Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves

Summary

Warfarin is the standard anticoagulant used for patients with mechanical heart valves; however, its use is complicated by a narrow therapeutic window, frequent drug and dietary interactions, and the need for regular international normalized ratio (INR) monitoring. In resource-limited settings such as Pakistan, many patients have difficulty accessing reliable INR testing, which can result in suboptimal anticoagulation and increased risks of thromboembolic or bleeding complications. Rivaroxaban, a direct oral factor Xa inhibitor, offers predictable pharmacokinetics and does not require routine laboratory monitoring, making it a potentially more convenient option for patients with limited access to INR testing. This prospective comparative study aims to evaluate rivaroxaban as an alternative to warfarin in patients with mechanical heart valves. Sixty adult patients will be enrolled and followed for one year, comparing the incidence of thromboembolic and bleeding events between patients treated with rivaroxaban and those maintained on dose-adjusted warfarin.

Timeline

Start

2025-11-13

Primary completion

2027-04-12

Completion

2027-04-12

Publications

• Background Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.
• Background Duraes AR, de Souza Lima Bitar Y, Schonhofen IS, Travassos KSO, Pereira LV, Filho JAL, Neto MG, Junior RA, Roever L. Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial-The RIWA study. Am J Cardiovasc Drugs. 2021 May;21(3):363-371. doi: 10.1007/s40256-020-00449-3. Epub 2020 Nov 5.
• Background Roost E, Weber A, Alberio L, Englberger L, Reineke D, Keller D, Nagler M, Carrel T. Rivaroxaban in patients with mechanical heart valves: A pilot study. Thromb Res. 2020 Feb;186:1-6. doi: 10.1016/j.thromres.2019.12.005. Epub 2019 Dec 7.

Drugs

Indications