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POISE-2. P eri O perative IS chemic E valuation- 2 Trial. Aspirin in Patients Undergoing Noncardiac Surgery. PJ Devereaux, Population Health Research Institute, Hamilton, Canada on behalf of POISE-2 Investigators. Background. Worldwide 200 million adults have noncardiac surgery annually
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POISE-2 PeriOperative ISchemic Evaluation-2 Trial Aspirin in Patients Undergoing Noncardiac Surgery PJ Devereaux, Population Health Research Institute, Hamilton, Canada on behalf of POISE-2 Investigators
Background Worldwide 200 million adults have noncardiac surgery annually 10 million suffer major vascular complication MI is most common Surgery – associated with platelet activation thrombosis may be mechanism of periop MI Substantial variability in periop usage of aspirin aspirin-naive pts and pts taking aspirin chronically
Methods Design – blinded RCT, 135 centres in 23 countries Eligibility criteria –undergoing noncardiac surgery, ≥45 yrs, at risk of vascular complication Recruitment –10,010 pts, July 2010 to Dec 2013 2 aspirin strata - Starting Stratum (n=5628), Continuation Stratum (n=4382) Intervention - aspirin/placebo (200 mg) just before surgery; continued daily (100 mg) 30 days in Starting and 7 days in Continuation Stratum Primary outcome: composite of death and nonfatal MI at 30 days
Results Primary and 2nd outcome results similar in both aspirin strata 65% of patients received prophylactic anticoag Multivariable regression – life-threatening or major bleed independent predictor of periop MI HR, 1.82; (95% CI, 1.40-2.36); P<0.001 Post-hoc analyses suggest 1.0-1.3% absolute increase in life-threatening or major bleeding if aspirin started within 2 days after Sx risk decreases to 0.3% if started on day 8 after surgery
Conclusions Perioperative aspirin did not prevent death or MI but increased risk of major bleeding Primary and 2nd outcome results consistent both aspirin strata Life-threatening and major bleeding independent predictor of MI Optimal time to restart aspirin 8 – 10 days after surgery