A study, funded by the German Research Foundation and others, concluded that the use of intraaortic balloon counterpulsation was not successful in reducing 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction (AMI) and for whom revascularization was planned.

 

The trial, known as IABP-SHOCK II, was presented on Aug. 27 as part of the ESC Congress 2012 in Munich and published in The New England Journal of Medicine (NEJM). Six-hundred patients with cardiogenic shock complicating AMI were randomly assigned to either an intraaortic balloon counterpulsation  group (IABP group, 301 patients) or a control group (no IABP 299 patients). At 30 days, results showed that 119 patients in the IABP group (39.7 percent) and 123 patients in the control group (41.3 percent) had not survived [relative risk with IABP, 0.96; 95 percent CI, 0.79 - 1.17]. While IABP before coronary revascularization may make the revascularization procedure safer by improving left ventricular unloading, there is no mortality benefit given the results from this current trial, the study authors said.

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In other findings, the IABP group and the control group had no major differences regarding secondary end points or in process-of-care measures, including time to hemodynamic stabilization, the length of stay in the ICU, serum lactate levels, renal function, etc. In addition, neither group differed significantly in terms of rates of major bleeding, peripheral ischemic complications, sepsis and stroke.

 

An NEJM editorial comment says that the "results of the IABP-SHOCK II trial parallel those from many recent outcome trials that have challenged [the] understanding of the management of acute and chronic heart failure, including those regarding the use of pulmonary artery catheters and the role of revascularization in ischemic cardiomyopathy."

"Therapeutic strategies for patients with cardiogenic shock have changed abruptly and are ready for renewed growth and development," the comment authors said. "We hope that the results of this trial will galvanize a broadly based mandate to address this devastating clinical problem by reestablishing equipoise and international engagement in research on novel devices and pharmacologic therapies."

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