Europe's professional body for heart surgeons has withdrawn support for clinical guidelines on how to treat left main coronary artery disease, a major form of heart disease, saying it was "a matter of serious concern" that some patients may have had the wrong advice, reports BBC News. Guidelines recommended both stents and heart surgery for low-risk patients. But trial data leaked to BBC’s Newsnight raises doubts about this conclusion, the report says.
The guidelines on how to treat it were largely based on a three-year trial to compare whether heart surgery or stents was more effective. The trial called Excel started in 2010 and was sponsored by big US stent maker, Abbott. But researchers had failed to publish data for the common, "Universal" definition of a heart attack.
Newsnight said it had seen the unpublished data and it shows that under the universal definition, patients in the trial that had received stents had 80% more heart attacks than those who had open heart surgery. The lead researchers on the trial have told Newsnight that this is "fake information". But, the report said, experts believe that the data is credible.
Professor Rod Stables, clinical lead for research at the British Heart Foundation, said this information should have been published and knowing it would have made a "substantial contribution to our ability to appreciate the nuances of the results".
Shortly after Excel was published, the professional bodies for heart surgeons and cardiologists got together to write a new set of guidelines. But, the report said, they had not seen the unpublished Universal definition data. Currently, European guidelines recommend either a stent or open-heart surgery for people who have less severe forms of this disease. The European Association for Cardio-thoracic Surgery (EACTS), which helped draw up the guidelines, is quoted in the report as saying if the information on the trial is proven to be correct, "the recommendation is unsafe".
The report says it has also learned that as the guidelines were being drawn up, the trial's Data Safety Monitoring Board – an independent body that looks after the interests of patients – was raising concerns.
The European Society of Cardiology, the other professional body involved in writing the guidelines, rejected the claim that the guidelines may have caused harm to patients. They stand by the guidelines, which they say were based on more than the Excel trial.BBC News report