Author/Authors :
Goodman، نويسنده , , Shaun G. and Wojdyla، نويسنده , , Daniel M. and Piccini، نويسنده , , Jonathan P. and White، نويسنده , , Harvey D. and Paolini، نويسنده , , John F. and Nessel، نويسنده , , Christopher C. and Berkowitz، نويسنده , , Scott D. and Mahaffey، نويسنده , , Kenneth W. and Patel، نويسنده , , Manesh R. and Sherwood، نويسنده , , Matthew W. and Becker، نويسنده , , Richard C. and Halperin، نويسنده , , Jonathan L. and Hacke، نويسنده , , Werner and Singer، نويسنده , , Daniel E. and Hankey، نويسنده , , Graeme J. and Breithardt، نويسنده , , Gunter and Fox، نويسنده , , Keith A.A. and Califf، نويسنده , , Robert M.، نويسنده ,
Abstract :
Objectives
tudy sought to report additional safety results 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).
ound
CKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin.
s
sk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model.
s
incipal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk.
sions
xaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767)
