Factors Associated With Bleeding Events in Patients on Rivaroxaban for Non-Valvular Atrial Fibrillation: A Real World Experience

Akhtar, Tauseef; Mattumpuram, Jishanth; Fugar, Setri; Ranka, Sagar; Fratti, Juan Del Cid; Mann, Hashim; Uprety, Alok; Putta, Aakash; Golzar, Yasmeen

doi:10.1016/s0735-1097(19)31079-4

Cited by 2 publications

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“…Although the optimal values of therapeutic range of rivaroxaban concentration in blood plasma have not been determined, in previous studies significant associations between equilibrium rivaroxaban concentration and incidence of bleeding among AF patients were revealed (48±30 vs 34 ± 26; p = 0.02). 48 In addition, apart from acknowledged factors (age, renal insufficiency 49,50 ), genetic factors such as gene polymorphisms АВСB1, CYP3A4 may exert influence on rivaroxaban pharmacokinetics and, therefore, on the risk of bleeding complications. This is extremely important in case of antithrombotic therapy among patients with AF and ACS, even more so in light of the correlation of the aforementioned genetic markers with pharmacologic response to clopidogrel, 2 while rivaroxaban indirectly affects platelet aggregation through thrombin generation inhibition.…”

Section: Discussionmentioning

confidence: 99%

CYP2C19*17 May Increase the Risk of Death Among Patients with an Acute Coronary Syndrome and Non-Valvular Atrial Fibrillation Who Receive Clopidogrel and Rivaroxaban

Sychev

Батурина

Мирзаев

et al. 2020

PGPM

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The aim of this study is to assess the influence of gene CYP2C19, CYP3A4, CYP3A5 and ABCB1 polymorphisms on clopidogrel antiplatelet activity, rivaroxaban concentration equilibrium, and clinical outcomes among patients with acute coronary syndrome and non-valvular atrial fibrillation. Methods: In the multicenter prospective registry study of the efficacy and safety of a combined antithrombotic therapy 103 patients with non-valvular atrial fibrillation both undergoing or not a percutaneous coronary intervention were enrolled. The trial assessed the primary outcomes (major bleeding, in-hospital death, cardiovascular death, stroke\transient ischaemic attack, death/renal insufficiency) and secondary outcomes (platelet reactivity units (PRU), rivaroxaban concentration). Results: For none of the clinical outcomes when combined with other covariates, the carriership of polymorphisms CYP3A5*3 rs776746, CYP2C19*2 rs4244285;*17 rs12248560, ABCB1 3435 C>T, ABCB1 rs4148738 was significant. None of the markers under study (CYP3A5*3 rs776746, CYP2C19*2 rs4244285, *17 rs12248560, ABCB1 3435 C>T, ABCB1 rs4148738) has proven to affect rivaroxaban equilibrium concentration in blood plasma among patients with atrial fibrillation and acute coronary syndrome. Conclusion: In situations of double or triple antithrombotic rivaroxaban and clopidogrel therapy among patients with atrial fibrillation and acute coronary syndrome, the genetic factors associated with bleeding complications risk (CYP2C19*17) may prove to be clinically relevant.

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Section: Discussionmentioning

confidence: 99%

CYP2C19*17 May Increase the Risk of Death Among Patients with an Acute Coronary Syndrome and Non-Valvular Atrial Fibrillation Who Receive Clopidogrel and Rivaroxaban

Sychev

Батурина

Мирзаев

et al. 2020

PGPM

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“…Therefore, rivaroxaban and aspirin are often taken concomitantly in NVAF combined with percutaneous coronary intervention (PCI), or with stable CHD accompanying high ischemic risk without high bleeding risk [8]. Previous studies have shown that aspirin is a separate factor which affects rivaroxaban bleeding [9], and aspirin combined with rivaroxaban may not bring net clinical benefits for stable CHD [10]. In order to understand the potential risks for death in patients treated with rivaroxaban and aspirin, we undertook this study to analyze the clinical characteristics of these fatal cases from the WHO global database of reported potential side effects of medicinal products (VigiBase).…”

Section: Introductionmentioning

confidence: 99%

Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase

Zhang

Qian

Yan

et al. 2022

Eur J Clin Pharmacol

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Purpose The aim of this study was to analyze the clinical characteristics of fatal adverse events (AEs) of rivaroxaban combined with aspirin and to underline the importance of the rational use of drugs. Methods The WHO global database of reported potential side effects of medicinal products (VigiBase) was searched for fatal AEs in the combined use of rivaroxaban and aspirin, and the clinical characteristics of those cases with sufficient information (vigiGrade completeness score ≥ 0.80) were analyzed. Results By January 19, 2020, 2309 fatal adverse event reports of rivaroxaban combined with aspirin from 21 countries were entered in VigiBase. One hundred and twenty cases contained further information, of which 42 were female (35%) and 78 were male (65%). The median age was 75 (range 34 to 93) years, and 109 cases (91%) were elderly patients (≥ 65 years). The AEs listed in the fatal case reports included bleeding in 114 cases (mainly intracranial hemorrhage and gastrointestinal hemorrhage, 59 and 46 respectively, accounting for 88%) and ischemic events in six cases (ischemic stroke in three, acute myocardial infarction in two, myocardial infarction combined with acute liver failure in one). Among the patients with bleeding events, 108 (95%) had existing risk factors for bleeding or for interacting with aspirin or rivaroxaban. These may be divided into the following: diseases (hypertension, renal impairment, history of stroke, peptic ulcer, or previous bleeding), drugs (high dose aspirin, antiplatelet drugs, anticoagulants, P-gp inhibitors/CYP3A4 inhibitors, non-steroidal anti-inflammatory drugs, steroids, and selective serotonin reuptake inhibitors), or other factors (e.g., elderly, low body weight, or excessive intake of ginger, fish oil, or alcohol). There were 45 cases with two or more of these risk factors in addition to rivaroxaban and aspirin. Patients with ischemic events are often in very high-risk groups of atherosclerotic cardiovascular disease (ASCVD) or self-discontinuation of treated drugs. Medication errors occurred in 24 patients (20%): excessive treatment in 17 cases, contraindication in three, frequency error in two, excessive treatment combined with contraindication in one, and self-discontinuation in one. Conclusions Fatal AEs related to rivaroxaban combined with aspirin, including bleeding and ischemic events, have been reported mostly in the elderly, and sometimes involved medication errors. The fatal AEs mainly manifested as serious bleeding, and most of them occurred in patients with concurrent multiple risk factors. Monitoring coagulation during rivaroxaban treatment is recommended in very high-risk ASCVD populations, and attention should be paid to prevention of medication errors.

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Factors Associated With Bleeding Events in Patients on Rivaroxaban for Non-Valvular Atrial Fibrillation: A Real World Experience

Cited by 2 publications

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<p><em>CYP2C19*17</em> May Increase the Risk of Death Among Patients with an Acute Coronary Syndrome and Non-Valvular Atrial Fibrillation Who Receive Clopidogrel and Rivaroxaban</p>

<p><em>CYP2C19*17</em> May Increase the Risk of Death Among Patients with an Acute Coronary Syndrome and Non-Valvular Atrial Fibrillation Who Receive Clopidogrel and Rivaroxaban</p>

Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase

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