ROCKET AF hit the AHA on Monday morning. Results of ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) had been the topic of intense speculation and interest.
The trial showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin in preventing stroke in 14,264 AF patients and did not increase their risk of bleeding. In the per-protocol analysis, the rate of stroke and embolism was lower in the rivaroxaban group than in the warfarin group (P<0.001 for noninferiority, P=0.018 for superiority). Major bleeding complications occurred at a similar rate in the two groups (P=0.576).
Rate of stroke and embolism:
- Rivaroxaban: 1.71 events per 100 patient-years
- Warfarin: 2.16 events per 100 patient-years
Major bleeding complications:
- Rivaroxaban: 3.60 events per 100 patient-years
- Warfarin: 3.45 events per 100 patient-years
However, in the full intention-to-treat analysis, the superiority of rivaroxaban over warfarin did not achieve statistical significance (P=0.177). Intracerebral hemorrhage occurred in 55 patients on rivaroxaban and 84 on warfarin (P=0.019).
“The main implication is that we have an alternative to warfarin,” said Robert Califf, M.D., co-principal investigator of the study, in an AHA press release. “Equally important, there was no increase in bleeding, so 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.”
Note: The AHA 2010 presentation slides for ROCKET-AF can be found on the Duke Clinical Research Institute website.