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. © 2011 Elsevier Inc.

Recombinant activated factor VII increases stroke in cardiac surgery: A meta-analysis / Ponschab, Martin; Landoni, Giovanni; Biondi-Zoccai, Giuseppe; Bignami, Elena; Frati, Elena; Nicolotti, Davide; Monaco, Fabrizio; Pappalardo, Federico; Zangrillo, Alberto. - In: JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. - ISSN 1053-0770. - 25:5(2011), pp. 804-810. [10.1053/j.jvca.2011.03.004]

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

Bignami, Elena;
2011

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. © 2011 Elsevier Inc.
Recombinant activated factor VII increases stroke in cardiac surgery: A meta-analysis / Ponschab, Martin; Landoni, Giovanni; Biondi-Zoccai, Giuseppe; Bignami, Elena; Frati, Elena; Nicolotti, Davide; Monaco, Fabrizio; Pappalardo, Federico; Zangrillo, Alberto. - In: JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. - ISSN 1053-0770. - 25:5(2011), pp. 804-810. [10.1053/j.jvca.2011.03.004]
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11381/2838870
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 48
  • ???jsp.display-item.citation.isi??? 42
social impact