Rationale, design, and organization of the PeriOperative ISchemic Evaluation (POISE) trial: a randomized controlled trial of metoprolol versus placebo in patients undergoing noncardiac surgery.
BACKGROUND
Noncardiac surgery is associated with significant cardiovascular mortality, morbidity, and cost. Small trials of beta-blockers suggest that they may prevent cardiovascular events in patients undergoing noncardiac surgery, but trial results are inconclusive. We have initiated the POISE trial to definitively establish the effects of beta-blocker therapy in patients undergoing noncardiac surgery.


METHODS
The POISE trial is a blinded, randomized, and controlled trial of controlled-release metoprolol versus placebo in 10000 patients at risk for a perioperative cardiovascular event who are undergoing noncardiac surgery. Patients will receive the study drug 2 to 4 hours before surgery and subsequently for 30 days. The primary outcome is a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal cardiac arrest at 30 days. Patients will also be followed for events at 1 year.


RESULTS
To date, the POISE trial has recruited >6300 patients in 182 centers in 21 countries. Currently, the patients' mean age is 69 years; 63% are males, 43% have a history of coronary artery disease, 43% have a history of peripheral arterial disease, and 30% have diabetes. Most participants have undergone vascular (42%), intraabdominal (23%), or orthopedic (19%) surgery.


CONCLUSIONS
The POISE trial is a large international trial that will provide a reliable assessment of the effects of beta-blocker therapy in patients undergoing noncardiac surgery.
Faculty of Health Sciences, Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. philipj@mcmaster.ca
Devereaux
P J
PJ
Yang
Homer
H
Guyatt
Gordon H
GH
Leslie
Kate
K
Villar
Juan Carlos
JC
Monteri
Victor M
VM
Choi
Peter
P
Giles
Julian W
JW
Yusuf
Salim
S
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D003692:Delayed-Action Preparations; D004066:Digestive System Diseases / Q000453:epidemiology; D005260:Female; D006323:Heart Arrest / Q000453:epidemiology; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008790:Metoprolol / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000453:epidemiology; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D014652:Vascular Diseases / Q000453:epidemiology
D000319:Adrenergic beta-Antagonists; D003692:Delayed-Action Preparations; D008790:Metoprolol