Desch / ; Georg Fuernau / ; Gerhard Schuler / ; Anja Leuschner / ; Suzanne de Waha / ; Ingo Eitel / ; Sabrina Wetzel / ; Tom Pausewang / ; Franz-Josef Neumann / ; Miroslaw Ferenc / ; Hans-Gerd Olbrich / ; Hans-Bernd Hopf / ; Jörg Hausleiter / ; Antoinette de Waha / ; Martin Orban / ; Carsten Lennerz / ; Melchior Seyfarth / ; Gert Richardt / ; Bettina Schwarz / ; Mohamed Abdel-Wahab / ; Ralph Toelg / ; Volker Geist / ; Monika Bahnsen-Maaß / ; Marcus Hennersdorf / ; Jochen Graf / ; Urs Riemann / ; Andreas Kuhn / ; Dominik Scharpf / ; Klaus Empen / ; Stefan Felix / ; Karl Werdan / ; Henning Ebelt / ; Michael Buerke / ; Axel Schlitt / ; Rainer Hambrecht / ; Andreas Fach / ; Eduard Fiehn / ; Uwe Zeymer / ; Anselm K Gitt / ; Bernd Mark / ; Ralph Winkler / ; Bernward Lauer / ; Jörg Fuhrmann / ; Michael Böhm / ; Andreas Link / ; Hans-Reiner Figulla / ; Markus Ferrari / ; Christian Jung / ; Stephan Utschig / ; Volkhard Kurowski / ; Sebastian Wolfrum / ; Peter W Radke / ; Heribert Schunkert / ; Hans-Heinrich Minden / ; Rüdiger C Braun-Dullaeus / ; Alexander Schmeißer / ; Friederike Walz / ; Jürgen Krülls-Münch / ; Kristin Rochor / ; Ruth H Strasser / ; Gregor Simonis / ; Sebastian Maier / ; Georg Ertl / ; Harald Mudra / ; Martin Hug / ; Peter Sick / ; Peter Bomba / ; Hans-Peter Schultheiss / ; Carsten Tschöpe / ; Dietrich Andresen / ; Harry Roth / ; Jürgen Krülls-Münch / ; Christian Kurek / ; Christoph Nienaber / ; Hüseyin Ince / ; Hendrick Schneider / ; Christian Hamm / ; Helge Möllmann / ; Harald Lapp / ; Gert Baumann / ; Fabian Knebel / ; Wolfgang Franz / ; Helmut Schühlen / ; Lars U Stracke / ; Robert H Schwinger / ; Herrmann Bäuml / ; Volker Schächinger / ; Daniel Gießmann / ; Michael Lichtenberg / ; Roland Prondzinsky / ; Ulrich Tebbe / ; Ralf Birkemeyer /
Comments/Corrections
Comment In:
Nat Rev Cardiol. 2012 Oct;9(10):551   [PMID:  22965109 ]
Crit Care. 2013;17(2):307   [PMID:  23472937 ]
Expert Rev Cardiovasc Ther. 2013 Feb;11(2):147-9   [PMID:  23405835 ]
N Engl J Med. 2012 Oct 4;367(14):1349-50   [PMID:  22920913 ]
Med Klin Intensivmed Notfmed. 2012 Oct;107(7):567-70   [PMID:  23052992 ]
N Engl J Med. 2013 Jan 3;368(1):80   [PMID:  23281983 ]
N Engl J Med. 2013 Jan 3;368(1):80-1   [PMID:  23281984 ]
N Engl J Med. 2013 Jan 3;368(1):81   [PMID:  23281982 ]
Ann Intern Med. 2012 Dec 18;157(12):JC6-11   [PMID:  23247960 ]

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