Revascularisation guidelines have been retracted by cardiac surgeons in a major dispute over a trial comparing outcomes for coronary artery bypass graft surgery and PCI in left main coronary artery disease.
The Council of the European Association for Cardiothoracic Surgery (EACTS) says it no longer has confidence in the five year mortality results of the EXCEL trial, published recently in the NEJM, after one of the investigators disassociated himself from the study over the interpretation of the data.
Professor David Taggart, an Oxford University cardiac surgeon and chair of the EXCEL surgical committee has accused other trial investigators of playing down a 38% higher rate of a secondary outcome, all-cause mortality, in the PCI arm.
In the trial involving 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity, the primary outcome of 5-year rate for a composite of death, stroke, or myocardial infarction, was similar for both groups (22.0% of PCI patients vs 19.2% of CABG patients, P=0.13).
But Professor Taggart said the all-cause mortality rates at five years (13.0% for PCI vs 9.9% for CABG at five years, OR 1.38; 95% CI 1.03-1.85) were a strong safety signal that had been ignored in the paper’s conclusions.
During a heated debate at the recent European Association for Cardio-Thoracic Surgery (EACTS) 2019 meeting he also accused other investigators of changing the definition of MI mid-way through the trial, and said he was taking his name off the paper.
The lead investigator, Professor Gregg Stone of Icahn School of Medicine at Mount Sinai, New York, has vehemently rejected the allegations of bias, saying that the trial was run transparently and pointing out that it reached the same conclusions as other randomised controlled trials of PCI and CABG. He accused Professor Taggart of cherry picking a secondary non-powered trial outcome that was likely a false positive since most of the excess all-cause deaths were non-cardiovascular.
And here is the meta-analysis showing very similar 5-year all-cause mortality after left main DES versus CABG. Normally I am not a great fan of meta-analysis, but considering aggregate data is appropriate to assess low frequency non-pre-specified under-powered events. pic.twitter.com/19zah5zNbg
— Gregg W. Stone MD (@GreggWStone) October 10, 2019
The debate has spilled over into social media, with cardiologists and cardiac surgeons picking through the EXCEL findings and coming to polarised conclusions about the merits of the trials.
However the EACTS council has announced that it is retracting its support for guidelines it recently published in conjunction with the European Society of Cardiology (ESC), which were based on the EXCEL trial results.
“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,” the Council said in response to claims on the BBC TV program Newsnight that definition data from the EXCEL had been withheld from publication.
“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 Clinical Guidelines for Myocardial Revascularisation.
“If the information on the trial is proven to be correct, the recommendation is unsafe. We urge our members to disregard the guidelines relating to left main disease for the time being.”
EACTS said it would be inviting the ESC to work with them 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.”