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Aspirin in Patients Undergoing Noncardiac Surgery
- Source :
- NEW ENGLAND JOURNAL OF MEDICINE, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname
- Publication Year :
- 2014
- Publisher :
- MASSACHUSETTS MEDICAL SOC, 2014.
-
Abstract
- 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.) Copyright © 2014 Massachusetts Medical Society.
- Subjects :
- Male
Myocardial Infarction
Kaplan-Meier Estimate
noncardiac surgery
postoperative period
law.invention
low drug dose
hazard ratio
Postoperative Complications
Randomized controlled trial
law
Myocardial infarction
Treatment Failure
Aspirin
Medicine (all)
Hazard ratio
drug effect
article
risk assessment
General Medicine
Middle Aged
female
priority journal
Anesthesia
drug withdrawal
factorial design
Surgical Procedures, Operative
Platelet aggregation inhibitor
Female
medicine.drug
hospitalization
heart infarction
perioperative period
preoperative treatment
Postoperative Hemorrhage
Perioperative Care
length of stay
death
medicine
Humans
follow up
controlled study
human
clonidine
outcome assessment
Aged
treatment duration
Vascular disease
business.industry
Platelet Aggregation Inhibitor
patient care
acetylsalicylic acid
medicine.disease
bleeding
major clinical study
Confidence interval
purl.org/pe-repo/ocde/ford#3.02.00 [https]
Clinical research
multicenter study
randomized controlled trial
placebo
Postoperative Complication
business
Platelet Aggregation Inhibitors
Subjects
Details
- ISSN :
- 00284793
- Database :
- OpenAIRE
- Journal :
- NEW ENGLAND JOURNAL OF MEDICINE, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, instname
- Accession number :
- edsair.doi.dedup.....b8fcb032dcd7b9a88545ca66c9dbb554