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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib | Adult patients with a chronic B-cell malignancy exposed to zanubrutinib |
| |
| Acalabrutinib | Adult patients with a chronic B-cell malignancy exposed to acalabrutinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Adult patients with a chronic B-cell malignancy exposed to zanubrutinib |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 intra-cerebral hemorrhage in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients - diagnose with chronic B-cell malignancies expose to zanubrutinib or acalabrutinib in the TrinetX database
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Alexandre, MD, PhD | Contact | +33231064670 | alexandre-j@chu-caen.fr |
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Actually, data from TrinetX are only freely available for health care organizations participating to the health research network database.
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C000604908 | acalabrutinib |
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| Acalabrutinib |
| Drug |
Adult patients with a chronic B-cell malignancy exposed to acalabrutinib |
|
| 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 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 |
| 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 |