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Enrolling Older Adults in Revascularization Trials: Complete or Culprit-Only PCI in Older Patients With Myocardial Infarction (The FIRE Trial)

Quick Takes

  • The FIRE (Functional Assessment in Elderly MI Patients With Multivessel Disease) trial included 1,445 patients who were ≥75 years of age presenting with ST-segment elevation myocardial infarction (MI) and non−ST-segment elevation MI. The trial showed that patients who underwent physiology-guided complete revascularization had better cardiovascular (CV) outcomes compared with those who received culprit-only percutaneous coronary intervention. There were no significant differences in major adverse events, such as acute kidney injury and major bleeding, between the two groups.
  • Further studies are needed to assess whether these benefits extend across all subsets of the geriatric populations, including those with higher burden of geriatric conditions because age-associated risks affect therapeutic decision making regarding invasive CV care and postprocedural outcomes.

Both the COMPLETE (Complete Versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease After Early PCI for STEMI) and PRAMI (Preventive Angioplasty in Acute Myocardial Infarction) trial findings supported the benefits of complete revascularization over culprit-only percutaneous coronary intervention (PCI) in patients presenting with myocardial infarction (MI) and multivessel coronary artery disease.1,2 However, limited data exist regarding whether these benefits extend to older adult populations. These patients in general have a higher cardiovascular (CV) risk and live with multiple geriatric conditions that exclude them from randomized controlled trial enrollment in the coronary disease space.3 In practice, elective coronary interventions for nonculprit lesions (NCLs) are generally deferred in older patients because of concerns related to adverse events (AEs) and the presence of more complex anatomical multivessel disease (MVD).4

The FIRE (Functional Assessment in Elderly MI Patients With Multivessel Disease) trial was an investigator-initiated, multicenter, prospective, superiority, randomized trial that was designed to evaluate the benefits of complete revascularization over a culprit-only PCI strategy in older patients (≥75 years of age) presenting with ST-segment elevation myocardial infarction (STEMI) or non-STEMI who were found to have MVD.5 The study population included 1,445 patients who were randomly assigned in a 1:1 fashion to either the complete revascularization group (underwent PCI of all functionally significant NCLs as determined by physiologic assessment) or the culprit-only PCI group.5 Those assigned to the complete revascularization group underwent PCI of the NCLs within the index intervention or in a staged manner within the index hospitalization.5

The primary outcome of the trial was composite death, MI, stroke, or ischemia-driven revascularization within 1 year. The primary outcome was observed in 15.7% of patients in the complete revascularization group versus 21% in the culprit-only PCI group (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.57-0.93; p = 0.01). These results show a 27% lower relative risk of the primary outcome events in the group of older patients who underwent physiology-guided complete revascularization. The number needed to treat to prevent the occurrence of the primary outcome event (a composite of death, MI, stroke, or ischemia-driven revascularization) was only 19. The secondary outcome of composite CV death or MI was 8.9% in the complete revascularization group versus 13.5% in the culprit-only PCI group (HR, 0.64; 95% CI, 0.47-0.88). These differences were driven by a reduction in each individual component (all-cause deaths, CV deaths, MI, and ischemia-driven revascularization within 12 months) in the secondary outcome analysis, except for strokes, for which there was no difference between the two groups. Safety outcomes, which included a composite of contrast-induced acute kidney injury, strokes, or major bleeding events, showed no significant differences between the two groups (22.5% in the complete revascularization group vs. 20.4% in the culprit-only PCI group; HR, 1.11; 95% CI, 0.89-1.37; p = 0.37).

In the FIRE trial, the median age of the study population was 80 years, approximately 15-20 years older than those involved in some of the previous trials such as the COMPLETE (mean age 61.6 years in the complete revascularization group and 62.4 years in the culprit-only PCI group), CvLPRIT (Complete versus Lesion-only PRimary PCI) (mean age 64.6 years in the complete revascularization group and 65.3 years in the culprit-only PCI group), and PRAMI (mean age 62 years in both groups) trials.1,2,5,6 Although there were no differences in safety outcomes between the complete revascularization group and the culprit-only PCI group among older adults in the FIRE trial, the incidence of AEs was higher (20-23%) than in previous trials in younger cohorts that had estimates in the 1-5% range.1,2,5,6 This higher AE rate observed in the older adult populations reflects their inherent underlying procedural risks.7 By opting for a physiology-driven approach to revascularization, the trial investigators were able to outweigh the higher risk of AEs by targeting NCLs that were only functionally significant. Although this study's findings certainly add to the body of evidence supporting complete revascularization, these outcomes may vary on the basis of certain subsets within the older population, such as those with a higher burden of geriatric syndromes such as frailty, cognitive impairment, depression, and delirium.8 Additionally, it would be reasonable and practical to evaluate whether treating NCLs leads to an overall improvement in quality-of-life measures, such as a reduction in anginal burden and increased exercise capacity in the older population.9

References

  1. Mehta SR, Wood DA, Storey RF, et al.; COMPLETE Trial Steering Committee and Investigators. Complete revascularization with multivessel PCI for myocardial infarction. N Eng J Med 2019;381:1411-21.
  2. Wald DS, Morris JK, Wald NJ, et al.; PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Eng J Med 2013;369:1115-23.
  3. Damluji AA, Forman DE, Wang TY, et al.; American Heart Association Cardiovascular Disease in Older Populations Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; and Council on Lifestyle and Cardiometabolic Health. Management of acute coronary syndrome in the older adult population: a scientific statement from the American Heart Association. Circulation 2023;147:e32-e62.
  4. Kassimis G, Karamasis GV, Katsikis A, et al. Should percutaneous coronary intervention be the standard treatment strategy for significant coronary artery disease in all octogenarians? Curr Cardiol Rev 2021;17:244-59.
  5. Biscaglia S, Guiducci V, Escaned J, et al.; FIRE Trial Investigators. Complete or culprit-only PCI in older patients with myocardial infarction. N Engl J Med 2023;389:889-98.
  6. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol 2015;65:963-72.
  7. Nanna MG, Sutton NR, Kochar A, et al. Assessment and management of older adults undergoing PCI, part 1: a JACC: Advances expert panel. JACC Adv 2023;2:[ePub ahead of print].
  8. Nanna MG, Sutton NR, Kochar A, et al. A geriatric approach to percutaneous coronary interventions in older adults, part ii: a JACC: Advances expert panel. JACC Adv 2023;2:[ePub ahead of print].
  9. Kalra K, Moumneh MB, Nanna MG, Damluji AA. Beyond MACE: a multidimensional approach to outcomes in clinical trials for older adults with stable ischemic heart disease. Frontiers in Cardiovascular Medicine 2023;Nov 17:[ePub ahead of print].

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Cardiac Surgery and SIHD, Interventions and Vascular Medicine, Chronic Angina, Acute Coronary Syndromes, Cardiovascular Care Team

Keywords: Geriatrics, Myocardial Revascularization, ST Elevation Myocardial Infarction


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