Myocardial infarction: left ventricular dysfunction: carvedilol reduced death and myocardial infarction

Clinical bottom line (level 1b)

  1. Patients with left ventricular dysfunction following a myocardial infarction who received carvedilol compared with placebo were less likely to die (NNT = 29 at 1.3 years) or have a nonfatal myocardial infarction (NNT = 43 at 1.3 years) .
  2. Patients on carvedilol are not clearly less likely to be admitted to hospital with heart failure, not clearly more likely to stop medicaiton.
the CAPRICORN investigators : Lancet 2001; 357 : 1385-1390
Expires March 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 163 hospitals in 17 countries worldwide

1959 patients (aged 25 to 90; mean 63, 74% male) stable following a confirmed myocardial infarction within previous 3-21 days and
  • left ventricular dysfunction (ejection fraction 40% or less or wall-motion-score index 1.3 or less)
  • on ACEI for at least 48 hours and on a stable dose for at least 24 hours


Excluded if
  • requiring iv diuretics or inotropes
  • uncontrolled heart failure
  • unstable angina
  • hypotension (systolic bp < 90 mmHg), or uncontrolled hypertension
  • bradycardia (< 60 beats per minute)
  • unstable type I diabetes mellitus
  • continuing indication for beta-blockers other than heart failure
  • requiring ongoing therapy with inhaled beta-2-agonists or steroids
  • aged < 18

Control Group: (n = 984, 984 analysed): placebo
Experimental Group: (n = 975, 975 analysed): carvedilol initial dose 6.25 mg twice daily titred to maximum tolerated dose (up to 25 mg twice daily) i.e. heart rate > 50 beats/min, systolic bp > 80 mmHg and no adverse effects

100% followed for 1.3 years

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death 1.3 years 151
(15.4%)		 116
(11.9%)		 22%
(3% to 38%)		 3.45%
(0.41% to 6.48%)		 29
(15 to 240)
nonfatal myocardial infarction 1.3 years 57
(5.79%)		 34
(3.49%)		 40%
(9% to 60%)		 2.31%
(0.45% to 4.16%)		 43
(24 to 220)
admission to hospital with heart failure 1.3 years 138
(14.0%)		 118
(12.1%)		 14%
(-9% to 31%)		 1.92%
(-1.06% to 4.90%)		 52
(NNT = 20 to infinity;
NNH = 94 to infinity)
withdrew permanently 1.3 years 174
(17.7%)		 198
(19.7%)		 -11%
(-34% to 7%)		 -2.01%
(-5.46% to 1.44%)		 -50
(NNT = 69 to infinity;
NNH = 18 to infinity)

Comments

  1. Patients were randomised in permuted blocks and stratified by centre.

Citation

  1. the CAPRICORN investigators , : effects of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001; 357 : 1385-1390
Search Terms: from ACP Journal Club
Contributor: Chris Ball, March 2002
Reviewer:

Clinical Question.
Patient myocardial infarction and heart failure
Intervention or Exposure carvedilol
Comparison placebo
Outcome death, myocardial infarction, withdrawal