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ROCKET AF: Rivaroxaban, warfarin comparable in AF
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American Heart Association Scientific Sessions 2010
CHICAGO — Rivaroxaban was not inferior to warfarin in preventing stroke and non-CNS embolism among high-risk patients with atrial fibrillation, according to data from the ROCKET AF trial.
“[W]hen we designed this trial, warfarin had been around for decades and no one had been able to beat it, despite the fact that it was sort of like a battered up old boxer that you think had had its day but keeps winning,” Robert M. Califf, MD, vice chancellor for clinical research at Duke University School of Medicine in Durham, said during a press conference.
Califf and colleagues began their study of rivaroxaban by testing inferiority. They then looked for superiority while patients were taking the study drug, and finally, they studied superiority in an intention-to-treat analysis.
The double-blind, double-dummy study enrolled 14,264 patients from 1,178 sites in 45 countries. More than half of patients in both arms (55%) had a prior stroke, transient ischemic attack or embolism, and one-fourth of patients were over the age of 78 years.
During treatment, rivaroxaban was associated with a decreased rate of stroke and non-CNS embolism events compared with warfarin (1.70 per 100 patient-years vs. 2.15 per 100 patient-years; P=.015). Though not superior in preventing stroke and non-CNS embolism during the intention-to-treat analysis, rivaroxaban was not inferior to warfarin (2.12 per 100 patient-years vs. 2.42 per 100 patient-years; P=.117).
“It’s fair to say that the trial did not demonstrate, by the highest standard, superiority according to the usual rules of clinical trials,” Califf said.
However, he added that when looking at the data a reasonable conclusion about the net balance of risk and benefit, one way or another, can be reached without relying on results from the intention-to-treat analysis.
According to Califf, the rate of bleeding and adverse events was similar between the two arms, and rivaroxaban was associated with less intercraniall hemorrhage and fatal bleeding. – by Stacey Fisher
For more information:
- Califf R. LBCT I, Abstract 21839. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.
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