November 10, 2015 – Preliminary exploratory safety and efficacy data on apixaban in these patients are reported by the DCRI’s Sean D. Pokorney, MD, MBA, and others.
The first multicenter trial data on the use of apixaban in a small number of patients with bioprosthetic valves and atrial fibrillation suggests that there were few major bleeding and stroke or systemic embolism events in both the apixaban and warfarin groups. Apixaban is a non-vitamin K antagonist oral anticoagulant (NOAC), a class of medications with similar to superior safety and efficacy compared with warfarin in patients with atrial fibrillation.
The Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE) trial randomized patients with atrial fibrillation to apixaban versus warfarin. The ARISTOTLE trial included 260 patients with a history of valve surgery, and detailed valve surgery data has been collected on 165 of these patients.
Before this study, there were no data on NOACs in patients with atrial fibrillation who have bioprosthetic valves, since these patients were excluded from earlier trials. As a result, the package insert for apixaban recommends against its use for stroke prevention in these patients.
The results of this analysis were presented on Tuesday at the 2015 American Heart Association Scientific Sessions in Orlando, Florida.
“Despite the small numbers of bioprosthetic valve patients and events, our analysis does not identify any concerning differences in the safety or efficacy outcomes between the apixaban and warfarin groups of atrial fibrillation patients,” said lead author Sean D. Pokorney, MD, MBA, of the DCRI. “We are continuing to collect additional surgical data on patients with bioprosthetic valves from the ARISTOTLE trial, to facilitate further investigation of the safety and efficacy of apixaban within this important, understudied patient population.”
In addition to Pokorney, Duke and DCRI co-authors were Meena P. Rao, MD, MPH; Daniel M. Wojdyla, MS; Renato D. Lopes, MD, Ph.D.; John H. Alexander, MD, MHS; and Christopher B. Granger, MD.