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)

Vol. 2 No. 2 (2023)
Submitted: 14 May 2023
Accepted: 22 June 2023
Published: 27 June 2023
Atrial fibrillation, anticoagulation, bleeding event, stroke
Abstract Views: 817
PDF: 180
Supplementary File: 71
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.

Authors

  • Daniela Poli • polida@aou-careggi.toscana.it Center of Atherothrombotic Disease, Careggi University Hospital, Florence, Italy.
  • Walter Ageno https://orcid.org/0000-0002-1922-8879 Short Stay Observation and Short Recovery Unit, Department of Internal Medicine, Circolo Hospital and Macchi Foundation, ASST Sette Laghi, Varese, Italy.
  • Emilia Antonucci Arianna Anticoagulazione Foundation, Bologna, Italy.
  • Salvatore Bradamante Transfusion Center, Hemostasis and Thrombosis Center, Annunziata Hospital, Taranto, Italy.
  • Eugenio Bucherini Vascular Medicine and Angiology SS, AUSL Romagna, Ravenna, Italy.
  • Paolo Chiarugi Clinical Chemical Analysis Organizational Unit, Pisana University Hospital, Pisa, Italy.
  • Antonio Chistolini Department of Translational and Precision Medicine, Sapienza University of Rome, Italy.
  • Benilde Cosmi Division of Angiology and Blood Coagulation, S. Orsola-Malpighi University Hospital, Bologna, Italy.
  • Anna Falanga Thrombosis, Hemostasis Immunohematology and Transfusion Medicine Center, ASST Papa Giovanni XXIII, Bergamo, Italy.
  • Antonio Insana SC Chemical-Clinical Analysis and Microbiology Laboratory, Ordine Mauriziano Hospital, Turin, Italy.
  • Domenico Lione Complex Operating Unit of Clinical Pathology, A. Perrino Hospital, Brindisi, Italy.
  • Rosa Maria Lombardi Internal Medicine Organization Unit, Hemostasis and Thrombosis Center, University Hospital of Parma, Italy.
  • Giuseppe Malcangi Hemophilia and Thrombosis Center, Polyclinic of Bari, Italy.
  • Rossella Marcucci Center of Atherothrombotic Disease, Careggi University Hospital, Florence, Italy.
  • Giuliana Martini Hemostasis Center, Civilian Hospitals of Brescia, Italy.
  • Lucilla Masciocco Complex Operating Unit of Internal Medicine, Lastaria Hospital, Lucera (FG), Italy.
  • Carmelo Paparo Analysis Laboratory, Maggiore Chieri Hospital, Turin, Italy.
  • Daniele Pastori Department of Clinical Internal Medicine, Anesthesiology and Cardiovascular Sciences, Thrombosis Center, Sapienza University of Rome, Italy.
  • Simona Pedrini Laboratory Service, Poliambulanza Foundation Hospital, Brescia, Italy.
  • Vittorio Pengo Department of Cardio-Thoracic-Vascular Sciences, University Hospital of Padua, Italy.
  • Pasquale Pignatelli Department of Clinical Internal Medicine, Anesthesiology and Cardiovascular Sciences, Thrombosis Center, Sapienza University of Rome, Italy.
  • Andrea Toma Complex Operating Unit of Clinical Pathology, Oral Anticoagulant Therapy Outpatient Clinic, L. Cazzavillan Civilian Hospital, Arzignano (VI), Italy.
  • Sophie Testa Department of Laboratory Medicine, Hemostasis and Thrombosis Center, ASST Cremona, Italy.
  • Gualtiero Palareti Arianna Anticoagulazione Foundation, Bologna, Italy.

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.

Dimensions

Altmetric

PlumX Metrics

Downloads

Download data is not yet available.

Citations

Crossref
Scopus
Google Scholar
Europe PMC

Plaudit

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) Creative Commons License

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.