American Heart Association 2010 Scientific Sessions and American Society of Nephrology: Renal Week 2010: 43rd Annual Meeting & Scientific Exposition.

ROCKET–AF, which included 14,264 patients, was conducted in 45 countries and at 1,178 sites. The primary clinical endpoint was stroke or non–central nervous system (CNS) systemic embolism, and the primary safety outcome was major or non-major clinically relevant bleeding. Among the included patients, 62.5% had congestive heart failure, 90.5% had hypertension, 39.5% had diabetes, and 55% had a prior stroke or transient ischemic attack or an embolism. In the primary analysis, participants taking rivaroxaban, compared with those taking warfarin, had fewer strokes and non-CNS emboli. With rivaroxaban, there were 1.71 events per 100 patient-years (188 patients); with warfarin, there were 2.16 events per 100 patient-years (241patients) (P < 0.001 for noninferiority). Superiority for rivaroxaban was shown in an ontreatment analysis (P = 0.015) but not in an intention-to-treat (ITT) analysis (P = 0.117). Major bleeding complications were comparable in both treatment groups, occurring at rates of 3.60 per 100 patientyears (in 395 rivaroxaban patients) and 3.45 per 100 patientyears (in 386 warfarin patients) (P = 0.576). Intracranial hemorrhage and fatal bleeding rates were lower with rivaroxaban. Hemoglobin decreases of 2 g/dL or more were more frequent with rivaroxaban (P = 0.019), as was the need for transfusions (more than 2 units) (P = 0.044). Dr. Mahaffey concluded, “Rivaroxaban is a proven alternative to warfarin for moderateor high-risk patients with atrial fibrillation.” Dr. Califf, co-principal investigator of the study, stated, “We have a drug you can take once a day without monitoring that is at least as good as warfarin and carries no additional risk.” Dr. Hylek noted that the overall safety profile of rivaroxaban was made less clear by the fact that there were more hemorrhages requiring transfusions and more drops in hematocrit. Preventing Stroke with Rivaroxaban (Xarelto) The ROCKET–AF Trial