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Cardiovascular Risk Associated With Ibrutinib Use in Chronic Lymphocytic Leukemia: A Population-Based Cohort Study
Husam Abdel-Qadir1,2,3,4,5, Nasruddin Sabrie1, Darryl Leong6,7
1Division of Cardiology and Department of Medicine, Women's College Hospital, Toronto, Ontario, Canada.
Insights
Ibrutinib use in chronic lymphocytic leukemia (CLL) is linked to increased risks of atrial fibrillation (AF), bleeding, and heart failure (HF). These cardiovascular and bleeding risks require careful consideration in CLL patient management.
Area of Science:
- Oncology
- Cardiology
- Pharmacovigilance
Background:
- Ibrutinib is a targeted therapy that improves survival in chronic lymphocytic leukemia (CLL).
- However, concerns exist regarding its association with adverse cardiovascular and bleeding events, including atrial fibrillation (AF), heart failure (HF), and bleeding.
- The precise quantification of these risks in a real-world setting is crucial for clinical decision-making.
Purpose of the Study:
- To quantify the risks of AF, bleeding, heart failure (HF), and ischemic events (stroke, AMI) associated with ibrutinib treatment in patients with chronic lymphocytic leukemia (CLL).
- To compare these risks between ibrutinib-treated patients and a matched cohort of CLL patients treated with chemotherapy.
Main Methods:
- A population-based cohort study was conducted using linked administrative databases in Ontario, Canada.
- Patients with CLL diagnosed between 2007 and 2019 were included.
- Ibrutinib-treated patients were matched with chemotherapy-treated controls based on age, prior AF, anticoagulant use, and propensity for ibrutinib treatment. Outcomes were assessed using cumulative incidence functions and cause-specific regression.
Main Results:
- The 3-year incidence of AF-related healthcare contact was 22.7% for ibrutinib users versus 11.7% for controls.
- The 3-year risk of hospital-diagnosed bleeding was 8.8% for ibrutinib users compared to 3.1% for controls.
- Ibrutinib was associated with a higher 3-year risk of HF (7.7% vs. 3.6%), but no significant difference was observed for ischemic stroke or acute myocardial infarction (AMI).
Conclusions:
- Ibrutinib treatment in CLL patients is associated with significantly increased risks of atrial fibrillation (AF), bleeding, and heart failure (HF).
- The study did not find a significant association between ibrutinib and the risk of acute myocardial infarction (AMI) or stroke.
- These findings highlight the importance of monitoring for cardiovascular and bleeding complications in CLL patients receiving ibrutinib therapy.
Purpose:
Ibrutinib reduces mortality in chronic lymphocytic leukemia (CLL). It increases the risk of atrial fibrillation (AF) and bleeding and there are concerns about heart failure (HF) and central nervous system ischemic events. The magnitude of these risks remains poorly quantified.
Methods:
Using linked administrative databases, we conducted a population-based cohort study of Ontario patients who were treated for CLL diagnosed between 2007 and 2019. We matched ibrutinib-treated patients with controls treated with chemotherapy but unexposed to ibrutinib on prior AF, age ≥ 66 years, anticoagulant exposure, and propensity for receiving ibrutinib. Study outcomes were AF-related health care contact, hospital-diagnosed bleeding, new diagnoses of HF, and hospitalizations for stroke and acute myocardial infarction (AMI). The cumulative incidence function was used to estimate absolute risks. We used cause-specific regression to study the association of ibrutinib with bleeding rates, while adjusting for anticoagulation as a time-varying covariate.
Results:
We matched 778 pairs of ibrutinib-treated and unexposed patients with CLL (N = 1,556). The 3-year incidence of AF-related health care contact was 22.7% (95% CI, 19.0 to 26.6) in ibrutinib-treated patients and 11.7% (95% CI, 9.0 to 14.8) in controls. The 3-year risk of hospital-diagnosed bleeding was 8.8% (95% CI, 6.5 to 11.7) in ibrutinib-treated patients and 3.1% (95% CI, 1.9 to 4.6) in controls. Ibrutinib-treated patients were more likely to start anticoagulation after the index date. After adjusting for anticoagulation as a time-varying covariate, ibrutinib remained positively associated with bleeding (HR, 2.58; 95% CI, 1.76 to 3.78). The 3-year risk of HF was 7.7% (95% CI, 5.4 to 10.6%) in ibrutinib-treated patients and 3.6% (95% CI, 2.2 to 5.4) in controls. There was no significant difference in the risk of ischemic stroke or AMI.
Conclusion:
Ibrutinib is associated with higher risk of AF, bleeding, and HF, but not AMI or stroke.
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