The European Society of Cardiology and European Association for Cardiothoracic Surgery (ESC/EACTS) have announced they will review their joint recommendations for left main coronary artery disease in light of emerging data.
The myocardial revascularization guidelines were updated in 2018 based in part on 3-year-data from the highly controversial EXCEL trial, which showed that percutaneous coronary intervention (PCI) was noninferior to coronary artery bypass graft surgery (CABG) for the composite primary endpoint in left main patients.
But late last year, EACTS council withdrew its support for the left main chapter of the revascularization guidelines after a BBC Newsnight report showed an excess risk for MI with PCI in EXCEL.
Several subsequent publications, including a recent post hoc analysis zeroing in on how MI was defined in EXCEL, have failed to quell the controversy.
“It’s very unfortunate that the EXCEL trial has created all this uncertainty,” ESC’s Committee for Practice Guidelines chair Colin Baigent, FMedSci, told theheart.org | Medscape Cardiology. “It’s created a situation where patients are advised by their doctors what to do and the doctors themselves are a bit uncertain now.”
“It’s really important that we work together; so there’s a real commitment by the two organizations to do that and to do that swiftly so we have some answers by the middle of next year,” he said.
Baigent noted that the EXCEL data make up almost half of the data but that long-term follow-up from three other left main trials and a planned patient-level meta-analysis will be reviewed by an independent panel of between 5 to 15 experts.
“We’re going to try to make it completely independent, not only of the EACTS and ESC leadership, but also of the trials themselves,” Baigent said. “So it will be completely fresh people involved, and both societies are completely clear about the need to do that.”
EACTS secretary general Domenico Pagano, MD, told theheart.org | Medscape Cardiology that the two organizations are committed to an independent review of the new evidence.
“We are aware that the recent revelations from the EXCEL trial have heightened the noise, the social media, and so on. So we felt this was the right time to come jointly to make sure we are going to review the guidelines,” he said. “In the end, it is what trials are for, to form the basis of evidence-based medicine.”
The ESC/EACTS 2018 guidelines kept a class IA recommendation for CABG in all patients with left main disease regardless of anatomic complexity but, in light of the 3-year EXCEL data, upgraded PCI to a class IA indication for patients with a low SYNTAX score and gave a class IIA and III recommendation for those with intermediate and high SYNTAX scores.
Although the task will be difficult and require forensic analysis of data bias and quality, the independent panel will have more data available to it than when the 2018 guidelines were developed, suggested Pagano.
“Regardless of the EXCEL new data, we have longer data from EXCEL, longer data from NOBLE, so to be honest, I think we are in a good position to do it now and I’m hopeful that we will produce something of value,” he said.
Only the left main chapter of the guidelines will be revised, and plans are to release the new document at the ESC 2021 Congress in London, Pagano and Baigent said.
“In the meantime, ESC and EACTS recommend that treatment decisions for individual patients take into account all available published information. As stated in the ESC/EACTS Guidelines on Myocardial Revascularization, a discussion within the heart team and with the patient should be the basis of all treatment decisions,” the two organizations said today in a joint statement announcing the review of the left main revascularization guidance.
ESC/EACTS joint statement. Published October 6, 2020.