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Aprotinin for primary coronary artery bypass grafting: a multicenter trial of three dose regimens
J H Lemmer1, E W Dilling, J R Morton
1Good Samaritan Hospital, Portland, Oregon.
Insights
Low-dose aprotinin effectively reduces bleeding and transfusion needs in coronary artery bypass grafting (CABG) patients. However, it
Area of Science:
- Cardiovascular Surgery
- Pharmacology
Background:
- High-dose aprotinin is known to reduce transfusions in coronary artery bypass grafting (CABG).
- The safety and efficacy of lower aprotinin doses remain unclear.
- Optimal patient selection criteria for aprotinin use are not well-defined.
Purpose of the Study:
- To evaluate the safety and effectiveness of different aprotinin doses (high, low, pump-prime-only) compared to placebo in first-time CABG patients.
- To determine if aprotinin is indicated for patients at low risk of bleeding.
Main Methods:
- Seven hundred and four first-time CABG patients were randomized.
- Treatment groups included high-dose aprotinin, low-dose aprotinin, pump-prime-only aprotinin, and placebo.
- Patients were stratified based on their risk of excessive bleeding.
Main Results:
- All aprotinin doses significantly reduced bleeding and transfusion requirements.
- Efficacy was inconsistent in low-risk bleeding patients.
- No significant differences in mortality, renal failure, or stroke were observed; however, the pump-prime-only dose showed a slight increase in myocardial infarctions (p=0.045).
Conclusions:
- Low-dose and pump-prime-only aprotinin regimens offer similar bleeding and transfusion reductions as high-dose regimens.
- Aprotinin is not routinely recommended for first-time CABG patients at low risk for bleeding.
- The pump-prime-only dose is not advised due to a potential increase in myocardial infarctions.
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.