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Ann Thorac Surg 1996;62:1575-1577
© 1996 The Society of Thoracic Surgeons
Division of Thoracic Surgery, Department of Surgery, and Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina
| The first 20% of the full text of this article appears below. |
Although the efficacy of aprotinin in reducing transfusion requirements has been demonstrated for many subsets of cardiac surgical patients, the indications for its use remain controversial. There have been concerns regarding heparin management and safety since the initial United States randomized trial results were reported in 1992 [1]. Thoracic surgeons are also aware of safety concerns when aprotinin is employed with profound hypothermia and circulatory arrest [2, 3].
In this issue, Lemmer and associates [4] report the results achieved in the fourth published United States randomized, double-blind, placebo-controlled trial designed to establish the effectiveness of aprotinin in coronary artery bypass grafting (CABG). Both Food and Drug Administration-approved dosing schemes (regimen A, full-dose "Hammersmith"; regimen B, half-dose) as well as a nonapproved pump-prime–only dosing scheme were shown to be effective in reducing blood and blood component use in primary CABG. They noted no significant difference in myocardial infarction rate, as determined by a central laboratory using predefined enzyme and electrocardiographic criteria, when comparing full-dose and half-dose aprotinin with placebo. A significantly increased rate of the most sensitive expression of myocardial infarction (definite, probable, or possible) was noted in the pump-prime–only arm compared with placebo. There were no statistically significant differences in mortality.
See also page 1659.
As Lemmer and associates point out, it is perhaps not surprising that a nonlinear dose-response curve could exist for aprotinin. The drug appears to act in a complicated way to alter the balance of procoagulant and anticoagulant enzyme cascades as they are effected by operation and cardiopulmonary bypass. Currently available information reveals that
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