Comparison of factor products for treatment of bleeding related to cardiac surgery

Authors: Caldwell, L; van Berkel Patel, M; Bhakta, R; Naik, N; Neel, C; Knowles, D

Affiliations: Erlanger Medical Center, United States

Publication: Critical care medicine ; 2023 ; 51. 1

Abstract: INTRODUCTION: Recombinant factor VIIa (rFVIIa) and 4-factor prothrombin concentrate complex (PCC) are often used for uncontrolled bleeding in cardiac surgery, however, there are limited direct comparisons of these agents. The objective of this study is to evaluate the efficacy and safety of rFVIIa and PCC in cardiac surgery related bleeding. METHODS: This retrospective study included adult patients who underwent cardiac surgery and received either rFVIIa (< 30 mcg/kg) or PCC during or after cardiac surgery. Patients were excluded if they had bleeding disorders, required extracorporeal membrane oxygenation, or refused blood products. The primary outcome was transfusion requirements of packed red blood cells (pRBC) within 6 hours of factor product. Secondary efficacy outcomes were transfusion requirements within 18 hours and additional doses of factor product. Secondary safety outcomes were thrombotic events and acute kidney injury. Continuous data were analyzed with Wilcoxon Rank Sum and categorical data were analyzed with Chi-Square or Fisher’s Exact test as appropriate. RESULTS: Of the 179 patients included, 78 received rFVIIa and 101 received PCC. Baseline characteristics were well matched between groups. The median dose of rFVIIa was 14.9 mcg/kg (IQR 12.9 – 16.6), and for PCC was 524 units (IQR 500 – 556). Within 6 hours of rFVIIa or PCC administration, patients received PRBC transfusion at a rate of 57.7% and 50.5%, respectively. There was no difference in PRBC transfusion volume between groups (500 mL vs 640 mL, p=0.0723). The PCC group received a greater volume of FFP and platelet transfusions. Patients in the PCC group were more likely to require additional factor products (24.4% vs 47.5%, p = 0.0015), develop acute kidney injury (AKI) (12.8% vs 26%, p=0.0141), had a longer ICU length of stay [2 (IQR 1-5) vs 4 (IQR 2-6), p=0.0487] and had a greater in hospital mortality (2.6% vs 10.9%, p=0.033). There was no difference in thrombotic events (2.6% vs 5.9%, p=0.4687). CONCLUSIONS: Low doses of PCC and rFVIIa showed similar efficacy with no differences in PRBC transfusion requirements. However, patients who received PCC experienced greater rates of additional factor products, increased rates of AKI, ICU length of stay, and in-hospital mortality.