All-Cause Mortality and Cardiovascular Outcomes With Non-Vitamin K Oral Anticoagulants Versus Warfarin in Patients With Heart Failure in the Food and Drug Administration Adverse Event Reporting System

Background: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes. Study Question: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Study Design: We extracted and examined outcome cases in subjects with HF and on warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban and stratified these according to anticoagulants. Measures and Outcomes: Annual all-cause mortality, myocardial infarction, and stroke in FAERS. Analysis Method: Odds ratio (OR) and χ2 JOURNAL/ajthe/04.02/00045391-201912000-00001/math_1MM1/v/2019-11-24T103634Z/r/image-tiff for oral anticoagulants from FAERS with and without HF among complete primary reports issued in 2015. Results: FAERS reported 137,026 HF cases, with death co-reported in 42,942 (31.3%). In total, 11,278 (8.2%) HF patients were treated with anticoagulants, with more prescribed warfarin (n = 8260) than all NOACs combined (n = 3018). Very few reports for edoxaban were available. Warfarin consistently displayed a signal for exces...
Source: American Journal of Therapeutics - Category: Drugs & Pharmacology Tags: Original Research Source Type: research