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CArvedilol Post-infaRct survIval COntRolled evaluatioN - CAPRICORN
Description:
The CArvedilol Post-infaRct survIval COntRolled evaluatioN (CAPRICORN) trial was a randomized, placebo-controlled trial designed to test the long-term efficacy of carvedilol on morbidity and mortality in patients with left ventricular (LV) dysfunction after myocardial infarction (MI) already treated with angiotensin-converting enzyme (ACE) inhibitors.
Hypothesis:
Carvedilol, in addition to standard modern management, would reduce mortality and morbidity compared to placebo in patients with LV dysfunction after recent MI.
Study Design
Study Design:
Patients Enrolled: 1,959
Mean Follow Up: average 1.3 years
Mean Patient Age: mean 63
Female: 27
Mean Ejection Fraction: Mean 32.9% in carvedilol group; mean 32.7% in placebo group
Patient Populations:
Age ≥18 years; stable definite MI within 3-21 days of randomization; LV ejection fraction of ≤40% by echocardiography, radionuclide or contrast ventriculography, or wall motion-score index of 1.3 or less; and receipt of concurrent treatment of ACE inhibitors for at least 48 hours with a stable dose for more than 24 hours, unless there was a proven intolerance of ACE inhibitors
Exclusions:
Continuing requirement for intravenous diuretics or inotropes; uncontrolled heart failure; unstable angina; hypotension (systolic blood pressure <90 mm Hg); uncontrolled hypertension; bradycardia (heart rate <60 beats per minute); unstable insulin-dependent diabetes mellitus; continuing indication for β-blockers for any clinical indication other than heart failure; or ongoing therapy with inhaled β2-agonists or steroids
Primary Endpoints:
The original primary endpoint was all-cause mortality. After an interim analysis demonstrated that the study was underpowered to detect a difference in the primary endpoint, the secondary endpoint of all-cause mortality or hospital admissions was adopted as a coprimary endpoint.
Secondary Endpoints:
Sudden death and hospital admission for heart failure
Drug/Procedures Used:
Carvedilol (starting dose of 6.25 mg twice a day, uptitrated to a maximum of 25 mg twice a day) versus placebo
Concomitant Medications:
ACE inhibitors and other current standard therapy, excluding intravenous diuretics or inotropes
Principal Findings:
A total of 1,959 patients were randomized to carvedilol (n=975) or placebo (n=984). The primary endpoint of all-cause mortality or hospital admissions was similar between arms (35% vs. 37%, hazard ratio [HR] 0.92, p=0.296).
Although the coprimary endpoint of all-cause mortality was lower in the carvedilol arm than in the placebo arm (12% vs. 15%, HR 0.77, p=0.031), this did not satisfy statistical significance for the revised coprimary endpoint. Sudden death and hospital admissions from heart failure were similar between arms, but cardiovascular mortality was lower in the carvedilol arm (11% vs. 14% for placebo, HR 0.75, p=0.024), as was all-cause mortality or nonfatal MI (14% vs. 20%, HR 0.71, p=0.002).
Interpretation:
When administered to patients after recent MI who were already receiving ACE inhibitors and standard modern medical therapy, carvedilol appears to have beneficial effects on cardiovascular clinical outcomes. Although all-cause mortality was reduced in the trial, the level of reduction did not satisfy the revised criteria for significance adopted when the coprimary endpoint of all-cause mortality and hospital admissions (which was also similar between carvedilol and placebo arms) was adopted.
References:
Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001;357:1385-90.
Keywords: Myocardial Infarction, Radioisotopes, Carbazoles, Heart Failure, Death, Sudden, Propanolamines, Ventricular Dysfunction, Left, Echocardiography
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