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J Thorac Cardiovasc Surg 1995;110:1096-1106
© 1995 Mosby, Inc.
CARDIOPULMONARY BYPASS, MYOCARDIAL MANAGEMENT, |
Paris, France, Birmingham, United Kingdom, Leuven, Belgium
Paris, France, Vancouver, B.C., Canada,
Supported by a grant from Gensia, Inc., San Diego, Calif.
Presented in part, in abstract form, at the 1993 Annual Meeting of the American College of Cardiology, Anaheim, Calif., and the Fifteenth Congress of the European Society of Cardiology, 1993, Nice, France.
Received for publication April 20, 1994. Accepted for publication Jan. 9, 1995. Address for reprints: Philippe Menashé, MD, PhD, Service de Chirurgie Cardio-Vasculaire, Hôpital Lariboisière, 2, Rue Ambroise-Paré, 75475 Paris, France
Abstract
The effect of acadesine, an adenosine-regulating agent, on the incidence of myocardial infarction, all adverse cardiovascular outcomes (myocardial infarction, cardiac death, left ventricular dysfunction, life-threatening arrhythmia, or cerebrovascular accident) and mortality was assessed in 821 patients undergoing coronary artery bypass grafting. Patients were prospectively stratified to a high-risk group (age>70 years, unstable angina, previous coronary bypass, unsuccessful angioplasty, or ejection fraction<30%) or a non-high-risk group. They were randomized in a double-blind manner to placebo (n = 418) or acadesine (n = 403) by intravenous infusion over 7 hours (0.1 mg/kg per minute) and in the cardioplegic solution (placebo or acadesine; 5µg/ml). Acadesine did not significantly affect the incidence of myocardial infarction in the overall study population, but it significantly reduced the incidence of Q-wave myocardial infarction in high-risk patients (placebo, 19.7%; acadesine, 10.0%; p= 0.032). The incidences of all adverse cardiovascular outcomes (placebo, 19.4%; acadesine, 18.4%) and overall mortality (placebo, 3.4%; acadesine, 2.7%) were similar between the two treatment groups. However, acadesine reduced the incidence of cardiac related events that contributed to deaths occurring during the first 3 postoperative days so that the incidence of death in this period was lower (placebo, 1.9%; acadesine, 0.2%; p= 0.038). No adverse events were related to acadesine treatment. Although overall there were no statistically significant between-group differences for the primary study end points, a secondary analysis in a prospectively defined high-risk subgroup suggests that acadesine may be beneficial in some patients. (J THORAC CARDIOVASC SURG 1995;110:1096-106)
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