BTK Inhibitors, Cardiovascular Diseases, Chronic B-cell Malignancies
Conditions
Brief summary
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.
Interventions
DRUGBTK 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)
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort. | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code I48 will be used to identify AF during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort categorized according their baseline cardiovascular risk level for developing AF | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code ill be used to identify AF during follow-up |
| Risk of all-cause mortality in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort | from the introduction of the BTK inhibitor and up to 120 months | death from any cause during follow-up |
| Risk of incident intra-cerebral hemorrhage in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code ill be used to identify intra-cerebral hemorrhage during follow-up |
| Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort restricted to patients aged ≤75 and to patients aged >75 | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code I48 will be used to identify AF during follow-up |
| Risk of incident hypertension in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code ill be used to identify hypertension during follow-up |
| Risk of incident MACE (composite) in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code ill be used to identify MACE (composite of acute myocardial infraction, ischemic stroke or thromboembolism and heart failure) during follow-up |
| Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code ill be used to identify VT/VF/cardiac arrest (composite of ventricular tachycardia, ventricular fibrillation and cardiac arrest) during follow-up |
| Risk of incident major bleeding in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort | from the introduction of the BTK inhibitor and up to 120 months | ICD-10-CM code ill be used to identify major bleeding during follow-up |
Countries
France
Outcome results
None listed