Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15,000
- 主要终点
- Risk of incident atrial fibrillation in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •diagnose with chronic B-cell malignancies
- •exposed to zanubrutinib or acalabrutinib
排除标准
- 未提供
研究组 & 干预措施
Zanubrutinib
Adult patients with a chronic B-cell malignancy exposed to zanubrutinib
干预措施: Zanubrutinib (Drug)
Acalabrutinib
Adult patients with a chronic B-cell malignancy exposed to acalabrutinib
干预措施: Acalabrutinib (Drug)
结局指标
主要结局
Risk of incident atrial fibrillation in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort.
时间窗: from the introduction of the BTK inhibitor and up to 5 years
次要结局
- 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(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)