Rational Pharmacotherapy in Cardiology

Advanced search

Application of rivaroxaban in clinical practice: results of a prospective observational study XANTUS in patients with atrial fibrillation

Full Text:


In XANTUS study the safety and efficacy of factor Xa inhibitor rivaroxaban were evaluated in routine clinical practice in patients with non-valvular atrial fibrillation. In consecutive patients who started treatment with rivaroxaban, all adverse events were recorded every 3 months for 1 year. Conclusions of major bleeding, symptomatic thromboembolic complications (stroke, systemic embolism, transient ischemic attack, and myocardial infarction) and death from all causes were centrally adjudicated. In total 6784 patients were treated with rivaroxaban at 311 centers in Europe, Israel, and Canada, on average, 329 days. The mean CHADS2 and CHA2DS2-VASc scores were 2.0 and 3.4, respectively. Treatmentemergent major bleeding occurred in 128 patients (2.1 events per 100 patient-years), 118 (1.9 events per 100 patient-years) died, and 43 (0.7 events per 100 patient-years) suffered a stroke. XANTUS is the first international, prospective, observational study to describe the use of rivaroxaban in a broad non-valvular atrial fibrillation patient population. Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice.

About the Author

S. G. Kanorskii
Kuban State Medical University
Russian Federation
Sedina ul. 4, Krasnodar, 350063


1. Haim M.,Hoshen M., Reges O. et al. Prospective national study ofthe prevalence, incidence, management and outcome of a large contemporary cohort of patients with incident non-valvular atrial fibrillation. J Am Heart Assoc 2015;4(1):e001486.

2. Camm A.J., Lip G.Y.H., De Caterina R. et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012;33(21):2719-47.

3. January C.T., Wann L.S., Alpert J.S. et al. 2014 AHA/ACC/HRS Guideline for the management of patients with atrialfibrillation: a report of theAmerican College of Cardiology/AmericanHeartAssociation Task Force on Practice Guidelines and theHeart Rhythm Society.JAm Coll Cardiol 2014;64(21):e1-e76.

4. Verma A., Cairns J.A., Mitchell L.B. et al. 2014 focused update of the Canadian Cardiovascular Society Guidelines for the management of atrial fibrillation. Can J Cardiol 2014;30(10):1114-30.

5. Hicks T., Stewart F., Eisinga A. NOACs versus warfarin for stroke prevention in patients with AF: a systematic review and meta-analysis. Open Heart 2016;3(1):e000279.

6. Patel M.R., Mahaffey K.W., Garg J. et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365(10):883-91.

7. Loukianov M.M., Boytsov S.A., Yakushin S.S. et al. Diagnosis, treatment, concomitant cardiovascular disease and comorbidities in patients with a diagnosis of "atrial fibrillation" in a real outpatient practice (according to the register of cardiovascular diseases REKVAZA). Rational Pharmacotherapy in Cardiology 2014;10(4):366=77. In Russian (Лукьянов М.М., Бойцов С.А., Якушин С.С. и др. Диагностика, лечение, сочетанная сердечно-сосудистая патология и сопутствующие заболевания у больных с диагнозом «фибрилляция предсердий» в условиях реальной амбулаторно-поликлинической практики (по данным Регистра Кардиоваскулярных Заболеваний РЕКВАЗА). Рациональная Фармакотерапия в Кардиологии 2014;10(4):366=77).

8. Camm A.J., Amarenco P., Haas S. et al. XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation. Vasc Health Risk Manag 2014;10:425-34.

9. Camm A.J.,Amarenco P.,Haas S. et al.XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J 2016;37(14):1145-53.

10. Connolly S.J., Ezekowitz M.D., Yusuf S. et al. RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361(12):1139-51.

11. Granger C.B., Alexander J.H., McMurray J.J. et al. ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365(11):981-92.

12. Di Minno M.N., Ambrosino P., Dello Russo A. et al. Prevalence of left atrial thrombus in patients with non-valvular atrialfibrillation.A systematic review and meta-analysis of the literature. ThrombHaemost 2016;115(3):663-77.

13. Abraham N.S., Singh S., Alexander G.C. et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ 2015;350:h1857.

14. Ho P.M., Peterson P.N., Masoudi F.A. Evaluating the evidence: is there a rigid hierarchy? Circulation 2008;118(16):1675-84.

15. Tamayo S., Frank P.W., Patel M. et al. Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27467 patients taking rivaroxaban. Clin Cardiol 2015;38(2):63-8.

16. Beyer-Westendorf J., Förster K., Pannach S. et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC Registry. Blood 2014;124(6):955-62.

17. Nessel C., Mahaffey K., Piccini J. et al. Incidence and outcomes of gastrointestinal hemorrhage in patients with atrialfibrillation treated with rivaroxaban or warfarin:results from the ROCKETAF trial. Chest 2012;142(1):84-92.

18. Piccini J.P., Garg J., Patel M.R. et al. ROCKET AF Investigators. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. Eur Heart J 2014;35(28):1873-80.

19. Hu T.Y., Vaidya V.R., Asirvatham S.J. Reversing anticoagulant effects of novel oral anticoagulants: role of ciraparantag, andexanet alfa, and idarucizumab. Vasc Health Risk Manag 2016;12:35-44.

20. Laliberte F., Cloutier M., NelsonW.W. et al. Real-world comparative effectiveness and safety ofrivaroxaban and warfarin in nonvalvular atrial fibrillation patients. Curr Med Res Opin 2014;30(7):1317-25.

21. Nelson W.W., Song X., Coleman C.I. et al. Medication persistence and discontinuation of rivaroxaban versus warfarin among patients with non-valvular atrial fibrillation. Curr Med Res Opin 2014;30(12):2461-9.

22. Beyer-Westendorf J., Förster K., Ebertz F. et al. Drug persistence with rivaroxaban therapy in atrial fibrillation patients-results from the Dresden non-interventional oral anticoagulation registry. Europace 2015;17(4):530-8.

23. Nguyen E., White C.M., Patel M.R. et al. Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials. Curr Med Res Opin 2016;Apr 1.[Epub ahead of print].

24. Coleman C.I., Antz M., Simard E. et al. Real-world evidence of stroke prevention in patients with nonvalvular atrial fibrillation in the United States: The REVISIT-US study. The 12th Annual Congress of the European Cardiac Arrhythmia Society (ECAS). Paris, France; April 17-19, 2016. 3-5 Abstract 15-48.

25. Böttger B., Thate-Waschke I.M., Bauersachs R. et al. Preferences for anticoagulation therapy in atrial fibrillation: the patients' view. J Thromb Thrombolysis 2015;40(4):406-15.

26. Piccini J.P., Hellkamp A.S., Washam J.B. et al. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation 2016;133(4):352-60.

27. Chao T.F., LiuC.J., Tuan T.C. et al. Impact onOutcomes ofChanging Treatment GuidelineRecommendations for Stroke Prevention inAtrial Fibrillation:A Nationwide Cohort Study. Mayo Clin Proc 2016;Apr 8.[Epub ahead of print].


For citations:

Kanorskii S.G. Application of rivaroxaban in clinical practice: results of a prospective observational study XANTUS in patients with atrial fibrillation. Rational Pharmacotherapy in Cardiology. 2016;12(4):443-449. (In Russ.)

Views: 761

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

ISSN 1819-6446 (Print)
ISSN 2225-3653 (Online)