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John H. Lemmer, Jr
Emery W. Dilling
Jeremy R. Morton
Jeffrey B. Rich
Francis Robicsek
Jack G. Copeland, III
John L. Ochsner
Pat O. Daily
George P. Noon
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Ann Thorac Surg 1996;62:1659-1668
© 1996 The Society of Thoracic Surgeons

Original Articles: Cardiovascular

Aprotinin for Primary Coronary Artery Bypass Grafting: A Multicenter Trial of Three Dose Regimens

John H. Lemmer, Jr, MD, Emery W. Dilling, MD, Jeremy R. Morton, MD, Jeffrey B. Rich, MD, Francis Robicsek, MD, Donald L. Bricker, MD, Charles B. Hantler, MD, Jack G. Copeland, III, MD, John L. Ochsner, MD, Pat O. Daily, MD, Charles W. Whitten, MD, George P. Noon, MD, Rosemarie Maddi, MD

Good Samaritan Hospital, Portland, Oregon; Cardiothoracic and Vascular Surgeons, Austin, Texas; Heart and Lung Surgical Associates, Portland, Maine; Sentara Norfolk General Hospital, Norfolk, Virginia; The Carolinas Heart Institute, Charlotte, North Carolina; Southwestern Cardiovascular Surgical Associates, Lubbock, Texas; University of Texas Health Science Center, San Antonio, Texas; University of Arizona College of Medicine, Tucson, Arizona; Ochsner Clinic, New Orleans, Louisiana; Sharp Memorial Hospital, San Diego, California; University of Texas Southwestern Medical Center, Dallas, Texas; Baylor College of Medicine, Houston, Texas; and Brigham and Women's Hospital, Boston, Massachusetts

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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Discussion
Ann. Thorac. Surg. 1996 62: 1667-1668. [Extract] [Full Text]



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