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.
Study Type
OBSERVATIONAL
Enrollment
64,920
Follow the physician's prescription.
2.5 mg or 5 mg, twice daily
15 mg or 20 mg, once daily
30 mg or 60 mg, once daily
Many Locations
Multiple Locations, Germany
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
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
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses
Time frame: 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
Time frame: Retrospective analysis from January 2012 - December 2017
Overall costs in patients with renal impairment determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses
Fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of recurrent hospitalizations (in general and for IS/SE)
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of Kidney failure determined by inpatient claims based diagnoses
Time frame: Retrospective analysis from January 2012 - December 2017
Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses
Time frame: 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
Time frame: 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
Time frame: Retrospective analysis from January 2012 - December 2017
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