Analyses of coronary graft patency after aprotinin use: Results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial

E. L. Alderman, J. H. Levy, J. B. Rich, M. Nili, B. Vidne, Hartzell V Schaff, G. Uretzky, G. Pettersson, J. J. Thiis, C. B. Hantler, B. Chaitman, A. Nadel, S. Westaby, B. Bidstrup, R. B. Griepp

Research output: Contribution to journalArticle

215 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)716-730
Number of pages15
JournalJournal of Thoracic and Cardiovascular Surgery
Volume116
Issue number5
DOIs
StatePublished - 1998
Externally publishedYes

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Aprotinin
Transplants
Placebos
Veins
Myocardial Infarction
Saphenous Vein
Cardiopulmonary Bypass
Aspirin
Drainage
Angiography
Electrocardiography
Thorax
Erythrocytes
Odds Ratio

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

Analyses of coronary graft patency after aprotinin use : Results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial. / Alderman, E. L.; Levy, J. H.; Rich, J. B.; Nili, M.; Vidne, B.; Schaff, Hartzell V; Uretzky, G.; Pettersson, G.; Thiis, J. J.; Hantler, C. B.; Chaitman, B.; Nadel, A.; Westaby, S.; Bidstrup, B.; Griepp, R. B.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 116, No. 5, 1998, p. 716-730.

Research output: Contribution to journalArticle

Alderman, EL, Levy, JH, Rich, JB, Nili, M, Vidne, B, Schaff, HV, Uretzky, G, Pettersson, G, Thiis, JJ, Hantler, CB, Chaitman, B, Nadel, A, Westaby, S, Bidstrup, B & Griepp, RB 1998, 'Analyses of coronary graft patency after aprotinin use: Results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial', Journal of Thoracic and Cardiovascular Surgery, vol. 116, no. 5, pp. 716-730. https://doi.org/10.1016/S0022-5223(98)00431-0
Alderman, E. L. ; Levy, J. H. ; Rich, J. B. ; Nili, M. ; Vidne, B. ; Schaff, Hartzell V ; Uretzky, G. ; Pettersson, G. ; Thiis, J. J. ; Hantler, C. B. ; Chaitman, B. ; Nadel, A. ; Westaby, S. ; Bidstrup, B. ; Griepp, R. B. / Analyses of coronary graft patency after aprotinin use : Results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial. In: Journal of Thoracic and Cardiovascular Surgery. 1998 ; Vol. 116, No. 5. pp. 716-730.
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abstract = "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.",
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T1 - Analyses of coronary graft patency after aprotinin use

T2 - Results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial

AU - Alderman, E. L.

AU - Levy, J. H.

AU - Rich, J. B.

AU - Nili, M.

AU - Vidne, B.

AU - Schaff, Hartzell V

AU - Uretzky, G.

AU - Pettersson, G.

AU - Thiis, J. J.

AU - Hantler, C. B.

AU - Chaitman, B.

AU - Nadel, A.

AU - Westaby, S.

AU - Bidstrup, B.

AU - Griepp, R. B.

PY - 1998

Y1 - 1998

N2 - 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.

AB - 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.

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