2 research outputs found
Natriuretic peptides predict left ventricular remodeling in response to metoprolol CR in patients with congestive heart failure: the RESOLVD phase II neurohumoral substudy
Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: A subgroup analysis of the ARISTOTLE trial
Background: In the ARISTOTLE trial, the rate of stroke or systemic embolism was reduced by apixaban compared with warfarin in patients with atrial fibrillation (AF). Patients with AF and previous stroke or transient ischaemic attack (TIA) have a high risk of stroke. We therefore aimed to assess the efficacy and safety of apixaban compared with warfarin in prespecified subgroups of patients with and without previous stroke or TIA. Methods: Between Dec 19, 2006, and April 2, 2010, patients were enrolled in the ARISTOTLE trial at 1034 clinical sites in 39 countries. 18 201 patients with AF or atrial flutter were randomly assigned to receive apixaban 5 mg twice daily or warfarin (target international normalised ratio 2路0-3路0). The median duration of follow-up was 1路8 years (IQR 1路4-2路3). The primary efficacy outcome was stroke or systemic embolism, analysed by intention to treat. The primary safety outcome was major bleeding in the on-treatment population. All participants, investigators, and sponsors were masked to treatment assignments. In this subgroup analysis, we estimated event rates and used Cox models to compare outcomes in patients with and without previous stroke or TIA. The ARISTOTLE trial is registered with ClinicalTrials.gov, number NTC00412984. Findings: Of the trial population, 3436 (19%) had a previous stroke or TIA. In the subgroup of patients with previous stroke or TIA, the rate of stroke or systemic embolism was 2路46 per 100 patient-years of follow-up in the apixaban group and 3路24 in the warfarin group (hazard ratio [HR] 0路76, 95% CI 0路56 to 1路03); in the subgroup of patients without previous stroke or TIA, the rate of stroke or systemic embolism was 1路01 per 100 patient-years of follow-up with apixaban and 1路23 with warfarin (HR 0路82, 95% CI 0路65 to 1路03; p for interaction=0路71). The absolute reduction in the rate of stroke and systemic embolism with apixaban versus warfarin was 0路77 per 100 patient-years of follow-up (95% CI -0路08 to 1路63) in patients with and 0路22 (-0路03 to 0路47) in those without previous stroke or TIA. The difference in major bleeding with apixaban compared with warfarin was 1路07 per 100 patient-years (95% CI 0路09-2路04) in patients with and 0路93 (0路54-1路32) in those without previous stroke or TIA. Interpretation: The effects of apixaban versus warfarin were consistent in patients with AF with and without previous stroke or TIA. Owing to the higher risk of these outcomes in patients with previous stroke or TIA, the absolute benefits of apixaban might be greater in this population. Funding: Bristol-Myers Squibb and Pfizer. 漏 2012 Elsevier Ltd