ANALYSES OF CORONARY GRAFT PATENCY AFTER APROTININ USE - RESULTS FROMTHE INTERNATIONAL MULTICENTER APROTININ GRAFT PATENCY EXPERIENCE (IMAGE) TRIAL

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.