Key result
Acalabrutinib linked to ~68% lower incident AF vs ibrutinib in real-world use.
Why the study?
To evaluate the real-world incidence of cardiovascular adverse events and clinical outcomes among patients with CLL or SLL treated with covalent Bruton's Tyrosine Kinase inhibitors.
Does acalabrutinib exposure reduce the incidence of cardiovascular adverse events compared to ibrutinib in real-world patients with CLL/SLL?
Cohort (n=2,163)
Does acalabrutinib exposure reduce the incidence of cardiovascular adverse events compared to ibrutinib in real-world patients with CLL/SLL?
Absolute Event Rate: 4.3% vs 13.5%
p-value: p=<0.001
This real-world study extends trial data by confirming that second-generation cBTKis like acalabrutinib significantly lower the incidence of cardiovascular events compared to ibrutinib, though the overall cardiac burden in this population remains substantial.
AIM: To evaluate the real-world incidence of cardiovascular adverse events (CVAE) and clinical outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) treated with covalent Bruton's Tyrosine Kinase inhibitors (cBTKis). METHODS: Patients initiating cBTKi treatment from 1 January 2020 to 1 January 2023 were identified using claims data. Demographics, first-line (1L) and second-line or later (2L+) therapy, incident CVAEs, and clinical outcomes were assessed. RESULTS: 9.2 years and 40.6% female. The most common incident CVAEs were hypertension (23.4%), atrial fibrillation (10.2%), ventricular arrhythmias (10.1%), heart failure (8.5%), and atrial flutter (4.2%). Those with CVAEs experienced higher switching to next treatment + death and worse overall survival than those without CVAEs. Incidence rates were ~2-3 fold lower with acalabrutinib than ibrutinib for hypertension, atrial fibrillation, and atrial flutter. Kaplan-Meier estimates for the likelihood of not experiencing a CVAE were 83% (acalabrutinib) and 72% (ibrutinib) at 12-months. CONCLUSIONS: Despite improvements in 2nd-generation cBTKi cardiotoxicity, patients with CLL/SLL receiving cBTKis have a considerable cardiovascular disease burden. These findings highlight the unmet need for CLL/SLL treatment options with improved efficacy and safety profiles.
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Dingli et al. (2025) conducted a cohort in Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (n=2,163). Acalabrutinib vs. Ibrutinib was evaluated on Incident atrial fibrillation (p=<0.001). Real-world exposure to acalabrutinib was associated with significantly lower incidence of atrial fibrillation (4.3% vs 13.5%, p<0.001) and hypertension (9.6% vs 30.1%, p<0.001) compared to ibrutinib.
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