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

OBJECTIVES Recombinant activated factor VII (rFVIIa) is used in various surgical procedures to reduce the incidence of major blood loss and the need for re-exploration. Few clinical trials have investigated rFVIIa in cardiac surgery. The authors performed a meta-analysis focusing on the rate of stroke and surgical re-exploration. DESIGN Meta-analysis. SETTING Hospitals. PARTICIPANTS A total of 470 patients. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Four investigators independently searched PubMed and conference proceedings including backward snowballing (ie, scanning of reference of retrieved articles and pertinent reviews) and contacted international experts. A total of 470 patients (254 receiving rFVIIa and 216 controls) from 6 clinical trials (2 randomized, 3 propensity matched, and 1 case matched) were included in the analysis. The use of rFVIIa was associated with an increased rate of stroke (12/254 [4.7%] in the rFVIIa group v 2/216 [0.9%] in the control arm, odds ratio [OR] = 3.69 [1.1-12.38], p = 0.03) with a nonsignificant reduction in rate of surgical re-exploration (13% v 42% [OR = 0.27 (0.04-1.9), p = 0.19]). The authors observed a trend toward an increase of overall perioperative thromboembolic events (19/254 [7.5%] in the rFVIIa group v 10/216 [5.6%] in the control arm [OR = 1.84 (0.82-4.09), p = 0.14]). No difference in the rate of death was observed. CONCLUSIONS The administration of rFVIIa in cardiac surgery patients could result in a significant increase of stroke with a trend toward a reduction of the need for surgical re-exploration. The authors do not recommend routine use in cardiac surgery patients. rFVIIa may be considered with caution in patients with refractory life-threatening bleeding.