Controversy reportedly erupted at a European cardiovascular society conference this week after a prominent cardiologist accused the study’s investigators of manipulating the trial to skew the results.
Five-year data from the Excel trial, released last month at the Transcatheter Cardiovascular Therapies conference, showed that percutaneous coronary intervention was as good as coronary artery bypass grafts when measured by death from any cause, myocardial infarction or stroke. But as the data was being presented this week at the European Assn. for Cardio-Thoracic Surgery in Lisbon, a member of the study’s executive committee, Dr. David Taggart of the U.K.’s University of Oxford, alleged that the trial’s definition of MI was changed mid-stream to favor PCI over CABG, according to Medscape.
The Excel study defined peri-procedural MIs as occurring within 72 hours, measured by a biomarker and electrocardiographic and imaging criteria. That’s in line with 2013 guidelines from the Society of Cardiovascular Angiography & Interventions, the website reported.
“What happened in EXCEL was a disgrace,” Taggart said, according to the site. “To equate a peri-procedural biochemical definition of myocardial infarction, and give it the same weight as a nonprocedural myocardial infarction, was an absolute outrage in my opinion.
“So I believe the data was manipulated, using a changed definition of myocardial infarction, to try and prove that for the composite endpoint, there’s no difference,” he said. “In my 13 years of being involved in authorships and publications, I have never witnessed such an attempt to distort what the actual data in this paper showed.”
Study investigators, including co-principal investigator Dr. Arie Pieter Kappetein of Rotterdam’s Erasmus University Medical Center, were quick to refute Taggart’s allegations.
“The definition was not changed during the study,” Kappetein said. “It’s a lie, it’s misleading the audience here.”
“No one has any idea what he’s talking about, and it is an outright falsehood,” co-PI Dr. Gregg Stone, of New York City’s Icahn School of Medicine at Mount Sinai, told the website, adding that no change was made to the peri-procedural-MI definition either before or after the Excel data were unblinded.
“He is not justified in focusing on secondary endpoints that lack power,” Stone said. “Plus in Excel, there was no significant difference in cardiovascular mortality, which is what would be expected between two cardiac procedures if one was to improve survival.
“Dr Taggart is a master of cherry picking, selectively choosing one data point from one study and conveniently ignoring all other data in the field,” he said.
Taggart declined on two occasions to be interviewed for the Medscape story, telling the website only that he “stands by every word” in his EACTS presentation. Taggart withdrew as a co-author of the five-year results.