Recombinant activated factor VII increases stroke in cardiac surgery: a meta-analysis

Area of Science:

• Cardiovascular Surgery
• Hematology
• Pharmacology

Background:

• Recombinant activated factor VII (rFVIIa) is utilized in various surgeries to mitigate blood loss and re-exploration rates.
• Clinical evidence on rFVIIa's efficacy and safety specifically within cardiac surgery remains limited.

Purpose of the Study:

• To conduct a meta-analysis evaluating the impact of rFVIIa on stroke incidence and surgical re-exploration in cardiac surgery patients.
• To assess the overall perioperative thromboembolic event rate and mortality associated with rFVIIa administration.

Main Methods:

• A meta-analysis was performed, synthesizing data from 6 clinical trials involving 470 patients (254 receiving rFVIIa, 216 controls).
• Study selection involved comprehensive literature searches of PubMed and conference proceedings, supplemented by expert consultation and reference scanning.
• Patient groups included randomized, propensity-matched, and case-matched cohorts.

Main Results:

• rFVIIa administration was associated with a statistically significant increase in stroke rate (4.7% vs. 0.9%, OR=3.69, p=0.03).
• A trend towards a reduction in surgical re-exploration was observed, though not statistically significant (13% vs. 42%, OR=0.27, p=0.19).
• Perioperative thromboembolic events showed a non-significant increasing trend (7.5% vs. 5.6%, OR=1.84, p=0.14), with no difference in mortality.

Conclusions:

• The use of rFVIIa in cardiac surgery is linked to a significant rise in stroke incidence and a potential, though not significant, decrease in re-exploration.
• Routine administration of rFVIIa in cardiac surgery is not recommended due to the increased stroke risk.
• rFVIIa may be cautiously considered for patients experiencing refractory, life-threatening bleeding.