Elsevier

International Journal of Cardiology

Volume 320, 1 December 2020, Pages 78-82
International Journal of Cardiology

Factors associated with bleeding events in patients on rivaroxaban for non-valvular atrial fibrillation: A real-world experience

https://doi.org/10.1016/j.ijcard.2020.06.032Get rights and content

Highlights

  • Aspirin co-prescription is common among NVAF patients prescribed rivaroxaban, in the community.

  • The incidence of reported major bleeding is 2.7%, among NVAF patients prescribed rivaroxaban.

  • Non-fatal GI bleeding and epistaxis are the most commonly reported rivaroxaban-induced BEs.

  • Advanced age and concurrent aspirin use are independent predictors of rivaroxaban-induced BE.

Abstract

Background

Rivaroxaban is a direct oral anticoagulant (DOAC) approved for the treatment of non-valvular atrial fibrillation (NVAF). Data related to the risk factors associated with rivaroxaban-induced bleeding in patients with NVAF remain scarce in the community setting. We sought to investigate these bleeding risk factors in a racially diverse patient population.

Methods

We conducted a single-center, retrospective study based on a chart review of patients who received rivaroxaban from our outpatient pharmacy from January 2015 to April 2018 for NVAF. Any reported bleeding event (BE) was recorded as either major or minor bleeding event. Demographic and clinical data were collected and analyzed.

Results

Of the 327 patients included in our analysis, 105 (32%) were female, and the mean age was 62 ± 12 years. Among the included patients, 176 (54%) patients were black, 71 (22%) were white, 51 (15.6%) were Hispanic, 13 (4%) were Asian, and 15 (4.6%) belonged to other races. 89 (27.2%) of the patients had co-prescription of aspirin. A total of 24 (7.3%) patients developed BE, out of which 9 (2.7%) patients had a major BE, and 15 (4.5%) patients had minor BE. Non-fatal gastrointestinal bleeding and epistaxis were the most common type of BE. On multivariable analysis, concurrent aspirin use (81 to 325 mg) (P = 0.03; odds ratio (OR) 2.60 [1.08–6.28]) and increasing age (P = 0.00; OR 1.06 [1.01–1.11]) were independent predictors of BE.

Conclusion

In community practice, aspirin co-prescription is common among NVAF patients prescribed rivaroxaban. Increasing age and concurrent aspirin use are independent predictors of BE.

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)

  • A.J. Camm et al.

    XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation

    Eur. Heart J.

    (2016)
  • Y.H. Kim et al.

    XANAP: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Asia

    J. Arrhythmia

    (2018)
  • S. Tamayo et al.

    Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban

    Clin. Cardiol.

    (2015)
  • Cited by (4)

    1

    All the author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

    View full text