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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-25

Study Completion Date

2024-10-30

Brief Summary

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Background. Ibrutinib 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 ibrutinib 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 ibrutinib or acalabrutinib. Patients will be divided into 2 groups based on ibrutinib or acalabrutinib exposure. After propensity score matching (PSM), hazard ratios (HRs) and their associated 95% confidence intervals (CIs) will be used to compare AF risk during follow-up between the matched 2 groups.

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Detailed Description

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Conditions

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Chronic B-cell Malignancies BTK Inhibitors Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ibrutinib

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

BTK inhibitor (Ibrutinib or Acalabrutinib)

Intervention Type DRUG

Adult patients with a chronic B-cell malignancy included in this study will be separate into 2 groups according to the BTK inhibitor (ibrutinib and acalabrutinib)

Acalabrutinib

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

BTK inhibitor (Ibrutinib or Acalabrutinib)

Intervention Type DRUG

Adult patients with a chronic B-cell malignancy included in this study will be separate into 2 groups according to the BTK inhibitor (ibrutinib and acalabrutinib)

Interventions

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BTK inhibitor (Ibrutinib or Acalabrutinib)

Adult patients with a chronic B-cell malignancy included in this study will be separate into 2 groups according to the BTK inhibitor (ibrutinib and acalabrutinib)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients
* diagnose with chronic B-cell malignancies using ICD-10-CM codes C91 (lymphoid leukemia), C88.0 (Waldenström macroglobulinemia), C83.1 (mantle cell lymphoma), C81-C96 (malignant neoplasms of lymphoid, hematopoietic and related tissue) or C95 (leukemia of unspecified cell type)
* expose to ibrutinib or acalabrutinib determined by the Anatomical Therapeutic Chemical codes