Skip to main content
Free access
Research Article
13 August 2018

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)

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
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).