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FDA: ROCKET AF results not affected by faulty INR monitoring device
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The FDA announced that its analysis of the impact of a faulty INR monitoring device on the outcomes of the ROCKET AF trial of rivaroxaban concluded that the effects of the device on outcomes were minimal and that rivaroxaban remains safe and effective.
The point-of-care monitoring device (INRatio, Alere) was used in ROCKET AF, the pivotal trial of rivaroxaban (Xarelto, Janssen Pharmaceuticals) vs. warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. INR monitoring is necessary in patients assigned warfarin.
Alere had announced in December 2014 that INRatio and another of its monitoring systems should not be used by patients with characteristics such as abnormal hematocrit levels; raised fibrinogen levels and related conditions; and bleeding or bruising. Shortly afterward, the company reported the concerns to the FDA and began an investigation.
Post hoc analyses published in a letter to The New England Journal of Medicine determined that use of the Alere device did not affect the safety and efficacy outcomes of ROCKET AF. In July, Alere announced it was withdrawing the monitoring systems from the market.
In its announcement, the FDA stated that “effects on strokes or bleeding, including bleeding in the head, were minimal. The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with [AF].”
Although analyses by the FDA and Janssen concluded that a lower bleeding rate would have been seen in patients from ROCKET AF assigned warfarin had a properly working monitoring device been used, “these estimated reductions in the rates of bleeding events in the warfarin arm were small enough so that the benefits of rivaroxaban would still outweigh the risks if efficacy were not affected,” Martin Rose, MD, JD, a reviewer for the FDA, wrote in the analysis.
In addition, he wrote, had the device worked correctly, more ischemic stroke events would have been reported in the warfarin arm, further confirming that the benefits of rivaroxaban outweigh its risks compared with warfarin.
Disclosure: Rose is an employee of the FDA.