Abstract
Objective
To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment.
Methods
This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included.
Outcomes and measures
Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs).
Results
We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA2DS2VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA2DS2VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17–1.28/1.22; 1.17–1.28), IS (1.90; 1.69–2.15/1.92; 1.69–2.19), non-specified strokes (2.04; 1.16–3.70/1.93; 1.13–3.32), TIAs (1.52; 1.29–1.79/1.44; 1.21–1.70), MIs (1.26; 1.10–1.15/1.31; 1.13–1.52), AE (1.75; 1.32–2.32/1.81; 1.36–2.34) and severe bleeding (1.92; 1.71–2.15/1.95; 1.74–2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under clinicaltrials.gov (NCT02657616).
Conclusion and relevance
A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients.
Acknowledgments
This work was financially supported by AOK PLUS. Since UM is employed by AOK PLUS, AOK PLUS as the study sponsor was involved in this study in the following way: conception/design of the study, data collection, validation of database, and interpretation of results in discussion section.
Author contributions
SM, AG: project lead, participated in writing all parts of the paper, statistical analysis; UM, AP, AS, SM: conception/design of the study, data collection, validation of database, and interpretation of results in discussion section; SGS: conception/design of the study and interpretation of results in discussion section with regard to clinical practice. All authors made substantial contributions to all the following: 1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, 2) drafting the article or revising it critically for important intellectual content, 3) final approval of the version to be submitted.
Disclosure
UM received modest honoraria from several pharmaceutical companies. SGS received modest honoraria from BMS/Pfizer and Bayer Vital, and modest research grant support from BMS/Pfizer and Daiichi Sankyo. SM and AG participated in this study as staff members of IPAM. AP and AS do not have any conflicts of interest except those potentially related to their employer, AOK Baden-Württemberg and AOK Bayern, respectively. The authors report no other conflicts of interest in this work.