Use of recombinant activated factor VII for the treatment of perioperative bleeding in noncardiac surgery patients without hemophilia: A systematic review and meta-analysis of randomized controlled trials.

Abstract

To evaluate the efficacy and safety of perioperative use of recombinant activated factor VII (rFVIIa) in noncardiac patients. We searched electronic databases for randomized controlled trials (RCTs) that involved the use of rFVIIa through December 13, 2019 in noncardiac patients without hemophilia. Two investigators extracted the related data and assessed the quality of the included trials. Eleven RCTs examining 993 perioperative patients were ultimately included. The use of rFVIIa did not decrease all-cause mortality (RR:0.90; 95% CI:0.50,1.64; I2=0.0%; P=0.738), shorten the length of ICU (SMD:-0.15; 95% CI:-0.47,0.17; I2=0.0%; P=0.346) or hospital (SMD:0.42; 95% CI:-0.05,0.89; I2=0.0%; P=0.078) stay, or increase incidence of the thromboembolic events (RR:1.30; 95% CI:0.70,2.41; I2=0.0%; P=0.403) among perioperative patients. However, individual RCT analyses showed that the use of rFVIIa could reduce the volume of blood loss (including prostatic cancer, severe acute pancreatitis (SAP), and spinal disease) and the transfusion of RBCs (including prostatic cancer, SAP, and spinal disease) and FFP (SAP) in a subset of perioperative patients. Publication bias was not present. For perioperative hemorrhagic patients, rFVIIa-based hemostatic therapy showed no effect on mortality, ICU or hospital LOS, or the rate of thromboembolic events, although it appears to decrease blood loss and reduce the need for blood product transfusion in a subset of patients.