Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 64,920
- 试验地点
- 1
- 主要终点
- Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses
研究概览
简要总结
Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting.
The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.
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
- •First NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st January 2013 to 30th June 2017 (index date).
- •Age of at least 18 years at index date.
- •Continuous enrollment in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
- •A verified ambulatory or primary/ secondary hospital discharge diagnosis of NVAF in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
排除标准
- •A verified ambulatory or primary/ secondary hospital discharge diagnosis of valvular atrial fibrillation, indicating pregnancy, transient cause of atrial fibrillation or venous thromboembolism (VTE).
- •A claim for hip or knee replacement surgery in the 60 days prior to or on the index date.
- •A prescription of more than one oral anticoagulant (rivaroxaban, apixaban, edoxaban or phenprocoumon) on the index date.
- •A prescription of warfarin or dabigatran in the baseline period or on the index date.
- •A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period.
- •Patients receiving an initial dose of rivaroxaban 10 mg/ 2.5 mg or edoxaban 15 mg (these dosages are not indicated for the treatment of NVAF).
研究组 & 干预措施
Phenprocoumon
Patients with NVAF who initiated the treatment of Phenprocoumon.
干预措施: Phenprocoumon (Drug)
Rivaroxaban (Xarelto, BAY59-7939)
Patients with NVAF who initiated the treatment of Rivaroxaban.
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Apixaban
Patients with NVAF who initiated the treatment of Apixaban.
干预措施: Apixaban (Drug)
Edoxaban
Patients with NVAF who initiated the treatment of Edoxaban.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses
时间窗: Retrospective analysis from January 2012 - December 2017
Healthcare resource consumption in patients with non-valvular atrial fibrillation (NVAF) and renal impairment determined by inpatient claims based diagnoses
时间窗: Retrospective analysis from January 2012 - December 2017
Risk of Ischemic stroke (IS) / Systemic embolism(SE) (as combined endpoint and alone), recurrent IS/SE (as combined endpoint) and severe IS in patients with NVAF and renal impairment determined by inpatient claims based diagnoses
时间窗: Retrospective analysis from January 2012 - December 2017
Severe IS will be defined according to an approach proposed by Schubert et al. as hospitalization with a primary hospital discharge diagnosis of IS in combination with an OPS (Operationen und Prozedurenschlüssel) code indicating one of the following: intubation, mechanical ventilation or percutaneous endoscopic gastronomy
Overall costs in patients with renal impairment determined by inpatient claims based diagnoses
时间窗: Retrospective analysis from January 2012 - December 2017
Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses
时间窗: Retrospective analysis from January 2012 - December 2017
次要结局
- Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses(Retrospective analysis from January 2012 - December 2017)
- Risk of treatment discontinuation in patients with NVAF (overall population as well as patients with renal impairment) determined by pharmacy claims(Retrospective analysis from January 2012 - December 2017)
- Risk of recurrent hospitalizations (in general and for IS/SE)(Retrospective analysis from January 2012 - December 2017)
- Risk of Kidney failure determined by inpatient claims based diagnoses(Retrospective analysis from January 2012 - December 2017)
- Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses(Retrospective analysis from January 2012 - December 2017)
- Risk of IS, SE, Severe IS and recurrent IS/SE in patient with NVAF determined determined by inpatient claims based diagnoses(Retrospective analysis from January 2012 - December 2017)