Prothrombin complex concentrate versus fresh frozen plasma in patients undergoing cardiac surgery: a systematic review and meta-analysis of randomized controlled trials

Résumé

Background and aims Bleeding is an important prognostic factor following cardiac surgery. Coagulopathic bleeding is a well-known complication of cardiac surgery, and it is usually managed using Fresh Frozen Plasma (FFP). However, the use of FFP poses a significant risk of adverse reactions. Results from recent trials and prior meta-analyses suggest that Prothrombin Complex Concentrate (PCC) may be safer and more efficacious in managing coagulopathic bleeding in patients undergoing cardiac surgery. To determine the most effective and safest approach to managing coagulopathic bleeding in cardiac surgery, we conducted a systematic review and meta-analysis of randomized controlled trials comparing prothrombin complex concentrate with fresh frozen plasma in patients undergoing cardiac surgery. Methods The PubMed, Embase, and Cochrane databases were searched for randomized controlled trials comparing prothrombin complex concentrate with fresh frozen plasma in patients undergoing cardiac surgery. Results We included five randomized controlled trials with 711 patients, of whom 363 (51.06%) received PCC. A statistically significant reduction in chest tube drainage was noted in the PCC group (mean difference [MD], −143.59 mL; 95% CI, −278.76 to −8.41 mL; p = 0.04; I 2 = 69%; low certainty). The PCC group had a significantly lower rate of reoperation for bleeding (5.83% vs. 8.53%; RR, 0.69; 95% CI, 0.48–0.98; p = 0.04; I 2 = 0%; moderate certainty). No statistically significant difference was noted between the two approaches for the occurence of adverse events (87.53% vs. 89.36%; 0.99 RR, 95% CI 0.95–1.04; I 2 = 0%) including all-cause mortality, thromboembolic events, transient ischemic attack, acute kidney injury, length of hospital stay, and stay in the intensive care unit. Conclusions These findings suggest that using prothrombin complex concentrate in patients undergoing cardiac surgery may confer some benefits in select patients over fresh frozen plasma in managing coagulopathic bleeding following cardiac surgery; however, the level of evidence for most outcomes is low to moderate, underscoring the need for more clinical trials to bridge this gap. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420251066886 , PROSPERO CRD420251066886.

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