Analyses of coronary graft patency after aprotinin use: results from the International Multicenter Aprotinin Graft Patency Experience (IMAGE) trial.
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.
Alderman
E L
EL
Division of Cardiovascular Medicine, Stanford University Medical Center, Calif 94305, USA.
Levy
J H
JH
Rich
J B
JB
Nili
M
M
Vidne
B
B
Schaff
H
H
Uretzky
G
G
Pettersson
G
G
Thiis
J J
JJ
Hantler
C B
CB
Chaitman
B
B
Nadel
A
A
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D007611:Aprotinin / Q000008:administration & dosage / Q000009:adverse effects*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D016063:Blood Loss, Surgical / Q000517:prevention & control; D002315:Cardiopulmonary Bypass; D001026:Coronary Artery Bypass; D005260:Female; D006083:Graft Occlusion, Vascular / Q000139:chemically induced* / Q000401:mortality; D006490:Hemostatics / Q000008:administration & dosage / Q000009:adverse effects*; D006493:Heparin / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced* / Q000401:mortality; D012307:Risk Factors; D015996:Survival Rate; D014680:Veins / Q000637:transplantation
D000894:Anti-Inflammatory Agents, Non-Steroidal; D006490:Hemostatics; D006493:Heparin; D007611:Aprotinin; D001241:Aspirin