BTK Inhibitors, Cardiovascular Diseases, Chronic B-cell Malignancies
Conditions
Brief summary
Background. Zanubrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown. Objectives. Our aim was to examine the risk of developing incident AF with zanubrutinib exposure compared with acalabrutinib exposure. Methods. Using the TriNetX research network database, authors will conduct a retrospective cohort analysis of deidentified, aggregate adult patients with chronic B-cell malignancies and exposed to zanubrutinib or acalabrutinib. Patients will be divided into 2 groups based on zanubrutinib or acalabrutinib exposure. After propensity score matching (PSM), Cox proportional hazard models will be used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) to compare the 2 matched groups. The appropriateness of the proportional hazard assumption will be examined and risk differences (RDs) will be used if appropriate. Results will summarized with the use of Kaplan-Meier survival curves.
Interventions
DRUGZanubrutinib
Adult patients with a chronic B-cell malignancy exposed to zanubrutinib
DRUGAcalabrutinib
Adult patients with a chronic B-cell malignancy exposed to acalabrutinib
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients * diagnose with chronic B-cell malignancies * exposed to zanubrutinib or acalabrutinib
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk of incident atrial fibrillation in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort. | from the introduction of the BTK inhibitor and up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Risk of incident intra-cerebral hemorrhage in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort | from the introduction of the BTK inhibitor and up to 5 years |
| Risk of incident major bleeding in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort | from the introduction of the BTK inhibitor and up to 5 years |
| Risk of all-cause mortality in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in thematched cohort | from the introduction of the BTK inhibitor and up to 5 years |
| Risk of incident MACE (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort | from the introduction of the BTK inhibitor and up to 5 years |
| Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort | from the introduction of the BTK inhibitor and up to 5 months |
| Risk of incident hypertension in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort | from the introduction of the BTK inhibitor and up to 5 years |
Contacts
Primary ContactJoachim Alexandre, MD, PhD
Outcome results
None listed