ORCID Profile
0000-0003-4110-7675
Current Organisation
Brigham and Women's Hospital
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Publisher: Elsevier BV
Date: 07-2004
Publisher: Elsevier BV
Date: 09-2016
DOI: 10.1016/J.JACC.2016.06.034
Abstract: Anticoagulation is often avoided in patients with atrial fibrillation who are at an increased risk of falling. This study assessed the relative efficacy and safety of edoxaban versus warfarin in the ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial in patients with atrial fibrillation judged to be at increased risk of falling. We performed a pre-specified analysis of the ENGAGE AF-TIMI 48, comparing patients with versus without increased risk of falling. Nine hundred patients (4.3%) were judged to be at increased risk of falling. These patients were older (median, 77 vs. 72 years p < 0.001), and had a higher prevalence of comorbidities including prior stroke/transient ischemic attack, diabetes, and coronary artery disease. After multivariable adjustment, patients at increased risk of falling experienced more bone fractures caused by falling (adjusted hazard ratio [HRadj]: 1.88 95% confidence interval [CI]: 1.49 to 2.38 p < 0.001), major bleeding (HRadj: 1.30 95% CI: 1.04 to 1.64 p = 0.023), life-threatening bleeding (HRadj: 1.67 95% CI: 1.11 to 2.50 p = 0.013), and all-cause death (HRadj: 1.45 95% CI: 1.23 to 1.70 p < 0.001), but not ischemic events including stroke/systemic embolic event (HRadj: 1.16 95% CI: 0.89 to 1.51 p = 0.27). No treatment interaction was observed between either dosing regimens of edoxaban and warfarin for the efficacy and safety outcomes. Treatment with edoxaban resulted in a greater absolute risk reduction in severe bleeding events and all-cause mortality compared with warfarin. Edoxaban is an attractive alternative to warfarin in patients at increased risk of falling, because it is associated with an even greater absolute reduction in severe bleeding events and mortality. (Effective aNticaoGulation with factor xA next Generation in Atrial Fibrillation [ENGAGE AF-TIMI 48] NCT00781391).
Publisher: Elsevier BV
Date: 06-2016
DOI: 10.1016/J.JACC.2016.02.082
Abstract: Nonvitamin K-dependent oral anticoagulant agents (NOACs) are currently recommended for patients with atrial fibrillation at risk for stroke. As a group, NOACs significantly reduce stroke, intracranial hemorrhage, and mortality, with lower to similar major bleeding rates compared with warfarin. All NOACs are dependent on the kidney for elimination, such that patients with creatinine clearance <25 ml/min were excluded from all the pivotal phase 3 NOAC trials. It therefore remains unclear how or if NOACs should be prescribed to patients with advanced chronic kidney disease and those on dialysis. The authors review the current pharmacokinetic, observational, and prospective data on NOACs in patients with advanced chronic kidney disease (creatinine clearance <30 ml/min) and those on dialysis. The authors frame the evidence in terms of risk versus benefit to bring greater clarity to NOAC-related major bleeding and efficacy at preventing stroke specifically in patients with creatinine clearance <30 ml/min.
No related grants have been discovered for Robert Giugliano.