Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

Caen University Hospital

Status: Not yet enrolling

Conditions: Chronic B-cell Malignancies; BTK Inhibitors; Cardiovascular Diseases

Treatments: Drug: Acalabrutinib; Drug: Zanubrutinib

Study type: Observational

Funder types: Other

Identifiers

NCT07283965

Pharmaco111525

Details and patient eligibility

About

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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• diagnose with chronic B-cell malignancies
• exposed to zanubrutinib or acalabrutinib

Exclusion criteria

• none

Trial design

15,000 participants in 2 patient groups

Zanubrutinib

Description:

Adult patients with a chronic B-cell malignancy exposed to zanubrutinib

Treatment:

Drug: Zanubrutinib

Acalabrutinib

Description:

Adult patients with a chronic B-cell malignancy exposed to acalabrutinib

Treatment:

Drug: Acalabrutinib