Robert A. Harrington, MD
In patients with acute myocardial infarction (AMI) with cardiogenic shock and planned early revascularization, does intraaortic balloon counterpulsation reduce mortality?
Randomized controlled trial (RCT) (Intraaortic Balloon Pump in Cardiogenic Shock II [IABP-SHOCK II] trial). ClinicalTrials.gov NCT00491036.
37 centers in Germany.
600 patients ≤ 90 years of age with AMI complicated by cardiogenic shock (median age 69 to 70 y, 69% men) and planned early revascularization. Exclusion criteria included resuscitation for > 30 minutes; lack of intrinsic heart action; coma with fixed dilatation of pupils not induced by drugs; mechanical cause of cardiogenic shock; shock onset > 12 hours before screening; massive pulmonary embolism, severe peripheral arterial disease precluding insertion of an intraaortic balloon pump (IABP), or aortic regurgitation > grade II severity; or shock resulting from a condition other than AMI.
IABP (n = 301) or no IABP (n = 299). The IABP was inserted before or immediately after percutaneous coronary intervention.
Mortality. Safety outcomes included in-hospital reinfarction, stroke, peripheral ischemic complications requiring intervention, and sepsis. The trial was powered (α = 0.05) to detect a 12% difference in 30-day survival assuming a control event rate of 56%.
99.7% (intention-to-treat analysis).
Groups did not differ for mortality or the safety outcomes (Table).
Intraaortic balloon counterpulsation did not reduce mortality in patients with acute myocardial infarction with cardiogenic shock and planned early revascularization.
Intraaortic balloon pump (IABP) vs no IABP in acute myocardial infarction complicated by cardiogenic shock and planned early revascularization†
†Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from control event rates and relative risks in article.
Harrington RA. Intraaortic balloon counterpulsation did not reduce mortality in acute MI with cardiogenic shock. Ann Intern Med. ;157:JC6–11. doi: 10.7326/0003-4819-157-12-201212180-02011
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Published: Ann Intern Med. 2012;157(12):JC6-11.
Acute Coronary Syndromes, Cardiology, Coronary Heart Disease, Emergency Medicine.
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