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CC BY 4.0 · Thromb Haemost
DOI: 10.1055/a-2576-7760
Invited Clinical Focus

Personalized Medicine, Public Health and Patient-Centred Aspects in the Prevention of Stroke in Intracerebral Haemorrhage Survivors with Atrial Fibrillation (PRESTIGE-AF) Project

Kirsten H. Harvey
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
,
Eleni Korompoki
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
2   Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Alexandra Hospital, Athens, Greece
,
Emily R. Harvey
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
,
Cornelia Fießler
3   Clinical Trial Center Wüzburg, University Hospital Würzburg, Würzburg, Germany
,
Uwe Malzahn
3   Clinical Trial Center Wüzburg, University Hospital Würzburg, Würzburg, Germany
,
Klemens Hügen
3   Clinical Trial Center Wüzburg, University Hospital Würzburg, Würzburg, Germany
,
Sabine Ullmann
3   Clinical Trial Center Wüzburg, University Hospital Würzburg, Würzburg, Germany
,
Carolin Schuhmann
3   Clinical Trial Center Wüzburg, University Hospital Würzburg, Würzburg, Germany
,
Gabriele Putz Todd
3   Clinical Trial Center Wüzburg, University Hospital Würzburg, Würzburg, Germany
,
Joan Montaner
4   Department of Neurology, Institute de Biomedicine of Seville, IBiS/Hospital Universitario Virgen del Rocío/CSIC/University of Seville, Hospital Universitario Virgen Macarena, Seville, Spain
5   Neurovascular Research Laboratory, Vall d'Hebron Institute of Research (VHIR), Hospital Vall d'Hebron, Barcelona, Spain
,
Anna Penalba
5   Neurovascular Research Laboratory, Vall d'Hebron Institute of Research (VHIR), Hospital Vall d'Hebron, Barcelona, Spain
,
Daisy Guaman-Pilco
5   Neurovascular Research Laboratory, Vall d'Hebron Institute of Research (VHIR), Hospital Vall d'Hebron, Barcelona, Spain
,
Igor Sibon
6   University of Bordeaux, UMR-CNRS 5287, INCIA, Bordeaux, France
7   Stroke Unit, Bordeaux University Hospital, Bordeaux, France
,
Stephanie Debette
8   UMR 1219 Bordeaux Population Health Center, University of Bordeaux, Bordeaux, France
9   Department of Neurology, Institute for Neurodegenerative Diseases, Bordeaux University Hospital, Bordeaux, France
,
Timothy D'Aoust
8   UMR 1219 Bordeaux Population Health Center, University of Bordeaux, Bordeaux, France
,
Morgane Lachaize
8   UMR 1219 Bordeaux Population Health Center, University of Bordeaux, Bordeaux, France
9   Department of Neurology, Institute for Neurodegenerative Diseases, Bordeaux University Hospital, Bordeaux, France
,
Christian Enzinger
10   Department of Neurology, Medical University of Graz, Graz, Austria
,
Stefan Ropele
10   Department of Neurology, Medical University of Graz, Graz, Austria
,
Simon Fandler-Höfler 
10   Department of Neurology, Medical University of Graz, Graz, Austria
,
Viktoria Ruecker
11   Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany
,
Kirsten Haas
11   Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany
,
Peter B. Nielsen
12   Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
13   Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark
,
Charles Wolfe
14   School of Life Course and Population Sciences, King's College London, London, United Kingdom
15   NIHR Applied Research Collaboration (ARC) South London, London, United Kingdom
,
Yanzhong Wang
14   School of Life Course and Population Sciences, King's College London, London, United Kingdom
,
Hatem Wafa
14   School of Life Course and Population Sciences, King's College London, London, United Kingdom
,
Valeria Caso
16   Stroke Unit - Internal, Vascular and Emergency Medicine, University of Perugia, Santa Maria della Misericordia Hospital Perugia, Perugia, Italy
,
Maria Giulia Mosconi
16   Stroke Unit - Internal, Vascular and Emergency Medicine, University of Perugia, Santa Maria della Misericordia Hospital Perugia, Perugia, Italy
,
Gregory Y. H. Lip 
13   Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark
17   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
,
Deirdre A. Lane 
13   Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark
17   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
18   Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, United Kingdom
,
Walter E. Haefeli
19   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Cooperation Unit Clinical Pharmacy, Heidelberg University Hospital, Heidelberg, Germany
20   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany
,
Kathrin I. Foerster
20   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany
,
Viktoria S. Wurmbach
19   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Cooperation Unit Clinical Pharmacy, Heidelberg University Hospital, Heidelberg, Germany
20   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany
,
Peter Ringleb
21   Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany
,
Peter U. Heuschmann
3   Clinical Trial Center Wüzburg, University Hospital Würzburg, Würzburg, Germany
11   Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany
23   Institute for Medical Data Science, University Hospital Würzburg, Germany
,
Roland Veltkamp
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
21   Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany
22   Department of Neurology, Alfried-Krupp Krankenhaus Essen Germany
,
on behalf of PRESTIGE-AF investigators› Institutsangaben
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Introduction

Although systematic reviews and meta-analysis of observational studies have suggested a benefit of oral anticoagulation (OAC) for ischaemic stroke prevention without a significant increase in recurrent ICH, experts agree that more evidence is required from randomized controlled trials (RCTs).[1] [2] PRESTIGE-AF is a European Union Horizon 2020 funded project with a consortium of 12 institutions across 7 countries since 2019 ([Fig. 1]). The aim is to explore optimal stroke prevention strategies for intracerebral haemorrhage (ICH) survivors with atrial fibrillation (AF), investigating the balance between the risk of ischaemic stroke against the risk of recurrent ICH.

Zoom Image
Fig. 1 PRESTIGE-AF consortium institutions.

The complexity of clinical management in ICH patients with AF is compounded by differences in clinical and patient characteristics, such as stroke severity, risk factors, and socio-demographics. Consequently, it is unlikely that RCTs alone will provide a solution for stroke prevention that will fit individual patients. Therefore, in addition to the main RCT, PRESTIGE-AF is examining how blood-based biomarkers, genetic factors, neuroimaging, and clinical features can be used to personalize stroke management. We are also exploring patient-centred aspects which can influence medication use and clinical trial participation. The project overview is shown in [Fig. 2]. Clinical trial results can have a broad impact on health policy. This will be addressed within the project by modelling the health economic impact of our results and exploring if our findings are generalizable to a European population.

Zoom Image
Fig. 2 PRESTIGE-AF project overview.

The review process for this paper was fully handled by Christian Weber, Editor in Chief.




Publikationsverlauf

Eingereicht: 11. Dezember 2024

Angenommen: 04. März 2025

Artikel online veröffentlicht:
30. April 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

  • References

  • 1 Korompoki E, Filippidis FT, Nielsen PB. et al. Long-term antithrombotic treatment in intracranial hemorrhage survivors with atrial fibrillation. Neurology 2017; 89 (07) 687-696
    CrossrefPubMedSuche in Google Scholar
  • 2 Ivany E, Ritchie LA, Lip GYH, Lotto RR, Werring DJ, Lane DA. Effectiveness and safety of antithrombotic medication in patients with atrial fibrillation and intracranial hemorrhage: systematic review and meta-analysis. Stroke 2022; 53 (10) 3035-3046
    CrossrefPubMedSuche in Google Scholar
  • 3 Reilly PA, Lehr T, Haertter S. et al; RE-LY Investigators. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol 2014; 63 (04) 321-328
    PubMedSuche in Google Scholar
  • 4 Charidimou A, Boulouis G, Frosch MP. et al. The Boston criteria version 2.0 for cerebral amyloid angiopathy: a multicentre, retrospective, MRI-neuropathology diagnostic accuracy study. Lancet Neurol 2022; 21 (08) 714-725
    CrossrefPubMedSuche in Google Scholar
  • 5 Fandler-Höfler S, Obergottsberger L, Ambler G. et al. Association of the presence and pattern of MRI markers of cerebral small vessel disease with recurrent intracerebral hemorrhage. Neurology 2023; 101 (08) e794-e804
    PubMedSuche in Google Scholar
  • 6 Van Gelder IC, Rienstra M, Bunting KV. et al; ESC Scientific Document Group. 2024 ESC guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2024; 45 (36) 3314-3414
    CrossrefPubMedSuche in Google Scholar
  • 7 Wang Y, Guo Y, Qin M. et al; Expert Reviewers. 2024 Chinese expert consensus guidelines on the diagnosis and treatment of atrial fibrillation in the elderly, endorsed by Geriatric Society of Chinese Medical Association (Cardiovascular Group) and Chinese Society of Geriatric Health Medicine (Cardiovascular Branch): executive summary. Thromb Haemost 2024; 124 (10) 897-911
    Thieme ConnectPubMedSuche in Google Scholar
  • 8 Chao TF, Joung B, Takahashi Y. et al. 2021 focused update of the 2017 consensus guidelines of the Asia Pacific Heart Rhythm Society (APHRS) on stroke prevention in atrial fibrillation. J Arrhythm 2021; 37 (06) 1389-1426
    CrossrefPubMedSuche in Google Scholar
  • 9 Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010; 137 (02) 263-272
    CrossrefPubMedSuche in Google Scholar
  • 10 Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010; 138 (05) 1093-1100
    CrossrefPubMedSuche in Google Scholar
  • 11 Guo YT, Zhang Y, Shi XM. et al. Assessing bleeding risk in 4824 Asian patients with atrial fibrillation: the Beijing PLA Hospital Atrial Fibrillation Project. Sci Rep 2016; 6: 31755
    PubMedSuche in Google Scholar
  • 12 Krishnamurthi RV, Feigin VL, Forouzanfar MH. et al; Global Burden of Diseases, Injuries, Risk Factors Study 2010 (GBD 2010), GBD Stroke Experts Group. Global and regional burden of first-ever ischaemic and haemorrhagic stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet Glob Health 2013; 1 (05) e259-e281
    CrossrefPubMedSuche in Google Scholar
  • 13 van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol 2010; 9 (02) 167-176
    CrossrefPubMedSuche in Google Scholar
  • 14 Al-Shahi Salman R, Stephen J, Tierney JF. et al; Collaboration of Controlled Randomised Trials of Long-Term Oral Antithrombotic Agents After Spontaneous Intracranial Haemorrhage (COCROACH). Effects of oral anticoagulation in people with atrial fibrillation after spontaneous intracranial haemorrhage (COCROACH): prospective, individual participant data meta-analysis of randomised trials. Lancet Neurol 2023; 22 (12) 1140-1149
    CrossrefPubMedSuche in Google Scholar
  • 15 Wang Y, Rudd AG, Wolfe CD. Trends and survival between ethnic groups after stroke: the South London Stroke Register. Stroke 2013; 44 (02) 380-387
    PubMedSuche in Google Scholar
  • 16 Wafa HA, Marshall I, Wolfe CDA. et al; PRESTIGE-AF consortium. Burden of intracerebral haemorrhage in Europe: forecasting incidence and mortality between 2019 and 2050. Lancet Reg Health Eur 2024; 38: 100842
    CrossrefPubMedSuche in Google Scholar
  • 17 Nielsen PB, Melgaard L, Overvad TF, Jensen M, Larsen TB, Lip GYH. PRESTIGE-AF Consortium. Risk of cerebrovascular events in intracerebral hemorrhage survivors with atrial fibrillation: a nationwide cohort study. Stroke 2022; 53 (08) 2559-2568
    PubMedSuche in Google Scholar
  • 18 Hoffmann S, Harms H, Ulm L. et al; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia—The PREDICT study. J Cereb Blood Flow Metab 2017; 37 (12) 3671-3682
    PubMedSuche in Google Scholar
  • 19 Hoffmann S, Malzahn U, Harms H. et al; Berlin Stroke Register and the Stroke Register of Northwest Germany. Development of a clinical score (A2DS2) to predict pneumonia in acute ischemic stroke. Stroke 2012; 43 (10) 2617-2623
    PubMedSuche in Google Scholar
  • 20 Rücker V, Keil U, Fitzgerald AP. et al. Predicting 10-year risk of fatal cardiovascular disease in Germany: an update based on the SCORE-Deutschland Risk Charts. PLoS One 2016; 11 (09) e0162188
    PubMedSuche in Google Scholar
  • 21 Smith CJ, Bray BD, Hoffman A. et al; Intercollegiate Stroke Working Party Group. Can a novel clinical risk score improve pneumonia prediction in acute stroke care? A UK multicenter cohort study. J Am Heart Assoc 2015; 4 (01) e001307
    PubMedSuche in Google Scholar
  • 22 Gattringer T, Ferrari J, Knoflach M. et al. Sex-related differences of acute stroke unit care: results from the Austrian stroke unit registry. Stroke 2014; 45 (06) 1632-1638
    PubMedSuche in Google Scholar
  • 23 Cordonnier C, Sprigg N, Sandset EC. et al; Women Initiative for Stroke in Europe (WISE) group. Stroke in women—from evidence to inequalities. Nat Rev Neurol 2017; 13 (09) 521-532
    PubMedSuche in Google Scholar
  • 24 Corica B, Lobban T, True Hills M, Proietti M, Romiti GF. Sex as a risk factor for atrial fibrillation-related stroke. Thromb Haemost 2024; 124 (04) 281-285
    Thieme ConnectPubMedSuche in Google Scholar
  • 25 Ivany E, Lotto RR, Lip GYH, Lane DA. Managing uncertainty: physicians' decision making for stroke prevention for patients with atrial fibrillation and intracerebral hemorrhage. Thromb Haemost 2022; 122 (09) 1603-1611
    Thieme ConnectPubMedSuche in Google Scholar
  • 26 Lane DA. Patient involvement in decision-making. PRESTIGE-AF. Accessed November 20, 2024; available at: https://www.imperial.ac.uk/media/imperial-college/medicine/brain-sciences/PRESTIGE-AF-educational-materials.pdf
    PubMed
  • 27 Schreuder FHBM, van Nieuwenhuizen KM, Hofmeijer J. et al; APACHE-AF Trial Investigators. Apixaban versus no anticoagulation after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation in the Netherlands (APACHE-AF): a randomised, open-label, phase 2 trial. Lancet Neurol 2021; 20 (11) 907-916
    CrossrefPubMedSuche in Google Scholar
  • 28 So SC. SoSTART Collaboration. Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage in the UK: a randomised, open-label, assessor-masked, pilot-phase, non-inferiority trial. Lancet Neurol 2021; 20 (10) 842-853
    CrossrefPubMedSuche in Google Scholar