(236) Recombinant Factor VIIa vs Prothrombin Complex Concentrate for Bleeding in Cardiovascular Surgery

Introduction: Recombinant factor VIIa (rFVIIa) and prothrombin complex concentrate (PCC) have been historically used to help achieve hemostasis in patients with significant bleeding during cardiothoracic surgery. Due to the increasing evidence favoring PCC in this patient population, the formal factor pathway for refractory bleeding developed at Rush University Medical Center (RUMC) removed rFVIIa and switched to PCC in April of 2020. The purpose of this study was to assess the overall impacts to patients at RUMC since switching factor products by evaluating factor efficacy, patient safety, and cost.

Methods: This was a single-center, retrospective, observational, cohort study of adult cardiovascular surgery patients who received either rFVIIa or PCC identified through Epic SlicerDicer. Outcomes of interest included the amount of blood products transfused post factor administration, chest tube output post factor administration, acute kidney injury, thromboembolic events, and 30-day mortality.

Results: Of the 198 cardiovascular surgery patients screened, 67 met inclusion criteria. No differences were observed in the amount of blood products (both total use and individual products) between the two groups. There was also no difference in chest tube output at 2, 6, and 24 hours; failed chest closure; mortality; or thromboembolic events. There was a higher incidence of AKI in the rFVIIa group (43.5% vs 11.4%, p = 0.005) with a trend towards higher rates of new post-operative hemodialysis. Finally, there was no difference between the two groups in rates of thromboembolic events or mortality. The cost analysis revealed lower median costs of PCC at $2,020.00 per patient compared to rFVIIa at $2,175.62 per patient (p = 0.001).

Conclusions: Both factor products demonstrated similar effectiveness in achieving hemostasis. However, there was a lower incidence of AKI and reduced factor costs associated with PCC administration. Large, randomized, controlled trials are necessary to further compare efficacy and safety between the two products.