Characteristics and 5-year outcomes in patients with chronic lymphocytic leukemia receiving ibrutinib (a real-world study)

Aim. To evaluate major cardiovascular complications in chronic lymphocytic leukaemia (CLL) patients receiving ibrutinib, and to characterise those with new-onset atrial fibrillation (AF) during ibrutinib therapy, examining their outcomes in a real-world clinical setting. Materials and methods. A retrospective analysis of the medical records of 641 patients diagnosed with CLL who were treated with ibrutinib at the haematology centre of the Botkin Moscow Multidisciplinary Scientific and Clinical Center from 2013 to 2024 was conducted. The primary endpoint of the study was the occurrence of atrial fibrillation during ibrutinib therapy. The secondary endpoint of the study was thrombotic and haemorrhagic complications. To assess the impact of AF on patient outcomes, a comparison was made between patients with AF and those without AF based on sex and age. A composite endpoint was used to evaluate outcomes, which included cardiovascular death and fatal bleeding. Results. The incidence of new-onset AF in patients receiving ibrutinib therapy during the five-year was 15%. Patients with AF occurring during ibrutinib therapy were found to be older and characterised by the presence of standard risk factors for AF. No significant differences were observed in the characteristics of CLL and its treatment. The occurrence of AF during ibrutinib therapy was associated with a fourfold increased risk of thrombotic complications (OR 4.071, 95% CI 1.837–9.024; p 0.001), including an increased incidence of fatal pulmonary embolism (p = 0.035) with a comparable incidence of fatal bleeding. Conclusion. The incidence of AF in patients with CLL receiving ibrutinib is significantly higher than the incidence of AF in elderly patients without CLL. The occurrence of new-onset AF during ibrutinib therapy has been observed to be associated with an increased incidence of thrombotic complications, including fatal thrombotic complications. The incidence of fatal haemorrhagic complications has been noted to be comparable.