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Despite limited supportive evidence, intra-aortic balloon counterpulsation (IABP) therapy for acute myocardial infarction (AMI) complicated by cardiogenic shock is a Class I recommendation in current guidelines. Although IABP's hemodynamic benefits are not disputed, its impact on hard outcomes remains questionable.
In an open-label, multicenter, industry-supported, German trial, researchers randomized 600 patients with AMI and cardiogenic shock to IABP or no IABP. All patients (average age, 70; approximately 30% women; >75% with impaired organ perfusion) received best available medical therapy. Early revascularization was planned for all patients and performed in 97% (percutaneous coronary intervention, 96%; coronary artery bypass grafting, 4%). Median duration of IABP was 3 days.
At 30 days, all-cause mortality did not differ significantly between the IABP and no-IABP groups (40% and 41%, respectively; P=0.69). Prespecified subgroup analyses revealed no significant between-group differences in death rates, even in patients with systolic blood pressure ≤80 mm Hg, although a favorable trend with IABP was seen in patients aged <50 compared with those aged ≥50 (19% vs. 44%; P=0.09). Mortality was similar whether IABP was inserted before or after revascularization (13% and 87% of patients, respectively). Safety endpoints — including major bleeding, peripheral ischemic complications, sepsis, and stroke — did not differ significantly between the two groups.
Thiele H et al. for the IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med 2012 Aug 27; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa1208410)
O'Connor CM and Rogers JG. Evidence for overturning the guidelines in cardiogenic shock. N Engl J Med 2012 Aug 27; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMe1209601)
Comment
In patients with acute myocardial infarction complicated by cardiogenic shock and treated with early revascularization, the use of intra-aortic balloon counterpulsation did not significantly reduce 30-day mortality. Beneficial effects would not be expected after 30 days; however, the authors plan further analyses at 6 and 12 months. Nonetheless, as noted by an editorialist, the concordance of data from previous meta-analyses and the current trial does not support the routine use of IABP in these patients, strongly challenging the Class I guideline recommendation.