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document
Aspirin in patients undergoing noncardiac surgery . BACKGROUND There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery , both among patients who are already on an aspirin regimen and among those who are not . METHODS Using a 2-by-2 factorial trial design , we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo . The results of the aspirin trial are reported here . The patients were stratified according to whether they had not been taking aspirin before the study ( initiation stratum , with 5628 patients ) or they were already on an aspirin regimen ( continuation stratum , with 4382 patients ) . Patients started taking aspirin ( at a dose of 200 mg ) or placebo just before surgery and continued it daily ( at a dose of 100 mg ) for 30 days in the initiation stratum and for 7 days in the continuation stratum , after which patients resumed their regular aspirin regimen . The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days . RESULTS The primary outcome occurred in 351 of 4998 patients ( 7.0 % ) in the aspirin group and in 355 of 5012 patients ( 7.1 % ) in the placebo group ( hazard ratio in the aspirin group , 0.99 ; 95 % confidence interval [ CI ] , 0.86 to 1.15 ; P=0.92 ) . Major bleeding was more common in the aspirin group than in the placebo group ( 230 patients [ 4.6 % ] vs. 188 patients [ 3.8 % ] ; hazard ratio , 1.23 ; 95 % CI , 1.01 , to 1.49 ; P=0.04 ) . The primary and secondary outcome results were similar in the two aspirin strata . CONCLUSIONS Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding . ( Funded by the Canadian Institutes of Health Research and others ; POISE-2 ClinicalTrials.gov number , NCT01082874 . ) .
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Intervention_Pharmacological
Aspirin
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Intervention_Pharmacological
aspirin
64633
Intervention_Pharmacological
aspirin
64634
Intervention_Pharmacological
aspirin
64635
Intervention_Control
placebo
64636
Intervention_Pharmacological
aspirin
64637
Intervention_Pharmacological
aspirin
64638
Intervention_Pharmacological
aspirin
64639
Intervention_Pharmacological
aspirin
64640
Intervention_Control
placebo
64641
Intervention_Pharmacological
aspirin
64642
Intervention_Pharmacological
aspirin
64643
Intervention_Control
placebo
64644
Intervention_Control
placebo
64645
Intervention_Pharmacological
aspirin
64646
Intervention_Pharmacological
aspirin
64647
Outcome_Mortality
composite of death
64648
Outcome_Physical
nonfatal myocardial infarction
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Outcome_Physical
Major bleeding
64650
Outcome_Mortality
rate of a composite of death
64651
Outcome_Physical
nonfatal myocardial infarction
64652
Outcome_Physical
major bleeding
64653
Participant_Condition
patients undergoing noncardiac surgery .
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Participant_Condition
patients undergoing noncardiac surgery
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Participant_Condition
patients who are already on an aspirin regimen and among those who are not .