Congestive heart failure: milrinone caused adverse effects without shortening hospital stays

Clinical bottom line (level 1b)

  1. Patients hospitalised with severe congestive heart failure who received milrinone compared with placebo did not spend less time in hospital due to cardiovascular causes in the next 2 months.
  2. Patients given milrinone were more likely to develop new atrial fibrillation or flutter (NNH = 32 at 2 months) or have sustained hypotension (NNH = 13 at 2 months) .
Cuffe et al: JAMA 2002; 287 : 1541-1547
Expires June 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 78 acute hospitals, USA

951 patients (aged mean 65, 66% male) with an acute exacerbation of systolic heart failure (92% with baseline NYHA class III or IV; mean LV ejection fraction 23%)

Excluded if
  • requiring iv inotropic support
  • in hospital for > 48 hours
  • aged < 18
  • LV ejection fraction > 40%
  • active myocardial ischaemia within previous 3 months
  • atrial fibrillation with poor ventricular control rate (> 110 beats/min), or sustained VT or VF
  • systolic bp < 80 mmHg
  • serum creatinine > 265 micromol/l

Control Group: (n = 472, 472 analysed): placebo
Experimental Group: (n = 479, 477 analysed): milrinone 0.5 microg/kg/min adjusted if hypotension occured for at least 48 hours and up to 72 hours.

99.8% followed for 2 months

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNH
(95% CI)
new atrial fibrillation or flutter 2 months 7
(1.48%)		 22
(4.61%)		 -210%
(-620% to -34%)		 -3.13%
(-5.30% to -0.954%)		 32
(19 to 100)
sustained hypotension 2 months 15
(3.18%)		 51
(10.7%)		 -240%
(-490% to -92%)		 -7.51%
(-10.7% to -4.32%)		 13
(9 to 23)

Outcome Control Group
(SD)		 Experimental Group
(SD)		 Mean Difference
(95% CI)
days in hospital due to cardiovascular causes 12.5
(14.0) 		12.3
(14.1) 		0.2
(-1.6 to 2.0)

Citation

  1. Cuffe MS, Califf RM, Adams KF, et al: short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial (OPTIME-CHF). JAMA 2002; 287 : 1541-1547
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, June 2002
Reviewer:

Clinical Question.
Patient severe congestive heart failure
Intervention or Exposure milrinone
Comparison placebo
Outcome length of hospital stay, adverse effects