Patient characteristics and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban or vitamin K antagonists: real-world evidence from Italian administrative databases
Abstract
Aim: This study aimed to evaluate the risk of major bleeding among two cohorts of nonvalvular atrial fibrillation patients newly initiating a vitamin K antagonist (VKA) or apixaban in a real-world setting in Italy. Patients & methods: A retrospective study using a large administrative database of Italian local health units was performed, using data from ten local health units and patients were included from the date of new initiation of apixaban or VKAs from January 2012 to June 2015. Results: Risk of major bleeding was calculated using an adjusted Cox regression model. Compared with VKA, apixaban had a significantly lower risk of major bleeding (hazard ratio = 0.44 [95% CI: 0.12–0.97]). Conclusion: In this analysis, apixaban was associated with a lower risk of major bleeding compared with VKA.
Supplementary Material
File (suppl_file.docx)
- Download
- 24.52 KB
References
1.
Kirchhof P, Benussi S, Kotecha D et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur. Heart J. 37, 2893–2962 (2016).
2.
Heidbuchel H, Verhamme P, Alings M et al. Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 17, 1467–1507 (2015).
3.
Lip G, Freedman B, De Caterina R, Potpara TS. Stroke prevention in atrial fibrillation: past, present and future. Comparing the guidelines and practical decision-making. Thromb. Haemost. 117, 1230–1239 (2017).
4.
Agenzia Italiana del Farmaco (AIFA). AIFA Concept paper. I nuovi anticoagulanti orali nella prevenzione di ictus e tromboembolismo sistemico in pazienti con fibrillazione atriale non valvolare. www.agenziafarmaco.gov.it/sites/default/files/version_2012_09_24_cp_noacs_1.pdf
5.
Filippi A. Nuovi Anticoagulanti orali per la prevenzione di ictus ed embolia sistemica nella fibrillazione atriale non valvolare. S.I.M.G. Società Italiana di Medicina Generale Area Cardiovascolare. www.dbcf.unisi.it/sites/st13/files/allegati/02-02-2015/nao.pdf
6.
Nardi F, Gulizia MM, Colivicchi F et al. ANMCO position paper: direct oral anticoagulants for stroke prevention in atrial fibrillation: clinical scenarios and future perspectives. Eur. Heart J. Suppl. 19, D70–D88 (2017).
7.
Perrone V, Sangiorgi D, Buda S, Degli Esposti L. Farmacoutilizzazione e consumo di risorse sanitarie nei pazienti in terapia con anticoagulanti orali: il progetto Nemawashi. SPS n. 2, 2017 Supplemento a Politiche sanitarie, 18, 2 (2017).
8.
Agenzia Italiana del Farmaco (AIFA). Guideline for the classification and conduction of the observational studies on medicines. (2010). www.agenziafarmaco.gov.it/ricclin/sites/default/files/files_wysiwyg/files/CIRCULARS/Circular%2031st%20May%202010.pdf
9.
Gonnella JS, Louis DZ, Gozum MV, Callahan CA, Barnes CA. Disease Staging Clinical and Coded Criteria (Version 5.26). Thomson Medstat, Ann Arbor, MI, USA (2010).
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 138, 1093–100 (2010).
11.
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 137, 263–272 (2010).
12.
Camm AJ, Kirchhof P, Lip GY 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). Europace 12, 1360–1420 (2010).
13.
Posner MA, Ash AS (Eds). Comparing weighting methods in propensity score analysis. www.stat.columbia.edu/∼gelman/stuff_for_blog/posner.pdf
14.
Opinion 05/2014 on Privacy and Data Protection. http://ec.europa.eu/justice/data-protection/article-29/documentation/opinion-recommendation/files/2014/wp216_it.pdf
15.
Adeboyeje G, Sylwestrzak G, Barron JJ et al. Major bleeding risk during anticoagulation with warfarin, dabigatran, apixaban, or rivaroxaban in patients with nonvalvular atrial fibrillation. J. Manag. Care Spec. Pharm. 23, 968–978 (2017).
16.
Weitz JI, Semchuk W, Turpie AG et al. Trends in prescribing oral anticoagulants in Canada, 2008–2014. Clin. Ther. 37, 2506–2514.e4 (2015).
17.
Gadsbøll K, Staerk L, Fosbøl EL et al. Increased use of oral anticoagulants in patients with atrial fibrillation: temporal trends from 2005 to 2015 in Denmark. Eur. Heart J. 38(12), 899–906 (2017).
18.
Loo SY, Dell'Aniello S, Huiart L, Renoux C. Trends in the prescription of novel oral anticoagulants in UK primary care: novel oral anticoagulant prescription trends. Br. J. Clin. Pharmacol. 83, 2096–2106 (2017).
19.
Deitelzweig S, Bruno A, Trocio J et al. An early evaluation of bleeding-related hospital readmissions among hospitalized patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants. Curr. Med. Res. Opin. 32, 573–582 (2016).
20.
Graham DJ, Reichman ME, Wernecke M et al. Stroke, bleeding, and mortality risks in elderly medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation. JAMA Intern. Med. 176, 1662–1671 (2016).
21.
Noseworthy PA, Yao X, Abraham NS, Sangaralingham LR, McBane RD, Shah ND. Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation. Chest 150, 1302–1312 (2016).
22.
Yao X, Abraham NS, Sangaralingham LR et al. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J. Am. Heart Assoc. 5, e003725 (2016).
23.
Chang HY, Zhou M, Tang W, Alexander GC, Singh S. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ 350, h1585 (2015).
24.
Proietti M, Romanazzi I, Romiti GF, Farcomeni A, Lip GYH. Real-world use of apixaban for stroke prevention in atrial fibrillation: a systematic review and meta-analysis. Stroke 49, 98–106 (2018).
25.
Yao X, Abraham NS, Sangaralingham LR et al. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J. Am. Heart Assoc. 5(6), (2016) (Epub ahead of print).
26.
López-López JA, Sterne JAC, Thom HHZ et al. Oral anticoagulants for prevention of stroke in atrial fibrillation: systematic review, network meta-analysis, and cost effectiveness analysis. BMJ 359, j5058 (2017).
27.
Amin A, Keshishian A, Vo L et al. Real-world comparison of all-cause hospitalizations, hospitalizations due to stroke and major bleeding, and costs for non-valvular atrial fibrillation patients prescribed oral anticoagulants in a US health plan. J. Med. Econ. 21(3), 244–253 (2018).
28.
Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 365, 981–992 (2011).
Information & Authors
Information
Published In
Copyright
© 2018 Sreeram Ramagopalan et al.
History
Received: 14 June 2018
Accepted: 27 July 2018
Published online: 13 August 2018
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
Patient characteristics and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban or vitamin K antagonists: real-world evidence from Italian administrative databases. (2018) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2018-0054
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Allie Cichewicz, Shantanu Jawla, Priccila Zuchinali, Morodoluwa Akin-Fajiye, Daniela Massierer, Italo Porto, Xavier Garcia-Moll, Real-world evidence comparing oral anticoagulants for NVAF in Europe: a systematic review and network meta-analysis, Future Cardiology, 10.1080/14796678.2025.2484119, 21, 6, (371-390), (2025).
- Benjamin J. R. Buckley, Deirdre A. Lane, Peter Calvert, Juqian Zhang, David Gent, C. Daniel Mullins, Paul Dorian, Shun Kohsaka, Stefan H. Hohnloser, Gregory Y. H. Lip, Effectiveness and Safety of Apixaban in over 3.9 Million People with Atrial Fibrillation: A Systematic Review and Meta-Analysis, Journal of Clinical Medicine, 10.3390/jcm11133788, 11, 13, (3788), (2022).
- Valentina Lorenzoni, Salvatore Pirri, Giuseppe Turchetti, Cost-Effectiveness of Direct Non-Vitamin K Oral Anticoagulants Versus Vitamin K Antagonists for the Management of Patients with Non-Valvular Atrial Fibrillation Based on Available “Real-World” Evidence: The Italian National Health System Perspective, Clinical Drug Investigation, 10.1007/s40261-021-01002-z, 41, 3, (255-267), (2021).
- Katrin Krueger, Kathrin Jobski, Annemarie Voss, Ulrike Haug, Different Risk Profiles of European Patients Using Direct Oral Anticoagulants or Vitamin K Antagonists: a Rapid Review, Current Epidemiology Reports, 10.1007/s40471-020-00257-y, 7, 4, (290-299), (2020).
- Sreeram V Ramagopalan, Antoni Sicras-Mainar, Carlos Polanco-Sanchez, Robert Carroll, Jaime F de Bobadilla, Patient characteristics and stroke and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban and vitamin K antagonists: a Spanish real-world study, Journal of Comparative Effectiveness Research, 10.2217/cer-2019-0079, 8, 14, (1201-1212), (2019).
- Ameenathul M. Fawzy, Wang-Yang Yang, Gregory YH. Lip, Safety of direct oral anticoagulants in real–world clinical practice: translating the trials to everyday clinical management, Expert Opinion on Drug Safety, 10.1080/14740338.2019.1578344, 18, 3, (187-209), (2019).
