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Published on: September 9, 2012
Outcomes Following Three-Factor Inactive Prothrombin Complex Concentrate Versus Recombinant Activated Factor VII
Patrick C Harper1, Mark M Smith1, Nathan J Brinkman2
1Department of Anesthesiology and Perioperative Medicine, Mayo Clinic College of Medicine, Rochester, MN.
Insights
Inactive prothrombin complex concentrate (PCC) reduced postoperative bleeding and transfusions compared to recombinant activated factor VII (rFVIIa) in cardiac surgery patients. PCC also decreased the need for dialysis, with no difference in mortality.
Area of Science:
- Anesthesiology
- Cardiovascular Surgery
- Hematology
Background:
- Managing bleeding during cardiac surgery is critical.
- Recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) are used for hemostasis.
- Comparing their efficacy and safety is important for patient outcomes.
Purpose of the Study:
- To compare the clinical outcomes of using inactive 3-factor PCC versus rFVIIa in patients undergoing cardiac surgery.
- To evaluate the impact on postoperative bleeding, transfusion requirements, and renal function.
Main Methods:
- Retrospective propensity-matched analysis of patients undergoing cardiac surgery with cardiopulmonary bypass.
- Comparison of outcomes between patients receiving intraoperative rFVIIa or inactive 3-factor PCC for bleeding control.
Main Results:
- Patients receiving PCC had significantly less chest tube output, lower rates of fresh frozen plasma and platelet transfusions compared to rFVIIa.
- PCC use was associated with a significantly lower likelihood of requiring postoperative dialysis.
- No significant differences were observed in stroke, deep venous thrombosis, pulmonary embolism, myocardial infarction, intracardiac thrombus, or 30-day mortality between the groups.
Conclusions:
- Inactive 3-factor PCC is associated with reduced postoperative bleeding and transfusion needs compared to rFVIIa in cardiac surgery.
- PCC use may decrease the incidence of renal failure requiring dialysis post-cardiac surgery.
- rFVIIa use was linked to increased postoperative bleeding, transfusions, and renal failure.
Objective:
To compare outcomes following inactive prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) administration during cardiac surgery.
Design:
Retrospective propensity-matched analysis.
Setting:
Academic tertiary-care center.
Participants:
Patients undergoing cardiac surgery requiring cardiopulmonary bypass who received either rFVIIa or the inactive 3-factor PCC.
Interventions:
Outcomes following intraoperative administration of rFVIIa (263) or factor IX complex (72) as rescue therapy to treat bleeding.
Measurements And Main Results:
In the 24 hours after surgery, propensity-matched patients receiving PCC versus rFVIIa had significantly less chest tube outputs (median difference -464 mL, 95% confidence interval [CI] -819 mL to -110 mL), fresh frozen plasma transfusion rates (17% v 38%, p = 0.028), and platelet transfusion rates (26% v 49%, p = 0.027). There were no significant differences between propensity-matched groups in postoperative stroke, deep venous thrombosis, pulmonary embolism, myocardial infarction, or intracardiac thrombus. Postoperative dialysis was significantly less likely in patients administered PCC versus rFVIIa following propensity matching (odds ratio = 0.3, 95% CI 0.1-0.7). No significant difference in 30-day mortality in patients receiving PCC versus rFVIIa was present following propensity matching.
Conclusions:
Use of rFVIIa versus inactive PCCs was significantly associated with renal failure requiring dialysis and increased postoperative bleeding and transfusions.
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