A strategy of complete revascularization (CR) achieved superior 1-year outcomes compared with the culprit-lesion-only approach in older patients with acute myocardial infarction (MI) and multivessel disease (MVD) in a large, randomized trial.
In the study with more than 1400 patients, CR was guided by assessments of the functional effect of coronary lesions other than the MI culprit, a process that selects or excludes the lesions, regardless of angiographic profile, as targets for percutaneous coronary intervention (PCI).
Such physiology-guided CR led to a significant 27% drop in risk for a composite primary endpoint over 1 year in the trial, called FIRE (Functional Assessment in Elderly MI Patients with Multivessel Disease), compared with the culprit-only approach. The endpoint included death, MI, stroke, or ischemia-driven revascularization.
Risk for cardiovascular (CV) death or MI fell by 36% in the trial, and all-cause mortality declined 30%. The differences were significant, although the study wasn't powered for those secondary endpoints. Safety outcomes were similar for the two revascularization approaches.
FIRE was noteworthy for entering only patients with ST-segment elevation or non–ST-segment elevation MI (STEMI or NSTEMI) who were age 75 years or older, a higher-risk age group poorly represented in earlier CR trials. Such patients in practice are usually managed with the culprit-lesion-only approach because of a lack of good evidence supporting CR, observed Simone Biscaglia, MD, the study's principal investigator.
"This is the first trial actually showing a benefit" from physiology-guided CR in older patients with acute MI that is similar to what the strategy can offer younger patients, said Biscaglia, from Azienda Ospedaliera Universitaria S. Anna, Ferrara, Italy.
Biscaglia made the comments in Amsterdam, the Netherlands, at a media briefing on FIRE held during the European Society of Cardiology (ESC) 2023 Congress, where he presented the study on August 26. He is also lead author on its same-day publication in the New England Journal of Medicine.
"This is a remarkable trial that adds substantially to prior studies that examined the topic of complete versus culprit-only revascularization," Deepak L. Bhatt, MD, MPH, Icahn School of Medicine at Mount Sinai, New York City, told theheart.org | Medscape Cardiology.
It shows "quite clearly" that physiology-guided CR is superior to the culprit-only approach in patients with acute MI, said Bhatt, who is also director of Mount Sinai Heart at Mount Sinai Hospital and not connected to FIRE.
The primary findings, he observed, applied to a range of different patient subgroups, including those older than 80. That's important, he said, because "it is sometimes incorrectly assumed that patients who are older may not benefit from complete revascularization in this setting."
And the trial's finding of reduced risk for CV death or MI in the CR group "really should make the complete revascularization approach the standard of care in MI patients without contraindications," Bhatt said. And certainly, "age per se should no longer be considered a contraindication."
"First and foremost, the FIRE trial confirms the benefit of complete revascularization that has been observed in previous trials and provides additional evidence for this approach in older patients," says the author of an editorial accompanying the published report.
The mortality reduction with CR at 1 years "is particularly notable" and underscores that CR should be considered in all patients with acute MI, "regardless of age," writes Shamir R. Mehta, MD, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
Mehta was principal investigator for the 2019 COMPLETE trial, which made the case for CR, guided by standard angiography, in patients with MVD and STEMI; their age averaged about 62 years.
FIRE definitely ought to sway practice toward greater use of physiology-guided CR regardless of age, observed Vijay Kunadian, MBBS, MD, invited discussant for the Biscaglia presentation. "My oldest patient is 98," she said, "and it is beneficial without a doubt."
But Kunadian, from Newcastle University, United Kingdom, said that the trial results can't be generalized to all older patients. That's because their outcomes after CR could vary depending on, for example, their different frailties or comorbidities, cognition, or CV history, she cautioned. "So, there is an absolute need to individualize care."
FIRE enrolled patients 75 years or older with MVD, about 64% male, who had been admitted with acute STEMI or NSTEMI at 34 sites in Italy, Spain, and Poland. All underwent successful culprit-lesion PCI using, as "strongly" recommended, the same model of sirolimus-eluting stent, notes the report.
Patients were randomly assigned to physiology-guided CR of nonculprit lesions, at the same session or at least during the same hospitalization, or to no further revascularization: 720 and 725 patients, respectively.
The hazard ratio (HR) for the composite primary outcome, CR vs culprit-only PCI was 0.73 (95% CI, 0.57 - 0.93; P = .01). The benefit was driven by reductions in three individual components of the primary endpoint: death, MI, and revascularization, but not stroke.
The HR for CV death or MI was 0.64 (95% CI, 0.47 - 0.88) and for death from any cause was 0.70 (95% CI, 0.51 - 0.96).
There was no significant difference in the primary safety outcome, a composite of contrast-related acute kidney injury, stroke, or BARC (Bleeding Academic Research Consortium) grade 3 to 5 bleeding at 1 year. The rates were 22.5% in those assigned to CR and 20.4% in the culprit-only group.
The functional effect of individual lesions was assessed by either of two methods, crossing them with a standard "pressure wire" or by angiographic derivation of their quantitative flow ratio.
The choice was "left to operator discretion," Biscaglia told theheart.org | Medscape Cardiology, "because we wanted to mirror clinical practice at the participating centers." Still, he noted, the CR primary benefit was independent of the physiology-guidance method.
FIRE's sponsor, the nonprofit Consorzio Futuro, Ricerca, Italy, received grant support from Sahajanand Medical Technologies, Medis Medical Imaging systems, Eukon, Siemens Healthineers, General Electric Healthcare, and Insight Lifetech. Biscaglia had no other disclosures. Disclosure statements for the other authors can be found at nejm.org. Mehta reports receiving grants from Abbott Vascular and personal fees from Amgen, Janssen, and Bristol Myers Squibb. Bhatt's disclosures can be found at mountsinai.org. Kunadian had no disclosures.
European Society of Cardiology (ESC) 2023 Congress. Hot Line 3, presented August 26, 2023.
N Engl J Med. Published online August 26, 2023. Abstract, Editorial
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Cite this: Steve Stiles. FIRE a Win for Physiology-Guided MI Complete Revascularization in Older Patients - Medscape - Aug 26, 2023.
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