ESC/EACTS Task Force Recommends Downgrading PCI in Left Main CAD
For those with LM CAD and a low SYNTAX score, PCI should be no longer be a class I recommendation, the group says.
AMSTERDAM, the Netherlands—A new task force is recommending that PCI for the treatment of left main CAD in patients at low surgical risk be downgraded from its current place in the European revascularization guidelines.
The task force, which is made up of general cardiologists, interventionalists, and cardiac surgeons from the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS), is “suggesting” that PCI should now be a class IIa (level of evidence A) recommendation for stable patients with left main disease and a low or intermediate SYNTAX score (0-32). Notably, the European Association of Percutaneous Cardiovascular Interventions—the ESC’s own interventional subspecialty organization—was not involved in the document.
In the current 2018 ESC/EACTS guidelines on myocardial revascularization, PCI has a class I (level of evidence A) recommendation for patients with left main CAD and a low SYNTAX score (0-22). Given that PCI is currently a class IIa (level of evidence A) recommendation for those with an intermediate SYNTAX score (23-32), no changes are suggested here by the ESC/EACTS task force.
The suggestions, which are not formalized guideline recommendations, were published online recently in the European Heart Journal. They follow years of controversy over the best way to treat patients with left main CAD.
“First and foremost, both PCI and CABG are clinically reasonable for the treatment of these patients,” Robert Byrne, MBBCh, PhD (Mater Private Network, Dublin, Ireland), who chaired the task force reviewing the left main recommendations, told TCTMD. “We’ve maintained a class I recommendation for CABG. I think that was an easy decision. As for the IIa recommendation for PCI, there were a couple of reasons. Number one, the SYNTAX score or SYNTAX tertiles didn’t seem to be a strong effect modifier in the lower two tertiles. It was really an arbitrary distinction between low and intermediate risk so we felt that the same recommendation should really apply to both.”
A review of the data was reassuring from the standpoint of all-cause mortality, said Byrne, noting that there appears to be no significant difference in risk between the two revascularization strategies in studies with at least 5 years of follow-up. Rates of spontaneous MI are higher with PCI, while the risk of procedural MI differs depending on the definition. Stroke risk is higher early for patients undergoing surgery, but there’s no long-term difference in stroke rates. Unplanned repeat revascularization favors the surgical approach, although Byrne pointed out that this not a clinical outcome, but rather a procedure.
“The focus then was more on death, myocardial infarction, and stroke,” said Byrne. “Depending on the definition you use for procedural MI, that three-point composite is statistically significant in favor of CABG surgery or borderline statistically significant. I think those are some of the things that led us to think, on balance, it was best for a IIa [recommendation] for PCI in the lower and intermediate [SYNTAX] tertiles.”
A Long-Running Controversy
It’s been 4 years since David Taggart, MD, PhD (University of Oxford, England), the chairman of the EXCEL surgical committee during the design and recruitment phase of the trial, famously launched a maelstrom by accusing the EXCEL investigators of downplaying the risk of all-cause mortality with PCI. At 5 years in EXCEL, he pointed out, there was a statistically significant 3.1% higher absolute risk of all-cause mortality in the PCI arm. The trial, Taggart also claimed, was largely biased in favor of PCI, as the primary endpoint included a definition of procedural MI that disadvantaged surgery.
While the EXCEL researchers strongly denied the claims, and published an extensive rebuttal, this led EACTS to formally withdraw their support for the left main section of the 2018 revascularization guidelines.
Given the shadow over the field, the ESC formally requested an independent review of all published trials in patients with left main CAD; it was led by Marc Sabatine, MD (Brigham and Women’s Hospital, Boston, MA), and published in 2021. In that analysis, reported by TCTMD when it was presented at the American Heart Association Scientific Sessions, the TIMI researchers found no significant difference in the risk of death following revascularization with PCI or surgery at 5 years, including no difference in two trials with extended 10-year follow-up.
The ESC also formally launched a review of the left main guidelines, which was conducted by the ESC/EACTS task force.
To TCTMD, Byrne said their work took place over the last 18 months, with most of the intensive first meetings conducted online given the pandemic lockdowns. He also noted that Sabatine, as well as others from the TIMI research group, presented their data to the task force, which allowed them to ask questions about the findings. Quorum for agreement was 75%, or nine of the 12 members making up the task force.
The task force noted that the meta-analysis by Sabatine and colleagues was large enough only to exclude any differences in mortality. To determine if there are any survival differences between PCI and CABG, a study of more than 8,000 patients, possibly as many as 14,000, would be needed, and it’s unlikely such a trial will ever be done.
In their recommendations, the task force reemphasizes the importance of the heart team, stating that it remains of “central importance” when deciding on the best revascularization strategy in patients with left main CAD.
EAPCI Will Participate in Guidelines
Emanuele Barbato, MD, PhD (Sant’Andrea Hospital, Sapienza University of Rome, Italy), the current president of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), said that not involving EAPCI and other ESC organizations in the task force was a “missed opportunity.” He emphasized, however, that he spoke solely as an interventional cardiologist and not on behalf of the EAPCI, noting that the task force was convened before his term as president.
While he believes the EAPCI could have provided valuable input, he emphasized that the dozen members of the task force, which includes interventional cardiologists, are “excellent” representatives of their fields. The ESC—the parent organization that is responsible for the broader cardiology community and is responsible for drafting treatment guidelines—has the full remit to decide who was involved in the review, he added.
“We have to state that this is not a formal guideline,” said Barbato. “It’s a review of previous guidelines, so I am eager to hear how the upcoming chronic coronary syndrome guidelines are going to inform the community on this topic. They will have the opportunity to further discuss this point.”
Barbato stressed that the most important aspect of this long-running debate is not answering whether CABG or PCI is “winning,” but ensuring that patients receive the best possible care. “In the end, I don't mind if PCI is downgraded as compared to surgery as long as that is the best thing for our patient,” he said. “That is the bottom line.”
Asked about the lack of EAPCI involvement, Byrne said that their “rules of engagement” differed from a task force pulled together to draft clinical guidelines.
“Our terms of reference were to present a recommendation or a common position for future guidelines,” said Byrne. “While it's true to say that the 2018 [ESC/EACTS] guideline, for example, had a special collaboration with the EAPCI, this wasn't the case here. The reason for that is because it had a different structure [compared with] a regular guideline committee.”
For one, the review of evidence was much more streamlined, focusing on contemporary trials, such as EXCEL, NOBLE, PRECOMBAT, and SYNTAX, as well as the Sabatine meta-analysis. Future iterations of the myocardial revascularization guidelines, like those before it, will include representatives from the EAPCI, as well as from other associations, he said.
As for the controversy started in 2019, Barbato said he’s not aware of any lingering antagonism between surgeons and interventionalists, although he concedes this might be a generational issue. He came of age as an operator in an era when the heart team concept was already formalized in the myocardial revascularization guidelines.
“This feeling is not just personal,” he said. “It comes also from conversations with colleagues in the interventional cardiology community. I speak to colleagues in Europe, and more and more at meetings, and I see cardiac surgeons involved. Really, there is no bitterness. On the contrary, there is a true, genuine willingness to work together because we learned that by doing things together, we do more difficult and complex things. Just complementing each other. Who cares who scores the final goal? In the end, everyone has won.”
Byrne RA, Fremes S, Capodanno D, et al. 2022 joint ESC/EACTS review of the 2018 guideline recommendations on the revascularization of left main coronary artery disease in patients at low surgical risk and anatomy suitable for PCI or CABG. Eur Heart J. 2023;Epub ahead of print.
- Byrne reports research or education grants (no personal remuneration) from Abbott Vascular, Biosensors, Boston Scientific, and Translumina.