Literature DB >> 21596585

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

Martin Ponschab1, Giovanni Landoni, Giuseppe Biondi-Zoccai, Elena Bignami, Elena Frati, Davide Nicolotti, Fabrizio Monaco, Federico Pappalardo, Alberto Zangrillo.   

Abstract

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.
Copyright © 2011 Elsevier Inc. All rights reserved.

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Year:  2011        PMID: 21596585     DOI: 10.1053/j.jvca.2011.03.004

Source DB:  PubMed          Journal:  J Cardiothorac Vasc Anesth        ISSN: 1053-0770            Impact factor:   2.628


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