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Aprotinin for Primary Coronary Artery Bypass Grafting: A Multicenter Trial of Three Dose Regimens |
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| Authors: | John H. Lemmer Emery W. Dilling Jeremy R. Morton Jeffrey B. Rich Francis Robicsek Donald L. Bricker Charles B. Hantler Jack G. Copeland III John L. Ochsner Pat O. Daily Charles W. Whitten George P. Noon Rosemarie Maddi |
| Affiliation: | Good Samaritan Hospital, Portland, Oregon, USA Cardiothoracic and Vascular Surgeons, Austin, Texas, USA Heart and Lung Surgical Associates, Portland, Maine, USA Sentara Norfolk General Hospital, Norfolk, Virginia, USA The Carolinas Heart Institute, Charlotte, North Carolina, USA Southwestern Cardiovascular Surgical Associates, Lubbock, Texas, USA University of Texas Health Science Center, San Antonio, Texas, USA University of Arizona College of Medicine, Tucson, Arizona, USA Ochsner Clinic, New Orleans, Louisiana, USA Sharp Memorial Hospital, San Diego, California, USA University of Texas Southwestern Medical Center, Dallas, Texas, USA Baylor College of Medicine, Houston, Texas, USA Brigham and Women's Hospital, Boston, Massachusetts, USA |
| Abstract: | Background. High-dose aprotinin reduces transfusion requirements in patients undergoing coronary artery bypass grafting, but the safety and effectiveness of smaller doses is unclear. Furthermore, patient selection criteria for optimal use of the drug are not well defined. Methods. Seven hundred and four first-time coronary artery bypass grafting patients were randomized to receive one of three doses of aprotinin (high, low, and pump-prime-only) or placebo. The patients were stratified as to risk of excessive bleeding. Results. All three aprotinin doses were highly effective in reducing bleeding and transfusion requirements. Consistent efficacy was not, however, demonstrated in the subgroup of patients at low risk for bleeding. There were no differences in mortality or the incidences of renal failure, strokes, or definite myocardial infarctions between the groups, although the pump-prime-only dose was associated with a small increase in definite, probable, or possible myocardial infarctions (p = 0.045). Conclusions. Low-dose and pump-prime-only aprotinin regimens provide reductions in bleeding and transfusion requirements that are similar to those of high-dose regimens. Although safe, aprotinin is not routinely indicated for the first-time coronary artery bypass grafting patient who is at low risk for postoperative bleeding. The pump-prime-only dose is not currently recommended because of a possible association with more frequent myocardial infarctions. |
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