title: Intraaortic balloon support for myocardial infarction with cardiogenic shock.
abstract: 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.affiliation: University of Leipzig-Heart Center, Department of Internal Medicine/Cardiology, Leipzig, Germany. thielh@medizin.uni-leipzig.de
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Miroslaw
authors.initials: M
authors.lastname: Ferenc
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Olbrich
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Marcus
authors.initials: M
authors.lastname: Hennersdorf
authors.forename: Klaus
authors.initials: K
authors.lastname: Empen
authors.forename: Georg
authors.initials: G
authors.lastname: Fuernau
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.forename: Ingo
authors.initials: I
authors.lastname: Eitel
authors.forename: Rainer
authors.initials: R
authors.lastname: Hambrecht
authors.forename: Jörg
authors.initials: J
authors.lastname: Fuhrmann
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: Henning
authors.initials: H
authors.lastname: Ebelt
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Karl
authors.initials: K
authors.lastname: Werdan
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D007423:Intra-Aortic Balloon Pumping; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000628:therapy; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D012770:Shock, Cardiogenic / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D015607:Stents / Q000009:adverse effects; D015996:Survival Rate; D017211:Treatment Failure