ArticlesIntra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial
Introduction
Despite advances in treatment, mainly by early revascularisation, mortality in acute myocardial infarction complicated by cardiogenic shock remains high.1, 2, 3, 4 Intra-aortic balloon pump (IABP) counterpulsation has been the most widely used mechanical haemodynamic support device for nearly five decades.5 It improves diastolic blood pressure, thereby improving coronary perfusion, and by its afterload reduction properties myocardial oxygen consumption is reduced leading to an increase in cardiac output.6 However, on the basis of insufficient and conflicting evidence derived only from registry data,7 American and European guidelines recently downgraded IABP use for cardiogenic shock from a class I to a class IIa and IIb recommendation.8, 9, 10
Currently, only one sufficiently large randomised trial of intra-aortic counterpulsation in cardiogenic shock secondary to myocardial infarction (IABP-SHOCK II trial) has been done. Short-term follow-up data at 30 days from this trial showed no survival benefit with IABP support by comparison with control.11 However, long-term follow-up is necessary, especially since a previous trial in cardiogenic shock examining early revascularisation with no difference after 30 days showed a significant mortality benefit at extended follow-up.3, 12, 13 Therefore, the IABP-SHOCK II trial had prespecified intermediate 6 and 12 month follow-up for clinical outcome and quality of life.
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Study design
The trial design of the prospective, randomised, open-label, controlled IABP-SHOCK II trial at 37 German centres, and the 30 day results including the primary endpoint, have been previously published.11, 14 The study was investigator-initiated and coordinated by the University of Leipzig—Heart Centre, Leipzig, Germany, and the Institut für Herzinfarktforschung, Ludwigshafen, Germany, acted as the clinical research organisation.
In brief, the main inclusion criterion was cardiogenic shock with
Results
Between June 16, 2009, and March 3, 2012, 600 patients of 790 initially screened were randomly assigned to IABP (n=301) or control (n=299). Figure 1 shows revascularisation, study protocol compliance, and follow-up. 12 month follow-up was complete in 595 (99%) patients. The baseline characteristics were well balanced between treatment groups.11 The median age was 70 years (IQR 58–77) and 413 (69%) were male. 270 (45%) underwent cardiopulmonary resuscitation before randomisation, 463 (77%) had
Discussion
In this prospective, randomised trial of patients with cardiogenic shock complicating acute myocardial infarction, IABP support did not increase 6 and 12 month survival compared with control, supporting the short-term 30 day follow-up data (panel). Despite early revascularisation and optimum medical therapy in both groups, mortality was still slightly higher than 50% at 1 year follow-up. Nevertheless, for survivors, the self-reported quality of life was moderate to good.
There are several
References (30)
- et al.
Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial
Am Heart J
(2012) EuroQol: the current state of play
Health Policy
(1996)- et al.
Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry
J Am Coll Cardiol
(2004) - et al.
Comparison of hospital mortality with intra-aortic balloon counterpulsation insertion before versus after primary percutaneous coronary intervention for cardiogenic shock complicating acute myocardial infarction
Am J Cardiol
(2010) - et al.
Predictors of 30-day mortality in patients with refractory cardiogenic shock following acute myocardial infarction despite a patent infarct artery
Am Heart J
(2009) - et al.
A severity scoring system for risk assessment of patients with cardiogenic shock: a report from the SHOCK Trial and Registry
Am Heart J
(2010) - et al.
Improved outcome of cardiogenic shock at the acute stage of myocardial infarction: a report from the USIK 1995, USIC 2000, and FAST-MI French Nationwide Registries
Eur Heart J
(2012) - et al.
Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective
Circulation
(2009) - et al.
Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should we emergently revascularize occluded coronaries for cardiogenic shock
N Engl J Med
(1999) - et al.
Ten-year incidence and treatment of cardiogenic shock
Ann Intern Med
(2008)