Background: Apixaban and rivaroxaban are increasingly used for thromboembolism prophylaxis in patients with non-valvular atrial fibrillation (NVAF) and commonly in patients with obesity and body mass index (BMI) ≥50 kg/m 2 despite the limited data.Objectives: This study aimed to establish the effectiveness and safety of apixaban and rivaroxaban in patients with NVAF and BMI ≥50 kg/m 2 .Methods: A single health-system, retrospective cohort study evaluated the effectiveness and safety of apixaban and rivaroxaban initiated in adult patients (≥18 years of age) with BMI ≥50 kg/m 2 and NVAF. Outcomes of ischemic stroke, systemic embolic events, and bleeding were compared to a cohort of patients with BMI 18 to 30 kg/m 2 .Results: After 1619 patient-years worth of follow-up in 595 patients, the primary endpoint of incidence of ischemic stroke was numerically similar in both groups, 1.3 per 100 patient-years in the BMI ≥50 kg/m 2 group, compared to 2.0 per 100 patientyears in the BMI <30 kg/m 2 group (RR 0.65, 95% CI 0.38-1.82, p = 0.544). Incidence of major bleeding and clinically relevant non-major bleeding was also numerically similar between the two groups.Conclusions: This study demonstrated that apixaban and rivaroxaban in patients with a BMI ≥50 kg/m 2 for treatment of NVAF may be safe and effective at preventing thromboembolic events and had no increased risk of bleeding. Although, findings should be interpreted with caution and confirmed with additional studies. This study contributes to the growing body of evidence that direct oral anticoagulants (DOACs) may be effective and safe to use for the treatment of NVAF in patients with BMI ≥50 kg/m 2 .
Background
Ibrutinib is a Bruton’s tyrosine kinase inhibitor used in the treatment of hematological malignancies. The most common cardiotoxicity associated with ibrutinib is atrial arrhythmia (atrial fibrillation and flutter). It is known that patients with cardiovascular disease (CVD) are at an increased risk for developing atrial arrhythmia. However, the rate of atrial arrhythmia in patients with pre-existing CVD treated with ibrutinib is unknown.
Objective
This study examined whether patients with pre-existing CVD are at a higher risk for developing atrial arrhythmias compared to those without prior CVD.
Methods
A single-institution retrospective chart review of patients with no prior history of atrial arrhythmia treated with ibrutinib from 2012 to 2020 was performed. Patients were grouped into two cohorts: those with CVD (known history of coronary artery disease, heart failure, pulmonary hypertension, at least moderate valvular heart disease, or device implantation) and those without CVD. The primary outcome was incidence of atrial arrhythmia, and the secondary outcomes were all-cause mortality, risk of bleeding, and discontinuation of ibrutinib. The predictors of atrial arrhythmia (namely atrial fibrillation) were assessed using logistic regression. A Cox-Proportional Hazard model was created for mortality.
Results
Patients were followed for a median of 1.1 years. Among 217 patients treated with ibrutinib, the rate of new-onset atrial arrhythmia was nearly threefold higher in the cohort with CVD compared to the cohort without CVD (17% vs 7%, p = 0.02). Patients with CVD also demonstrated increased adjusted all-cause mortality (OR 1.9, 95% CI 1.06-3.41, p = 0.01) and decreased survival probability (43% vs 54%, p = 0.04) compared to those without CVD over the follow-up period. There were no differences in risk of bleeding or discontinuation between the two cohorts.
Conclusions
Pre-existing cardiovascular disease was associated with significantly higher rates of atrial arrhythmia and mortality in patients with hematological malignancies managed with ibrutinib.
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