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Long-Term Antithrombotic Treatments Prescribed for Cardiovascular Diseases in Patients with Hemophilia: Results from the French Registry

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Long-Term Antithrombotic Treatments Prescribed for Cardiovascular Diseases in Patients with Hemophilia: Results from the French Registry Published online: 2020-10-24 THIEME Coagulation and Fibrinolysis 287 Long-Term Antithrombotic Treatments Prescribed for Cardiovascular Diseases in Patients with Hemophilia: Results from the French Registry à à Benoît Guillet1,2, Guillaume Cayla3, Aurélien Lebreton4 Nathalie Trillot5 Bénédicte Wibaut5 Céline Falaise6 Sabine Castet7 Philippe Gautier8 Ségolène Claeyssens9 Jean-François Schved10 1 Centre Régional de Traitement des Maladies Hémorragiques, CHU Address for correspondence Jean-François Schved, Laboratoire de Rennes, et Université de Rennes 1, France Central D’hématologie, CHRU de Montpellier – Hôpital Saint-Eloi, 80 2 CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, Avenue Augustin Fliche, F-34295 Montpellier, France environnement et travail), Univ Rennes, UMR_S 1085, Rennes, France (e-mail: [email protected]). 3 Service de Cardiologie CHU de Nîmes, Université de Montpellier, Nimes, France 4 Centre Régional de Traitement des Hémophiles, CHU de Clermont- Ferrand, France 5 Centre Régional de Traitement des Hémophiles, CHU de Lille, France 6 Centre Régional de Traitement des Hémophiles, CHU La Timone, Marseille, France 7 Centre Régional de Traitement des Hémophiles, CHU de Bordeaux, France 8 Centre Régional de Traitement des Hémophiles, CHU de Caen, France 9 Centre Régional de Traitement des Hémophiles, CHU de Toulouse, France 10Centre Régional de Traitement des Hémophiles, Hôpital Saint-Eloi, CHRU de Montpellier, Montpellier, France Thromb Haemost 2021;121:287–296. Abstract Cardiovascular diseases (CVDs) are a major issue in aging patients with hemophilia (PWHs). Antithrombotic agents are widely used in the general population for CVD treatment, but this recommendation is not fully applicable to PWHs. To improve treatment strategies, a prospective case–control study (COCHE) that analyzed CVD management and follow-up (2 years/patient) in PWHs was performed in France from 2011 to 2018. In total, 68 PWHs (median age: 65 years [39–89]; 48 mild, 10 moderate, Keywords and 10 severe hemophilia) were included (n ¼ 50 with acute coronary syndrome, ► antithrombotic n ¼ 17 with atrial fibrillation, n ¼ 1 with both). They were matched with 68 control treatment PWHs without antithrombotic treatment. In our series, bleeding was significantly ► atrial fibrillation influenced by (1) hemophilia severity, with a mean annualized bleeding ratio signifi- ► cardiovascular cantly higher in COCHE patients than in controls with basal clotting factor level up to disease 20%, (2) antihemorrhagic regimen (on-demand vs. prophylaxis) in severe (hazard ratio ► hemophilia [HR] ¼ 16.69 [95% confidence interval, CI: 8.2–47.26]; p < 0.0001) and moderate ► bleeding risk hemophilia (HR ¼ 42.43 [95% CI: 1.86–966.1]; p ¼ 0.0028), (3) type of antithrombotic à Benoît Guillet and Guillaume Cayla contributed equally to the present work. received DOI https://doi.org/ © 2020. The Author(s). June 10, 2019 10.1055/s-0040-1718410. This is an open access article published by Thieme under the terms of the accepted after revision ISSN 0340-6245. Creative Commons Attribution-NonDerivative-NonCommercial-License, August 28, 2020 permitting copying and reproduction so long as the original work is given published online appropriate credit. Contents may not be used for commercial purposes, or October 24, 2020 adapted, remixed, transformed or built upon. (https://creativecommons.org/ licenses/by-nc-nd/4.0/) Georg Thieme Verlag KG, Rüdigerstraße 14, 70469 Stuttgart, Germany 288 Cardiovascular Disorders and Hemophilia Care Guillet et al. treatment in mild hemophilia, with a significantly higher risk of bleeding in COCHE patients than in controls for dual-pathway therapy (HR ¼ 15.64 [95% CI: 1.57–115.8]; p ¼ 0.019), anticoagulant drugs alone (HR ¼ 9.91 [95% CI: 1.34–73.47]; p ¼ 0.0248), dual antiplatelet therapy (HR ¼ 5.31 [95% CI: 1.23–22.92]; p ¼ 0.0252), and single antiplatelet therapy (HR ¼ 3.76 [95% CI: 1.13–12.55]; p ¼ 0.0313); and (4) HAS-BLED score 3 (odds ratio [OR] ¼ 33 [95% CI: 1.43–761.2]; p ¼ 0.0065). Gastrointestinal bleeding was also significantly higher in COCHE patients than in controls (OR ¼ 15 [95% CI: 1.84–268]; p ¼ 0.0141). The COCHE study confirmed that antithrombotic treat- ments in PWHs are associated with increased bleeding rates in function of hemophilia- specific factors and also of known factors in the general population. Introduction the general population. For each included patient, a specially designed case report form was filled at inclusion, and then all Hemophilia management has significantly improved in the last treatment changes, new cardiovascular events, and bleeding decades. Since the emergence of clotting factor concentrates in events were recorded in a follow-up form at month 1 after the 1970s,1 the life expectancy of patients with hemophilia inclusion, and every 6 months for 2 years. The collected data (PWHs) has dramatically increased from less than 30 to over included demographic features and disease characteristics, – 60 years in high-income countries.2 8 Consequently, aging cardiovascular risk factors and antecedents, ACS/CAD or AF PWHs are increasingly confronted with age-related conditions, treatment modalities, major and minor bleeding events, and such as cardiovascular diseases (CVDs), primarily acute coro- factor replacement therapy before, during, and after any nary syndrome (ACS) and atrial fibrillation (AF). cardiovascular event. According to the International Society Antithrombotic treatments, mainly antiplatelet agents, on Thrombosis and Haemostasis recommendations, major play a central role in secondary CVD prevention. It is now bleeds were defined as events that required pro-hemostatic well established that dual antiplatelet therapy (DAPT) with substitutive treatment, hospitalization, transfusion, or surgi- aspirin and P2Y12 inhibitors, such as clopidogrel, is required cal/radiological interventions.16,17 after drug-eluting stent (DES) implantation.9 There are also The control group included PWHs followed at the Hemo- well-defined guidelines for AF management in function of philia Treatment Centre (HTC) of Rennes, France. Each con- the patient’sCHA2D2-VASc score. This includes the long-term trol patient was matched with one patient of the COCHE use of anticoagulant drugs, mainly vitamin K antagonists group on the basis of age (Æ5 years), hemophilia type and (VKAs) or direct oral anticoagulants (DOAs).10 Inthecaseof severity (Æ5andÆ 2% of clotting factor level for mild and high ischemic/thrombogenic risk, anticoagulant and anti- moderate forms, respectively), antifactor inhibitor status, platelet drugs can be combined.11 Although these drug and type (on-demand or prophylaxis) of clotting factor combinations are expected to increase the bleeding risk in replacement therapy (only for patients with severe hemo- PWHs, this effect has not yet been demonstrated by studies philia). Data for the control group were retrospectively with high levels of evidence. Evidence-based guidelines for collected from February 2016 to January 2018, for the the optimal management of acute CVD in PWHs or same number of months as for the matched case. These for secondary prevention are limited, as well as the published data were extracted from the HTC medical file, HTC compre- recommendations on how to handle the higher bleeding risk hensive daily board of hospitalization, and each patient’s associated with invasive procedures that require hemostasis- hemophilia diary. This allowed collecting precise informa- – interfering drugs.12 15 tion on each clotting factor infusion, hospitalization, and As properly controlled randomized trials are not feasible emergency surgery in the control group. in PWHs, we set up a case–control study in France to The mean annualized bleeding rates (ABRs) and annualized prospectively collect data on the management of coronary cardiovascular event rates (ACvR) during the study follow-up artery disease (CAD)/ACS or AF in PWHs, and on the con- were calculated for both groups. For each patient, the sum of all sequences, particularly of antithrombotic treatments, during events was divided by the exact number of months (then the 2-year follow-up. transformed in years) of follow-up. The mean ABR and ACvR were compared between groups and also within the COCHE Methods group in function of the used antithrombotic treatment, antihemorrhagic regimen (prophylaxis/on-demand), hemo- The COCHE study is a French prospective, noninterventional, philia severity, clotting factor levels, and HAS-BLED score for multicenter case–control registry. The study was started in patients with AF. Number and causes of death were recorded. July 2011 and data were collected until December 2017. The This study did not affect the normal patient management COCHE group (i.e., the cases) included PWHs A or B who started anddidnotleadtospecific treatments or investigations. The an antithrombotic treatment for ACS/CAD or for nonvalvular physicians’ prescribing freedom was entirely maintained. Prior AF, according tothe recommendations for CVD management in to inclusion, each patient was informed about the registry Thrombosis and Haemostasis Vol. 121 No. 3/2021 © 2020. The Author(s). Cardiovascular Disorders and Hemophilia Care Guillet et al. 289 procedures and provided a written consent. For the study, only curves were drawn and analyzed using the Mantel–Cox log- anonymized data were used. This study followed the Declara- rank test that computes also the chi square and HR values, tion of Helsinki and local legislation. In accordance with the including the 95%
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