Cardiovascular Adverse Events During Venetoclax-Based Treatment in Acute Myeloid Leukemia.

BACKGROUND

Venetoclax, a potent B-cell leukemia/lymphoma-2 inhibitor, is an antineoplastic agent used in various hematologic malignancies, including acute myeloid leukemia (AML). The aim of the study is to evaluate the incidence, risk factors, and outcomes of major adverse cardiac events (MACEs) among patients with newly diagnosed AML receiving venetoclax-based therapy.

METHODS

We conducted a retrospective, single-center cohort study of 214 patients with newly diagnosed AML treated with venetoclax. MACE was defined as a composite of new-onset heart failure, heart failure exacerbation requiring hospitalization, myocardial infarction/coronary revascularization, or stroke/transient ischemic attack during active venetoclax-based therapy. The Fine-Gray subdistribution hazard model determined the association between baseline clinical characteristics and MACEs, with noncardiovascular death as a competing risk. A Cox proportional hazard model determined the association between time-dependent MACEs and overall survival.

RESULTS

Among 214 patients (mean age, 71.5 years; 41% women), MACEs occurred in 14 (6.5%) patients. Patients with non-de novo (secondary /treatment-related) AML had a higher incidence of MACEs compared with de novo AML (85.7% versus 14.3%; subdistribution hazard ratio [HR], 7.1 [95% CI, 1.5-33]; P<0.01). Time-dependent MACE was independently associated with inferior overall survival (adjusted HR, 2.75 [95% CI, 1.41-5.35]).

CONCLUSIONS

In conclusion, MACE is a clinically significant event that occurs in 6.5% of patients with AML treated with venetoclax and is a higher-risk event for patients with secondary AML or treatment-related AML.