Updated March 9, 2013, at 8:30 p.m. PST with comment, slides from Boston Scientific.
Medical device giant Boston Scientific (NYSE:BSX) did not present its highly anticipated PREVAIL clinical trial results at the American College of Cardiology conference as planned this weekend after the presentation was canceled when the company inadvertently leaked the data ahead of time.
Boston Scientific sent a press release to its investors Saturday morning, breaking an embargo on the study that was meant to be lifted during the presentation.
The news is another dramatic turn for the PREVAIL results, which were at the center of controversy last week over the company’s initial announcement that it would unveil only the acute procedural safety results from the trial, leaving out 2 co-primary endpoints.
The exclusion made headlines, and Boston Scientific reported shortly after that it would scramble to ensure that results for all 3 co-primary endpoints were ready for the presentation, which ACC organizers pulled from the lineup.
The medical device maker issued an apology late on Saturday, announcing that it had published online the slides that principal investigator Dr. David Holmes planned to present during the conference.
"Boston Scientific considers scientific exchange in a peer-reviewed setting to be of the utmost importance and we deeply regret that the data were not shared at ACC," Boston Scientific cardiac rhythm management chief medical officer Dr. Kenneth Stein said in prepared remarks.
The PREVAIL results were among the top highlights of this year’s ACC meeting and thousands of attendees showed up Saturday morning only to find out that the study had been pulled.
Online reactions came swiftly via Twitter, with some expressing surprise and others speculating that the results were too early to report anyway:
Just from what I’m reading, no way PREVAIL should have been presented yet… Not enough follow up #ACC13
— Kevin Woolf, MD (@kwoolfmd) March 9, 2013
— Jeddacath (@Jeddacath) March 9, 2013
Had preconceived notions about LAA occlusion >negative. Sketchiness of all this (embargo breaks) doesn’t bode well for the strategy #acc13
— John Mandrola, MD (@drjohnm) March 9, 2013