Administration of Fibrinogen Concentrate in Patients with Persistent Bleeding After Cardiac Surgery

Methodology and Course of the Study

The study included all consecutive adult patients who underwent initial cardiac surgery at the Sahlgrenska University Hospital in Gothenburg between 2009 and 2014. Procedures included coronary artery bypass grafting, valve defect surgeries, combined procedures, surgeries for arrhythmia treatment, and surgeries for congenital heart defects in adulthood. Fibrinogen concentrate was administered to patients with persistent bleeding and signs of impaired fibrinogen function according to rotational thromboelastometry (ROTEM) in the FIBTEM test. Excessive bleeding was defined as a loss of > 100 ml/12 hours post-surgery.

The authors compared outcomes in patients who were administered fibrinogen concentrate perioperatively with those who were not. The primary endpoint was composite and included the incidence of thromboembolic complications (myocardial infarction, percutaneous coronary revascularization, ischemic stroke, deep vein thrombosis, pulmonary embolism, portal vein thrombosis, peripheral artery embolism, and mesenteric artery embolism) and death within 1 year post-surgery. Secondary endpoints included the incidence of the same composite parameter within 30 days post-surgery and 30-day and 1-year mortality.

Results

The study included 5408 patients with an average age of 68 years (75% men), of whom 564 (10.4%) were administered fibrinogen concentrate.

After 1 year, no significant difference was found in the incidence of the primary composite endpoint between the group with fibrinogen concentrate and the group without it: adjusted hazard ratio (aHR) 1.11 (95% confidence interval [CI] 0.84–1.46; p = 0.45).

There was also no significant difference between the groups in terms of the secondary endpoints including 1-year mortality (aHR 1.38; 95% CI 0.93–2.04; p = 0.11), incidence of the composite endpoint within 30 days post-surgery (adjusted odds ratio [aOR] 1.07; 95% CI 0.64–1.81; p = 0.79) and 30-day mortality (aOR 1.00; 95% CI 0.51–1.96; p = 0.50).

Sensitivity analyses confirmed the results of the main analysis.

Conclusion

This study did not demonstrate an increased risk of thromboembolic complications or death within 30 days or 1 year post-initial cardiac surgery in adult patients treated perioperatively with fibrinogen concentrate due to persistent bleeding.

(zza)

Source: Waldén K., Jeppsson A., Nasic S., Karlsson M. Fibrinogen concentrate to cardiac surgery patients with ongoing bleeding does not increase the risk of thromboembolic complications or death. Thromb Haemost 2020; 120 (3): 384−391, doi: 10.1055/s-0039-3402759.