ESC Hot Line ACCOAST Was Halted; Bleeds, No Benefit With Earlier Prasugrel

Shelley Wood

August 28, 2013

PARSIPPANY, NJ — Enrollment in one of the trials scheduled for a hot-line presentation at this year's European Society of Cardiology 2013 Congress was halted in November 2012 by the trial's data monitoring committee (DMC) for safety reasons, although the company sponsoring the study never publicly announced the decision.

The ACCOAST trial, comparing the use of prasugrel (Effient, Lilly/Daiichi-Sanyo) at the time of PCI or as pretreatment at the time of diagnosis in patients with non-STEMI, will appear in hot-line session 2 this coming Sunday. Principal investigator for the study, Dr Gilles Montalescot (Pitié-Salpêtrière University Hospital, Paris, France), is scheduled to present the full results and confirmed to heartwire that the trial had been stopped early, having recruited 4033 of 4100 patients.

Daiichi Sankyo media officer Alyssa Dargento also verified to heartwire in an email that enrollment had been stopped following the recommendation from an independent DMC, "which found that pretreatment with an investigational, split loading dose of prasugrel was associated with an increased risk of early TIMI major (including life-threatening) bleeding, with no observed difference in reduction of cardiovascular events among patients with NSTEMI," she said.

Montalescot said that he believed the company had, in fact, made an announcement about the trial being stopped, but Dargento confirmed that no press release was issued at the time enrollment was halted.

A slide presentation by Dr Thomas Cuisset (CHU Timone, Marseille, France), apparently part of a French Cardiology Society event in January 2013, is the first mention of the news[1].

A second mention of ACCOAST's termination--and the lack of benefit/excess bleeding seen in the study--is buried in a comment by Dr Deepak Bhatt (Brigham and Women's Hospital, Boston, MA), responding to a related post on CardioExchange. Bhatt told heartwire he learned of the ACCOAST trial's termination when he, too, stumbled across the French presentation online.

It is increasingly common for top-line results or news of a trial's termination to be released ahead of its presentation, usually if the news might affect share prices. It's much rarer for terminated studies to fly beneath the radar until the moment they are publicly released in full.

To heartwire , Dargento stated, "Patient safety is the top priority for Daiichi Sankyo and Eli Lilly"; hence, they decided to stop the trial. She stressed: "The DMC recommendations were not the result of a mortality difference between the investigational and standard dosing arms."

After enrollment was terminated, investigators completed follow-up for all enrolled patients "to ensure the final data set is complete."

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