Peripheral artery occlusive disease (PAOD) in chronic phase chronic myeloid leukemia patients treated with nilotinib or Imatinib

Several retrospective studies have described the clinical manifestation of peripheral artery occlusive disease (PAOD) in patients receiving nilotinib. We thus prospectively screened for PAOD in patients with chronic phase chronic myeloid leukemia (CP CML) being treated with tyrosine kinase inhibitors (TKI), including imatinib and nilotinib. One hundred and fifty-nine consecutive patients were evaluated for clinical and biochemical risk factors for cardiovascular disease. Non-invasive assessment for PAOD included determination of the ankle-brachial index (ABI) and duplex ultrasonography. A second cohort consisted of patients with clinically manifest PAOD recruited from additional collaborating centers. Pathological ABI were significantly more frequent in patients on 1st-line nilotinib (7 of 27; 26 %) and in patients on 2nd-line nilotinib (10 of 28; 35.7 %) as compared to patients on 1st-line imatinib (3 of 48; 6.3 %). Clinically manifest PAOD was identified in 5 patients, all with current or previous nilotinib exposure only. Relative risk for PAOD determined by a pathological ABI in 1st-line nilotinib-treated patients as compared to 1st-line imatinib-treated patients was 10.3. PAOD is more frequently observed in patients receiving nilotinib as compared to imatinib. Due to the severe nature of clinically manifest PAOD longitudinal non-invasive monitoring and careful assessment of risk factors is warranted