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.
RCT Entities:
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.
Authors: K Leslie; D McIlroy; J Kasza; A Forbes; A Kurz; J Khan; C S Meyhoff; R Allard; G Landoni; X Jara; G Lurati Buse; K Candiotti; H-S Lee; R Gupta; T VanHelder; W Purayil; S De Hert; T Treschan; P J Devereaux Journal: Br J Anaesth Date: 2015-07-25 Impact factor: 9.166
Authors: Patrizia Natale; Suetonia C Palmer; Valeria M Saglimbene; Marinella Ruospo; Mona Razavian; Jonathan C Craig; Meg J Jardine; Angela C Webster; Giovanni Fm Strippoli Journal: Cochrane Database Syst Rev Date: 2022-02-28
Authors: B M Biccard; A Sigamani; M T V Chan; D I Sessler; A Kurz; J G Tittley; T Rapanos; J Harlock; D Szalay; M E Tiboni; E Popova; S M Vásquez; B Kabon; M Amir; M Mrkobrada; B R Mehra; H El Beheiry; E Mata; B Tena; S Sabaté; M K Zainal Abidin; V R Shah; K Balasubramanian; P J Devereaux Journal: Br J Surg Date: 2018-07-18 Impact factor: 6.939
Authors: Jacob T Gutsche; Hynek Riha; Prakash Pate; Lance Atchley; Elizabeth Valentine; Ronak Shah; Sophia T Cisler; Stuart J Weiss; George Silvay; John G T Augoustides Journal: Heart Lung Vessel Date: 2015