Last week Abiomed issued a press release (reprinted below) that was about as dull as a press release can get. The main news of the press release was that the PROTECT II study testing the company’s Impella 2.5 circulatory support device had been published online in Circulation.
The press release provides no details or information about the trial and makes no claims about the clinical benefits of the company’s device. The only remotely interesting items in the press release are generic quotes from the principal investigator of the trial, William O’Neill, and from Michael Minogue, the chairman and CEO of Abiomed:
O’Neill: “Today marks a very significant milestone in providing new clinical insight for cardiovascular disease patients considered too risky for conventional surgery. The PROTECT II publication in Circulation underscores the importance of this study’s observations to the clinical community.”
Minogue: “PROTECT II is a landmark clinical trial and we are grateful to Dr. O’Neill and his colleagues for leading this study. The peer-reviewed publication of PROTECT II in the esteemed Circulation journal is a notable achievement for Abiomed. Most importantly, we believe that this study will advance the treatment for patients with heart failure.”
Now all this would be entirely unremarkable, except for the fact that O’Neill and Abiomed struck a very different tone earlier in the history of this trial.
In November 2010, when the trial was terminated early due to futility, the company issued a press release which contained numerous details about the results of the trial and then portrayed these results as a triumph, despite the fact that the overall trial was negative. Although the full results had not been publicly presented, much less undergone peer review or scrutiny from other physicians or regulators, the CEO said the trial would “pave the way to change the standard of care for PCI requiring prophylactic hemodynamic support.” And O’Neill told Wall Street investors that the trial was “a landmark trial that will impact practice.”
As I wrote then, the press release struck me as a perfect example of how to spin a negative result, relying on cherry picked endpoints and subgroups. (The original press release was removed from the company website but can be found in my news story.) Rick Lange and David Hillis provided their own critical perspective of the trial on CardioExchange.
The initial press release wasn’t the only problem with the rollout of PROTECT II. An additional issue became fully apparent a few months later in April 2011 when the full trial results were trial were scheduled for presentation at the American College of Cardiology meeting in New Orleans. Prior to the meeting the company issued a press release announcing that the study would be presented at a late-breaking clinical trials session, a highly prestigious and much-desired position.
But PROTECT II was not presented at a late-breaking clinical trial session. As I reported shortly before the ACC meeting, the trial “was resoundingly shot down as an ACC late-breaking clinical trial at the selection meeting” because the company had violated the Ingelfinger Rule, which prevents publication of trial information that has been previously submitted or reported elsewhere. In other words, the earlier Abiomed press release led the ACC to disqualify the trial for presentation as a prestigious late-breaker.
Circulation is unlikely to lift the veil on its editorial process, but my guess is that the journal played a big role in the final shape of last week’s remarkably modest publication and accompanying press release. The Circulation paper concludes– properly– that “Impella 2.5 did not result in a superior outcome of the primary endpoint at 30 days.” The paper also reports the results of a more promising secondary analysis suggesting a possible benefit for the device at 90 days, but rather than hyping these results as heralding a change in the standard of care, the authors write: “Since the difference in 30 day MAE [major adverse events] did not reach statistical significance for the entire study, the analysis of 90 day events remains exploratory.”
So let’s celebrate genuine progress, in this case represented by a dull scientific paper and an even duller press release.
Abiomed Announces Publication of PROTECT II Study in Circulation: Journal of the American Heart Association
DANVERS, Mass., Sept. 4, 2012 (GLOBE NEWSWIRE) — Abiomed, Inc.
(Nasdaq:ABMD), a leading provider of breakthrough heart support
technologies, today announced that results from its PROTECT II study
will be published in an upcoming print edition of Circulation, the
journal of the American Heart Association. The study, “A Prospective
Randomized Clinical Trial of Hemodynamic Support with Impella(R) 2.5
versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk
Percutaneous Coronary Intervention: the PROTECT II Study,” was accepted
for publication on August 20, 2012 and published online on August 30,
2012 via the following link:
The PROTECT II study was a prospective multicenter randomized trial
that was “designed to assess whether a high-risk percutaneous
revascularization strategy with the support of the Impella 2.5 device
would result in better outcomes than a revascularization strategy with
intra aortic balloon pump (IABP) support.”
“Today marks a very significant milestone in providing new clinical
insight for cardiovascular disease patients considered too risky for
conventional surgery. The PROTECT II publication in Circulation
underscores the importance of this study’s observations to the clinical
community,” said William W. O’Neill, M.D., principal investigator of
the PROTECT II trial and medical director of the Center for Structural
Heart Disease at Henry Ford Hospital in Detroit.
Study authors include William W. O’Neill, M.D.; Neal S. Kleiman, M.D.;
Jeffrey Moses, M.D.; Jose P.S. Henriques, M.D., Ph. D.; Simon Dixon,
MBChB; Joseph Massaro, Ph. D.; Igor Palacios, M.D.; Brijeshwar Maini,
M.D.; Suresh Mulukutla, M.D.; Vladimir Dzavik, M.D.; Jeffrey Popma,
M.D.; Pamela S. Douglas, M.D.; and Magnus Ohman, M.D. Circulation has
the highest ranking impact factor among journals in the Cardiac &
Cardiovascular Systems category.
“PROTECT II is a landmark clinical trial and we are grateful to Dr.
O’Neill and his colleagues for leading this study,” said Michael R.
Minogue, Chairman, President and Chief Executive Officer of Abiomed.
“The peer-reviewed publication of PROTECT II in the esteemed
Circulation journal is a notable achievement for Abiomed. Most
importantly, we believe that this study will advance the treatment for
patients with heart failure.”
These data in PROTECT II have been collected, validated, and monitored
by a third party academic research organization and the major adverse
events (MAE) were assessed at 30 and 90 days. Additionally, all
hospital charges were tracked by an independent health economic
organization in coordination with the study.
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider
of medical devices that provide circulatory support. Our products are
designed to enable the heart to rest by improving blood flow and/or
performing the pumping of the heart. For additional information please