Doctors react to ACC PREVAIL cancellation

March 09, 2013

San Francis c o, CA - Thousands of attendees packed into the first late-breaking clinical-trial session of the American College of Cardiology (ACC) 2013 Scientific Sessions this morning to hear the first presentation of the PREVAIL study of the Watchman (AtriTech/Boston Scientific) device for the prevention of stroke in AF patients were disappointed when it was announced that the trial was actually not going to be reported because of an embargo break.

Boston Scientific, the trial sponsor, issued an investor's notice by email "for immediate release" at 6:30 am Pacific time reporting the key results of the trial, and several news organizations released articles immediately, but the official embargo was 9.10 am Pacific time—the time of the actual ACC presentation. The company said it released the email early "due to an error with our investor-relations email system." In response to the embargo break, the ACC took the unprecedented step of canceling the study presentation and press conference.

Introducing the late-breaking clinical-trial session, cochair Dr Panagiotis Vardas (Heraklion University Hospital, Greece) said he had to make an "unusual announcement," which was necessary because protocols have to be adhered to. He stated: "The PREVAIL trial has been pulled today from presentation because of a break in embargo by Boston Scientific." This was greeted with gasps of surprise from the audience, for many of whom PREVAIL was the major reason for attending the session. Only one other clinical trial was included in the session— HPS-2 THRIVE —and top-line results of that study were released several months ago.

Holmes: "An awful event"

Lead investigator of PREVAIL, Dr David Holmes (Mayo Clinic, Rochester, MN), who found out only shortly before the session that he was not going to present, told heartwire : "This is an awful event. I can see that the ACC has a very clear policy on embargo breaks, and I agree with that policy. But the embargo break did not come from the investigators. I am very unhappy about the situation."

Several cardiologists told heart wire that they were disappointed as PREVAIL was the major news of the day—even of the meeting.

Dr Marcus Flather (Norfolk and Norwich University Hospitals, UK) commented: "I understand the ACC has to follow procedures, but the end result was very unhelpful to all its members who came here this morning to see the results of the study and hear the discussion about them."

Dr Ben Freedman (University of Sydney Concord Hospital, Australia) added: "I can see that it is contravention of ACC embargo policy, but this is a scientific meeting and I came to hear these new results discussed in a scientific forum. I feel cheated that I haven't been able to do that."

There is a nice report the on theheart. org!

Dr Sid Smith (University of North Carolina, Chapel Hill), an ACC committee member not involved in the decision to remove the PREVAIL presentation, said: "I know from the many organizations that I am involved with that any decision like this is done with a great deal of care and thought. I am sure the ACC thought very carefully about it. This is not an easy decision to make.

"But when rules are made, you have to stand by them. They have to penalize the sponsor for breaking the embargo—and this is penalizing the sponsor—but the trouble is it also penalizes the many people who came here today to hear the results and the investigators who have worked so hard and are now not able to present their work.

Asked how he was going to find out about the PREVAIL results now, Smith said "There is a nice report on !"

ACC stands by decision

The ACC stands by its decision. Dr John Harold (president elect of the ACC) told heart wire : "We had no choice—we have to follow procedures."

Dr Steve Nissen (Cleveland Clinic, OH, a past president who has no current role in the ACC and was not involved in today's decision, agreed with the ACC's stance. "It was absolutely the right decision," he told heart wire .

Although cardiologists have not had the opportunity to see the data, Nissen said this wasn't such a big issue, as the device is not available in the US. "The data do need to be reviewed and discussed, but the FDA and journals will do that," he added.

Contacted again by heart wire after the ACC's decision, Boston Scientific's media spokesperson Steven Campanini said the embargo break "was an honest mistake."

He reiterated that the investor relations email had gone out to a limited number of analysts and reporters, but he wouldn't give a number. While the email heart wire received appeared to come from the investor-relations address, Campanini confirmed that the media and investors list are "one and the same."

"This was unfortunate, but it doesn't change the preliminary results of the PREVAIL study," he commented.

Asked whether the ACC was angry over the break—implied by its unprecedented decision to cancel the presentation—Campanini said only that he has been "closely coordinating" details of the presentation with the ACC media office and "it has been cordial so far."

Boston Scientific issued a statement later on in the day apologizing for the embargo break. It stated, "Boston Scientific considers scientific exchange in a peer-reviewed setting to be of the utmost importance, and the company deeply regrets not being able to share the data at ACC."

With markets closed on Saturday, the earlier-than-expected news on PREVAIL likely won't budge the dial for Boston Scientific shares.


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