Pii: S1010-7940(02)00433-5

Objective: Effects of aprotinin in off-pump coronary artery bypass (OPCAB) surgery have not yet been described. This study analyses hemostasiologic changes and potential benefit in OPCAB patients treated with aprotinin. Methods: In a prospective, double-blind, randomized study 47 patients undergoing OPCAB surgery were investigated. Patients received either aprotinin (2 £ 10 KIU loading dose and 0.5 £ 10 KIU/h during surgery, n 1⁄4 22) or saline solution (control, n 1⁄4 25). Activated clotting time was adjusted to a target of 250 s intraoperatively. Blood samples were taken up to 18 h postoperatively: complete hematologic and hemostasiologic parameters including fibrinopeptide A (FPA) and D-dimer in a subgroup of 31 patients were analyzed. Blood loss, blood transfusion and other clinical data were collected. Results: Both groups showed comparable demographic and intraoperative variables. Forty-one (87%) patients of the whole study group received aspirin within 7 days prior to surgery. Number of grafts per patient were comparable (2.9 ^ 1.0 [mean ^ SD] in the aprotinin group and 2.8 ^ 1.2 in control, P 1⁄4 0:83). Blood loss during the first 18 h in intensive care unit was significantly reduced in patients treated with aprotinin (median [25th–75th percentiles]: 500 [395–755] ml vs. 930 [800–1170] ml, P , 0:001). Postoperatively only two patients (10%) in the aprotinin group received packed red blood cells, whereas eight (35%) in the control group ðP 1⁄4 0:07Þ. Perioperatively FPA levels reflecting thrombin generation were elevated in both groups. The increase in D-dimer levels after surgery was significantly inhibited in the aprotinin group ðP , 0:001Þ. Early clinical outcome was similar in both groups. Conclusions: Aprotinin significantly reduces blood loss in patients undergoing OPCAB surgery. Inhibition of enhanced fibrinolysis can be observed. FPA generation during and after OPCAB surgery seems not to be influenced by aprotinin. q 2002 Elsevier Science B.V. All rights reserved.