Efficacy and Safety of Prothrombin Complex Concentrate Compared to Fresh Frozen Plasma in Cardiac Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Coagulopathy and bleeding are common complications following cardiac surgery, often requiring the use of hemostatic agents such as prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). This systematic review and meta-analysis compared the efficacy and safety of PCC versus FFP in adult patients undergoing cardiac surgery complicated by bleeding or coagulopathy. A comprehensive search of PubMed, Embase, and Web of Science was conducted from inception to March 30, 2025, identifying randomized controlled trials comparing these interventions. Primary outcomes included chest tube drainage within 24 hours, the number of red blood cell (RBC) units transfused, and the proportion of patients requiring RBC transfusion. Secondary outcomes were hospital and intensive care unit length of stay, the incidence of stroke or transient ischemic attack, thromboembolic events, acute kidney injury, and all-cause mortality within 30 days. Four randomized controlled trials, including 671 patients (PCC: 343; FFP: 328), were analyzed. PCC significantly reduced chest tube output [mean difference = −162.12 mL, 95% confidence interval (CI): −264.46 to −59.78, P = 0.002], number of RBC units transfused (mean difference = −0.93, 95% CI: −1.34 to −0.51, P < 0.0001), and proportion of patients requiring RBC transfusion (risk ratio = 0.81, 95% CI: 0.71–0.91, P = 0.0007). No significant differences were found in intensive care unit/hospital stay, thromboembolic events, stroke/transient ischemic attack, or mortality. Sensitivity analysis suggested a potential reduction in acute kidney injury with PCC. These findings support the selective use of PCC for bleeding management in cardiac surgery.