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 stroke0 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 and hemorrhagic strokes was reduced in the rivaroxaban group.