麻豆传媒

BARCELONA -- For the complete revascularization of heart attack patients with multivessel disease, the decision whether to intervene on each nonculprit lesion was better guided by fractional flow reserve (FFR) rather than angiography in terms of long-term clinical outcomes, according to the FRAME-AMI trial.

In the 4 years after percutaneous coronary intervention (PCI) for acute myocardial infarction (MI), the composite endpoint of all-cause death, MI, or unplanned revascularization strongly favored patients who had been randomized to FFR-guided PCI outside the infarct-related artery (IRA), at 7.4% versus 19.7% with angiography-guided PCI (HR 0.43, 95% CI 0.25-0.75), reported Joo-Yong Hahn, MD, PhD, of Samsung Medical Center in Seoul, Korea.

Significant advantages were observed for the FFR group across the individual outcomes of death, cardiac death, and periprocedural MI. There were also numerical trends toward benefit in spontaneous MI and repeat revascularization. Furthermore, FFR-guided PCI required fewer stents and less contrast compared with angiography-guided PCI, Hahn told the audience at the annual European Society of Cardiology (ESC) congress.

The caveat was that the trial had been terminated early because of the COVID-19 pandemic. In total, 562 people were randomized from 2016 to 2020 -- well short of the 1,292 individuals needed for sufficient power for the study.

In any case, Hahn suggested in a press conference that operators are already putting FFR to greater use over recent years. The reluctance to adopt FFR has been attributed in part to its reliance on adenosine that is associated with extra cost and patient discomfort.

For now, FRAME-AMI is not enough to change the guidelines, as results conflict with other studies and more trials are needed, according to ESC session discussant Stefan James, MD, PhD, of Uppsala University and Uppsala Clinical Research Center in Sweden.

He cited the FLOWER-MI trial that showed no difference between FFR- and angiography-guided PCI on nonculprit lesions in ST-segment elevation MI (STEMI). In fact, in that study, clinical outcomes arguably went in the other direction to favor angiography, James recalled.

A meta-analysis has also found angiography to be superior to FFR in this setting, he said.

James did urge a change in guideline recommendations regarding the routine revascularization of non-IRA lesions in STEMI patients with multivessel disease before hospital discharge. This currently holds a class II-A endorsement in the most recent European guidelines, and should be upgraded to class I-A on the basis of studies like from 2019.

Preferably, revascularization in this setting would be performed at a second procedure, he suggested.

The FRAME-AMI trial was conducted at 14 Korean sites. After successful PCI to the culprit lesion, acute MI patients were eligible for randomization if they had at least one non-IRA lesion exceeding 50% diameter stenosis by visual estimation.

Average age was around 63 years, and over 84% of participants were men. The patients were roughly split between those with STEMI and non-STEMI.

In the FFR group, operators proceeded with PCI on non-IRA lesions if FFR was 0.80 or below; in the angiography group, operators proceeded if diameter stenosis was above 50% on visual estimation. Intervention was immediate in 60.6% of cases and staged during the same hospitalization in the remaining.

The proportion of people who had at least one non-IRA lesion treated was 64.1% with FFR guidance and 97.1% with angiographic guidance. Similarly, the proportion of non-IRA lesions selected for PCI was 58.5% and 94.3%, respectively.

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