Internal and Emergency Medicine

, Volume 14, Issue 8, pp 1199–1201 | Cite as

Real-world efficacy and safety of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

  • Francesco Violi
  • Daniele PastoriEmail author

The INSIghT investigators performed a real-world prospective observational cohort study to investigate the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) in 632 patients with atrial fibrillation (AF) according to the presence of chronic kidney disease (CKD), defined by a creatinine clearance (CrCl) < 60 ml/min [1]. Patients with CKD (n = 219) were at higher thromboembolic risk, as they were older, more likely to be women, hypertensive and diabetic. Among NOACs, apixaban was the most commonly used anticoagulant in CKD patients, followed by dabigatran and rivaroxaban. No patients on edoxaban were included.

At 2 years of follow-up, the rates of both thromboembolism and ISTH major bleeding events were 2.3% and 5.1%, respectively. The authors found no difference between patients with and without CKD (2.5 vs. 2.2% for thromboembolism and 5.0 vs. 5.2% for bleeding, respectively). A total of four intracranial hemorrhages occurred. However, the all-cause mortality...


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Conflict of interest

The authors declare that they have no conflict of interest.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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  1. 1.
    Godino C, Melillo F, Rubino F, Arrigoni L, Cappelletti A, Mazzone P, Mattiello P, Della Bella P, Colombo A, Salerno A, Cera M, Margonato A, Investigators IN (2019) Real-world 2-year outcome of atrial fibrillation treatment with dabigatran, apixaban, and rivaroxaban in patients with and without chronic kidney disease. Intern Emerg Med. CrossRefPubMedGoogle Scholar
  2. 2.
    Hu WS, Lin CL (2019) Comparison of incidence of acute kidney injury, chronic kidney disease and end-stage renal disease between atrial fibrillation and atrial flutter: real-world evidences from a propensity score-matched national cohort analysis. Intern Emerg Med. CrossRefPubMedGoogle Scholar
  3. 3.
    Violi F, Pastori D, Perticone F, Hiatt WR, Sciacqua A, Basili S, Proietti M, Corazza GR, Lip GY, Pignatelli P, Group AS (2015) Relationship between low Ankle-Brachial Index and rapid renal function decline in patients with atrial fibrillation: a prospective multicentre cohort study. BMJ Open 5(5):e008026. CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Apostolakis S, Guo Y, Lane DA, Buller H, Lip GY (2013) Renal function and outcomes in anticoagulated patients with non-valvular atrial fibrillation: the AMADEUS trial. Eur Heart J 34(46):3572–3579. CrossRefPubMedGoogle Scholar
  5. 5.
    Posch F, Ay C, Stoger H, Kreutz R, Beyer-Westendorf J (2019) Exposure to vitamin k antagonists and kidney function decline in patients with atrial fibrillation and chronic kidney disease. Res Pract Thromb Haemost 3(2):207–216. CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Bohm M, Ezekowitz MD, Connolly SJ, Eikelboom JW, Hohnloser SH, Reilly PA, Schumacher H, Brueckmann M, Schirmer SH, Kratz MT, Yusuf S, Diener HC, Hijazi Z, Wallentin L (2015) Changes in renal function in patients with atrial fibrillation: an analysis from the RE-LY trial. J Am Coll Cardiol 65(23):2481–2493. CrossRefGoogle Scholar
  7. 7.
    Fordyce CB, Hellkamp AS, Lokhnygina Y, Lindner SM, Piccini JP, Becker RC, Berkowitz SD, Breithardt G, Fox KA, Mahaffey KW, Nessel CC, Singer DE, Patel MR, Committee RAS, Investigators (2016) On-treatment outcomes in patients with worsening renal function with rivaroxaban compared with warfarin: insights from ROCKET AF. Circulation 134(1):37–47. CrossRefPubMedGoogle Scholar
  8. 8.
    Yao X, Tangri N, Gersh BJ, Sangaralingham LR, Shah ND, Nath KA, Noseworthy PA (2017) Renal outcomes in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol 70(21):2621–2632. CrossRefPubMedGoogle Scholar
  9. 9.
    Providencia R, Marijon E, Boveda S, Barra S, Narayanan K, Le Heuzey JY, Gersh BJ, Goncalves L (2014) Meta-analysis of the influence of chronic kidney disease on the risk of thromboembolism among patients with nonvalvular atrial fibrillation. Am J Cardiol 114(4):646–653. CrossRefPubMedGoogle Scholar
  10. 10.
    Prisco D, Ageno W, Becattini C, D'Angelo A, Davi G, De Cristofaro R, Dentali F, Di Minno G, Falanga A, Gussoni G, Masotti L, Palareti G, Pignatelli P, Santi RM, Santilli F, Silingardi M, Tufano A, Violi F, SIMI, FADOI, SISET (2017) Italian intersociety consensus on DOAC use in internal medicine. Intern Emerg Med 12(3):387–406. CrossRefPubMedGoogle Scholar
  11. 11.
    Miyazawa K, Pastori D, Lip GYH (2018) Changes in renal function in patients with atrial fibrillation: efficacy and safety of the non-vitamin K antagonist oral anticoagulants. Am Heart J 198:166–168. CrossRefPubMedGoogle Scholar
  12. 12.
    Lip GY, Keshishian A, Kamble S, Pan X, Mardekian J, Horblyuk R, Hamilton M (2016) 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(5):975–986. CrossRefPubMedGoogle Scholar
  13. 13.
    Norby FL, Bengtson LGS, Lutsey PL, Chen LY, MacLehose RF, Chamberlain AM, Rapson I, Alonso A (2017) Comparative effectiveness of rivaroxaban versus warfarin or dabigatran for the treatment of patients with non-valvular atrial fibrillation. BMC Cardiovasc Disord 17(1):238. CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Coleman CI, Kreutz R, Sood NA, Bunz TJ, Eriksson D, Meinecke AK, Baker WL (2019) Rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and severe kidney disease or undergoing hemodialysis. Am J Med. CrossRefPubMedGoogle Scholar
  15. 15.
    Chokesuwattanaskul R, Thongprayoon C, Tanawuttiwat T, Kaewput W, Pachariyanon P, Cheungpasitporn W (2018) Safety and efficacy of apixaban versus warfarin in patients with end-stage renal disease: meta-analysis. Pacing Clin Electrophysiol 41(6):627–634. CrossRefPubMedGoogle Scholar
  16. 16.
    Gallagher AM, Rietbrock S, Plumb J, van Staa TP (2008) Initiation and persistence of warfarin or aspirin in patients with chronic atrial fibrillation in general practice: do the appropriate patients receive stroke prophylaxis? J Thromb Haemost 6(9):1500–1506. CrossRefPubMedGoogle Scholar
  17. 17.
    O'Brien EC, Simon DN, Allen LA, Singer DE, Fonarow GC, Kowey PR, Thomas LE, Ezekowitz MD, Mahaffey KW, Chang P, Piccini JP, Peterson ED (2014) Reasons for warfarin discontinuation in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J 168(4):487–494. CrossRefPubMedGoogle Scholar
  18. 18.
    Ferroni E, Gennaro N, Costa G, Fedeli U, Denas G, Pengo V, Corti MC (2019) Real-world persistence with direct oral anticoagulants (DOACs) in naive patients with non-valvular atrial fibrillation. Int J Cardiol 288:72–75. CrossRefPubMedGoogle Scholar
  19. 19.
    Rivera-Caravaca JM, Roldan V, Esteve-Pastor MA, Valdes M, Vicente V, Lip GYH, Marin F (2017) Cessation of oral anticoagulation is an important risk factor for stroke and mortality in atrial fibrillation patients. Thromb Haemost 117(7):1448–1454. CrossRefPubMedGoogle Scholar
  20. 20.
    Hohnloser SH, Basic E, Nabauer M (2019) Changes in oral anticoagulation therapy over one year in 51,000 atrial fibrillation patients at risk for stroke: a practice-derived study. Thromb Haemost 119(6):882–893. CrossRefPubMedGoogle Scholar
  21. 21.
    Volterrani M, Iellamo F, Alberto C, Pasquale A, Salvatore P, Massimo P, Marco M, Lucia U, Cesare P, Bruno R, Enrico P, Investigators S (2018) NOAC in "real world" patients with atrial fibrillation in Italy: results from the ISPAF-2 (Indagine Sicoa Paziente Con Fibrillazione Atriale) survey study. Intern Emerg Med 13(7):1069–1075. CrossRefPubMedGoogle Scholar

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© Società Italiana di Medicina Interna (SIMI) 2019

Authors and Affiliations

  1. 1.Department of Internal Medicine and Medical Specialties, I Clinica Medica, Atherothrombosis CenterSapienza University of RomeRomeItaly

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