POISE 1
Trial question
What is the effect of extended-release metoprolol succinate in patients undergoing noncardiac surgery?
Study design
Multi-center
Quadruple blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 8351
8351 patients (3058 female, 5293 male).
Inclusion criteria: patients with, or at risk of, atherosclerotic disease who were undergoing noncardiac surgery.
Key exclusion criteria: HR under 50 beats/min; second or third-degree heart block; asthma; receiving a β-blocker; prior adverse reaction to a β-blocker; CABG surgery in the preceding 5 years and no cardiac ischemia since.
Interventions
N=4174 metoprolol succinate (oral extended-release 100 mg daily 2-4 hours before surgery).
N=4177 placebo (matching placebo 2-4 hours before surgery).
Primary outcome
CV death, nonfatal MI, or nonfatal cardiac arrest, at 30 days
5.8%
6.9%
6.9 %
5.2 %
3.5 %
1.7 %
0.0 %
Metoprolol
succinate
Placebo
Significant
decrease ▼
NNT = 90
Significant decrease in CV death, nonfatal MI, or nonfatal cardiac arrest, at 30 days (5.8% vs. 6.9%; HR 0.84, 95% CI 0.7 to 0.99).
Secondary outcomes
Significant decrease in MI (4.2% vs. 5.7%; HR 0.73, 95% CI 0.6 to 0.89).
Significant increase in death (3.1% vs. 2.3%; HR 1.33, 95% CI 1.03 to 1.74).
Significant increase in stroke (1% vs. 0.5%; HR 2.17, 95% CI 1.26 to 3.74).
Safety outcomes
Significant differences in clinically significant hypotension (15.0% vs. 9.7%, p < 0.0001) and bradycardia (6.6% vs. 2.4%, p < 0.0001).
Conclusion
In patients with, or at risk of, atherosclerotic disease who were undergoing noncardiac surgery, metoprolol succinate was superior to placebo with respect to CV death, nonfatal MI, or nonfatal cardiac arrest, at 30 days.
Reference
POISE Study Group, P J Devereaux, Homer Yang et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47.
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