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.