Heparin versus danaparoid in off-pump coronary bypass grafting: Results of a prospective randomized clinical trial

Abstract

Objective: The incidence of heparin-induced thrombocytopenia is increasing, and the thrombin inhibitor danaparoid could be a useful alternative. The objective of the present study was to compare danaparoid and heparin in patients undergoing off-pump coronary artery bypass grafting. Methods: In a prospective, randomized, double-blind clinical trial comparing heparin (bolus of 1 mg/kg) with danaparoid (bolus of 40 U/kg), 71 patients underwent off-pump coronary artery bypass grafting with one of the study drugs. The amount of blood lost, the number of homologous blood products transfused, the troponin T levels, and the amount of anti-Xa activity were monitored. Results: Thirty-four patients underwent 2.6 ± 0.7 bypasses with danaparoid, and 37 patients underwent 2.5 ± 0.9 grafts with heparin (P =.8). Postoperative blood losses averaged 1394 ± 1033 mL in patients receiving danaparoid and 1130 ± 868 mL in patients receiving heparin (P =.2). The number of homologous blood products transfused averaged 3.6 ± 7 units in patients receiving danaparoid and 1.9 ± 4.4 units in patients receiving heparin (P =.2). The number of patients requiring homologous blood transfusion was higher in patients receiving danaparoid (18/34 [53%]) than in patients receiving heparin (10/37 [27%], P =.03). Serum anti-Xa activity averaged 1.6 ± 0.6 U/mL in patients receiving danaparoid and 1.9 ± 0.8 U/mL in patients receiving heparin 30 minutes after injection of the drugs (P =.1) and 0.3 ± 0.1 and 0.04 ± 0.08 U/mL, respectively, 12 hours after coronary artery bypass grafting (P =.001). Troponin serum levels were similar 48 hours after coronary artery bypass grafting (0.5 ± 0.6 and 0.4 ± 0.6 μg/L, respectively). Conclusion: Although off-pump coronary artery bypass grafting with danaparoid versus heparin increases the number of patients exposed to homologous blood transfusion (relative risk, 2; 95% confidence limits, 1-4), off-pump coronary artery bypass grafting with danaparoid is a valuable alternative to heparin in patients with thrombocytopenia requiring surgical intervention.J Thorac Cardiovasc Surg 2003;125:325-9