Key result
Non-de novo AML linked to ~7.1-fold higher MACE risk during venetoclax therapy.
Why the study?
Venetoclax is used in acute myeloid leukemia, but the incidence, risk factors, and outcomes of major adverse cardiac events during venetoclax-based therapy needed evaluation.
Observational (n=214)
No
In patients with newly diagnosed AML, major adverse cardiac events occurred in 6.5% during venetoclax-based therapy and were independently associated with inferior overall survival.
Non-de novo AML may warrant closer MACE monitoring on venetoclax; this observational association leaves open prospective validation and causal inference.
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. 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.
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Selvakumar et al. (2026) conducted an observational in Acute Myeloid Leukemia (n=214). Non-de novo acute myeloid leukemia (secondary or treatment-related) vs. De novo acute myeloid leukemia was evaluated on Major adverse cardiac events (composite of new-onset heart failure, heart failure exacerbation, acute coronary syndrome/coronary revascularization, or stroke/TIA) (sHR 7.06, 95% CI 1.51-33.00, p=<0.01). In patients treated with venetoclax for acute myeloid leukemia, non-de novo AML was associated with a 7-fold increased risk of major adverse cardiac events compared to de novo AML (sHR 7.06).
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