Factors associated with bleeding events in patients on rivaroxaban for non-valvular atrial fibrillation: A real-world experience
Introduction
AF is the most common sustained arrhythmia in clinical practice accounting for significant morbidity and mortality secondary to the embolic complications, mainly ischemic stroke [1,2]. Rivaroxaban is a DOAC recommended for stroke reduction in patients with NVAF as an alternative to warfarin [3] following the landmark ROCKET AF trial [4]. Given the relative cost-effectiveness [5] and predictable anticoagulation effect of rivaroxaban as compared to warfarin without requiring INR monitoring or dietary alterations, it is the most widely used DOAC for NVAF in the community setting. Although several previous trials have investigated the efficacy and safety outcomes of rivaroxaban, the data regarding the predisposing factors for rivaroxaban-induced bleeding remains scarce in the community setting [4,[6], [7], [8]]. Moreover, the patient population included in the randomized multicenter trials [4,6,7] may also not represent the real world racially diverse patients with complex medical comorbidities. The objective of the present study is to evaluate the rivaroxaban-induced BE and their predisposing factors in a racially diverse NVAF population.
Section snippets
Study protocol
We conducted a retrospective single-center study at our urban, tertiary care public hospital. The study protocol was approved by our institutional review board. All the patients aged ≥18 years prescribed rivaroxaban from our outpatient pharmacy for NVAF from January 2015 to April 2018 were included in the study. Demographic and clinical data were collected based on chart review. Abnormal liver function test (LFT) was defined as any elevation in serum glutamatic-oxaloacetic transaminase
Patient characteristics
A total of 327 patients were included in the study. The mean age of included patients was 62 ± 12 years, and 32% of the patients were female. Table 1 describes the baseline characteristics of the study population. Blacks comprised 54% of the study population, followed by whites (22%), Hispanics (15.6%), Asians (4%), and other races (4.6%), respectively. Among the study population, 17.4% of the patients had coronary artery disease (CAD), 6% had cirrhosis, 17.4% had abnormal LFT, and 2.8% of the
Discussion
Our study describes the predisposing factors for rivaroxaban-induced BE in a racially diverse NVAF patient cohort in the community setting. The main findings of our study are 1) the incidence of rivaroxaban-induced BE among NVAF patients is 7.3% with 2.7% of them being major BE, GI bleeding and epistaxis are the most commonly reported BE; 2) concurrent aspirin use is common among patient with NVAF; 3) concurrent aspirin use and increasing age are independent predictors of rivaroxaban-induced BE
Author statement
All authors have seen and approved the manuscript being submitted, have contributed significantly to the work, attest to the validity and legitimacy of the data and its interpretation, and agree to its submission to the International Journal of Cardiology.
Credits and grant information supporting the research
We did not receive any kind of grants from any government or private agencies.
Declaration of competing interest
None.
References (26)
- et al.
2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society
J. Am. Coll. Cardiol.
(2014) - et al.
XANTUS-EL: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Eastern Europe, Middle East, Africa and Latin America
Egypt Heart J.
(2018) - et al.
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients
J. Thromb. Haemost.
(2005) - et al.
Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial
Lancet
(2018) - et al.
Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score
J. Am. Coll. Cardiol.
(2011) - et al.
Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial
Lancet
(2018) - et al.
Atrial fibrillation: a major contributor to stroke in the elderly: the Framingham Study
Arch. Intern. Med.
(1987) - et al.
Atrial fibrillation as an independent risk factor for stroke: the Framingham Study
Stroke.
(1991) - et al.
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
N. Engl. J. Med.
(2011) - et al.
Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation
Stroke.
(2013)
XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation
Eur. Heart J.
XANAP: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Asia
J. Arrhythmia
Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban
Clin. Cardiol.
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2022, European Journal of Clinical Pharmacology
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All the author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.