The European Association of Cardio-Thoracic Surgery (EACTS) has withdrawn its support of the left main recommendations of the society’s joint guidelines with the European Society of Cardiology (ESC) on myocardial revascularisation following an investigation into the EXCEL trial by the BBC current affairs programme Newsnight. The programme has cast doubt upon the conclusions drawn by EXCEL trial investigators.
A statement from Domenico Pagano, secretary general of EACTS, says: “The reported outcomes of the EXCEL trial were one of the major clinical trial results used to inform the joint 2018 EACTS-ESC 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 is 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.” Pagano adds that he has written to the ESC to invite them to work with EACTS to develop a new joint section of the guidelines “as a matter of urgency”.
In an official response released to Cardiovascular News, the ESC says that it currently stands by the joint guidelines which, it states, were “based on the totality of peer-reviewed, published data available at the time”. It adds: “In the past few days, we have been informed that there may be additional findings from one study that had not been included in the original publication or shared with the ESC or its guidelines taskforce. We look forward to reviewing these data with our surgical colleagues, also in the context of further evidence published in 2019, and to assess their relevance to our current recommendations.”
The three-year results of EXCEL were published in 2016; the study compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in patients with left main disease and concluded that there was no significant difference in the primary endpoint of death, stroke, or myocardial infarction (MI) between the treatments.
Unpublished data
However, according to Newsnight, lead EXCEL researcher Gregg Stone (Icahn School of Medicine, Mount Sinai, New York, USA) and colleagues guaranteed that, in addition to the findings in the trial on periprocedural MI, they would also publish data for incidence of MI according to the universal definition. The programme claims that Stone et al failed to publish these data. Furthermore, reporter Deborah Cohen said, during the broadcast, that the unpublished data that used the universal definition to measure MI showed that “80% more patients with stents had heart attacks than those who had surgery”.
This finding, though, is disputed by Stone et al. They apparently told Cohen that Newsnight had been sent “fake data”. Neither Stone nor any other main EXCEL investigators were featured in video interviews in the programme. Ed Brown, who worked on the investigation, told Cardiovascular News via Twitter that “we did offer them the opportunity to talk to us on camera, but as you saw they didn’t”.
The programme also claims that the committee working on the EACTS-ESC guidelines for myocardial revascularisation had not seen the unpublished data. Nick Freemantle (director of the Comprehensive Clinical Trials Unit at University College London, London, UK), a member of the guidelines committee, asserts on Newsnight that had he been aware of the findings on universal MI, he would not have agreed to the current recommendation that PCI and surgery “are interchangeable treatments for low- and moderate-risk patients with left main disease”. He commented: “The EXCEL trial was absolutely crucial to the recommendations for this particular group of patients.” He added that, as a result of making the “wrong recommendation”, “patients who have received stents will have died who otherwise would have lived for longer, survived for longer, had they had open heart surgery”.
The ESC, the programme noted, has rejected the view that the guidelines have harmed patients. The society told Newsnight that, even had the data on universal MI been available, the overall assessment of the EXCEL trial would not have changed, and that other evidence was taken into account in developing the guidelines.
Newsnight also reported that it has seen “leaked emails” in which the data safety monitoring board (DSMB) for EXCEL raised concerns about the “number of people with stents who were dying” and suggested the information should be made public “as soon as possible” in light of the fact that the guidelines that were being drawn up. The programme stated that the main trial investigators “pushed back on their concerns” but added that the researchers told them that the DSMB “allowed the trial to continue unchanged”.
The five-year outcomes of EXCEL were presented earlier this year at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019; 25–29 September, San Francisco, USA) and simultaneously published in the New England Journal of Medicine (NEJM). They showed that PCI with a second-generation drug-eluting stent in selected patients (low or intermediate anatomical complexity) with left main disease was non-inferior to CABG in terms of the primary endpoint of death, stroke, or myocardial infarction at five years. A week later, cardiothoracic surgeon David Taggart (University of Oxford, John Radcliffe Hospital, Oxford, UK) told delegates at the European Association for Cardio-Thoracic Surgery meeting (EACTS 2019; 3–5 October, Lisbon, Portugal) that the definition of MI in EXCEL was incorrect, leading to the wrong conclusion that PCI is non-inferior to CABG at five years for the management of selected patients with left main disease. He was an EXCEL trial investigator but said that he withdrew his name as an author because of his view on the conclusion. According to Taggart, the definition of MI was changed halfway through the trial—from 30 days’ post-procedure to a biochemical periprocedural one. Stone has refuted the claim.
Source CardiovscularNews
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