Objective: Perioperative microvascular bleeding is associated with increased morbidity and mortality and could be reduced by hemostatic drugs such as recombinant activated factor VII (rFVIIa). Few trials have investigated rFVIIa and each individually lacked power to detect a beneficial effect on transfusion of blood products or thromboembolic side effects. Design: Meta-analysis. Setting: Hospitals. Participants: The authors performed a meta-analysis of 5 clinical trials (1 randomized, 3 propensity matched, and 1 case matched) that included 298 patients and indicated major clinical outcome (survival and thromboembolic events). Interventions: Four of the 5 studies used rFVII in refractory blood loss. Doses varied between 17 and 70 μg/kg (repeatable) and 90 μg/kg for a single dose. Measurements and Main Results: The authors observed a nonsignificant reduction in the rate of surgical re-exploration (10/76 [13%] in the rFVIIa group v 42/74 [57%] in the control group, odds ratio [OR] = 0.25 [0.01-7.01], p for effect = 0.42), with a trend toward an increase in the rate of perioperative stroke (8/150 [5%] in the rFVIIa v 2/148 [1.4%] in the control arm, OR = 3.17 [0.83-12.10], p = 0.09) and no effect on mortality that was similar in the 2 groups (22/150 [15%] in the rFVIIa group and 22/148 [15%] in the control group [OR = 0.96 (0.50-1.86), p for effect=0.90]). Conclusions: This analysis suggests that the hemostatic properties of rFVIIa could reduce the rate of surgical reexploration after cardiac surgery even if an increase of hazardous side effects (eg, perioperative stroke) could not be excluded. Because meta-analyses are hypothesis generating, this issue should be investigated further in large randomized controlled trials. © 2009 Elsevier Inc. All rights reserved.

Recombinant Activated Factor VII in Cardiac Surgery: A Meta-analysis / Zangrillo, Alberto; Mizzi, Anna; Biondi-Zoccai, Giuseppe; Bignami, Elena; Calabrò, Maria Grazia; Pappalardo, Federico; Dedola, Elisa; Tritapepe, Luigi; Marino, Giovanni; Landoni, Giovanni. - In: JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. - ISSN 1053-0770. - 23:1(2009), pp. 34-40. [10.1053/j.jvca.2008.09.017]

Recombinant Activated Factor VII in Cardiac Surgery: A Meta-analysis

Bignami, Elena;
2009-01-01

Abstract

Objective: Perioperative microvascular bleeding is associated with increased morbidity and mortality and could be reduced by hemostatic drugs such as recombinant activated factor VII (rFVIIa). Few trials have investigated rFVIIa and each individually lacked power to detect a beneficial effect on transfusion of blood products or thromboembolic side effects. Design: Meta-analysis. Setting: Hospitals. Participants: The authors performed a meta-analysis of 5 clinical trials (1 randomized, 3 propensity matched, and 1 case matched) that included 298 patients and indicated major clinical outcome (survival and thromboembolic events). Interventions: Four of the 5 studies used rFVII in refractory blood loss. Doses varied between 17 and 70 μg/kg (repeatable) and 90 μg/kg for a single dose. Measurements and Main Results: The authors observed a nonsignificant reduction in the rate of surgical re-exploration (10/76 [13%] in the rFVIIa group v 42/74 [57%] in the control group, odds ratio [OR] = 0.25 [0.01-7.01], p for effect = 0.42), with a trend toward an increase in the rate of perioperative stroke (8/150 [5%] in the rFVIIa v 2/148 [1.4%] in the control arm, OR = 3.17 [0.83-12.10], p = 0.09) and no effect on mortality that was similar in the 2 groups (22/150 [15%] in the rFVIIa group and 22/148 [15%] in the control group [OR = 0.96 (0.50-1.86), p for effect=0.90]). Conclusions: This analysis suggests that the hemostatic properties of rFVIIa could reduce the rate of surgical reexploration after cardiac surgery even if an increase of hazardous side effects (eg, perioperative stroke) could not be excluded. Because meta-analyses are hypothesis generating, this issue should be investigated further in large randomized controlled trials. © 2009 Elsevier Inc. All rights reserved.
Recombinant Activated Factor VII in Cardiac Surgery: A Meta-analysis / Zangrillo, Alberto; Mizzi, Anna; Biondi-Zoccai, Giuseppe; Bignami, Elena; Calabrò, Maria Grazia; Pappalardo, Federico; Dedola, Elisa; Tritapepe, Luigi; Marino, Giovanni; Landoni, Giovanni. - In: JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. - ISSN 1053-0770. - 23:1(2009), pp. 34-40. [10.1053/j.jvca.2008.09.017]
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: https://hdl.handle.net/11381/2838939
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 35
  • ???jsp.display-item.citation.isi??? 37
social impact