A propensity score case‐control comparison of aprotinin and tranexamic acid in high‐transfusion‐risk cardiac surgery

Karkouti, Keyvan; Beattie, W. Scott; Dattilo, Kathleen M.; McCluskey, Stuart A.; Ghannam, Mohammed; Hamdy, Ahmed; Wijeysundera, Duminda N.; Fedorko, Ludwik; Yau, Terrence M.

doi:10.1111/j.1537-2995.2006.00724.x

Cited by 308 publications

(224 citation statements)

References 25 publications

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“…5 However, recent studies on large numbers of patients have raised growing concerns about the serious adverse effects observed following systemic administration of antifibrinolytic agents. These complications include increased mortality, 6 renal toxicity, 5,7,8 anaphylactic reactions, 9 graft vessel occlusion, 10 the risk of myocardial infarction (in high-risk cardiac surgery) following aprotinin use, 11 and, because of its mechanism of action, the potential risk of thromboembolic events after tranexamic acid administration. 12 Due to the natural barrier properties of the pericardium, which prevents free diffusion of substances, recent experimental studies have shown that local application of different medications into the pericardial cavity can lead to desirable therapeutic efficacy without significant systemic absorption.…”

Section: Introductionmentioning

confidence: 99%

Topical application of antifibrinolytic drugs for on-pump cardiac surgery: a systematic review and meta-analysis

Abrishami

Chung

Wong

2009

Can J Anesth/J Can Anesth

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Purpose This systematic review aimed to evaluate the efficacy and safety of topical application of antifibrinolytic drugs to reduce postoperative bleeding and transfusion requirements in patients undergoing on-pump cardiac surgery. Methods We searched The Cochrane Library, MED-LINE, EMBASE and SCI-EXPANDED for all randomized controlled trials on the topic. Trial inclusion, quality assessment, and data extraction were performed independently by two authors. Standard meta-analytic techniques were applied. Results Eight trials (n = 622 patients) met our inclusion criteria. The medication/placebo was applied into the pericardial cavity and/or mediastinum at the end of cardiac surgery. Seven trials compared antifibrinolytic agents (aprotinin or tranexamic acid) versus placebo. They showed that, on average, topical use of antifibrinolytic agents reduced the amount of 24-h postoperative chest tube (blood) loss by 220 ml (95% confidence interval: -318 to -126, P \ 0.00001, I 2 = 93%) and resulted in a saving of 1 unit of allogeneic red blood cells per patient (95% confidence interval: -1.54 to -0.53, P \ 0.0001, I 2 = 55%). The incidence of blood transfusion was not significantly changed following topical application of the medications. One study comparing topical versus intravenous administration of aprotinin found comparable results between the two methods of administration for the abovementioned outcomes. No adverse effects were reported following topical use of the medications. Conclusion This review suggests that topical application of antifibrinolytics can reduce postoperative bleeding and transfusion requirements in patients undergoing on-pump cardiac surgery. These promising findings need to be confirmed by more trials with large sample size using patient-related outcomes and more assessments regarding the systemic absorption of the medications. RésuméObjectif Le but de cette e´tude me´thodique e´tait d'e´valuer l'efficacite´et l'innocuite´de l'application topique d'agents anti-fibrinolytiques afin de re´duire les saignements et les besoins transfusionnels postope´ratoires chez les patients subissant une chirurgie cardiaque avec circulation extracorporelle. Méthode Nous avons fouille´les bases de donne´es suivantes afin d'extraire toutes les e´tudes randomise´es contrôle´es traitant de cette question : The Cochrane Library, MEDLINE, EMBASE et SCI-EXPANDED. L'inclusion des e´tudes, l'e´valuation de la qualite´et l'extraction des donne´es ont e´te´re´alise´es de façon inde´-pendante par deux auteurs. Des techniques de me´ta-analyse standard ont e´te´utilise´es. Résultats Huit e´tudes (n = 622 patients) ont satisfait aǹ os crite`res d'inclusion. Le me´dicament/placebo a e´teá pplique´dans la cavite´pe´ricardique et/ou dans le me´dia-stin a`la fin de la chirurgie cardiaque. Sept e´tudes ont compare´des agents anti-fibrinolytiques (aprotinine ou acide tranexamique) a`un placebo. Ces e´tudes ont montre´que, en moyenne, l'application topique d'agents

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Section: Introductionmentioning

confidence: 99%

Topical application of antifibrinolytic drugs for on-pump cardiac surgery: a systematic review and meta-analysis

Abrishami

Chung

Wong

2009

Can J Anesth/J Can Anesth

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“…These drugs, however, are often only partially effective as manifest by the high incidence of excessive blood loss despite their use. 5 Recombinant activated factor VII (rFVIIa) is a hemostatic agent that may be effective in preventing or treating excessive blood loss in on-pump cardiac surgery. It is currently not approved for this indication in any jurisdiction.…”

mentioning

confidence: 99%

The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

Karkouti

Beattie

Crowther

et al. 2007

Can J Anesth/J Can Anesth

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Purpose: Recombinant activated factor VII (rFVIIa) is currently not approved by Health Canada or the Food and Drug Administration for treating excessive blood loss in nonhemophiliac patients undergoing on-pump cardiac surgery, but is increasingly being used "off-label" for this indication. A Canadian Consensus Conference was convened to generate recommendations for rFVIIa use in on-pump cardiac surgery. Methods: The panel undertook a literature review of the use of rFVIIa in both cardiac and non-cardiac surgery. Appropriateness, timing, and dosage considerations were addressed for three cardiac surgery indications: prophylactic, routine, and rescue uses. Recommendations were based on evidence from the literature and derived by consensus following recognized grading procedures. Results: The panel recommended against prophylactic or routine use of rFVIIa, as there is no evidence at this time that the benefits of rFVIIa outweigh its potential risks compared with standard hemostatic therapies. On the other hand, the panel made a weak recommendation (grade 2C) for the use of rFVIIa (one to two doses of 35-70 µg·kg -1 ) as rescue therapy for blood loss that is refractory to standard hemostatic therapies, despite the lack of randomized controlled trial data for this indication. Conclusions: In cardiac surgery, the risks and benefits of rFVIIa are unclear, but current evidence suggests that its benefits may outweigh its risks for rescue therapy in selected patients. Methodologically rigorous studies are needed to clarify its riskbenefit profile in cardiac surgery patients. 200 Elizabeth Street, Toronto, Ontario M5G 2C4,; E-mail: keyvan.karkouti@uhn.on.ca Disclosure statement: Novo Nordisk (Mississauga, Ontario, Canada), the makers of rFVIIa, funded this project through an unrestricted educational grant. Novo Nordisk was not involved in the selection of the members of the consensus panel, nor were they involved in the panel's review process, deliberations, conclusions, or manuscript preparation. The panel's chair selected the panel members, with the objective of achieving relevant multi-disciplinary expertise (i.e., anesthesiology, cardiac surgery, hematology, intensive care, and clinical epidemiology). The manuscript was primarily written by the panel chair (Keyvan Karkouti) and was approved by all of the panel members. All of the authors received an honorarium for attending the consensus conference.

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“…Amongst the three main available drugs, the aprotinine was the most used and tested [8][9][10]. In 2007, Ferraris et al published a recommendation based on the evidences available in the literature as class I (evidence level A): 1.…”

Section: Resultsmentioning

confidence: 99%

Uso tópico de agente antifibrinolítico na redução do sangramento após revascularização cirúrgica do miocárdio

Breda¹,

Gurian²,

Breda³

et al. 2009

Rev Bras Cir Cardiovasc

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Uso tópico de agente antifibrinolítico na redução do sangramento após revascularização cirúrgica do miocárdioTopical use of antifibrinolytic agent to reduce postoperative bleeding after coronary artery bypass surgery Abstract Objective: Antifibrinolytic agents reduce bleeding after cardiac surgery, but there are adverse effects after their systemic use. These effects are avoided by topical application of antifibrinolytic agents in pericardial cavity. We compared the effects of topically applied epsilon-aminocaproic acid (EACA) and placebo on postoperative bleeding and transfusion requirements after coronary artery bypass surgery.Methods: In this single center prospective, randomized, double-blind trial, 53 patients were randomized into two groups to receive EACA (24 g in 250 ml of saline solution) or placebo (250 ml of saline solution) before sternal closure. Groups were compared according the preoperative and intraoperative variables. Postoperative bleeding, transfusion requirements and hematologic parameters were evaluated.Results

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A propensity score case‐control comparison of aprotinin and tranexamic acid in high‐transfusion‐risk cardiac surgery

Abstract: Aprotinin and tranexamic acid have similar hemostatic effectiveness in high-transfusion-risk cardiac surgery. Within the confines of propensity score matching, our results suggest that aprotinin may be associated with renal dysfunction.

Cited by 308 publications

References 25 publications

Topical application of antifibrinolytic drugs for on-pump cardiac surgery: a systematic review and meta-analysis

Topical application of antifibrinolytic drugs for on-pump cardiac surgery: a systematic review and meta-analysis

The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

Uso tópico de agente antifibrinolítico na redução do sangramento após revascularização cirúrgica do miocárdio

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