faculty

Publications

Rationale, design, and organisation of the PeriOperative Ischemic Evaluation (POISE) trial: a randomised controlled trial of metoprolol versus placebo in patients undergoing noncardiac surgery

Groups and Associations 14. Devereaux PJ, Yang H, Guyatt GH, P. Pais, D. Xavier, Yusuf S, et al
American Heart Journal 2006

Background

Noncardiac surgery is associated with significant cardiovascular mortality, morbidity, and cost. Small trials of β-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 β-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 10 000 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 β-blocker therapy in patients undergoing noncardiac surgery.