Skip to main content
Open access
Research Article
23 July 2019

Patient characteristics and stroke and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban and vitamin K antagonists: a Spanish real-world study

Abstract

Aim: To compare the risk of stroke, systemic thromboembolism and bleeding, in patients initiating apixaban or acenocoumarol for the treatment of nonvalvular atrial fibrillation. Methods: An observational, retrospective study was performed using medical records of patients who initiated apixaban or acenocoumarol between 2015 and 2017. Propensity score matching was used to match patients; stroke, systemic thromboembolism, major and minor bleeding events were compared between the matched patients. Results: Patients who were prescribed apixaban had a lower rate of systemic embolism/stroke (hazard ratio [HR] = 0.54; 95% CI: 0.38–0.78; p = 0.001), minor bleeding (HR = 0.64; 95% CI: 0.52–0.79; p < 0.001) and major bleeding (HR = 0.51; 95% CI: 0.37–0.72; p < 0.001). Conclusion: Patients prescribed apixaban for the treatment of nonvalvular atrial fibrillation had lower rates of thromboembolic events and minor/major bleeding than patients on acenocoumarol.

Supplementary Material

File (suppl_data.docx)

References

1.
January CT, Wann LS, Alpert JS et al. American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J. Am. Coll. Cardiol. 64, e1–e76 (2014).
2.
Rodríguez-Capitán J, Fernández-Meseguer A, Romero-González E, Calvo-Bonacho E, Gómez-Doblas JJ, De Teresa-Galván E. Frequency of atrial fibrillation in a large sample of young adults selected from the Spanish working population. Rev. Esp. Cardiol. (Engl. Ed.) 71, 498–500 (2018).
3.
Baena-Díez JM, Grau M, Forés R et al. Prevalence of atrial fibrillation and its associated factors in Spain: an analysis of 6 population-based studies. DARIOS Study. Rev. Clin. Esp. 214, 505–512 (2014).
4.
Gómez-Doblas JJ, Muñiz J, Martin JJ et al. Prevalence of atrial fibrillation in Spain. OFRECE study results. Rev. Esp. Cardiol. (Engl. Ed.) 67, 259–269 (2014).
5.
Anguita M, Dávalos A, López de Sá E et al. Novel oral anticoagulants in non-valvular atrial fibrillation: how to improve its management in Spain. Semergen 45, 109–116 (2019).
6.
Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc. Disord. 13, 31 (2013).
7.
Lip GY, Potpara T, Boriani G, Blomström-Lundqvist C. A tailored treatment strategy: a modern approach for stroke prevention in patients with atrial fibrillation. J. Intern. Med. 279, 467–476 (2016).
8.
Dzeshka MS, Lane DA, Lip GY. Stroke and bleeding risk in atrial fibrillation: navigating the alphabet soup of risk-score acronyms (CHADS2, CHA2 DS2 -VASc, R2 CHADS2, HAS-BLED, ATRIA, and more). Clin. Cardiol. 37, 634–644 (2014).
9.
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 383, 955–962 (2014).
10.
Kalra L, Lip GY. Guideline Development Group for the NICE clinical guideline for the management of atrial fibrillation. Heart 93, 39–44 (2007).
11.
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).
12.
Lip GY, Keshishian A, Kamble S et al. Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin. A propensity score matched analysis. Thromb. Haemost. 116, 975–986 (2016).
13.
Hernandez I, Zhang Y, Saba S. Comparison of the effectiveness and safety of apixaban, dabigatran, rivaroxaban, and warfarin in newly diagnosed atrial fibrillation. Am. J. Cardiol. 120, 1813–1819 (2017).
14.
Martinez BK, Sood NA, Bunz TJ, Coleman CI. Effectiveness and safety of apixaban, dabigatran, and rivaroxaban versus warfarin in frail patients with nonvalvular atrial fibrillation. J. Am. Heart Assoc. 7, e008643 (2018).
15.
Tepper PG, Mardekian J, Masseria C et al. Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, or rivaroxaban. PLoS ONE 13, e0205989 (2018).
16.
Briere JB, Bowrin K, Coleman C et al. Real-world clinical evidence on rivaroxaban, dabigatran, and apixaban compared with vitamin K antagonists in patients with nonvalvular atrial fibrillation: a systematic literature review. Expert Rev. Pharmacoecon. Outcomes Res. 19, 27–36 (2019).
17.
Deitelzweig S, Lip GYH. Real-world clinical evidence on rivaroxaban, dabigatran, and apixaban compared with vitamin K antagonists in patients with non-valvular atrial fibrillation: a systematic literature review. Expert Rev. Pharmacoecon. Outcomes Res. 19, 243–244 (2019).
18.
Deitelzweig S, Farmer C, Luo X et al. Risk of major bleeding in patients with non-valvular atrial fibrillation treated with oral anticoagulants: a systematic review of real-world observational studies. Curr. Med. Res. Opin. 33, 1583–1594 (2017).
19.
Sicras-Mainar A, Sánchez-Álvarez L, Navarro-Artieda R, Darbà J. Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis. Lipids Health Dis. 17, 277 (2018).
20.
Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J. Clin. Epidemiol. 45, 613–619 (1992).
21.
The Anatomical Therapeutic Chemical Classification System with Defined Daily Doses (ATC/DDD): World Health Organization (2019) www.who.int/classifications/atcddd/en
22.
Gomez-Lumbreras A, Cortes J, Giner-Soriano M, Quijada-Manuitt MA, Morros R. Characteristics of apixaban-treated patients, evaluation of the dose prescribed, and the persistence of treatment: a cohort study in catalonia. J. Cardiovasc. Pharmacol. Ther. 23, 494–501 (2018).
23.
Anguita Sánchez M, Bertomeu Martínez V, Ruiz Ortiz M et al. FANTASIIA study investigators. Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study. Rev. Esp. Cardiol. (Engl. Ed.) (2019) (Epub ahead of print).
24.
Granger CB, Alexander JH, McMurray JJ et al. ARISTOTLE committees and investigators. Apixaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 365, 981–992 (2011).
25.
Raskob GE, Gallus AS, Pineo GF et al. Apixaban versus enoxaparin for thromboprophylaxis after hip or knee replacement: pooled analysis of major venous thromboembolism and bleeding in 8464 patients from the ADVANCE-2 and ADVANCE-3 trials. J. Bone Joint Surg. Br. 94, 257–264 (2012).
26.
Li XS, Deitelzweig S, Keshishian A et al. Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in ‘real-world’ clinical practice. A propensity-matched analysis of 76,940 patients. Thromb. Haemost. 117, 1072–1082 (2017).
27.
Himmler S, Müller M, Ostwald D, Seddik A, Basic E, Hradetzky E. Long-term health benefits of stroke prevention with apixaban versus vitamin K antagonist warfarin in patients with non-valvular atrial fibrillation in Germany: a population-based modelling study. Expert Rev. Pharmacoecon. Outcomes Res. 19, 223–230 (2019).
28.
Ramagopalan S, Allan V, Saragoni S et al. a LHUs group. Patient characteristics and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban or vitamin K antagonists: real-world evidence from Italian administrative databases. J. Comp. Eff. Res. 7, 1063–1071 (2018).
29.
Kohsaka S, Katada J, Saito K, Terayama Y. Safety and effectiveness of apixaban in comparison to warfarin in patients with nonvalvular atrial fibrillation: a propensity-matched analysis from Japanese administrative claims data. Curr. Med. Res. Opin. 34, 1627–1634 (2018).
30.
Sicras-Mainar A, Fernández de Bobadilla J, Navarro-Artieda R, Rejas-Gutiérrez J. All-cause mortality and incidence of major cardiovascular events in hypertensive patients with ASCOT-type profile in a Spanish population setting. Aten Primaria 42, 420–430 (2010).