Intraaortic balloon support for myocardial infarction with cardiogenic shock.

By Holger Thiele, U. Zeymer, Franz-Josef Neumann, Miroslaw Ferenc, Hans G. Olbrich, J. Hausleiter, G. Richardt, M. Hennersdorf, K. Empen, Georg Fuernau and 9 more. New England Journal of Medicine, 2012

1,253 citations recorded by the source corpus.

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.).

Subfields: Biomedical Engineering, Cardiology and Cardiovascular Medicine, Emergency Medicine

View Paper: https://www.semanticscholar.org/paper/efd161003f6fa69f3e6cf805ccea32a706875355

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Citations in the corpus

• 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure (2016, neutral): “Recently the IABP-SHOCK II trial showed that the use of an IABP did not improve outcomes in patients suffering from AMI and cardiogenic shock.(585,586)”
• Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction. (2017, methodology): “Left circumflex 6/24 (25) 3/24 (13) Right coronary artery 1/24 (4) 4/24 (17) Multivessel disease* 15/24 (63) 21/24 (88)”
• European Resuscitation Council and European Society of Intensive Care Medicine Guidelines 2021: Post-resuscitation care. (2021, methodology): “In patients with cardiogenic shock without cardiac arrest some centres still advocate use of an intra-aortic balloon pump (IABP), although the IABP-SHOCK II Trial failed to show that use of the IABP improved 30-day mortality in patients with myocardial infarction and cardiogenic shock [172, 173].”
• 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. (2014, background): “When studied in rigorous RCTs, IABP counterpulsation failed to reduce MACE in high-risk elective PCI,(266) decrease infarct size after primary PCI for acute STEMI,(267) or diminish early mortality in patients with cardiogenic shock complicating AMI.(268)”
• Clinical picture and risk prediction of short‐term mortality in cardiogenic shock (2015, neutral): “3 Mean arterial pressure, mmHg 57 (11) 56 (11) 59 (9) 0.”