Efficacy and safety of prothrombin complex concentrate versus fresh frozen plasma in adult patients undergoing cardiac surgery: a systematic review and meta-analysis

Postoperative bleeding is a common and potentially life-threatening complication following cardiac surgery, often exacerbated by multifactorial coagulopathy from cardiopulmonary bypass, hypothermia, and platelet dysfunction. While fresh frozen plasma (FFP) has traditionally been used for coagulation correction, it has significant limitations, including large volume requirements, slow onset, and increased risk of transfusion-related complications. Prothrombin complex concentrate (PCC) has emerged as a potential alternative, offering rapid coagulation correction with reduced volume load and no ABO compatibility requirements. This systematic review and meta-analysis compared the efficacy and safety of PCC versus FFP in managing coagulopathic bleeding in adult cardiac surgery patients. We conducted a systematic review and meta-analysis following PRISMA guidelines. Electronic databases (MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials) were searched using MeSH terms and keywords related to “Cardiothoracic Surgery”, “Prothrombin Complex Concentrate”, and “Fresh Frozen Plasma”, from inception to Jan 2026. Cohort studies and randomized controlled trials comparing PCC and FFP in patients aged > 18 years undergoing cardiac surgery complicated by bleeding or coagulopathy were included. Primary outcomes were RBC transfusion requirement, chest tube drainage, and thromboembolic events. Secondary outcomes included surgical re-exploration for bleeding, stroke, duration of mechanical ventilation, hospital and ICU stays, and acute kidney injury. Risk of bias was assessed using the Cochrane Risk of Bias Tool 2.0 for RCTs and the Newcastle–Ottawa Scale for observational studies. Statistical analysis was conducted using Review Manager (RevMan) version 5.4, applying risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, both with 95% confidence intervals. The meta-analysis protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) under protocol number CRD420251088737. This meta-analysis included ten studies with 2,643 patients. PCC use moderately reduced RBC transfusion in the first 24 h (RR = 0.84; 95% CI: 0.76–0.93; p = 0.05; I 2 = 47%), 12–24-h chest tube drainage (MD = − 188.89 mL; 95% CI: − 248.48 to − 125.30; p < 0.00001; I 2 = 50%), and hospital stay (MD = − 1.19 days; 95% CI: − 2.21 to − 0.18; p = 0.004; I 2 = 67%). No significant differences were observed for surgical re-exploration (RR = 0.81; 95% CI: 0.66–1.00; p = 0.05; I 2 = 0%), mechanical ventilation (MD = − 0.08; 95% CI: − 0.34 to 0.19; p > 0.05; I 2 = 73%), ICU stay (MD = − 0.07 days; 95% CI: − 0.59 to 0.45; p = 0.78; I 2 = 59%), all-cause mortality (RR = 1.10; 95% CI: 0.82–1.50; p = 0.51; I 2 = 0%), thromboembolic events (RR = 1.22; 95% CI: 0.80–1.85; p = 0.35; I 2 = 0%), stroke (RR = 1.10; 95% CI: 0.75–1.63; p = 0.63; I 2 = 0%), acute kidney injury (RR = 1.08; 95% CI: 0.74–1.56; p = 0.70; I 2 = 77%), serious adverse events (RR = 0.78; 95% CI: 0.56–1.09; p = 0.15; I 2 = 35%), and any adverse event (RR = 0.95; 95% CI: 0.81–1.11; p = 0.54; I 2 = 53%). Moderate to high heterogeneity was noted in several outcomes, for which subgroup analyses were performed. This meta-analysis demonstrates that PCC is superior to FFP in reducing RBC transfusion requirements, 12–24-h chest tube drainage, and hospital length of stay in adult cardiac surgery patients, while maintaining a comparable safety profile. Further large-scale, high-quality RCTs are warranted to strengthen the evidence base and inform future guidelines.