Incidence of Cardiovascular Events and Carotid Artery USG Abnormalities in Chronic Myeloid Leukemia Patients on Nilotinib Therapy: A 20-Year Single-Center Study.

Background: The incidence of cardiovascular events (CVEs) among patients receiving nilotinib is a critical concern, particularly for those on long-term use. This study aimed to evaluate the incidence of CVEs among chronic myeloid leukemia (CML) patients and assess the efficacy of carotid artery ultrasonography (USG) in predicting CVEs in nilotinib-treated patients.

Methods: We retrospectively reviewed 218 patients diagnosed with CML chronic phase who received nilotinib at the Kyungpook National University Hospital, South Korea, from January 2000 to May 2024. Carotid USG was performed on 51 patients. CVEs were defined as acute coronary syndrome, ischemic stroke, and peripheral arterial occlusive disease.

Results: Among 218 patients, 41 (18.81%) experienced CVEs, with incidence increasing throughout nilotinib exposure - 15.0% at 5 years, 32.6% at 10 years, and 39.9% at 15 years. Cardiovascular risk factors, including hypertension, diabetes mellitus, dyslipidemia, influenced the occurrence of CVEs (P = .016). The 10-year cumulative CVE incidence in the patient group with ≥2 risk factors was 64.0% after nilotinib treatment. Carotid artery USG was performed in 51 out of 218 patients taking nilotinib. The correlation between cardiovascular risk factors and USG abnormalities was not statistically significant (P = 1.00).

Conclusions: Nilotinib treatment in CML patients is associated with significant CVE incidence, which increases with treatment duration and the number of risk factors. Our findings support routine cardiovascular monitoring, particularly carotid USG, within the first year and regular follow-ups every 1 to 2 years based on risk factors. Proactive monitoring, risk-adjusted follow-up, and treatment-free remission considerations could help mitigate CVE risks.