Recombinant activated factor VII is associated with postoperative thromboembolic adverse events in bleeding after coronary surgery

OBJECTIVES: To evaluate the impact of recombinant activated factor VII (rFVIIa) administration on thromboembolic adverse events (TAEs) in coronary artery bypass grafting (CABG) surgery patients showing postoperative bleeding. METHODS: From January 2004 to May 2015, 180 CABG surgery patients with postoperative bleeding were included in the study. All patients were managed conservatively and 81 (45%) also received rFVIIa. RESULTS: Ten patients developed new TAEs (5.6%), 15 (8.3%) were re-explored, 4 (2.2%) had postoperative dialysis and 6 (3.3%) died by day 30 postoperation. Among those with TAEs, 7 experienced cerebrovascular accidents, 2 had myocardial infarction and 1 had pulmonary embolism. A multivariable regression model confirmed rFVIIa as the only independent factor associated with the development of TAEs (odds ratio 6.19, 95% confidence interval 1.197-31.996; P= 0.0296). Fifteen (8.3%) patients were re-explored for bleeding according to our management protocol. No variables to predict the need for re-exploration were identified by the regression model. Chest tube output was statistically significantly lower in patients who received rFVIIa from 3 h [1.9 (Q1-Q31.7-2.1) ml/kg/h vs 3.2 (Q1-Q3 3-3.4) ml/kg/h, P = 0.000] through to 12 h after admission [0.6 (Q1-Q3 0.5-0.6) ml/kg/h vs 0.7 (Q1-Q3 0.6-0.9) ml/kg/h, P = 0.000]. CONCLUSIONS: rFVIIa for the treatment of post-CABG bleeding resulted in increased incidence of TAEs in spite of rapid control of bleeding. Hence, rFVIIa should only be used for selected patients and with extreme caution.