Initial Experience of the Use of 3-Factor Prothrombin Complex Concentrate and Thromboembolic Complications After Cardiac Surgery.

Background: 3-factor prothrombin complex concentrate (3F-PCC) may provide a valuable treatment option for coagulopathy in cardiac surgery patients. However, it may expose patients to increased risk of thromboembolic events. Accordingly, we compared the incidence of thromboembolic events between patients exposed to 3F-PCC and those receiving conventional therapy.

Methods: Demographic, operative and postoperative data was obtained in a cohort of consecutive patients exposed to 3F-PCC and a contemporaneous control population. Propensity-score matching was performed for risk adjustment. Unadjusted and adjusted patient demographics and incidence of thromboembolism were compared.

Results: Patients receiving 3F-PCC (PCC) were younger (mean age PCC: 64±14.2 vs. No PCC: 67.6±11.6, p=0.022), and less likely to have diabetes or previous myocardial infarction. PCC patients experienced more prolonged aortic cross clamp times (mean time in minutes PCC: 119.9±58.8 vs. No PCC: 92.3±54), more complex cardiac surgeries and were more likely to have received more fresh frozen plasma (FFP), cryoprecipitate and red blood cells. Despite this, both unadjusted and adjusted 30-day mortality and readmission rates were similar between groups. There were 9 (9.2%) and 34 (6.8%) (p=0.40) thromboembolic events in the unadjusted PCC and control groups respectively. Adjusted risk for thromboembolic event rates was also comparable (Odds ratio: 1.512, 95% Confidence Interval 0.401-5.7, p=0.541).

Conclusions: 3-factor prothrombin complex concentrate was administered to patients at greater risk of complications including bleeding. Our initial experience suggests that the use of PCC does not appear to increase thromboembolic risks compared to conventional treatment.