https://doi.org/10.4081/btvb.2023.84
Management of anticoagulation in atrial fibrillation patients in Italy: insight from the Atrial Fibrillation-Survey on Anticoagulated Patients Register (AF-START)
Submitted: 14 May 2023
Accepted: 22 June 2023
Published: 27 June 2023
Accepted: 22 June 2023
Abstract Views: 1093
PDF: 243
Supplementary File: 123
Supplementary File: 123
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
The survey on anticoagulated patients register (START-Register) is an independent, prospective, inception-cohort observational study aimed at providing information on patients on vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) in Italy. In this study, we describe the cohort of atrial fibrillation (AF) patients in the START-Register and report outcomes and changes in anticoagulant prescription from 2011 to 2021. The study included 11,078 AF patients, enrolled in 47 Italian centers distributed all over the Country; the median age was 77 years (range 18-99 years); 6029 (54.3%) were men; 5135 (46.4%) were on VKAs, and 5943 (53.6%) were on DOACs. Warfarin was the most prescribed VKA (98.4%), and apixaban was the most prescribed DOAC (31.6%). Among DOAC users, 4022 (67.7%) patients were naive to anticoagulation, and 2562 (43.1%) patients were treated with a reduced dose. DOAC patients were significantly older than VKA patients (median age 79 years vs 76 years respectively, P<0.001), but no gender difference was detected. The mean CHA2DS2VASc score was higher in DOAC users than in VKA users (3.7 vs 3.6; P=0.03). The mean HAS-BLED score was not different between the two groups. During follow-up, 542 bleeding events were recorded [2.44 per 100 patient-years (pt-yrs)]; 240 were major (1.08 per 100 pt-yrs), and 301 were clinically relevant non-major bleedings (1.34 per 100 pt-yrs). 146 thrombotic events were recorded during follow-up (0.66 per 100 pt-yrs). The total mortality rate was 3.5 per 100 pt-yrs; the mortality rate was 4.54 per 100 pt-yrs among patients on VKAs and 2.31 per 100 pt-yrs among patients on DOACs. During the last 10 years, in Italy, AF patient management has changed with the large spread of DOACs all over the Country. DOAC patients are frequently treated with reduced doses and show a lower mortality rate in comparison to patients on VKAs.
Wolf PA, Abbott RD and Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the framingham study. Stroke 1991;22:983-8.
DOI: https://doi.org/10.1161/01.STR.22.8.983
Hart RG, Pearce LA and Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857-67.
DOI: https://doi.org/10.7326/0003-4819-146-12-200706190-00007
Jorgensen HS, Nakayama H, Reith J, et al. Acute stroke with atrial fibrillation. The Copenhagen stroke study. Stroke 1996;27:1765-9.
DOI: https://doi.org/10.1161/01.STR.27.10.1765
Benjamin EJ, Wolf PA, D'Agostino RB, et al. Impact of atrial fibrillation on the risk of death: the framingham heart study. Circulation 1998;98:946-52.
DOI: https://doi.org/10.1161/01.CIR.98.10.946
European Heart Rhythm Association, European Association for Cardio-Thoracic Surgery, Camm AJ, et al. Guidelines for the management of atrial fibrillation: the task force for the management of atrial fibrillation of the european society of cardiology (ESC). Eur Heart J 2010;31:2369-429.
DOI: https://doi.org/10.1093/eurheartj/ehq278
Ogilvie IM, Newton N, Welner SA, et al. Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am J Med 2010;123:638-45.e4.
DOI: https://doi.org/10.1016/j.amjmed.2009.11.025
Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 2014;383:955-62.
DOI: https://doi.org/10.1016/S0140-6736(13)62343-0
Kakkar AK, Mueller I, Bassand JP, et al. International longitudinal registry of patients with atrial fibrillation at risk of stroke: global anticoagulant registry in the FIELD (GARFIELD). Am Heart J 2012;163:13-19.e1.
DOI: https://doi.org/10.1016/j.ahj.2011.09.011
Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the anticoagulation and risk factors in atrial fibrillation (ATRIA) study. JAMA 2001;285:2370-5.
DOI: https://doi.org/10.1001/jama.285.18.2370
Kirchhof P, Ammentorp B, Darius H, et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC guidelines on atrial fibrillation: primary results of the prevention of thromboemolic events--European registry in atrial fibrillation (prefer in AF). Europace 2014;16:6-14.
DOI: https://doi.org/10.1093/europace/eut263
Banerjee A, Fauchier L, Vourc'h P, et al. Renal impairment and ischemic stroke risk assessment in patients with atrial fibrillation: the Loire valley atrial fibrillation project. J Am Coll Cardiol 2013;61:2079-87.
DOI: https://doi.org/10.1016/j.jacc.2013.02.035
Piccini JP, Fraulo ES, Ansell JE, et al. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J 2011;162:606-12.e1.
DOI: https://doi.org/10.1016/j.ahj.2011.07.001
Poli D, Antonucci E, Pengo V, et al. Comparison of HAS-BLED and HAS-BED versus CHADS(2) and CHA(2)DS(2)VASC stroke and bleeding scores in patients with atrial fibrillation. Am J Cardiol 2017;119:1012-6.
DOI: https://doi.org/10.1016/j.amjcard.2016.12.007
Denas G, Zoppellaro G, Padayattil Jose S, et al. Warfarin prescription in patients with nonvalvular atrial fibrillation and one non-gender-related risk factor (CHA(2) DS(2) VASC 1 or 2): a treatment dilemma. Cardiovasc Ther 2018;36.
DOI: https://doi.org/10.1111/1755-5922.12310
Antonucci E, Poli D, Tosetto A, et al. The Italian START-Register on anticoagulation with focus on atrial fibrillation. PloS One 2015;10:e0124719.
DOI: https://doi.org/10.1371/journal.pone.0124719
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
DOI: https://doi.org/10.1159/000180580
Lip GY, Nieuwlaat R, Pisters R, et al. 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;137:263-72.
DOI: https://doi.org/10.1378/chest.09-1584
Pisters R, Lane DA, Nieuwlaat R, et al. 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;138:1093-100.
DOI: https://doi.org/10.1378/chest.10-0134
Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005;3:692-4.
DOI: https://doi.org/10.1111/j.1538-7836.2005.01204.x
Kaatz S, Ahmad D, Spyropoulos AC, et al. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost 2015;13:2119-26.
DOI: https://doi.org/10.1111/jth.13140
Apenteng PN, Gao H, Hobbs FR, et al. Temporal trends in antithrombotic treatment of real-world UK patients with newly diagnosed atrial fibrillation: findings from the GARFIELD-AF registry. BMJ Open 2018;8:e018905.
DOI: https://doi.org/10.1136/bmjopen-2017-018905
Ten Cate V, Ten Cate H, Verheugt FW. The global anticoagulant registry in the FIELD-atrial fibrillation (GARFIELD-AF) : exploring the changes in anticoagulant practice in patients with non-valvular atrial fibrillation in the Netherlands. Neth Heart J 2016;24:574-80.
DOI: https://doi.org/10.1007/s12471-016-0874-y
Farjat AE, Virdone S, Thomas LE, et al. The importance of the design of observational studies in comparative effectiveness research: lessons from the GARFIELD-AF and ORBIT-AF registries. Am Heart J 2022;243:110-21.
DOI: https://doi.org/10.1016/j.ahj.2021.09.003
Bassand JP, Virdone S, Badoz M, et al. Bleeding and related mortality with NOACs and VKAs in newly diagnosed atrial fibrillation: results from the GARFIELD-AF registry. Blood Adv 2021;5:1081-91.
DOI: https://doi.org/10.1182/bloodadvances.2020003560
Entezari-Maleki T, Dousti S, Hamishehkar H et al. A systematic review on comparing 2 common models for management of warfarin therapy; pharmacist-led service versus usual medical care. J Clin Pharmacol 2016;56:24-38.
DOI: https://doi.org/10.1002/jcph.576
Steinberg BA, Shrader P, Pieper K, et al. Frequency and outcomes of reduced dose non-vitamin K antagonist anticoagulants: results from ORBIT-AF II (the outcomes registry for better informed treatment of atrial fibrillation II). J Am Heart Assoc 2018;7:e007633.
DOI: https://doi.org/10.1161/JAHA.117.007633
Arbel R, Sergienko R, Hammerman A, et al. Effectiveness and safety of off-label dose-reduced direct oral anticoagulants in atrial fibrillation. Am J Med 2019;132:847-55.e3.
DOI: https://doi.org/10.1016/j.amjmed.2019.01.025
Santos J, Antonio N, Rocha M, Fortuna A. Impact of direct oral anticoagulant off-label doses on clinical outcomes of atrial fibrillation patients: a systematic review. Br J Clin Pharmacol 2020;86:533-47.
DOI: https://doi.org/10.1111/bcp.14127
Gibson CM, Smith CB, Davis S, Scalese MJ. Assessment of apixaban prescribing patterns for nonvalvular atrial fibrillation in hospitalized patients. Ann Pharmacother 2018;52:54-9.
DOI: https://doi.org/10.1177/1060028017726795
Bo M, Corsini A, Brunetti E, et al. Off-label use of reduced dose direct oral factor Xa inhibitors in subjects with atrial fibrillation: a review of clinical evidence. Eur Heart J Cardiovasc Pharmacother 2021;7:334-45.
DOI: https://doi.org/10.1093/ehjcvp/pvaa103
Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur J Cardiothorac Surg 2016;74:1359-469.
DOI: https://doi.org/10.5603/KP.2016.0172
How to Cite
Poli, D., Ageno, W., Antonucci, E., Bradamante, S., Bucherini, E., Chiarugi, P., … Palareti, G. (2023). Management of anticoagulation in atrial fibrillation patients in Italy: insight from the <i>Atrial Fibrillation-Survey on Anticoagulated Patients Register</i> (AF-START). Bleeding, Thrombosis and Vascular Biology, 2(2). https://doi.org/10.4081/btvb.2023.84
Copyright (c) 2023 The Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Most read articles by the same author(s)
- Daniela Poli, Emilia Antonucci, Gualtiero Palareti, Roberto Facchinetti, Pietro Falco, Giuseppina Serricchio, Teresa Lerede, Lucilla Masciocco, Paolo Gresele, Sophie Testa, Major bleedings in mechanical prosthetic heart valves patients on Vitamin K antagonist treatment. Data from the PLECTRUM Study , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 2 (2022)
- Marco P. Donadini, Walter Ageno, Milvexian and other drugs targeting Factor XI: a new era of anticoagulation? , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 1 (2022)
- Paolo Simioni, Vittorio Pengo, Paolo Prandoni, Thrombosis and hemostasis at the University of Padua: a reappraisal on the occasion of its 800th year of history , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 3 (2022)
- Cristina Legnani, Michela Cini, Sophie Testa, Alberto Tosetto, Claudia Dellanoce, Stefania Bellesso, Giuseppe Carli, Ilaria Nichele, Laura Lissandrini, Serena Zorzi, Emilia Antonucci, Gualtiero Palareti, Evaluation of Coaguchek®Pro II coagulation testing device performance to assess direct oral anticoagulant action. The DOAC-CHECK study , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 3 (2022)
- Gualtiero Palareti, Paolo Prandoni, Cristina Legnani, Emilia Antonucci, Serena Zorzi, Alberto Tosetto, Lorenza Bertù, Sophie Testa, Vittorio Pengo, Walter Ageno, Ida Martinelli, Benilde Cosmi, Eugenio Bucherini, Daniela Poli, Rationale and design of a study on D-dimer use to stratify patients after a first unprovoked venous thromboembolism for their risk of recurrence: extended low-dose Apixaban given only to patients with positive D-dimer results , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 1 (2022)
- Gualtiero Palareti, The diagnostic procedure for subjects with suspected pulmonary embolism. A recent comparison among the recommendations available from the international guidelines , Bleeding, Thrombosis and Vascular Biology: Vol. 3 No. 1 (2024)
- Vittorio Pengo, Luca Sarti, Emilia Antonucci, Stefania Di Agostino, Elisa Bison, Gentian Denas, Daniela Poli, Pier Luigi Meroni, Roberto Gerli, Antonella Radice, Gualtiero Palareti, on behalf of FIRMA group and START collaborators, Descriptive analysis of patients positive for anti-phospholipid antibodies included in two Italian registries , Bleeding, Thrombosis and Vascular Biology: Vol. 2 No. 3 (2023)
- Anna Maria Gori, Eleonora Camilleri, Alessia Bertelli, Angela Rogolino, Francesca Cesari, Elena Lotti, Tommaso Capobianco, Walther Iannotti, Betti Giusti , Rossella Marcucci, Pleiotropic effects of anti-thrombotic therapies: have direct oral anticoagulants any anti-inflammatory effect? , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 3 (2022)
- Giuseppe Camporese, Paolo Prandoni, Walter Ageno, Aspirin or low-molecular weight heparin for thromboprophylaxis after a fracture? That is the question , Bleeding, Thrombosis and Vascular Biology: Vol. 2 No. 2 (2023)
- Anna Falanga, Hugo Ten Cate, Bianca Rocca, How to manage antithrombotic treatments in thrombocytopenic patients with cancer. Comments on the European Haematology Association guidelines , Bleeding, Thrombosis and Vascular Biology: Vol. 2 No. 1 (2023)
Similar Articles
- Daniela Poli, Emilia Antonucci, Gualtiero Palareti, Roberto Facchinetti, Pietro Falco, Giuseppina Serricchio, Teresa Lerede, Lucilla Masciocco, Paolo Gresele, Sophie Testa, Major bleedings in mechanical prosthetic heart valves patients on Vitamin K antagonist treatment. Data from the PLECTRUM Study , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 2 (2022)
- Francesco Marongiu, Elvira Grandone, Silvia Marongiu, Antonella Mameli, Doris Barcellona, Stroke in women: anticoagulation in a complicated puzzle , Bleeding, Thrombosis and Vascular Biology: Vol. 3 No. 2 (2024)
- Ronda Lun, Deborah M. Siegal, Cancer-associated ischemic stroke: current knowledge and future directions , Bleeding, Thrombosis and Vascular Biology: Vol. 3 No. s1 (2024): 12th ICTHIC
- Yishi Tan, Marc Carrier, Nicola Curry, Michael Desborough, Kathryn Musgrave, Marie Scully, Tzu-Fei Wang, Mari Thomas, Simon J. Stanworth, Cancer complicated by thrombosis and thrombocytopenia: still a therapeutic dilemma , Bleeding, Thrombosis and Vascular Biology: Vol. 3 No. s1 (2024): 12th ICTHIC
- Gualtiero Palareti, Paolo Prandoni, Cristina Legnani, Emilia Antonucci, Serena Zorzi, Alberto Tosetto, Lorenza Bertù, Sophie Testa, Vittorio Pengo, Walter Ageno, Ida Martinelli, Benilde Cosmi, Eugenio Bucherini, Daniela Poli, Rationale and design of a study on D-dimer use to stratify patients after a first unprovoked venous thromboembolism for their risk of recurrence: extended low-dose Apixaban given only to patients with positive D-dimer results , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 1 (2022)
- Domenico Prisco, Irene Mattioli, Raffaele De Caterina, Alessandra Bettiol, The new era of anticoagulation: factor XI and XII inhibitors , Bleeding, Thrombosis and Vascular Biology: Vol. 2 No. 2 (2023)
- Lisa Pieri, Silvia Linari, Francesca Salvianti, Monica Attanasio, Giancarlo Castaman, Impaired platelet function in Hermansky-Pudlak syndrome associated with novel mutations in HPS3, HPS6 and HPS8 genes , Bleeding, Thrombosis and Vascular Biology: Vol. 3 No. 3 (2024)
- Paolo Prandoni, Personalized bleeding risk assessment for atrial fibrillation patients on direct oral anticoagulants: the DOAC score , Bleeding, Thrombosis and Vascular Biology: Vol. 2 No. 3 (2023)
- Anna Maria Gori, Eleonora Camilleri, Alessia Bertelli, Angela Rogolino, Francesca Cesari, Elena Lotti, Tommaso Capobianco, Walther Iannotti, Betti Giusti , Rossella Marcucci, Pleiotropic effects of anti-thrombotic therapies: have direct oral anticoagulants any anti-inflammatory effect? , Bleeding, Thrombosis and Vascular Biology: Vol. 1 No. 3 (2022)
- Alessandro Pezzini, The balance between hemorrhage and thrombosis in patients surviving spontaneous intracerebral bleeding: the nightmare of a neurologist , Bleeding, Thrombosis and Vascular Biology: Vol. 3 No. 2 (2024)
You may also start an advanced similarity search for this article.
