POISE-2 (clonidine)
Trial question
What is the role of clonidine in patients undergoing noncardiac surgery?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 10010
10010 patients (4727 female, 5283 male)
Inclusion criteria: patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery
Key exclusion criteria: hypersensitivity or known allergy to clonidine, active peptic ulcer disease, ICH in the 6 months before surgery, subarachnoid hemorrhage or epidural hematoma within 6 months, drug-eluting coronary stent < 1 year before surgery, or bare-metal coronary stent < 6 weeks before surgery
Interventions
N=5009 clonidine (0.2 mg/day just before surgery and continued until 72 hours after surgery)
N=5001 placebo (matching placebo per day just before surgery and continued until 72 hours after surgery)
Primary outcome
Death or nonfatal myocardial infarction at 30 days
7.3
6.8
7.3 %
5.5 %
3.6 %
1.8 %
0.0 %
Clonidine
Placebo
No significant
difference ↔
No significant difference in death or nonfatal myocardial infarction at 30 days (7.3% vs. 6.8%; HR 1.08, 95% CI 0.93 to 1.26)
Secondary outcomes
No significant difference in death, nonfatal myocardial infarction, or nonfatal stroke (7.6% vs. 7%; HR 1.08, 95% CI 0.93 to 1.25)
No significant difference in myocardial infarction (6.6% vs. 5.9%; HR 1.11, 95% CI 0.95 to 1.3)
Significant increase in nonfatal cardiac arrest (0.3% vs. 0.1%; HR 3.2, 95% CI 1.17 to 8.73)
Safety outcomes
Significant differences in clinically important hypotension (47/6% vs. 37.1, p < 0.001) and clinically important bradycardia (12.0% vs. 8.1%, p < 0.001).
Conclusion
In patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery, clonidine was not superior to placebo with respect to death or nonfatal myocardial infarction at 30 days.
Reference
Devereaux PJ, Mrkobrada M, Sessler DI et al. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503.
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