FARES-II Trial: PCC Outperforms Frozen Plasma in Managing Coagulopathic Bleeding During Cardiac Surgery
In the FARES-II trial, researchers investigated whether Prothrombin Complex Concentrate (PCC) could offer superior outcomes compared to frozen plasma for patients undergoing cardiac surgery who develop coagulopathic bleeding post-cardiopulmonary bypass.
This unblinded, randomized, noninferiority-controlled trial enrolled 420 adult patients undergoing cardiac surgery. Patients were randomized to receive either PCC (n = 213) or frozen plasma (n = 207) when bleeding occurred due to coagulation factor deficiency.
🔍 Primary Outcome: Hemostatic Effectiveness
The key finding was a significantly higher rate of hemostatic effectiveness in the PCC group:
- PCC: 77.9%
- Frozen Plasma: 60.4%
- Difference: 17.6% (95% CI, 8.7–26.4), P < 0.001
This reflects a meaningful reduction in the need for further interventions after PCC treatment.
🔄 Secondary Outcomes
- Total Blood Transfusions
- PCC: 6.6 units vs. Frozen Plasma: 9.3 units
- Difference: −2.7 units (95% CI, 1.0–4.4), P = 0.002
- Serious Adverse Events
- PCC: 36.2% vs. Frozen Plasma: 47.3%
- Relative Risk: 0.76 (95% CI, 0.61–0.96), P = 0.02
📌 Conclusion
PCC not only improved hemostatic control but also reduced transfusion requirements and serious adverse events. These findings suggest that PCC offers a safer and more effective option than frozen plasma for managing bleeding complications in cardiac surgery.
For clinicians managing post-bypass coagulopathy, PCC may represent a more efficient and targeted replacement strategy.
📚 Citation: Karkouti K et al. JAMA. 2025;333(20):1781–1792.