Cost Analysis of Aprotinin Reintroduction in French Cardiac Surgery Centres: A Real-World Data-Based Analysis

Pascal Colson, Jean-Luc Fellahi, Philippe Gaudard (), Sophie Provenchère and Bertrand Rozec ()
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Pascal Colson: Hôpital Arnaud de Villeneuve [CHU Montpellier] - CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier], IGF - Institut de Génomique Fonctionnelle - INSERM - Institut National de la Santé et de la Recherche Médicale - CNRS - Centre National de la Recherche Scientifique - UM - Université de Montpellier
Jean-Luc Fellahi: Hôpital Louis Pradel [CHU - HCL] - HCL - Hospices Civils de Lyon, CarMeN - Cardiovasculaire, métabolisme, diabétologie et nutrition - UCBL - Université Claude Bernard Lyon 1 - Université de Lyon - HCL - Hospices Civils de Lyon - INSERM - Institut National de la Santé et de la Recherche Médicale - INRAE - Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement
Philippe Gaudard: PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] - INSERM - Institut National de la Santé et de la Recherche Médicale - CNRS - Centre National de la Recherche Scientifique - UM - Université de Montpellier, Hôpital Arnaud de Villeneuve [CHU Montpellier] - CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
Sophie Provenchère: AP-HP - Hôpital Bichat - Claude Bernard [Paris] - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
Bertrand Rozec: CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital, ITX-lab - ITX-lab unité de recherche de l'institut du thorax UMR1087 UMR6291 - INSERM - Institut National de la Santé et de la Recherche Médicale - CNRS - Centre National de la Recherche Scientifique - Nantes Univ - UFR MEDECINE - Nantes Université - UFR de Médecine et des Techniques Médicales - Nantes Université - pôle Santé - Nantes Univ - Nantes Université

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Abstract: Introduction: The European Medicines Agency restored aprotinin (APR) use for preventing blood loss in patients undergoing isolated coronary artery bypass graft (iCABG) in 2016 but requested the collection of patient and surgery data in a registry (NAPaR). The aim of this analysis was to evaluate the impact of APR reintroduction in France on the main hospital costs (operating room, transfusion and intensive unit stay) compared to the current use of tranexamic acid (TXA), which was the only antifibrinolytic available before APR reinstatement.Methods: A multicenter before-after post-hoc analysis to compare APR and TXA was carried out in four French university hospitals. APR use followed the ARCOTHOVA (French Association of Cardiothoracic and Vascular Anesthetists) protocol, which had framed three main indications in 2018. Data from 236 APR patients were retrieved from the NAPaR (N = 874); 223 TXA patients were retrospectively retrieved from each center database and matched to APR patients upon indication classes. Budget impact was evaluated using both direct costs associated with antifibrinolytics and transfusion products (within the first 48 h) and other costs such as surgery duration and ICU stay.Results: The 459 collected patients were distributed as: 17% on-label; 83% off-label. Mean cost per patient until ICU discharge tended to be lower in the APR group versus the TXA group, which resulted in an estimated gross saving of €3136 per patient. These savings concerned operating room and transfusion costs but were mainly driven by reduced ICU stays. When extrapolated to the whole French NAPaR population, the total savings of the therapeutic switch was estimated at around €3 million.Conclusion: The budget impact projected that using APR according to ARCOTHOVA protocol resulted in decreased requirement for transfusion and complications related to surgery. Both were associated with substantial cost savings from the hospital's perspective compared with exclusive use of TXA.

Date: 2023-03-03
New Economics Papers: this item is included in nep-des
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Published in Advances in Therapy, 2023, 40, pp.1803-1817. ⟨10.1007/s12325-023-02464-7⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-04014514

DOI: 10.1007/s12325-023-02464-7

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