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IABP-SHOCK II: IABP failed to reduce 30-day mortality in patients with cardiogenic shock
MUNICH — Despite demonstrated safety, the intraaortic balloon pump did not reduce the primary endpoint of 30-day mortality among patients with acute MI who experienced cardiogenic shock in the IABP-SHOCK II trial.
The primary study endpoint results were supported by a lack of benefit in secondary endpoints.
Although the intraaortic balloon pump (IABP) received a Class 1C recommendation by the European Society of Cardiology and Class IB recommendation by the American College of Cardiology and American Heart Association for patients with an acute MI complicated by cardiogenic shock, Holger Thiele, MD, trial investigator at the University of Leipzig-Heart Center, Germany, explained during a press conference that only limited data support its use.
This led Thiele and colleagues to conduct the largest randomized trial on cardiogenic shock with 600 patients who had an acute MI and experienced cardiogenic shock. Patients were randomly assigned to the intraaortic balloon pump (IABP; n=301) or control therapy only (n=299).
The primary endpoint — 30-day mortality — was 39.7% in the IABP arm and 41.3% in the control arm, which did not reach statistical significance (P=.92). Subgroup analysis revealed additional data that also did not find a benefit for the IABP, including 30-day mortality among women (IABP, 44.4% vs. control, 43.2%) and men (IABP, 37.3% vs. control, 40.5%), and 30-day mortality in patients aged younger than 50 years (IABP, 19.4% vs. control, 44.1%), 50 to 75 years (IABP, 34.6% vs. control, 36.5%) and older than 75 years (IABP, 53.7% vs. control, 40%).
“Altogether, this was a negative trial and we could not show that the IABP, which has been highly recommended in guidelines, could improve outcomes,” Thiele said. – by Brian Ellis
For more information:
Thiele H. Hot Line II: Late breaking trials on interventions. Presented at: the European Society of Cardiology Congress; Aug. 25-29, 2012; Munich.
Disclosure: Dr. Thiele reports receiving funding from Eli Lilly, Maquet Cardiovascular, Teleflex and Terumo; has consulted for Eli Lilly and Maquet Cardiovascular; and has received speaker honoraria from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Maquet Cardiovascular and The Medicines Company.
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This is an interesting trial because most physicians would assume that a patient with acute MI complicated by cardiogenic shock would be benefited by a balloon pump. It’s one of those areas of medicine that seems intuitive and some might have argued that a study wasn’t necessary to answer this question, but the IAPB-SHOCK II investigators are to be congratulated for conducting this study. They found that it did not improve outcomes, which was to my surprise. As a result of this large trial, the current guidelines recommendations will likely need to be tempered.
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Practitioners are comfortable with IABP and will continue to use for acute instability, but the use of more significant support with true support should expand and be studied further as this may be an important missing piece for success.