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Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology

Background and Objectives: In anticoagulated atrial fibrillation (AF) patients, the validity of models recommended for the stratification of the risk ratio between benefits and hemorrhage risk is limited. Cerebral small vessel disease (SVD) represents the pathologic substrate for primary intracerebr...

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Autores principales: Poggesi, Anna, Barbato, Carmen, Galmozzi, Francesco, Camilleri, Eleonora, Cesari, Francesca, Chiti, Stefano, Diciotti, Stefano, Galora, Silvia, Giusti, Betti, Gori, Anna Maria, Marzi, Chiara, Melone, Anna, Mistri, Damiano, Pescini, Francesca, Pracucci, Giovanni, Rinnoci, Valentina, Sarti, Cristina, Fainardi, Enrico, Marcucci, Rossella, Salvadori, Emilia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6843419/
https://www.ncbi.nlm.nih.gov/pubmed/31548494
http://dx.doi.org/10.3390/medicina55100626
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author Poggesi, Anna
Barbato, Carmen
Galmozzi, Francesco
Camilleri, Eleonora
Cesari, Francesca
Chiti, Stefano
Diciotti, Stefano
Galora, Silvia
Giusti, Betti
Gori, Anna Maria
Marzi, Chiara
Melone, Anna
Mistri, Damiano
Pescini, Francesca
Pracucci, Giovanni
Rinnoci, Valentina
Sarti, Cristina
Fainardi, Enrico
Marcucci, Rossella
Salvadori, Emilia
author_facet Poggesi, Anna
Barbato, Carmen
Galmozzi, Francesco
Camilleri, Eleonora
Cesari, Francesca
Chiti, Stefano
Diciotti, Stefano
Galora, Silvia
Giusti, Betti
Gori, Anna Maria
Marzi, Chiara
Melone, Anna
Mistri, Damiano
Pescini, Francesca
Pracucci, Giovanni
Rinnoci, Valentina
Sarti, Cristina
Fainardi, Enrico
Marcucci, Rossella
Salvadori, Emilia
author_sort Poggesi, Anna
collection PubMed
description Background and Objectives: In anticoagulated atrial fibrillation (AF) patients, the validity of models recommended for the stratification of the risk ratio between benefits and hemorrhage risk is limited. Cerebral small vessel disease (SVD) represents the pathologic substrate for primary intracerebral hemorrhage and ischemic stroke. We hypothesize that biological markers—both circulating and imaging-based—and their possible interaction, might improve the prediction of bleeding risk in AF patients under treatment with any type of oral anticoagulant. Materials and Methods: The Strat-AF study is an observational, prospective, single-center hospital-based study enrolling patients with AF, aged 65 years or older, and with no contraindications to magnetic resonance imaging (MRI), referring to Center of Thrombosis outpatient clinic of our University Hospital for the management of oral anticoagulation therapy. Recruited patients are evaluated by means of a comprehensive protocol, with clinical, cerebral MRI, and circulating biomarkers assessment at baseline and after 18 months. The main outcome is SVD progression—particularly microbleeds—as a selective surrogate marker of hemorrhagic complication. Stroke occurrence (ischemic or hemorrhagic) and the progression of functional, cognitive, and motor status will be evaluated as secondary outcomes. Circulating biomarkers may further improve predictive potentials. Results: Starting from September 2017, 194 patients (mean age 78.1 ± 6.7, range 65–97; 61% males) were enrolled. The type of AF was paroxysmal in 93 patients (48%), and persistent or permanent in the remaining patients. Concerning the type of oral anticoagulant, 57 patients (29%) were on vitamin K antagonists, and 137 (71%) were on direct oral anticoagulants. Follow-up clinical evaluation and brain MRI are ongoing. Conclusions: The Strat-AF study may be an essential step towards the exploration of the role of a combined clinical biomarker or multiple biomarker models in predicting stroke risk in AF, and might sustain the incorporation of such new markers in the existing stroke prediction schemes by the demonstration of a greater incremental value in predicting stroke risk and improvement in clinical outcomes in a cost-effective fashion.
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spelling pubmed-68434192019-11-25 Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology Poggesi, Anna Barbato, Carmen Galmozzi, Francesco Camilleri, Eleonora Cesari, Francesca Chiti, Stefano Diciotti, Stefano Galora, Silvia Giusti, Betti Gori, Anna Maria Marzi, Chiara Melone, Anna Mistri, Damiano Pescini, Francesca Pracucci, Giovanni Rinnoci, Valentina Sarti, Cristina Fainardi, Enrico Marcucci, Rossella Salvadori, Emilia Medicina (Kaunas) Article Background and Objectives: In anticoagulated atrial fibrillation (AF) patients, the validity of models recommended for the stratification of the risk ratio between benefits and hemorrhage risk is limited. Cerebral small vessel disease (SVD) represents the pathologic substrate for primary intracerebral hemorrhage and ischemic stroke. We hypothesize that biological markers—both circulating and imaging-based—and their possible interaction, might improve the prediction of bleeding risk in AF patients under treatment with any type of oral anticoagulant. Materials and Methods: The Strat-AF study is an observational, prospective, single-center hospital-based study enrolling patients with AF, aged 65 years or older, and with no contraindications to magnetic resonance imaging (MRI), referring to Center of Thrombosis outpatient clinic of our University Hospital for the management of oral anticoagulation therapy. Recruited patients are evaluated by means of a comprehensive protocol, with clinical, cerebral MRI, and circulating biomarkers assessment at baseline and after 18 months. The main outcome is SVD progression—particularly microbleeds—as a selective surrogate marker of hemorrhagic complication. Stroke occurrence (ischemic or hemorrhagic) and the progression of functional, cognitive, and motor status will be evaluated as secondary outcomes. Circulating biomarkers may further improve predictive potentials. Results: Starting from September 2017, 194 patients (mean age 78.1 ± 6.7, range 65–97; 61% males) were enrolled. The type of AF was paroxysmal in 93 patients (48%), and persistent or permanent in the remaining patients. Concerning the type of oral anticoagulant, 57 patients (29%) were on vitamin K antagonists, and 137 (71%) were on direct oral anticoagulants. Follow-up clinical evaluation and brain MRI are ongoing. Conclusions: The Strat-AF study may be an essential step towards the exploration of the role of a combined clinical biomarker or multiple biomarker models in predicting stroke risk in AF, and might sustain the incorporation of such new markers in the existing stroke prediction schemes by the demonstration of a greater incremental value in predicting stroke risk and improvement in clinical outcomes in a cost-effective fashion. MDPI 2019-09-23 /pmc/articles/PMC6843419/ /pubmed/31548494 http://dx.doi.org/10.3390/medicina55100626 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Poggesi, Anna
Barbato, Carmen
Galmozzi, Francesco
Camilleri, Eleonora
Cesari, Francesca
Chiti, Stefano
Diciotti, Stefano
Galora, Silvia
Giusti, Betti
Gori, Anna Maria
Marzi, Chiara
Melone, Anna
Mistri, Damiano
Pescini, Francesca
Pracucci, Giovanni
Rinnoci, Valentina
Sarti, Cristina
Fainardi, Enrico
Marcucci, Rossella
Salvadori, Emilia
Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology
title Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology
title_full Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology
title_fullStr Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology
title_full_unstemmed Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology
title_short Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology
title_sort role of biological markers for cerebral bleeding risk stratification in patients with atrial fibrillation on oral anticoagulants for primary or secondary prevention of ischemic stroke (strat-af study): study design and methodology
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6843419/
https://www.ncbi.nlm.nih.gov/pubmed/31548494
http://dx.doi.org/10.3390/medicina55100626
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