Rivaroxaban Experience at Tertiary Care Centre in Saudi Arabia:A Retrospective Observational Study
DOI:
https://doi.org/10.31661/gmj.v9i.1882Keywords:
Anticoagulants; Atrial Fibrillation; Rivaroxaban; Stroke; Thromboembolism  Correspondence to:Abstract
Background: Atrial fibrillation (AF) and Venous Thromboembolism (VTE) are significant causes of morbidity and mortality. Direct oral anticoagulants (DOACs) are as effective as vitamin K antagonists (VKAs) with a propensity to cause less major bleeding. This study aimed to assess the safety and effectiveness of rivaroxaban in routine clinical practice in a large tertiary referral center in Saudi Arabia. Methods and Materials: In this study, patients who received rivaroxaban at a tertiary referral hospital were included in this study. All adverse events were recorded, including major bleeding, non-major bleeding events, symptomatic thromboembolic events (deep vein thrombosis, pulmonary embolism) and all-cause death. Results: A total of 509 patients were prescribed rivaroxaban during the study period. The most common indication for rivaroxaban was non-valvular AF (65.3%) and VTE (34.7%). The mean age was 60.4 ± 16.4 years, and 50.8% were female. The median CHA2DS2-Vasc score was 2.1 in patients on rivaroxaban for non-valvular AF. Bleeding occurred in 72 (14.1%) patients, of which 20 (3.9%) had major bleeds. Thrombosis events occurred in 13 (2.5%) patients in the overall cohort. Fourteen (2.7%) patients died during the study, including a case of fatal bleeding secondary to rivaroxaban. Conclusion: This study describes the use of rivaroxaban in a broad patient population in clinical practice in the Middle East. The overall bleeding and thrombosis rates in this study were comparable to those seen in major clinical trials. [GMJ.2020;9:e1882] DOI:10.31661/gmj.v9i0.1882
References
Hersi AS, Alsheikh-Ali AA, Zubaid M, Al Suwaidi J. Prospective observational studies of the management and outcomes in patients with atrial fibrillation: A systematic review. J Saudi Heart Assoc. 2012;24(4):243-52. https://doi.org/10.1016/j.jsha.2012.08.001PMid:24174832 PMCid:PMC3809474 Zubaid M, Rashed WA, Alsheikh-Ali AA, et al. Management and 1-year outcomes of patients with atrial fibrillation in the Middle East: Gulf survey of atrial fibrillation events. Angiology. 2015;66(5):464-71. https://doi.org/10.1177/0003319714536980PMid:24904179 Essam AE, Sharif G, Al-Hameed F. Venous thromboembolism-related mortality and morbidity in King Fahd General Hospital, Jeddah, Kingdom of Saudi Arabia. Ann Thorac Med. 2011;6(4):193-98. https://doi.org/10.4103/1817-1737.84772PMid:21977063 PMCid:PMC3183635 Guyatt G, Akl E, Crowther M, Gutterman D, Schuünemann H. Executive Summary. Chest. 2012;141(2):7S-47S. https://doi.org/10.1378/chest.1412S3PMid:22315257 PMCid:PMC3278060 January C, Wann L, Alpert J, Calkins H, Cigarroa J, Cleveland J, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary. Circulation. 2014;130(23):2071-104. https://doi.org/10.1161/CIR.0000000000000040PMid:24682348 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. 2016;37(38):2893-962. https://doi.org/10.1093/eurheartj/ehw210PMid:27567408 Connolly S, Ezekowitz M, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009;361(12):1139-51. https://doi.org/10.1056/NEJMoa0905561PMid:19717844 Granger C, Alexander J, McMurray J, Lopes R, Hylek E, Hanna M, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med.. 2011;365(11):981-92. https://doi.org/10.1056/NEJMoa1107039PMid:21870978 Patel M, Mahaffey K, Garg J, Pan G, Singer D, Hacke W, et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med.. 2011;365(10):883-91. https://doi.org/10.1056/NEJMoa1009638PMid:21830957 Giugliano R, Ruff C, Braunwald E, Murphy S, Wiviott S, Halperin J, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med.. 2013;369(22):2093-104. https://doi.org/10.1056/NEJMoa1310907PMid:24251359 Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-510. https://doi.org/10.1056/NEJMoa1007903PMid:21128814 Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-97. https://doi.org/10.1056/NEJMoa1113572PMid:22449293 Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, et al. Oral Apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9):799-808 https://doi.org/10.1056/NEJMoa1302507PMid:23808982 Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3(4):692-4. https://doi.org/10.1111/j.1538-7836.2005.01204.xPMid:15842354 Kaatz S, Ahmad D, Spyropoulos A, Schulman S. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015;13(11):2119-26. https://doi.org/10.1111/jth.13140PMid:26764429 Johnston K, Osenenko KM, Donato BM, et al. Treatment Patterns and Health Resource Utilization Among Atrial Fibrillation Patients in United Arab Emirates and Saudi Arabia. Value Health. 2014;17(7):A504. https://doi.org/10.1016/j.jval.2014.08.1527PMid:27201532 http://www.diabetesatlas.org Kirchhof P, Radaideh G, Kim YH, et al. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018;72(2):141-53. https://doi.org/10.1016/j.jacc.2018.04.058PMid:29976287
