Dataset Information

Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study.

ABSTRACT:

Background

Ibrutinib is an oral irreversible inhibitor of Bruton's tyrosine kinase, indicated for the treatment of chronic lymphocytic leukaemia. The drug is generally well tolerated; however, not infrequent side effects are reported, with the major two being bleeding and ibrutinib-related atrial fibrillation. Atrial fibrillation pathogenesis in this setting is not completely clear, and no prospective studies have evaluated the impact of previous cardiologic history and baseline characteristics.

Methods

We prospectively performed cardiologic assessment in 43 CLL patients before starting ibrutinib therapy. Cardiologic workup included comorbidity collection and electrocardiographic and echocardiographic baseline evaluation.

Results

After a median observation of 8 months, seven patients developed atrial fibrillation (16.3%). Cases developing atrial fibrillation were all elderly males (p?=?0.04), and mostly with a history of previous arterial hypertension (p?=?0.009). Atrial fibrillation occurrence also correlated with the presence of one or more pre-existent cardiologic comorbidities (p?=?0.03), with a higher atrial fibrillation risk score (calculated with comorbidities and cardiologic risk factor evaluation p?ConclusionOur data show that echocardiography is a highly informative and reproducible tool that should be included in pre-treatment workup for patients who are candidates for ibrutinib therapy.

SUBMITTER: Reda G

PROVIDER: S-EPMC5996546 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Publications

Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study.

Reda Gianluigi G Fattizzo Bruno B Cassin Ramona R Mattiello Veronica V Tonella Tatiana T Giannarelli Diana D Massari Ferdinando F Cortelezzi Agostino A

Journal of hematology & oncology 20180611 1

<h4>Background</h4>Ibrutinib is an oral irreversible inhibitor of Bruton's tyrosine kinase, indicated for the treatment of chronic lymphocytic leukaemia. The drug is generally well tolerated; however, not infrequent side effects are reported, with the major two being bleeding and ibrutinib-related atrial fibrillation. Atrial fibrillation pathogenesis in this setting is not completely clear, and no prospective studies have evaluated the impact of previous cardiologic history and baseline characte ...[more]

PMID: 29891001

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Project description:IntroductionAtrial fibrillation (AF) is characterised by a high stroke risk. Vitamin K antagonists (VKAs) are the most commonly used oral anticoagulants (OACs) in Spain, but their efficacy and safety depend on the time in therapeutic range of International Normalized Ratio (INR) 2.0-3.0 over 65%-70%. Unfortunately, the difficulties of maintaining an optimal level of anticoagulation and the complications of VKAs (particularly haemorrhagic ones), frequently lead to cessation of this therapy, which has been associated with higher risk of adverse events (AEs), including ischaemic stroke. Our aims are as follows: (1) to evaluate the quality of oral anticoagulation with VKAs, the prevalence of poor quality of anticoagulation, and to identify factors predisposing to poor quality anticoagulation; and (2) to identify patients who will stop OAC and to investigate what factors influence the decision of OAC withdrawal.Methods and analysisProspective observational cohort study including outpatients newly diagnosed with AF and naïve for OACs from July 2016 to June 2018 in an anticoagulation clinic. Patients with prosthetic heart valves, rheumatic mitral valves or valvular AF will be excluded. Follow-up will extend for up to 3 years. During this period, the INR results and changes in the anticoagulant therapy will be recorded, as well as all AEs, or any other information that would be relevant to the proper conduct of research.Ethics and disseminationAll patients were informed about the nature and purpose of the study, and the protocol was approved by the Ethics Committee of Hospital General Universitario Morales Meseguer (reference: EST:20/16). This is an observational study focusing on 'real life' practice and therefore all treatments and follow-up will be performed in accordance to the routine clinical practice with no specific interventions or visits. The results of our study will be disseminated by presentations at national and international meetings, and publications in peer-reviewed journals.

Project description:BackgroundPatients with atrial fibrillation (AF) underwent a high risk of hospitalization, which has not been paid much attention to in practice. Therefore, we aimed to assess the incidence, causes and predictors of hospitalization in AF patients.MethodsFrom August 2011 to December 2017, a total number of 20,172 AF patients from the Chinese Atrial Fibrillation Registry (China-AF) Study were prospectively selected for this study. We described the incidence, causes of hospitalization by age groups and sex. The Fine-Gray competing risk model was employed to identify predictors of first all-cause and first cause-specific hospitalization.ResultsAfter a mean follow-up of 37.3 ± 20.4 months, 7,512 (37.2%) AF patients experienced one or more hospitalizations. The overall incidence of all-cause hospitalization was 24.0 per 100 patient-years. Patients aged < 65 years were predominantly hospitalized for AF (42.1% of the total hospitalizations); while patients aged 65-74 and ≥ 75 years were mainly hospitalized for non-cardiovascular diseases (43.6% and 49.3%, respectively). We found patients complicated with heart failure (HF)[hazard ratio (HR) 1.10, 95% confidence interval (CI) 1.02-1.18], established coronary artery disease (CAD) (HR 1.24, 95%CI 1.17-1.33), ischemic stroke/transient ischemic attack (TIA) (HR 1.22, 95%CI 1.15-1.30), diabetes (HR 1.14, 95%CI 1.08-1.20), chronic obstructive pulmonary disease (COPD) (HR 1.28, 95%CI 1.02-1.62), gastrointestinal disorder (HR 1.37, 95%CI 1.21-1.55), and renal dysfunction (HR 1.24, 95%CI 1.09-1.42) had higher risks of hospitalization.ConclusionsMore than one-third of AF patients included in this study were hospitalized at least once during over 3-year follow-up. The main cause for hospitalization among the elderly patients (≥ 65 years) is non-cardiovascular diseases rather than AF. Multidisciplinary management of comorbidities should be advocated to reduce hospitalization in AF patients older than 65 years old. Clinical Registry http://www.chictr.org.cn/showproj.aspx?proj=5831 . Unique identifier: ChiCTR-OCH-13003729. The registration date is October 22, 2013.

Dataset Information

Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study.

Background

Methods

Results

Publications

Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study.

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