LONDON — Routine coronary intervention was safe and somewhat beneficial for older people with non-ST-segment elevation myocardial infarction (NSTEMI) in the SENIOR-RITA trial, unique for being designed to be broadly representative of seniors in the real world.
For study participants 75 and older, whether they were subject to an invasive treatment strategy or got conservative treatment alone for their heart attack made no difference in the composite primary outcome counting cardiovascular deaths and nonfatal myocardial infarctions (MIs) over a median 4.1 years (25.6% vs 26.3%, HR 0.94, 95% CI 0.77-1.14).
Breaking down the combined endpoint, cardiovascular death came out equally likely between groups (15.8% vs 14.2%, HR 1.11, 95% CI 0.86-1.44), while results for nonfatal MIs did support some clinical benefit to the invasive strategy (11.7% vs 15.0%, HR 0.75, 95% CI 0.57-0.99), reported Vijay Kunadian, MD, of Newcastle University in Newcastle upon Tyne in England.
Notably, the 1,500-plus study cohort had procedural complications reported in fewer than 1%. Risks of transient ischemic attacks and bleeding trended higher with the invasive strategy without either reaching statistical significance, Kunadian reported here at the annual European Society of Cardiology (ESC) conference. The SENIOR-RITA manuscript was also published in the New England Journal of Medicine.
“The SENIOR-RITA trial is the largest trial to date in older adults with heart attacks than all previous trials combined. Among older adults with type 1 NSTEMI, an invasive strategy is safe,” Kunadian concluded. “The results provide a foundation for older heart attack patients and their clinicians to make an informed decision about whether to undergo invasive coronary angiography or not.”
Unlike prior studies, this trial sought to recruit older people who fit a complex patient profile. The included participants had a median Charlson Comorbidity index score of 5 (indicating some burden of comorbidities), 32.4% had some degree of frailty and 62.5% had cognitive impairment.
“Clinicians are often reluctant to offer an invasive strategy to frail, older adults owing to a fear of bleeding and procedure-related complications. In the present study, we found that using contemporary angiography and interventional strategies, with the radial artery used as the access site in 89.3% of the patients, bleeding and procedure-related complications were minimal,” the SENIOR-RITA authors wrote.
ESC discussant Simone Biscaglia, MD, of University Hospital of Ferrara in Italy, said this was an “important trial” that was relevant to “an unmet clinical need in our practice.”
“We are finally getting the answers we need,” he said, adding that he agreed that the safety of the invasive approach to these patients is demonstrated by the trial.
Biscaglia emphasized that time to revascularization and complete revascularization matter with percutaneous coronary intervention (PCI) for older people.
The prospective SENIOR-RITA randomized trial included NSTEMI patients 75 years and older who were enrolled at 48 sites in the U.K. There were 1,518 people randomized to optimal medical therapy with or without invasive coronary angiography and potential revascularization.
Mean age was 82 years, and 45% were women. Medical therapy was similar between study arms.
Half the people in the invasive-strategy group underwent revascularization (mostly PCI rather than surgery) as part of the study. There was a median 5 days between hospital admission and coronary angiography, and 3 days from randomization to coronary angiography.
Both invasive and control group patients were permitted to undergo subsequent coronary angiography (5.6% and 24.2%, respectively) and revascularization procedures (3.9% and 13.7%).
The SENIOR-RITA trialists acknowledged that they were unable to reach the 1,668 planned patients in the trial. This was partly due to recruitment challenges during the COVID-19 pandemic.
“One in every five patients who had undergone screening was recruited into the trial, which emphasizes the challenges associated with recruiting all-comer older adults into research and the associated chronic clinical conditions, such as cognitive impairment, that prevent these patients from participating in clinical research,” they noted.
During the panel Q&A after her presentation, Kunadian explained why she thought the trial wound up being consistent with prior studies showing no better cardiovascular survival when older heart attack patients are given invasive treatment.
“Of course, as you grow older you die of so many other reasons than cardiovascular alone,” she reasoned. “It just makes us think as people grow older, it’s the quality of life, freedom from events [that matter more] than the quantity of life, because they succumb to so many conditions.”
Kunadian nonetheless cautioned that these findings may not apply to people with ST-segment elevation MI.
Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow
Disclosures
The trial was funded by the British Heart Foundation.
Kunadian and Biscaglia had no disclosures.
Primary Source
New England Journal of Medicine
Source Reference: Kunadian V, et al “Invasive treatment strategy for older patients with myocardial infarction” N Engl J Med 2024; DOI: 10.1056/NEJMoa2407791.
