Clinical InvestigationRisk of cardiovascular events and incident atrial fibrillation in patients without prior atrial fibrillation: Implications for expanding the indications for anticoagulation
Section snippets
Data source and study population
We conducted a retrospective cohort analysis using OptumLabs Data Warehouse, which contains privately insured and Medicare Advantage enrollees of all ages and races from all 50 states.8., 9. The data include inpatient, outpatient, and pharmacy claims. A subset of patients with claims data has linked laboratory results and electronic health records (EHRs).
Our cohort consists of patients who were at least 50 years old and had continuously enrolled in medical and pharmacy insurance plans for at
Results
The study population included 6,495,875 patients aged 50 years or older who were not previously diagnosed with AF. Patients' demographic characteristics and medical history are shown in Table I. Over a mean follow-up of 2.26 ± 1.74 years, we observed 46,294 ischemic strokes, 52,229 MIs, 139,511 AFs, 76,328 major bleeds, 18,534 intracranial bleeds, and 102,229 deaths. The event rates were 0.67%/y for ischemic stroke and MI, 0.32%/y for ischemic stroke, 0.36%/y for MI, 0.96%/y for AF, 0.52%/y for
Discussion
Using 6.5 million people and nearly 15 million person-years of follow-up, our study is the first to assess the risk of ischemic stroke, MI, AF, and major bleeding in a large cohort of patients without diagnosed AF in contemporary routine clinical practice. These data will provide context for the recently published COMPASS trial and other forthcoming trials examining the use of NOACs in non-AF populations. The study also yields important insights into the potential benefits and harms from NOAC
Disclosures
Drs Yao, Sangaralingham, Shah, and Noseworthy report no relationshipswith industry. Dr Gersh has consulted for Janssen Pharmaceuticals.
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Cited by (0)
Sources of funding: This study was funded by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, which receives no industry funding. The design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication were solely the responsibility of the authors listed.