Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced at the ESC Congress 2013, organized by the European Society of Cardiology, results of a post-hoc subanalysis from the Phase III ARISTOTLE trial, which was designed to demonstrate the efficacy and safety of Eliquis compared to warfarin for the prevention of stroke or systemic embolism in nonvalvular atrial fibrillation (NVAF) patients. The ARISTOTLE trial excluded patients with clinically significant mitral stenosis, or a mechanical prosthetic heart valve. This subanalysis evaluated Eliquis compared to warfarin in patients with or without other types of valvular heart disease (VHD) who were eligible for enrollment in the ARISTOTLE trial, including mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or valve surgery. Those 4,808 patients were the focus of this subanalysis.
The results of this subanalysis were consistent with the results of the overall ARISTOTLE trial and demonstrated that Eliquis compared with warfarin reduced stroke or systemic embolism, caused fewer major bleeding events, and reduced all-cause mortality in NVAF patients with or without VHD. These results were presented in an oral session today at the ESC Congress 2013 in Amsterdam, The Netherlands.
“This subanalysis provides better insight into the efficacy and safety of apixaban in nonvalvular atrial fibrillation patients with certain types of valvular heart disease, which are common in an elderly population,” said study lead author Dr. Alvaro Avezum of the Dante Pazzanese Institute of Cardiology in San Paulo, Brazil. ”These patients are generally older and considered to be at greater risk for clinical events than NVAF patients without VHD.”
This subanalysis evaluated data from 4,808 NVAF patients (26.4 percent of the ARISTOTLE trial population) who had both VHD and NVAF. For the purpose of this analysis, subjects with VHD were identified by any history of at least moderate mitral regurgitation (N=3,526), mitral stenosis (N=131), aortic regurgitation (N=384), aortic stenosis (N=887), tricuspid regurgitation (N=2,124), or valve surgery (N=251). Note that some of these patients had more than one valvular abnormality.