Problem Heart failure (EF < 35%; Stage II - IV)
Format Multicenter, double-blind, parallel-group, randomised controlled trial
Treatment Carvedilol OR Metoprolol
Control Nil
Population 3,029 patients
Inclusion criteria LVEF <35%
NYHA class II-IV
Previous admission for a cardiovascular reason
Optimal treatment with diuretics and ACE inhibitors
Exclusion criteria Study objective-related
-Recent change of heart failure treatment
-Treatment with calcium channel blocker (diltiazem or verapamil)
-Unstable angina or myocardial infarction within past 2 months
-Heart transplantation anticipated within 2 months
-Hemodynamically significant valvular disease
-Arrhythmias (unless adequately treated)
Contraindications to beta-blocker therapy
-Heart rate < 60 beats per minute
-Systolic blood pressure < 85 mm Hg
-Atrioventricular block (unless treated with a pacemaker)
-History of asthma or chronic obstructive pulmonary disease
-Unstable insulin-dependent diabetes mellitus
General exclusion criteria
-Hepatic disease
-Pregnancy or childbearing potential (unless using adequate
-Stroke in past 2 months
-Some specific endocrine disorders
Follow-up Mean 4.8 years
Primary endpoint All-cause mortality
Secondary endpoint(s) Composite endpoint of all-cause mortality or all-cause admission
Details -
Brief summary: Carvedilol superior to metoprolol reducing mortality in NYHA II+ & EF <35%
PAPER: Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial.
Date 5 Jul 2003
Journal Lancet. 2003 Jul 5;362(9377):7-13.
Information Significant reduction for carvedilol (vs. metoprolol) for:
-All-cause mortality (17%)
No significant difference in:
-Composite of mortality or all-cause hospitalisation
-Side effects