aprotinine et xie cardiaque - arcothova.com
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Aprotinine et Xie cardiaque
…le retour ?
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Mangano DT et al. N Engl J Med. 2006;354:353-65
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Aprotinine
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Aprotinine
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Diminution des hémorragies massives et de la mortalité de 50% (Aprotinine vs ac tranexanique
Diminution de la mortalité de 50% (Aprotinine vs ac tranexanique)
Augmentation de la mortalité par 2,5
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Aprotinine • Product:
– Injectable solution (0.5 Mio KIU/vial)
– Antifibrinolytic properties
• Indication:
Aprotinin is indicated for “Prophylactic use to reduce blood loss and blood transfusion in
adult patients who are at high risk of major blood loss undergoing isolated
cardiopulmonary bypass graft surgery (i.e. CABG that is not combined with other
cardiovascular surgery)”
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3 conditions for aprotinin MA*
• Submission of an updated RMP**: referring to the agreed products’ safety concerns and their risk minimisation which includes a direct healthcare professional communication
• Conduct of a registry • Restricted distribution: aprotinin available only to centres that
perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry
*MA: Marketing Authorization = AMM **RMP: Risk Management Plan = Plan de Gestion des Risques
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What is the NAPaR ?
NAPaR = Nordic Aprotinin Patient Registry
• The NAPaR) is a non-interventional Post-Authorisation Safety Study (PASS)
• A registry is to be conducted to monitor the pattern of use of aprotinin
* The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines.
Mandatory Pharmacovigilance Risk Assessment Committee (PRAC)* endorsed protocol in
March 2015
Record on patients information exposed to aprotinin at cardiac surgery centres in
participating countries
Easy-to-use web-based database (“eCRF”)
Duration of study: at least three years or 12,000 patients… and the decision to terminate
the Registry will be taken based on agreement with the PRAC
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The NAPaR in Europe
Countries:
Countries Active sites First included
patient Nbre of patients
SE 4 02/2016 122
UK 31 03/2016 1 858
DE 6 02/2017 259
AT 1 09/2017 4
FI 1 05/2018 4
2 247 patients
Status on September 6, 2018:
Active
Achieve regulatory acceptance
Pending regulatoy validation
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Approved by CPP (France)
Approved centers (n=7)
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Aprotinin
• Full « Royston » : 2 million KIU load, 2 million
KIU pump prime, and 0.5 million KIU/h
continuous infusion
• Half « Roytson »
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Objectif de recrutement : 3 patients /mois….
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Conclusion
• Registre en France : étude multicentrique
• Réintroduction de l’Aprotinine ?
– Chirurgies à haut risque
– Patients à haut risque
– Intérêt médico-économique
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Remerciements
Pr JL Fellahi