Changing from Aprotinin to Tranexamic Acid Results in Increased Use of Blood Products and Recombinant Factor VIIa for Aortic Surgery Requiring Hypothermic Arrest

Sniecinski, Roman M.; Chen, Edward P.; Makadia, Sunal; Kikura, Mutsuhito; Bolliger, Daniel; Tanaka, Kenichi A.

doi:10.1053/j.jvca.2010.02.018

Cited by 38 publications

(18 citation statements)

References 23 publications

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“…Other studies have shown an increase in blood use and in off-label use of recombinant activated FVII without an effect on renal failure or early mortality. [46][47][48] Overall, it can be said that the controversy surrounding aprotinin has not been resolved satisfactorily and that further large randomized controlled studies will be necessary to confirm the benefits and the risks associated with its use. Other effective and possibly safer drugs may come to market in a predictable future, rendering this whole debate moot.…”

Section: Discussionmentioning

confidence: 99%

Major transfusions remain frequent despite the generalized use of tranexamic acid: an audit of 3322 patients undergoing cardiac surgery

et al. 2016

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Section: Discussionmentioning

confidence: 99%

Major transfusions remain frequent despite the generalized use of tranexamic acid: an audit of 3322 patients undergoing cardiac surgery

et al. 2016

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“…A total of 266 Medline articles were identified and the abstracts were searched for reference to in-hospital mortality or mortality to 30-days after surgery. We also searched reference lists of identified articles and included 12 studies additionally [8], [9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19]. Additionally, we searched Cochrane Library using “Cardiac Surgical Procedures” and “Aprotinin” with publication date from 1 st January 1990 and found 50 articles in English.…”

Section: Methodsmentioning

confidence: 99%

Aprotinin May Increase Mortality in Low and Intermediate Risk but Not in High Risk Cardiac Surgical Patients Compared to Tranexamic Acid and ε-Aminocaproic Acid – A Meta-Analysis of Randomised and Observational Trials of over 30.000 Patients

et al. 2013

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BackgroundTo compare the effect of aprotinin with the effect of lysine analogues (tranexamic acid and ε-aminocaproic acid) on early mortality in three subgroups of patients: low, intermediate and high risk of cardiac surgery.Methods and FindingsWe performed a meta-analysis of randomised controlled trials and observational with the following data sources: Medline, Cochrane Library, and reference lists of identified articles. The primary outcome measure was early (in-hospital/30-day) mortality. The secondary outcome measures were any transfusion of packed red blood cells within 24 hours after surgery, any re-operation for bleeding or massive bleeding, and acute renal dysfunction or failure within the selected cited publications, respectively.Out of 328 search results, 31 studies (15 trials and 16 observational studies) included 33,501 patients. Early mortality was significantly increased after aprotinin vs. lysine analogues with a pooled risk ratio (95% CI) of 1.58 (1.13–2.21), p<0.001 in the low (n = 14,297) and in the intermediate risk subgroup (1.42 (1.09–1.84), p<0.001; n = 14,427), respectively. Contrarily, in the subgroup of high risk patients (n = 4,777), the risk for mortality did not differ significantly between aprotinin and lysine analogues (1.03 (0.67–1.58), p = 0.90).ConclusionAprotinin may be associated with an increased risk of mortality in low and intermediate risk cardiac surgery, but presumably may has no effect on early mortality in a subgroup of high risk cardiac surgery compared to lysine analogues. Thus, decisions to re-license aprotinin in lower risk patients should critically be debated. In contrast, aprotinin might probably be beneficial in high risk cardiac surgery as it reduces risk of transfusion and bleeding complications.

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“…Their study also showed that with aprotinin, the ventilation time was shorter with no increase in in-hospital mortality or other major adverse events. Another retrospective study by Sniecinski et al, [71] compared their center's results for hypothermic circulatory arrest. As compared to aprotinin (when it was available and used) TA (post aprotinin era) showed increased use of blood products and recombinant factor VIIa in the post aprotinin era.…”

Section: Post Aprotinin Dilemmamentioning

confidence: 99%

Antifibrinolytics in cardiac surgery

Dhir

2013

Ann Card Anaesth

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Cardiac surgery exerts a significant strain on the blood bank services and is a model example in which a multi-modal blood-conservation strategy is recommended. Significant bleeding during cardiac surgery, enough to cause re-exploration and/or blood transfusion, increases morbidity and mortality. Hyper-fibrinolysis is one of the important contributors to increased bleeding. This knowledge has led to the use of anti-fibrinolytic agents especially in procedures performed under cardiopulmonary bypass. Nothing has been more controversial in recent times than the aprotinin controversy. Since the withdrawal of aprotinin from the world market, the choice of antifibrinolytic agents has been limited to lysine analogues either tranexamic acid (TA) or epsilon amino caproic acid (EACA). While proponents of aprotinin still argue against its non-availability. Health Canada has approved its use, albeit under very strict regulations. Antifibrinolytic agents are not without side effects and act like double-edged swords, the stronger the anti-fibrinolytic activity, the more serious the side effects. Aprotinin is the strongest in reducing blood loss, blood transfusion, and possibly, return to the operating room after cardiac surgery. EACA is the least effective, while TA is somewhere in between. Additionally, aprotinin has been implicated in increased mortality and maximum side effects. TA has been shown to increase seizure activity, whereas, EACA seems to have the least side effects. Apparently, these agents do not differentiate between pathological and physiological fibrinolysis and prevent all forms of fibrinolysis leading to possible thrombotic side effects. It would seem prudent to select the right agent knowing its risk-benefit profile for a given patient, under the given circumstances.

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Changing from Aprotinin to Tranexamic Acid Results in Increased Use of Blood Products and Recombinant Factor VIIa for Aortic Surgery Requiring Hypothermic Arrest

Cited by 38 publications

References 23 publications

Major transfusions remain frequent despite the generalized use of tranexamic acid: an audit of 3322 patients undergoing cardiac surgery

Major transfusions remain frequent despite the generalized use of tranexamic acid: an audit of 3322 patients undergoing cardiac surgery

Aprotinin May Increase Mortality in Low and Intermediate Risk but Not in High Risk Cardiac Surgical Patients Compared to Tranexamic Acid and ε-Aminocaproic Acid – A Meta-Analysis of Randomised and Observational Trials of over 30.000 Patients

Antifibrinolytics in cardiac surgery

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