Effect of adenosine-regulating agent acadesine on morbidity and mortality associated with coronary artery bypass grafting: the RED-CABG randomized controlled trial.
JAMA
; 308(2): 157-64, 2012 Jul 11.
Article
em En
| MEDLINE
| ID: mdl-22782417
ABSTRACT
CONTEXT Ischemia/reperfusion injury remains an important cause of morbidity and mortality after coronary artery bypass graft (CABG) surgery. In a meta-analysis of randomized controlled trials, perioperative and postoperative infusion of acadesine, a first-in-class adenosine-regulating agent, was associated with a reduction in early cardiac death, myocardial infarction, and combined adverse cardiac outcomes in participants undergoing on-pump CABG surgery. OBJECTIVE:
To assess the efficacy and safety of acadesine administered in the perioperative period in reducing all-cause mortality, nonfatal stroke, and severe left ventricular dysfunction (SLVD) through 28 days. DESIGN, SETTING, ANDPARTICIPANTS:
The Reduction in Cardiovascular Events by Acadesine in Patients Undergoing CABG (RED-CABG) trial, a randomized, double-blind, placebo-controlled, parallel-group evaluation of intermediate- to high-risk patients (median age, 66 years) undergoing nonemergency, on-pump CABG surgery at 300 sites in 7 countries. Enrollment occurred from May 6, 2009, to July 30, 2010.INTERVENTIONS:
Eligible participants were randomized 11 to receive acadesine (0.1 mg/kg per minute for 7 hours) or placebo (both also added to cardioplegic solutions) beginning just before anesthesia induction. MAIN OUTCOMEMEASURE:
Composite of all-cause mortality, nonfatal stroke, or need for mechanical support for SLVD during and following CABG surgery through postoperative day 28.RESULTS:
Because results of a prespecified futility analysis indicated a very low likelihood of a statistically significant efficacious outcome, the trial was stopped after 3080 of the originally projected 7500 study participants were randomized. The primary outcome occurred in 75 of 1493 participants (5.0%) in the placebo group and 76 of 1493 (5.1%) in the acadesine group (odds ratio, 1.01 [95% CI, 0.73-1.41]). There were no differences in key secondary end points measured.CONCLUSION:
In this population of intermediate- to high-risk patients undergoing CABG surgery, acadesine did not reduce the composite of all-cause mortality, nonfatal stroke, or SLVD. TRIAL REGISTRATION clinicaltrials.gov Identifier NCT00872001.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ribonucleosídeos
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Traumatismo por Reperfusão
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Adenosina
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Ponte de Artéria Coronária
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Aminoimidazol Carboxamida
Tipo de estudo:
Clinical_trials
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Risk_factors_studies
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Systematic_reviews
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
JAMA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Estados Unidos