The European Association for Cardio-thoracic Surgery (EACTS) has withdrawn its support for clinical guidelines on treating left main coronary artery disease following a BBC Newsnight investigation. The guidelines, which recommended both stents and heart surgery for low-risk patients, were based on the Excel trial, sponsored by US stent maker Abbott.
Leaked trial data seen by Newsnight reveals that under the commonly used 'Universal' definition of a heart attack, patients who received stents had 80% more heart attacks than those who had open heart surgery. The lead researchers, including Dr Gregg Stone, have dismissed the leaked data as 'fake information', but independent experts believe it is credible.
Prof Domenico Pagano, EACTS secretary general, said if the information is proven correct, 'the recommendation is unsafe'. He added: 'It is a matter of serious concern to us that some results in the Excel trial appear to have been concealed and that some patients may therefore have received the wrong clinical advice.'
The trial's Data Safety Monitoring Board had raised concerns about higher mortality rates among stent patients during the guideline drafting process, but the main investigators did not make this public. Prof Nick Freemantle, who worked on the guidelines, said he would 'never' have agreed the treatments were interchangeable if he had seen the leaked data, and warned that patients may have died as a result.
The European Society of Cardiology, the other body involved in drafting the guidelines, rejected claims that the guidelines caused harm. The guidelines are now under review.
