Comparison of low- and high-dose recombinant activated factor VII for postcardiac surgical bleeding.

AIM OF THE STUDY: A retrospective observational study to compare safety and efficacy of high and low doses of recombinant activated factor VIIa (rFVIIa) in severe postcardiac surgical bleeding.

PATIENTS AND METHODS: From 2004 to 2014, all patients who received rFVIIa for bleeding after cardiac surgery were included and arranged in two groups; Group 1: Low dose (40-50 mcg/kg) (n = 98) and Group 2: High dose (90-120 mcg/kg) (n = 156).

RESULTS: There was no significant difference in demographic and surgical characteristics of both groups on admission to Cardiac Surgical Intensive Care Unit (CSICU). There was no significant difference between the two groups regarding the reduction in chest tube bleeding in the first 6 h or the transfusion requirement in the 24 h after admission to CSICU. A total of 15 patients (5.9%) had thromboembolic adverse events. (Seven (7.1%) patients in Group 1 compared to 8 (5.1%) patients in Group 2, P = 0.58). There were no significant differences in all-cause mortality at 30 days (2% in Group 1 vs. 3.2% in Group 2, P = 0.6) and at hospital discharge between the two study groups (6.1% in Group 1 vs. 8.3% in Group 2, P = 0.5), respectively. There was no significant difference between the two groups regarding the need for re-exploration, days on mechanical ventilation, CSICU, or hospital stay.

CONCLUSION: In this report, Low-dose rFVIIa showed equivalent efficacy and safety to high-dose rFVIIa. Further prospective randomized studies are needed to confirm these findings.