POISE-2 (aspirin)
Trial question
What is the role of aspirin 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 undergoing noncardiac surgery who were at risk for vascular complications.
Key exclusion criteria: hypersensitivity or known allergy to aspirin, consumption of aspirin within 72 hours prior to surgery, SBP < 105 m Hg, active peptic ulcer disease or gastrointestinal bleeding within 6 weeks before surgery, undergoing intracranial surgery, carotid endarterectomy, or retinal surgery.
Interventions
N=4998 aspirin (at a dose of 200 mg before surgery and continued daily at a dose of 100 mg for 30 days in the initiation stratum and for 7 days in the continuation stratum).
N=5012 placebo (matching dose).
Primary outcome
Death or nonfatal MI at 30 days
7%
7.1%
7.1 %
5.3 %
3.5 %
1.8 %
0.0 %
Aspirin
Placebo
No significant
difference ↔
No significant difference in death or nonfatal MI at 30 days (7% vs. 7.1%; HR 0.99, 99% CI 0.86 to 1.15).
Secondary outcomes
No significant difference in MI (6.2% vs. 6.3%; HR 0.98, 95% CI 0.84 to 1.15).
Safety outcomes
Significant differences in major bleeding (4.6% vs. 3.8%, p = 0.04; HR 1.23, 95% CI 1.01 - 1.49).
Conclusion
In patients undergoing noncardiac surgery who were at risk for vascular complications, aspirin was not superior to placebo with respect to death or nonfatal MI 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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