European clinical guidelines on how to treat a major form of heart disease are under review following a Newsnight investigation.
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The guidelines recommended both stents and heart surgery for low-risk patients with something called left main coronary artery disease after a clinical trial called EXCEL found they were as effective as each other in preventing heart attacks, strokes and death.
But unpublished data from the EXCEL trial seen by Newsnight has raised doubts about this conclusion.
It showed that under one definition, patients in the trial with stents had 80% more heart attacks after three years.
Newsnight also saw warnings from the trial’s safety board about the high mortality rate in patients with stents. Only after the guidelines were written did the researchers publish findings that showed increased mortality – 10% of those who’d had open heart surgery had died versus 13% of those with stents after 5 years.
The trial was sponsored by US stent manufacturer, Abbott.
It’s important to note that stents can still be lifesaving for some patients, and the professional body for cardiologists still back the guidelines.
Abbott said the study was designed and carried out by the researchers and the trial’s main researchers stand by the trial and its published conclusions.
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