This week the BBC Newsnight program aired their investigation into European Guidelines on heart disease.

The program focused on European guidelines for treatment of Left Main Coronary Artery (LMCA) stenosis and the current EU guidelines that recommend stents over open heart surgery.

Stents are an implantable medical device made from a short wire mesh tube. They are pushed into the heart through an open incision. 

The current European guidelines were developed following published data from a manufacturer sponsored clinical trial called EXCEL.  The EXCEL trial began in 2010 and compared conventional open heart surgery (coronary artery bypass graft surgery) with stents. 

The EXCEL clinical trial omitted and concealed key data in published medical journals.

The BBC Newsight program highlights the lack of oversight and accountability that underpins medical device clinical trials.

The program asks an extremely important question.

Whose responsibility is it to make sure all evidence from clinical trials is clearly and accurately reflected?

•Is it the manufacturers of medical devices who sponsor the trials?

•Is it the researchers who conduct the trials?

•Is it the journals who publish the trials?

•Is it the committees who draw up the guidelines?

Following the program the “The Council of the European Association for Cardiothoracic Surgery (EACTS) ‘unanimously decided, with immediate effect, to withdraw’ their support for the current clinical guidelines.

In Australia, approximately 28,131 procedures involving stents were performed in 2017. This is a 31 per cent increase in the last decade.

The coronary stent market is expected to reach $US15.2 billion by 2024. 

References 

https://www.michaelwest.com.au/inside-the-stent-investigating-the-boom-in-cardiac-surgery/

https://www.google.com.au/amp/s/www.bbc.com/news/amp/health-50715156