Rationale and design of the PeriOperative ISchemic Evaluation-2 (POISE-2) trial: an international 2 × 2 factorial randomized controlled trial of acetyl-salicylic acid vs. placebo and clonidine vs. placebo in patients undergoing noncardiac surgery

Am Heart J. 2014 Jun;167(6):804-9.e4. doi: 10.1016/j.ahj.2014.01.007. Epub 2014 Feb 22.

Abstract

Background: Worldwide, 200 million adults undergo major noncardiac surgery annually, and 10 million of these patients will have a major vascular complication. Low-dose clonidine and low-dose acetyl-salicylic acid (ASA) may prevent major perioperative vascular complications. We therefore initiated the POISE-2 trial to establish the perioperative effects of these 2 interventions.

Methods: The POISE-2 trial is a 2 × 2 factorial randomized controlled trial of low-dose ASA vs. placebo and low-dose clonidine vs. placebo in 10,000 patients at risk for a perioperative cardiovascular event who are undergoing noncardiac surgery. Both study drugs are initiated prior to surgery (goal 2-4 hours) and are continued after surgery. Patients, health care providers, data collectors, and outcome adjudicators are blinded to treatment allocation. The primary outcome is a composite of mortality and nonfatal myocardial infarction at 30 days after randomization.

Results: To date, the POISE-2 trial has recruited more than 9,000 patients from 135 centers in 23 countries. Among the first 7,500 patients recruited, patients' mean age was 68.2 years, 53.4% were male, 34.0% had a history of vascular disease, and 38.3% had diabetes that was treated. Participants had orthopedic (38.1%), general (27.0%), urologic or gynecologic (17.2%), vascular (6.6%), thoracic (5.7%), and other (5.4%) surgery.

Conclusions: POISE-2 is a large international trial that will rigorously evaluate the effects of low-dose clonidine and ASA in patients having noncardiac surgery.

Trial registration: ClinicalTrials.gov NCT01082874.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aspirin / therapeutic use*
  • Clonidine / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Intraoperative Complications / prevention & control*
  • Male
  • Middle Aged
  • Myocardial Infarction / prevention & control*
  • Myocardial Ischemia / prevention & control
  • Perioperative Care / methods*
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Postoperative Complications / prevention & control*
  • Surgical Procedures, Operative*
  • Sympatholytics / therapeutic use*

Substances

  • Platelet Aggregation Inhibitors
  • Sympatholytics
  • Clonidine
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT01082874