Boston Scientific Breaks ACC Embargo On Somewhat Inconclusive Watchman Results

In short

It seems, “Sorry, we made an honest mistake” wasn’t enough for the ACC Scientific Sessions when Boston Scientific broke the embargo on its much anticipated clinical study into the Watchman Left Atrial Appendage occlusion device. The result was that organisers pulled the presentation from its allotted slot in the late-breakers clinical session, as well as its associated press conference.

Background

On Friday we dutifully reported that one of the highlights of this past weekend’s ACC Scientific Sessions was likely to be the presentation of data from Boston Scientific’s PREVAIL study into the performance of its Watchman Left Atrial Appendage (LAA) Occlusion device.

According to heartwire, what happened next is that Boston Scientific issued an investor’s notice at 6:30 am PT, ¬†announcing the key results in the form of an email “for immediate release.” When heartwire queried the ACC and Boston Scientific about the email, Boston Scientific media spokesperson Steven Campanini responded, saying, “Due to an error with our investor-relations email system, the release went to a limited group at 6:30 am Pacific time” but insisted the embargo was still in place.

Heartwire has covered the story more than adequately, here, but in essence what then occurred was that a packed auditorium was informed by the session’s co-chair, that he “had to make an unusual announcement, made necessary because protocols need to be adhered to”.

The announcement was reportedly greeted with gasps of surprise, not least because many if not most attendees were only there for this paper.

The commonly held view as reported by Heartwire, was that while there was an understanding that embargo rules must be enforced, in this case the sponsor company was (rightly) penalised, but so were the research team and indeed the audience, quotes notably forthcoming from Australian and UK specialists.

And the study results?

Well, the good news, which is ironically probably now more well-known than it would have been had the presentation gone ahead, is that the study met its end points from a safety perspective.

The slightly less good news is that the audience sounds like it remains to be convinced from the efficacy data. Again we turn to heartwire for their excellent coverage of the piece, here. Investigator and originally scheduled presenter of the data, Dr David Holmes said that 50% of AF patients are currently not taking anticoagulants, and there is a large unmet need for alternatives. “Many people cannot take oral anticoagulants because they are at high bleeding risk, and others don’t like the inconvenience of warfarin monitoring and the nuisance bleeding with any of the anticoagulant drugs. The Watchman device offers them the alternative of undergoing one procedure instead of taking lifelong anticoagulant therapy.”

In a nutshell, “all cardiologists asked by heartwire about this statement said the same thing: if it were true that fitting this device just once would give the same outcome as lifelong anticoagulant therapy, then yes, they would use it, But the data so far available are nowhere near justifying that claim.

It seems to be a matter of drawing your own conclusions.

Source: Heartwire