To compare the haemostatic effects of fibrinolytic inhibitors (tranexamic acid, aprotinin) vs. placebo in off-pump coronary artery bypass surgery and to evaluate the impact of this therapy on cost-effectiveness.
Prospective, randomized, double-blind study.
University Teaching Hospital, Prague, Czech Republic.
Material and Method:
100 patients were enrolled in the study and 91 of them were assessed (group A, n = 32, tranexamic acid 1 g before skin incision followed by continuous infusion at 200 mg/h; group B, n = 29, aprotinin 1,000,000 IU before skin incision and 250,000 IU/h afterwards; group C, n = 30, placebo).
Highly significant inter-group differences were found in the cumulative blood loss within 4 h (geometric means [95% confidence intervals] – group A: 89.3 [72.7, 109.8] mL, group B: 72.3 [49.2, 106.3] mL and group C: 192.3 [151.8, 243.5] mL) (P < 0.001), within 8 h (group A: 152.1 [120.7, 191.6] mL, group B: 130.3 [88.1, 192.8] mL and group C: 283.8 [226.0, 356.3] mL) (P = 0.001), and within 24 h postoperatively (group A: 410.3 [337.6, 498.6] mL, group B: 345.8 [256.0, 398.2] mL and group C: 619.8 [524.3, 732.8] mL) (P < 0.001). At all time points, group C (placebo) was significantly distinct from the groups treated with fibrinolytic inhibitors (groups A, B). However, no essential differences between groups A and B were found. Treated groups did not demonstrate postoperative increase in mean levels of myocardial enzymes compared with group C. No statistically significant inter-group difference was found in the number of re-transfused patients (either packed red blood cells, P = 0.119, or fresh-frozen plasma, P = 0.118) during the first 24 h postoperatively, but the number of re-transfused patients during the hospital stay was statistically significantly higher in group C compared with group B (P = 0.002). Cost effectiveness of the antifibrinolytic agent and blood product treatment seems to be on average the most favourable in the tranexamic acid group.
Both tranexamic acid and aprotinin seem to be similarly effective in the reduction of postoperative blood loss in off-pump cardiac surgery. Tranexamic acid appears to be a cost-effective and safe alternative to aprotinin.
tranexamic acid – aprotinin – cardiac surgical procedures – off-pump coronary artery bypass