Abstract 4369697: Prothrombin Complex Concentrate versus Fresh Frozen Plasma for hemostatic management in patients undergoing cardiac surgery: A Meta Analysis of Randomised Controlled Trials

Abstract

Background: Fresh frozen plasma (FFP) is conventionally used for the management of bleeding and reversal of coagulopathy in cardiac surgery. It carries the risk of complications like volume overload and transfusion-related adverse events. Prothrombin Complex Concentrate has emerged as a potential alternative to FFP in this setting. Despite its increasing use, the comparative efficacy and safety of PCC versus FFP in cardiac surgery patients remain uncertain. This study systematically evaluates the clinical outcomes of PCC versus FFP in patients undergoing cardiac surgery. Methods: We systematically searched PubMed, Embase, and Cochrane Central for randomized controlled trials (RCTs) comparing Prothrombin Complex Concentrate versus Fresh Frozen Plasma in patients undergoing cardiac surgery who require hemostatic management. Outcomes of interest included stroke, resternotomy, and all-cause mortality, thromboembolic events, use of fibrinogen concentrate, and recombinant factor VIIa. Statistical analysis was performed using R 4.4.2. Heterogeneity was assessed with I2 statistics. Results: We analyzed data from 671 patients across four randomized controlled trials (RCTs). A total of 51.1% (n = 343) of patients received prothrombin complex concentrate. The mean age of the study population was 67.2 years. Thromboembolic events (6.9% vs. 6.4%; RR 1.08; 95% CI 0.62–1.90; p=0.787) were comparable between the PCC and FFP groups, suggesting no difference. Stroke (2.6% vs. 3.6%; RR 0.78; 95% CI 0.32–1.88; p=0.578), resternotomy (5.8% vs. 8.5%; RR 0.69; 95% CI 0.39–1.19; p=0.182), all-cause mortality (2.9% vs. 4.0%; RR 0.75; 95% CI 0.34–1.68; p=0.487) and fibrinogen concentrate use (12.7% vs. 16.1%; RR 0.78; 95% CI 0.51–1.19; p=0.245) were comparable in both groups, not favoring any group. Notably, recombinant factor VIIa use (0.3% vs. 4.3%; RR 0.15; 95% CI 0.03–0.86; p=0.034) was significantly lower in the PCC group compared to the FFP group. Conclusion: These findings support the use of PCC as an effective hemostatic agent, without a significant increase in adverse events. Future studies with larger sample sizes are warranted to confirm these results and explore the long-term safety of PCC. Given its favorable safety and efficacy profile, PCC may serve as a valuable component of contemporary cardiac surgical practice.