VASc score of 2 or more, moderate to severe mitral stenosis , left atrial spontaneous echo contrast, or left atrial thrombus.
During an average follow-up of 3.1 years, the primary outcome occurred in 446 patients in the VKA group and 560 patients in the rivaroxaban group . The restricted mean survival time for the primary outcome was 1675 vs 1599 days, respectively . Importantly, the mortality benefit emerged much later than in other trials and coincided with the time when the INR became therapeutic at about 3 years, Karthikeyan said. But it is unknown whether this is due to the INR or an unrelated effect.Following the presentation, session co-chair C. Michael Gibson, MD, Baim Institute for Clinical Research, Harvard Medical School, Boston, Massachusetts, questioned the 23% discontinuation rate for rivaroxaban.
Lopes said it is important to keep in mind that INVICTUS enrolled a"very different population" that was younger , was much more often female , and had fewer comorbidities than patients with AF who did not have rheumatic heart disease in the pivotal trials. "What's amazing is that what we're seeing here is something that hasn't been previously described with VKA or warfarin, which is that it reduces mortality," he toldRivaroxaban has never been shown to reduce mortality in any particular condition, and a meta-analysis of other novel oral anticoagulants shows only a small reduction in mortality, almost completely due to lessthan warfarin, he added."So, we don't think this is a problem with rivaroxaban.
Athena Poppas, MD, chief of cardiology at Brown University, Providence, Rhode Island, and past president of the American College of Cardiology, said,"INVICTUS is an incredibly important study that needed to be done."