El. Alderman et al., ANALYSES OF CORONARY GRAFT PATENCY AFTER APROTININ USE - RESULTS FROMTHE INTERNATIONAL MULTICENTER APROTININ GRAFT PATENCY EXPERIENCE (IMAGE) TRIAL, Journal of thoracic and cardiovascular surgery, 116(5), 1998, pp. 716-729
Objective: We examined the effects of aprotinin on graft patency, prev
alence of myocardial infarction? and blood loss in patients undergoing
primary coronary surgery with cardiopulmonary bypass. Methods: Patien
ts from 13 international sites were randomized to receive intraoperati
ve aprotinin (n = 436) or placebo (n = 434). Graft angiography was obt
ained a mean of 10.8 days after the operation. Electrocardiograms, car
diac 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 v
ersus placebo risk ratio decreased from 1.7 to 1.05 (90% confidence in
terval, 0.6 to 1.8). These factors included female gender, lack of pri
or aspirin therapy, small and poor distal vessel quality, and possibly
use of aprotinin-treated blood as excised vein perfusate, At United S
tates sites, patients had characteristics more favorable for graft pat
ency, 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 pat
ients had more adverse characteristics, occlusions occurred in 23.0% o
f aprotinin- and 12.4% of placebo-treated patients (P = .01). Aprotini
n did not affect the occurrence of myocardial infarction (aprotinin: 2
.9%; placebo: 3.8%) or mortality (aprotinin: 1.4%; placebo: 1.6%). Con
clusions: 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.