Publications by authors named "C S Nessel"
Article Synopsis
- DAOH (Days Alive Out of Hospital) is a key end point for assessing patient outcomes in atrial fibrillation treatments, but its clinical utility has not been previously explored in trials.
- The ROCKET AF trial compared the effectiveness of rivaroxaban and warfarin in patients with atrial fibrillation, revealing similar DAOH outcomes for both treatments, indicating no significant benefit of one over the other.
- Overall, low event rates among participants led to a skewed distribution in DAOH measurements, which may explain the lack of treatment differences observed in the study.
Background In event-driven clinical trials, study termination is based on accrual of a target number of primary efficacy events. For noninferiority trials in which superiority is conditionally examined, the ideal cohort in which to track event accrual is unclear. We used data from the 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) trial to determine the effect of primary efficacy-event tracking in the per-protocol cohort during the on-treatment period versus the intention-to-treat (ITT) cohort during the ITT period.
View Article and Find Full Text PDFBackground: Insulin use may be a better predictor of stroke risk and morbidity and mortality than diabetes in patients with atrial fibrillation (AF).
Objectives: Determine if the increased risk of stroke observed in patients with AF and diabetes is restricted to those treated with insulin.
Methods: We analyzed the association between diabetes and treatment and the occurrence of stroke/systemic embolism, myocardial infarction (MI), all-cause death, vascular death, composite outcomes, and bleeding risk in the ROCKET AF trial.
Background: ROCKET AF demonstrated the efficacy and safety of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism (SE) in patients with atrial fibrillation (AF). We examined baseline characteristics and outcomes in patients enrolled in Latin America compared with the rest of the world (ROW).
Methods: ROCKET AF enrolled 14,264 patients from 45 countries.
Introduction: Patient-reported outcomes (PROs) and satisfaction endpoints are increasingly important in clinical trials and may be associated with treatment adherence. In this post hoc substudy from ROCKET AF, we examined whether patient-reported satisfaction was associated with study drug discontinuation.
Methods: ROCKET AF (n = 14,264) compared rivaroxaban with warfarin for prevention of stroke and systemic embolism in patients with atrial fibrillation.