Comparative Effectiveness and Safety of Rivaroxaban and Warfarin for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation in an Omani Tertiary Care Hospital

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Abstract

Objective:

The aim of the study was to compare the effectiveness and safety of rivaroxaban and warfarin as well as to determine the appropriateness of dosing and prescribing of rivaroxaban in Omani patients with non-valvular atrial fibrillation (NVAF).

Methods:

This retrospective cohort study was conducted using the Royal Hospital data registry. The study included all adults newly diagnosed with NVAF and treated with rivaroxaban or warfarin. The outcomes measured include ischaemic stroke, gastrointestinal bleeding (GIB), non-gastrointestinal bleeding (NGIB), as well as appropriateness of dosing and prescribing of rivaroxaban.

Results:

The analysis included 96 rivaroxaban users and 183 warfarin users; 51% of the cohort included males. There were no significant differences observed in the risk of ischaemic stroke between the two groups (hazard ratio (HR), 1.1; 95% confidence interval (CI): 0.4-3.4; p=0.8). However, those on rivaroxaban exhibited a significantly higher rate of GIB compared to those on warfarin (HR, 5.9; 95% CI: 2.9-11.7; p=0.001). There were no differences observed with regards to NGIB between the two groups (HR, 0.9; 95% CI: 0.4-1.9; p=0.8). Dosing and prescribing of rivaroxaban were found to be appropriate in 89% of the patients, with only 6% being prescribed an inappropriately lower dose.

Conclusion:

The study demonstrated no significant differences in the risk of ischaemic stroke or NGIB between rivaroxaban and warfarin groups in newly diagnosed NVAF patients. However, rivaroxaban users were found to have a significantly higher risk of GIB. Rivaroxaban was appropriately prescribed to the majority of the patients, and only a small proportion of the group received an inappropriately lower dose of rivaroxaban.

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Most cited references 25

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Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF.

Graeme Hankey, Manesh R Patel, Susanna R Stevens … (2012)

In ROCKET AF, rivaroxaban was non-inferior to adjusted-dose warfarin in preventing stroke or systemic embolism among patients with atrial fibrillation (AF). We aimed to investigate whether the efficacy and safety of rivaroxaban compared with warfarin is consistent among the subgroups of patients with and without previous stroke or transient ischaemic attack (TIA). In ROCKET AF, patients with AF who were at increased risk of stroke were randomly assigned (1:1) in a double-blind manner to rivaroxaban 20 mg daily or adjusted dose warfarin (international normalised ratio 2·0-3·0). Patients and investigators were masked to treatment allocation. Between Dec 18, 2006, and June 17, 2009, 14 264 patients from 1178 centres in 45 countries were randomly assigned. The primary endpoint was the composite of stroke or non-CNS systemic embolism. In this substudy we assessed the interaction of the treatment effects of rivaroxaban and warfarin among patients with and without previous stroke or TIA. Efficacy analyses were by intention to treat and safety analyses were done in the on-treatment population. ROCKET AF is registered with ClinicalTrials.gov, number NCT00403767. 7468 (52%) patients had a previous stroke (n=4907) or TIA (n=2561) and 6796 (48%) had no previous stroke or TIA. The number of events per 100 person-years for the primary endpoint in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (2·79% rivaroxaban vs 2·96% warfarin; hazard ratio [HR] 0·94, 95% CI 0·77-1·16) and those without (1·44%vs 1·88%; 0·77, 0·58-1·01; interaction p=0·23). The number of major and non-major clinically relevant bleeding events per 100 person-years in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (13·31% rivaroxaban vs 13·87% warfarin; HR 0·96, 95% CI 0·87-1·07) and those without (16·69%vs 15·19%; 1·10, 0·99-1·21; interaction p=0·08). There was no evidence that the relative efficacy and safety of rivaroxaban compared with warfarin was different between patients who had a previous stroke or TIA and those who had no previous stroke or TIA. These results support the use of rivaroxaban as an alternative to warfarin for prevention of recurrent as well as initial stroke in patients with AF. Johnson and Johnson Pharmaceutical Research and Development and Bayer HealthCare. Copyright Â© 2012 Elsevier Ltd. All rights reserved.