Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion in improve Outcome and Survival at Six months follow-up - ALBATROSS

May 31, 2016
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Presenter/Author:
Gilles Montalescot, MD
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
French Ministry of Health, and Institute of Cardiometabolism and Nutrition
Date Presented:
08/30/2015
Date Published:
04/18/2016
Original Posted Date:
05/31/2016
References

Description:

The goal of the trial was to evaluate treatment with the aldosterone antagonist spironolactone compared with control among subjects with myocardial infarction (MI), but without heart failure.

Contribution to the Literature: The ALBATROSS trial failed to show that aldosterone antagonists were beneficial to patients with MI without heart failure.

Study Design

  • Randomized
  • Parallel

Subjects with MI without heart failure were randomized to an intravenous bolus of potassium canrenoate 200 mg as early as possible, then oral spironolactone 25 mg daily for 6 months (n = 802) versus control (n = 801).

Inclusion criteria:

  • Myocardial infarction without heart failure
  • Total number of enrollees: 1,622
  • Total number randomized: 1,603
  • Duration of follow-up: 6 months
  • Mean patient age: 58 years
  • Percentage diabetics: 16%
  • ST-segment elevation MI (STEMI): 77%, non-STEMI (NSTEMI): 23%

Principal Findings:

The primary outcome of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new/worsening heart failure at 6 months occurred in 11.8% of the spironolactone group versus 12.2% of the control group (p = 0.97). Mortality was reduced in the subset of patients with STEMI, but not NSTEMI.

Secondary outcomes:

  • Death: 1.4% vs. 2.1% (p = 0.26), respectively, for spironolactone vs. control
  • New or worsening heart failure: 5.9% vs. 5.6% (p = 0.85), respectively, for spironolactone vs. control
  • Hyperkalemia: 3% vs. 0.2% (p < 0.0001), respectively, for spironolactone vs. control

Interpretation:

Among patients with MI without heart failure, an early aldosterone antagonist (intravenous potassium canrenoate/oral spironolactone) was not beneficial at reducing adverse cardiac events compared with control. There was suggestion of benefit in the subset of patients with STEMI, but not NSTEMI. Aldosterone antagonists (spironolactone or eplerenone) remain indicated therapy among MI patients with signs of heart failure, where these agents have been shown to reduce mortality.

References:

Beygui F, Cayla G, Roule V, et al. Early aldosterone blockade in acute myocardial infarction: the ALBATROSS randomized clinical trial. J Am Coll Cardiol 2016;67:1917-27.

Presented by Dr. Gilles Montalescot at the European Society of Cardiology Congress, London, August 30, 2015.

Keywords: Acute Coronary Syndrome, Aldosterone, Arrhythmias, Cardiac, Canrenoic Acid, Defibrillators, Implantable, Heart Arrest, Heart Failure, Hyperkalemia, Myocardial Infarction, Secondary Prevention, Spironolactone, ESC Congress


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