Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial.

Summary

In 528 randomized patients analyzed (primary analysis n=420), PCC achieved higher hemostatic effectiveness than frozen plasma (77.9% vs 60.4%; difference 17.6%; 95% CI 8.7%-26.4%; P<.001 for noninferiority and superiority), reduced allogeneic transfusion requirements, and lowered serious adverse events and AKI through day 30.

Key Findings

• Hemostatic effectiveness was higher with PCC vs frozen plasma (77.9% vs 60.4%; difference 17.6%; 95% CI 8.7%-26.4%; P<.001).
• PCC reduced allogeneic transfusions (mean 6.6 vs 9.3 units; difference 2.7; 95% CI 1.0-4.4; P=.002).
• Serious adverse events were lower with PCC (RR 0.76; 95% CI 0.61-0.96; P=.02), including lower AKI (10.3% vs 18.8%; RR 0.55; 95% CI 0.34-0.89; P=.02).
• Trial registered at ClinicalTrials.gov (NCT05523297); conducted at 12 hospitals in Canada and the US.

Clinical Implications

Consider PCC as first-line factor replacement for coagulopathic bleeding during cardiac surgery to improve hemostasis, reduce transfusion exposure, and decrease AKI risk; update perioperative blood management protocols accordingly.

Limitations

• Unblinded design may introduce performance or detection bias
• Second-dose and post-24h use of only frozen plasma could influence downstream transfusion metrics

Future Directions

Evaluate implementation of PCC-first algorithms across diverse cardiac procedures, cost-effectiveness, and thromboembolic safety in broader populations.