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FIRE Trial: Physiology-Guided Complete Revascularization Benefits Older Myocardial Infarction Patients
Amsterdam, Netherlands: Physiology-guided complete revascularisation reduces ischaemic events compared with culprit-only revascularisation in myocardial (MI) infarction patients aged 75 years or older with multivessel disease, according to late breaking research presented in a Hot Line session today at ESC Congress 2023.1
Acute coronary syndrome patients aged 75 years or older are often underrepresented in clinical trials and2,3 management is challenging due to a lack of robust evidence.3,4 For example, complete revascularisation is well established in younger patients5,6 but its impact in older patients, who have a higher risk of complications, is uncertain.7,8 Guidelines reflect this lack of data, with no specific recommendations on the type of revascularisation for older myocardial infarction patients with multivessel disease.9-11 ESC guidelines state that routine revascularisation of non-culprit lesions should be considered in ST-segment elevation MI (STEMI) patients with multivessel disease before hospital discharge.9,10 For non ST-segment elevation MI (NSTEMI), ESC guidelines recommend applying the same interventional strategies in older patients as for younger patients.11
To address this knowledge gap, the FIRE trial examined whether complete revascularisation based on coronary physiology is superior to a culprit-only strategy in older patients with MI and multivessel disease.12 Patients were eligible if they were at least 75 years old, had been admitted to hospital with STEMI or NSTEMI, had undergone successful percutaneous coronary intervention (PCI) of the culprit lesion, and had multivessel disease with at least one lesion in a non-culprit coronary artery with a minimum vessel diameter of 2.5 mm and a visually estimated diameter stenosis of 50-99%.
After successful treatment of the culprit lesion, patients were randomised to culprit-only treatment or to physiology-guided complete revascularisation. Patients in the physiology-guided complete revascularisation group received 1) physiological assessment using wire-based and angiography-based measurements and 2) PCI of all functionally significant non-culprit lesions. Both physiological assessment and PCI of non-culprit lesions were allowed during either the index intervention or in a staged procedure within the index hospitalisation. Patients in the culprit-only revascularisation group did not undergo any physiological assessment or revascularisation of non-culprit lesions.
The primary outcome was a composite of death, MI, stroke, or ischaemia-driven coronary revascularisation occurring within one year of randomisation. A key secondary outcome was the one-year composite endpoint of cardiovascular death or MI. Other secondary outcomes included the individual components of the primary outcome. The safety outcome was a composite of contrast-associated acute kidney injury, stroke, or bleeding (Bleeding Academic Research Consortium [BARC] type 3 or 5) within one year of randomisation.
The trial enrolled 1,445 patients from 34 sites in Italy, Spain and Poland. The median age was 80 years and 36.5% were women. The primary outcome occurred in 113 patients (15.7%) in the physiology-guided complete revascularisation group and 152 patients (21.0%) in the culprit-only group (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.57 to 0.93; p=0.01). The number needed to treat to prevent the occurrence of one primary outcome event was 19 patients.
The key secondary outcome of cardiovascular death or MI appeared to be lower in the physiology-guided complete revascularisation group (HR, 0.64; 95% CI, 0.47 to 0.88). The number needed to treat to prevent one cardiovascular death or MI was 22 patients. With the exception of stroke, each component of the primary outcome appeared to be lower in the physiology-guided complete revascularisation group, including death (HR, 0.70; 95% CI, 0.51 to 0.96), and the number needed to treat to prevent one death was 27 patients. There was no apparent difference between the two groups in the incidence of the composite safety outcome, with a HR of 1.11 for physiology-guided complete revascularisation versus culprit-only revascularisation (95% CI, 0.89 to 1.37; p=0.37).
Principal investigator Dr. Simone Biscaglia of University Hospital Santa Anna, Ferrara, Italy said: “The FIRE trial provides much needed data on the safety and efficacy of physiology-guided complete revascularisation in older MI patients with multivessel disease. The reduction of the primary endpoint with physiology-guided complete revascularisation was mainly driven by hard endpoints such as death and myocardial infarction. The results suggest that in older MI patients with multivessel disease, complete revascularisation guided by physiology should be routinely pursued.”
Funding: Sahajanand Medical Technologies Ltd. (SMT), Medis Medical Imaging Systems, Eukon S.r.l., Siemens Healthineers, General Electric (GE) Healthcare, and Insight Lifetech provided unrestricted funding to the study sponsor for the conduction of the trial. These companies had no involvement in the trial design, data collection, analysis, interpretation, or writing of the manuscript.
Disclosures: Research Grants from Sahajanand Medical Technologies Ltd. (SMT), Medis Medical Imaging Systems, Eukon S.r.l., Siemens Healthineers, General Electric (GE) Healthcare, and Insight Lifetech, Abbott Vascular. Speaker’s fee from Medis Medical Imaging Systems, Eukon S.r.l., Siemens Healthineers, Insight Lifetech, and Abbott Vascular.
References and notes
1FIRE was discussed during Hot Line 3 on Saturday 26 August at 16:30 to 17:30 CEST in room Amsterdam.
2Sinclair H, Batty JA, Qiu W, Kunadian V. Engaging older patients in cardiovascular research: observational analysis of the ICON-1 study. Open Heart. 2016;3:e000436.
3Veerasamy M, Edwards R, Ford G, et al. Acute coronary syndrome among older patients: a review. Cardiol Rev. 2015;23:26–32.
4Madhavan MV, Gersh BJ, Alexander KP, et al. Coronary artery disease in patients ≥80 years of age. J Am Coll Cardiol. 2018;71:2015–2040.
5Biscaglia S, Erriquez A, Serenelli M, et al. Complete versus culprit-only strategy in older MI patients with multivessel disease. Catheter Cardiovasc Interv. 2022;99:970–978.
7Joshi FR, Lønborg J, Sadjadieh G, et al. The benefit of complete revascularization after primary PCI for STEMI is attenuated by increasing age: results from the DANAMI-3-PRIMULTI randomized study. Catheter Cardiovasc Interv. 2021;97:E467–E474.
8Køber L, Engstrøm T. A more COMPLETE picture of revascularization in STEMI. N Engl J Med. 2019;381:1472–1474.
9Ibanez B, James S, Agewall S, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2018;39:119-177.
10Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial
Revascularization. Eur Heart J. 2019;40:87–165.
11Collet JP, Thiele H, Barbato E, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021;42:1289-1367.
12Biscaglia S, Guiducci V, Santarelli A, et al. Physiology-guided revascularization versus optimal medical therapy of nonculprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial. Am Heart J. 2020;229:100-109.
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