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Dr. Keith Fox,
Dr. Stefan H Hohnloser,
Presenter | see Discussant report
Keith A Fox(United Kingdom)Presentation webcast
List of Authors: Keith A. A. Fox, Jonathan P. Piccini, Daniel Wojdyla, Richard C. Becker, Jonathan L. Halperin, Christopher C. Nessel, John F. Paolini, Graeme J. Hankey, Kenneth W. Mahaffey, Manesh R. Patel, Daniel E. Singer, Robert M. Califf
Aims: Patients with non-valvular atrial fibrillation (AF) and renal insufficiency are at increased risk for ischaemic stroke and bleeding during anticoagulation. Rivaroxaban, an oral, direct factor Xa inhibitor metabolized predominantly by the liver, preserves the benefit of warfarin for stroke prevention while causing fewer intracranial and fatal haemorrhages. Methods and Results: We randomised 14,264 patients with AF in a double-blind trial to rivaroxaban 20 mg/day (15 mg/day if creatinine clearance [CrCl] 30–49 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0–3.0). Compared with patients with CrCl >50 mL/min (mean age 73 years), the 2950 (20.7%) patients with CrCl 30–49 mL/min were older (79 years) and had higher event rates irrespective of study treatment. Among those with CrCl 30–49 mL/min, the primary endpoint of stroke or systemic embolism occurred in 2.32 per 100 patient-years with rivaroxaban 15 mg/day versus 2.77 per 100 patient-years with warfarin (hazard ratio [HR] 0.84; 95% confidence interval [CI] 0.57–1.23) in the per-protocol population. Intention-to-treat analysis yielded similar results (HR 0.86; 95% CI 0.63–1.17) to the per-protocol results. Rates of the principal safety endpoint (major and clinically relevant non-major bleeding: 17.82 vs. 18.28 per 100 patient-years; P=0.76) and intracranial bleeding (0.71 vs. 0.88 per 100 patient-years; P=0.54) were similar with rivaroxaban or warfarin. Fatal bleeding (0.28 vs. 0.74% per 100 patient-years; P=0.047) occurred less often with rivaroxaban. Conclusion: Patients with AF and moderate renal insufficiency have higher rates of stroke and bleeding than those with normal renal function. There was no evidence of heterogeneity in treatment effect across dosing groups. Dose adjustment in ROCKET-AF yielded results consistent with the overall trial in comparison with dose-adjusted warfarin. Funding: This work was supported by grants from Johnson & Johnson Pharmaceutical Research & Development L.L.C. (Raritan, NJ) and Bayer HealthCare Pharmaceuticals (Berlin, Germany). The Duke Clinical Research Institute (Durham, NC), guided by the Steering Committee, coordinated the trial, managed the database, and performed the primary analyses for this manuscript independent of the sponsors. Discussant | see Presenter abstract
Stefan H Hohnloser(Germany)Presentation webcast
709007 - 709008
Clinical Trial Update I - Drug treatment
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