This article is more than 5 years old. Information may no longer be current.
ROCKET AF: Oral anticoagulation yielded stroke-protective benefit in AF, valvular disease
Oral anticoagulation reduced the risk for stroke in patients with atrial fibrillation, even if they had significant valvular disease, according to new data from the ROCKET AF trial.
Günter Breithardt, MD, EFESC, FACC, FHRS, and colleagues conducted an analysis of the clinical characteristics and outcomes of ROCKET AF participants with significant valvular disease. The overall trial enrolled 14,173 patients with nonvalvular AF who were randomly assigned rivaroxaban (Xarelto, Janssen Pharmaceuticals) or warfarin. Of those, 14.1% had significant valvular disease. Patients with significant valvular disease were older and had more comorbidities than patients without significant valvular disease.
Günter Breithardt
The rate of stroke or systolic embolism with rivaroxaban vs. warfarin was consistent among patients in the ROCKET AF trial with significant valvular disease (2.01% vs. 2.43%; HR=0.83; 95% CI, 0.55-1.27) and those in the trial without significant valvular disease (1.96% vs. 2.22%; HR=0.89; 95% CI, 0.75-1.07).
However, rates of major and nonmajor clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with significant valvular disease (19.8% vs. 16.8%; HR=1.25; 95% CI, 1.05-1.49) compared with patients without significant valvular disease (14.2% vs. 14.1%; HR=1.01; 95% CI, 0.94-1.1), even after controlling for risk factors and potential confounders.
The rate of intracranial hemorrhage was lower with rivaroxaban than with warfarin in patients without significant valvular disease, but was about the same for both drugs in patients with significant valvular disease (P for interaction=.084).
The researchers noted that the generally accepted definition of nonvalvular AF is limited to patients who do not have mitral stenosis, artificial heart valve or valve repair, and therefore includes patients who could have other types of valvular heart disease.
“It is important for the physician to know that there might be some differences between patients with and without [significant valvular disease], even if patients meet the criteria for nonvalvular AF,” Breithardt, from the department of cardiovascular medicine, division of electrophysiology, University Hospital Münster, Germany, and colleagues wrote.
Disclosure: The study was funded by Janssen Pharmaceuticals and Bayer Healthcare. Some researchers report financial relationships with Janssen, Bayer, and other pharmaceutical and device companies.