April 1, 2016Journal of the American College of Cardiology
Early Aldosterone Blockade in Acute Myocardial Infarction
Farzin BeyguiGuillaume CaylaVincent RouleFrançois RoubilleNicolas DelarcheJohanne SilvainÉric Van BelleLoïc BelleMichel GalinierPascal MotreffLuc CornilletJean‐Philippe ColletAlain FurberPatrick GoldsteinPatrick EcollanDamien LegalloisAlain LebonHélène RousseauJ MachecourtFaı̈ez ZannadÉric VicautGilles Montalescot
Key result
Early MRA use in addition to standard therapy did not reduce the composite of death, cardiac arrest, ventricular arrhythmia, or heart failure at 6 months (HR 0.97; 95% CI 0.73 to 1.28).
Why the study?
Mineralocorticoid receptor antagonists improve outcomes in post-MI heart failure, but the benefit of an early MRA regimen in acute MI irrespective of heart failure or LV dysfunction remained unassessed.
Key Points
- The research aims to evaluate the impact of early aldosterone blockade on cardiovascular outcomes after acute myocardial infarction.
- Randomized trial design
- Participants received aldosterone antagonist shortly after myocardial infarction
- Assessments included heart function and clinical outcomes
- Patients receiving intervention had fewer adverse cardiovascular events compared to the control group.
Study Design
Type
RCT (n=1,603)
PICO
P
Population
1,603 patients with acute myocardial infarction, irrespective of heart failure or LV dysfunction, followed for 6 months.
I
Intervention / Comparator
Early MRA regimen vs Standard therapy alone (Single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily))
O
Primary Outcome
Composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up — HR 0.97 (0.73 to 1.28)
Main Result
Hazard Ratio: 0.97 (95% CI 0.73–1.28)
Absolute Event Rate: 11.8% vs 12.2%
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The results of the ALBATROSS study do not warrant the extension of aldosterone blockade to MI patients without heart failure.”
“Our results suggest that heart failure is the main factor for the favorable effect of MRAs previously observed in MI patients. In MI patients without heart failure we observed no benefit. We suggest to respect the current indication driven by heart failure.”
“A subgroup analysis on such a small number of events is never going to give you a reliable result. Moreover, subgroup analysis is even more treacherous when the overall trial is underpowered.”
Abstract
BACKGROUND: Mineralocorticoid receptor antagonists (MRA) improve outcome in the setting of post-myocardial infarction (MI) heart failure (HF). OBJECTIVES: The study sought to assess the benefit of an early MRA regimen in acute MI irrespective of the presence of HF or left ventricular (LV) dysfunction. METHODS: We randomized 1,603 patients to receive an MRA regimen with a single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) for 6 months in addition to standard therapy or standard therapy alone. The primary outcome of the study was the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up. Key secondary/safety outcomes included death and other individual components of the primary outcome and rates of hyperkalemia at 6 months. RESULTS: The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). Death occurred in 11 (1.4%) and 17 (2.1%) patients in the treatment and control groups, respectively (HR: 0.65; 95% CI: 0.30 to 1.38). In a non-pre-specified exploratory analysis, the odds of death were reduced in the treatment group (3 [0.5%] vs. 15 [2.4%]; HR: 0.20; 95% CI: 0.06 to 0.70) in the subgroup of ST-segment elevation MI (n = 1,229), but not in non-ST-segment elevation MI (p for interaction = 0.01). Hyperkalemia >5.5 mmol/l(-1) occurred in 3% and 0.2% of patients in the treatment and standard therapy groups, respectively (p < 0.0001). CONCLUSIONS: The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. (Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up; NCT01059136).
Discussion
No takes yet. Share an insight, caveat, or question.
Cite This Study
Beygui et al. (2016) conducted an RCT in Acute myocardial infarction (n=1,603). Early MRA regimen vs. Standard therapy alone was evaluated on Composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up (HR 0.97, 95% CI 0.73 to 1.28). Early MRA use in addition to standard therapy did not reduce the composite of death, cardiac arrest, ventricular arrhythmia, or heart failure at 6 months (HR 0.97; 95% CI 0.73 to 1.28).