Fibryga® Reduces Blood Component Transfusions in Specific Cardiac Surgery Patients

Fibryga® has demonstrated a reduced need for blood component transfusions compared to cryoprecipitate in two predefined subgroups of cardiac surgery patients, according to findings published in the Journal of Cardiothoracic and Vascular Anesthesia. These secondary analysis results, stemming from the FIBRES trial, show that fibrinogen concentrate significantly reduces the use of allogeneic blood products by 19% in patients undergoing elective surgery and by 19% in those in a non-critical state before surgery.

The FIBRES (Fibrinogen Replacement in Acquired Hypofibrinogenemia) study, a landmark randomized clinical trial, evaluated the efficacy of fibrinogen concentrate versus cryoprecipitate in managing bleeding following cardiac surgery. The trial involved 827 patients across 11 Canadian hospitals and was supported by an unrestricted grant from Octapharma, which also provided the fibrinogen concentrate used in the study.

In the primary analysis, which considered the overall study population, fibryga® met the trial's prespecified criterion for non-inferiority to cryoprecipitate in managing bleeding. The secondary subgroup analysis, however, provided additional insight into specific patient populations. Among 634 patients in a non-critical state before surgery, those receiving fibryga® had a 19% relative reduction in 24-hour blood product units transfused compared to those receiving cryoprecipitate (13.6 units vs. 16.2 units). Similarly, among 466 patients undergoing elective surgery, there was also a 19% relative reduction in 24-hour blood product units (11.7 units vs. 14.4 units).

Justyna Bartoszko, M.D., lead author of the analysis and a member of the FIBRES Research Group, stated, "These findings provide additional evidence and guidance around fibrinogen replacement in cardiac surgery patients who develop clinically significant bleeding and acquired hypofibrinogenemia. Blood transfusions can be lifesaving, but an efficient patient blood management strategy seeks to avoid unnecessary exposure to allogeneic blood components, as they are known to increase the risk of postoperative complications."

Huub Kreuwel, Ph.D., Vice President of Medical Affairs at Octapharma USA, added, "While the primary results from FIBRES have not changed, secondary analyses such as these provide relevant information about specific patient subgroups which may be useful for informing institutional patient blood management protocols."

Safety findings from the study indicated that in the full study population, 66.7% of patients in the fibryga® group and 72.7% in the cryoprecipitate group experienced treatment-emergent adverse events during the study (relative risk, 0.92; 95% CI, 0.83-1.01; P=0.07). Within the elective-surgery subgroup, adverse events were less frequent among patients assigned to fibryga® (relative risk, 0.85; 95% CI, 0.75-0.97; P=0.02), and serious adverse events were also less frequent among fibryga® recipients (relative risk, 0.71; 95% CI, 0.52-0.99; P=0.04). No treatment-emergent adverse events, serious adverse events, or deaths were deemed to be possibly or probably related to the use of fibryga® or cryoprecipitate.

Dr. Bartoszko noted, "The safety profile of fibryga® is important to consider, as it offers a standardized fibrinogen concentrate for targeted replacement in patients with acquired fibrinogen deficiency. While the primary results from FIBRES have not changed, these secondary analyses provide valuable information that may inform clinical practice."

The FIBRES trial, published in JAMA, demonstrated that fibrinogen concentrate is non-inferior to cryoprecipitate in managing bleeding following cardiac surgery. The study also highlighted the benefits of standardized dosing, faster preparation, and reduced risk of viral transmission associated with fibrinogen concentrate.

With these findings, Octapharma continues to support the use of fibrinogen concentrate in managing bleeding in cardiac surgery patients, particularly in those undergoing elective surgery or in a non-critical state before surgery. The company's commitment to advancing patient care through innovative treatments is underscored by the ongoing research and development efforts in this area.