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The Journal of Thoracic and Cardiovascular Surgery, Vol 116, 716-730, Copyright © 1998 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
EL Alderman, JH Levy, JB Rich, M Nili, B Vidne, H Schaff, G Uretzky, G Pettersson, JJ Thiis, CB Hantler, B Chaitman and A Nadel
OBJECTIVE: We examined the effects of aprotinin on graft patency,
prevalence of myocardial infarction, and blood loss in patients undergoing
primary coronary surgery with cardiopulmonary bypass. METHODS: Patients
from 13 international sites were randomized to receive intraoperative
aprotinin (n = 436) or placebo (n = 434). Graft angiography was obtained a
mean of 10.8 days after the operation. Electrocardiograms, cardiac enzymes,
and blood loss and replacement were evaluated. RESULTS: In 796 assessable
patients, aprotinin reduced thoracic drainage volume by 43% (P < .0001)
and requirement for red blood cell administration by 49% (P < .0001).
Among 703 patients with assessable saphenous vein grafts, occlusions
occurred in 15.4% of aprotinin-treated patients and 10.9% of patients
receiving placebo (P = .03). After we had adjusted for risk factors
associated with vein graft occlusion, the aprotinin versus placebo risk
ratio decreased from 1.7 to 1.05 (90% confidence interval, 0.6 to 1.8).
These factors included female gender, lack of prior aspirin therapy, small
and poor distal vessel quality, and possibly use of aprotinin-treated blood
as excised vein perfusate. At United States sites, patients had
characteristics more favorable for graft patency, and occlusions occurred
in 9.4% of the aprotinin group and 9.5% of the placebo group (P = .72). At
Danish and Israeli sites, where patients had more adverse characteristics,
occlusions occurred in 23.0% of aprotinin- and 12.4% of placebo-treated
patients (P = .01). Aprotinin did not affect the occurrence of myocardial
infarction (aprotinin: 2.9%; placebo: 3.8%) or mortality (aprotinin: 1.4%;
placebo: 1.6%). CONCLUSIONS: In this study, the probability of early vein
graft occlusion was increased by aprotinin, but this outcome was promoted
by multiple risk factors for graft occlusion.
ARTICLES
Analyses of coronary graft patency after aprotinin use: results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial
Division of Cardiovascular Medicine, Stanford University Medical Center, Calif 94305, USA.
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G. A. Nuttall, D. N. Fass, L. J. Oyen, W. C. Oliver Jr., and M. H. Ereth A Study of a Weight-Adjusted Aprotinin Dosing Schedule During Cardiac Surgery Anesth. Analg., February 1, 2002; 94(2): 283 - 289. [Abstract] [Full Text] [PDF]
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J. M. Murkin, J. Maurer, and S. Niemcryk Full dose aprotinin administration is associated with a significant decrease in perioperative stroke in patients undergoing elective cardiac surgery: a meta-analysis Ann. Thorac. Surg., January 1, 2002; 73(1): S374 - 374. [Full Text] [PDF]
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J. M. Murkin Adverse Central Nervous System Outcomes After Cardiopulmonary Bypass: A Beneficial Effect of Aprotinin? Seminars in Cardiothoracic and Vascular Anesthesia, November 1, 2001; 5(4): 282 - 285. [Abstract] [PDF]
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R. C. Landis, D. O. Haskard, and K. M. Taylor New antiinflammatory and platelet-preserving effects of aprotinin Ann. Thorac. Surg., November 1, 2001; 72(5): S1808 - 1813. [Abstract] [Full Text] [PDF]
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J. H. Levy Pharmacologic preservation of the hemostatic system during cardiac surgery Ann. Thorac. Surg., November 1, 2001; 72(5): S1814 - 1820. [Abstract] [Full Text] [PDF]
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