Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin
A ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) Analysis
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Patients with impaired renal function have higher rates of bleeding and thromboembolism.1 Our group recently described the impact of worsening renal function on patients in the ROCKET AF study (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) (ClinicalTrials.gov. Unique identifier: NCT00403767).2 In the process of publishing these findings, questions arose from reviewers regarding the influence of baseline creatinine clearance (CrCl) on trial outcomes in ROCKET AF.3
Bohula et al4 demonstrated higher relative rates of thromboembolism in those with CrCl >95 mL/min treated with edoxaban in the ENGAGE TIMI-AF 48 trial (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation -Thrombolysis in Myocardial Infarction 48). We present the findings of an analysis using data from ROCKET AF3 to evaluate the consistency of treatment effect of rivaroxaban versus warfarin across the full range of baseline CrCl included in the trial.
ROCKET AF included 14 264 patients with nonvalvular atrial fibrillation (AF). Patients were randomly assigned to 20 mg rivaroxaban once daily (15 mg once daily in patients with a CrCl of 30–49 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.5, range 2.0–3.0). Further description of the ROCKET AF results and design has been published previously.3,5 All patients provided written informed consent, and approval by appropriate ethics committees was obtained at all sites.
We included 14 221 patients with CrCl data who received the study drug. We examined the primary efficacy end point of stroke or systemic embolism (SE); the principal safety end point of major or nonmajor clinically relevant bleeding; the secondary efficacy outcomes of ischemic stroke, hemorrhagic stroke, …