Rivaroxaban FDA review of ROCKET AF data

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

The FDA conducted an advisory committee review regarding the approvability of rivaroxaban for reduction of stroke and systemic embolization in patients with non-valvular atrial fibrillation on September 8th, 2011.

Non-Inferiority Margin

An upper bound of the 95% CI of the hazard ratio was set at 1.38 by the FDA to establish non-inferiority. In no subgroup did the comparison come near the non-inferiority margin, and non-inferiority was clearly observed in all treatment subgroups and in all forms of analysis.

Primary Efficacy Endpoint

The primary efficacy endpoint was stroke and systemic embolization. The efficacy in the trial was driven by a reduction in hemorrhagic stroke and systemic embolization.

Secondary Efficacy Endpoints

There were fewer non-fatal myocardial infarctions in the Rivaroxaban group.

Safety Endpoint(s)

There were more major bleeding events in the rivaroxaban group, however, the risk of fatal bleeds (H.R.=0.61) and hemorrhagic strokes was reduced in the rivaroxaban group.

Cross Trial Comparisons

Dr. Califf emphasized that cross trial comparisons are inappropriate given the variation in design and patient risk.

Method of Transition at the End of the Trial

• The coumadin was started at a maintenance dose rather than using a loading dose
• There was no overlap with blinded study drug and coumading
• No INR was checked for three days
• Heparin bridging rarely used

IDMC indicated that there was no problem with the transition method. At the time the IDMC looked, there were more events in the warfarin arm. The excess number of events in the riva arm was due to an INR under 2 in the riva patients until they achieved anticoagulation. Following rug discontinuation there was a: 6.4% event rate per year in the rivaroxaban arm which is consistent with the rate in patients who are not anticoagulated 1.7 event rate per year in the coumadin arm consistent with effective coumadin therapy