SENIOR-RITA - Older patients with non-ST segment elevation myocardial infarction randomised interventional treatment trial
Reported from ESC Congress 2024
Mirvat Alasnag provides her take on the SENIOR-RITA trial, presented by Vijay Kunadian at the ESC Congress 2024 in London.
Background:
More often than not, elderly patients are excluded from trials addressing outcomes of revascularization. The gap in the evidence automatically places these patients at a disadvantage, as clinicians opt for a conservative approach.
In recent years, this was addressed in several trials including the FIRE trial, EARTH-STEMI meta-analysis and now the SENIOR-RITA trial as well1-3.
Methodology:
SENIOR-RITA trial was a prospective, multicenter, randomized trial conducted in 48 sites in the United Kingdom3. Patients 75 years of age or older with a non-ST elevation myocardial infarction (NSTEMI) were randomized to a conservative strategy of medical therapy or an invasive strategy of coronary angiography and revascularization in addition to medical therapy. The primary outcome was a composite of death from cardiovascular causes or non-fatal myocardial infarction.
Results:
A total of 1,518 patients were included, with a mean age of 82.4 years, of whom 72 % were aged 80 years or older (the oldest being 103 years old). Women constituted 45 % of the cohort, and 80 % were classified as prefrail or frail, more than 60 % had cognitive impairment, and the majority had a comorbidity index of ≥ 5, indicating multiple concurrent long-term conditions. Medical therapy was balanced between the two groups. In the invasive group, 90 % received the intended angiography, and 50 % underwent revascularization (for whom 3 % coronary artery bypass grafting was performed). The median follow-up was 4.1 years.
There was no difference in the primary endpoint of cardiovascular death or non-fatal MI between the invasive strategy group (25.6 %) and the conservative strategy group (26.3 %; hazard ratio [HR] 0.94, 95 % confidence interval [CI] 0.77–1.14; p = 0.53). This was consistent across all pre-specified subgroups, including those who were frail, cognitively impaired or had multiple comorbidities. In addition, there were no differences in the reported rates of cardiovascular death (15.8 % with invasive strategy vs. 14.2 % with conservative strategy; HR 1.11; 95 % CI 0.86–1.44).
However, there was a significant reduction in non-fatal MI, (11.7 % of patients in the invasive strategy group vs. 15.0 % in the conservative strategy HR 0.75; 95 % CI 0.57–0.99). This translated into fewer subsequent revascularisation procedures in the invasive strategy group (3.9 % vs. 13.7 %; HR 0.26; 95 % CI 0.17–0.39). There were no differences in the other secondary outcomes, such as all-cause death, MI, stroke, hospitalisation for heart failure or any bleeding complications. Reassuringly the rate of procedural complications was less than 1 %.
Discussion:
This trial is considered the largest trial to date examining outcomes of an invasive strategy in an elderly population who are often assigned to a conservative plan.
Although the SENIOR-RITA trial showed no significant reduction in the combined risk of cardiovascular death or non-fatal MI with an invasive strategy in patients aged ≥ 75 years presenting with a NSTEMI, there was a significant reduction in the risk of non-fatal MIs and subsequent revascularization with a more invasive strategy. The trial certainly permits a patient-centered discussion and an informed decision.
The trial notes that, contrary to common belief, it is safe to perform coronary revascularization in elderly; however, it does not prevent death or other devastating secondary endpoints such as stroke or rehospitalization. The FIRE NSTEMI Trial published previously had a similar population of elderly patients (mean age 82 years), yet there were salient differences. The SENIOR-RITA trial included a higher percentage of frailty (30 % vs 10 %) and cognitive impairment (< 10 % vs 60 %). The Grace score in the FIRE trial was higher (180 vs 135), signifying worse outcomes following the NSTEMI. In the FIRE trial, elderly patients with an acute coronary syndrome who underwent physiology-guided complete revascularization had a lower risk of a composite of death, MI, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. The EARTH STEMI meta-analysis demonstrated that complete revascularization was associated with a significant reduction in the composite endpoint of cardiovascular death or MI.
As such, complete revascularization should be considered a reliable strategy to reduce ischemic endpoints in the first 3 years following acute event in older patients with STEMI and multivessel disease. Further data are required to establish the impact at longer follow-up, particularly in terms of mortality.
Therefore, although frailty and cognitive impairment are important considerations, the cardiovascular risk including left ventricular dysfunction, Syntax Score, completeness of revascularization likely drive events and hard endpoints such as death more directly and should be part of the conversation with patients at the time of decision making.
Finally, in an elderly population, perhaps longevity is not the goal they set for themselves and freedom from stroke and rehospitalization is. Nevertheless, all these trials are telling us to engage the patients more in the decision-making process.
References:
- Biscaglia S, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, Cerrato E, Sacchetta G, Jurado-Roman A, Menozzi A, Amat Santos I, Díez Gil JL, Ruozzi M, Barbierato M, Fileti L, Picchi A, Lodolini V, Biondi-Zoccai G, Maietti E, Pavasini R, Cimaglia P, Tumscitz C, Erriquez A, Penzo C, Colaiori I, Pignatelli G, Casella G, Iannopollo G, Menozzi M, Varbella F, Caretta G, Dudek D, Barbato E, Tebaldi M, Campo G; FIRE Trial Investigators. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction. N Engl J Med. 2023 Sep 7;389(10):889-898.
- Presented ESC 2024
- DOI: 10.1056/NEJMoa240779
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