title: Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial.
abstract: BACKGROUND
  In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results.
  
  
  METHODS
  The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036.
  
  
  RESULTS
  Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86-1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95-7·10, p=0·05), recurrent revascularisation (0·91, 0·58-1·41, p=0·77), or stroke (1·50, 0·25-8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups.
  
  
  CONCLUSIONS
  In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality.
  
  
  BACKGROUND
  German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig--Heart Centre; Maquet Cardiopulmonary; Teleflex Medical.
authors.affiliation: University of Leipzig-Heart Centre, Leipzig, Germany. Electronic address: 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: Antoinette
authors.initials: A
authors.lastname: de Waha
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: Bernward
authors.initials: B
authors.lastname: Lauer
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: Karl
authors.initials: K
authors.lastname: Werdan
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000401:mortality* / Q000628:therapy; D009204:Myocardial Revascularization; D011788:Quality of Life; D012307:Risk Factors; D012770:Shock, Cardiogenic / Q000150:complications*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome