FIRE: Complete revascularization benefits older patients with MI, multivessel disease
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Key takeaways:
- In older patients who had PCI for a heart attack, performing complete revascularization led to better outcomes than treating the culprit lesion only.
- A composite safety outcome did not differ between the groups.
In patients aged 75 years or older with MI and multivessel CAD, physiology-guided complete revascularization improved outcomes compared with treating the culprit lesion only, according to the results of the FIRE trial.
The benefits of complete revascularization with PCI compared with culprit lesion-only PCI have been shown in younger patients with MI and multivessel disease, but not in patients aged 75 years or older, Simone Biscaglia, MD, PhD, interventional cardiologist at University Hospital Santa Anna in Ferrara, Italy, said during a press conference at the European Society of Cardiology Congress.
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“The number of older patients is increasing constantly across the years, and a huge percentage of older patients, at least 20%, develop myocardial infarction,” Biscaglia said during the press conference. “In the younger population, the overall cardiovascular mortality is decreasing. This is not the case for older patients, who are usually underrepresented in clinical trials regarding myocardial infarction, especially regarding revascularization strategies. We do not have data [on which] to base our intervention in clinical practice, up to now.”
The researchers randomly assigned 1,445 patients aged 75 years or older (median age, 80 years; 37% women) with multivessel disease who underwent successful PCI for MI (35.2% STEMI, the remainder non-STEMI) to receive physiology-guided complete revascularization or no further revascularization. Physiological assessment was conducted by hyperemic wire-based, nonhyperemic wire-based or angiography-based measurements.
The study was simultaneously published in The New England Journal of Medicine.
The primary outcome of death, MI, stroke or any revascularization at 1 year occurred in 15.7% of the complete revascularization group and 21% of the culprit lesion-only group (HR = 0.73; 95% CI, 0.57-0.93; P = .01), Biscaglia said during the press conference.
The key secondary outcome of CV death or MI at 1 year occurred in 8.9% of the complete revascularization group and 13.5% of the culprit lesion-only group (HR = 0.64; 95% CI, 0.47-0.88), according to the researchers.
The composite safety outcome of contrast-associated acute kidney injury, stroke or bleeding did not differ between the groups (complete revascularization, 22.5%; culprit lesion only, 20.4%; P = .37), Biscaglia and colleagues found.
The number needed to treat to prevent one event was 19 for the primary outcome, 22 for the key secondary outcome and 27 for death, Biscaglia said at the press conference.
“This is an impactful trial on clinical practice because the actual management of older MI patients is often the treatment of only the culprit lesion,” Biscaglia said during the press conference. “This is the first trial showing a benefit [of complete revascularization] that seems to be higher, or at least as high, as that with younger patients. Our practice needs to shift from a minimalistic approach to complete revascularization guided by physiology in older patients.” He noted the “vast majority” of older patients with MI and multivessel disease currently do not receive complete revascularization.
In a related editorial published in NEJM, Shamir R. Mehta, MD, MSc, the Douglas A. Holder/PHRI Endowed Chair in Interventional Cardiology and professor of medicine at McMaster University in Hamilton, Ontario, Canada, wrote that “the reduction in mortality with complete revascularization at 1 year is particularly notable and reinforces the finding that complete revascularization should be considered in all patients presenting with acute myocardial infarction, regardless of age.”
Mehta wrote that it remains unknown whether physiology-guided complete revascularization or angiography-guided complete revascularization is a better strategy, a question that the ongoing COMPLETE-2 trial is examining.
References:
- Biscaglia S, et al. N Engl J Med. 2023;doi:10.1056/NEJMoa2300468.
- Mehta SR. N Engl J Med. 2023;doi:10.1056/NEJMe2307941.
Perspective
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Dipti Itchhaporia, MD, MACC, FESC, FAHA
Previous trials of complete revascularization have focused on the younger patient population. We have not had a trial dedicated to evaluating the safety and efficacy of complete revascularization in older patients; the median age in this trial was 80. Interestingly, two-thirds of the patients had a non-STEMI and the discussion of complete revascularization has occurred more often in the context of a STEMI.
This trial reenforces the benefit of complete revascularization that we have seen in previous trials but provides additional evidence for this approach in older patients.
Based on trial data, we believe that complete revascularization is the way to go. The FIRE trial results are reassuring because we can now think about complete revascularization for our older patients.
However, not every patient in that age group is going to be the same, so we still must assess each patient for applicability. Additionally, we must think about how complete revascularization will impact the quality of life and the ability to live independently in this group, because it is not just about living longer, but living a good quality of life for whatever years they have and preventing future ischemic events. The data are compelling because they show we can truly help these patients.
Historically, we may have been reluctant to perform complete revascularization in this population because of fear of doing harm, but the safety signals in this study were good. These data can help us to have the conversation with our patients. We can say that there are data that shows that they will do better if we do complete revascularization.
The complete revascularization in this study was driven by a physiologic assessment and not just on angiographic data. Also in the trial, they used biodegradable stents, and we don’t know if we will see the same type of results with non-biodegradable stent. In addition, the complete revascularization was performed during the index hospitalization, so we don’t know the outcomes are changed if the complete revascularization is staged. Therefore, if we are going to do complete revascularization in an older patient, this data shows that it should be based on a functional assessment and during the index hospitalization.
It would be nice to see more data in this area, but it is reassuring to know that the thinking about complete revascularization holds in all patient groups, including older patients.
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Biscaglia S, et al. Hot line 3. Presented at: European Society of Cardiology Congress; Aug. 25-28, 2023; Amsterdam (hybrid meeting).
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