Following BBC Newsnight’s investigation, Professor Domenico Pagano, Secretary General of EACTS, says:
“The Council of the European Association for Cardiothoracic Surgery (EACTS) has considered the analysis of the data that BBC Newsnight has shown us. 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.
“Following the information presented to us by Newsnight, the EACTS Council has unanimously decided, with immediate effect, to withdraw our support for the Left Main Chapter of the joint 2018 EACTS-ESC (European Association for Cardiothoracic Surgery and European Society of Cardiology) Clinical Guidelines for Myocardial Revascularisation. If the information on the trial is proven to be correct, the recommendation is unsafe. On behalf of the EACTS Council I have written to the ESC to invite them to work with us to develop a new joint section of the guidelines as a matter of urgency.
“We deeply regret the obvious concern that this will raise for some patients and their families. We recommend that patients seek the advice of the multidisciplinary heart team at their hospital before deciding which treatment option is most appropriate for them.”
The EXCEL trial
Clinical trials are very important for our profession: advances in medicine can help save patients’ lives that only a few years ago would have been lost.
The EXCEL trial compared conventional open heart surgery (coronary artery bypass graft surgery) with stents (PCI) in patients with the disease of the main coronary artery vessel (left main stem) and concluded that there was no significant difference for patient outcomes, regardless of which treatment option was used.
We welcome Newsnight’s scrutiny of the EXCEL trial and the findings. These show patients with left main coronary artery disease treated with stents are 35% more likely to die than those treated with conventional open heart surgery.
New clinical trial data help inform the clinical guidelines that we rely on to advise our patients effectively on the best treatment options available. The reported outcomes of the EXCEL trial were one of the major clinical trial results used to inform the joint 2018 EACTS-ESC (European Association for Cardiothoracic Surgery and European Society of Cardiology) Clinical Guidelines for Myocardial Revascularisation. We recognise that if the data and the analysis Newsnight has carried out are correct, as they appear to us to be, patients have been subjected to an increased risk of death. That’s why the EACTS Council voted unanimously to withdraw our support for the guidelines on Left Main disease with immediate effect. We urge our members to disregard the guidelines relating to left main disease for the time being.
James Ford, firstname.lastname@example.org, 07974 565425
James McCollum, email@example.com, 07903 741829
Notes to editors
- At our annual conference this year, we invited leading international experts to debate the findings from the latest clinical trials, including EXCEL. In the interests of transparency we live streamed the discussion and you can watch it here (from 01:59:00).
- University College London’s Institute of Clinical Trials and Methodology will provide its expert advice to EACTS as the new guidelines are developed.