\n The SENIOR-RITA data suggest medical therapy is a better option for older, severely frail NSTEMI patients, says Vinay Kunadian.\n <\/p>\n
Older, frail patients presenting with NSTEMI do not appear to benefit more from invasive angiography and revascularization compared with conservative medical therapy, according to a new analysis of SENIOR-RITA. <\/p>\n
Over a median follow-up of 4.1 years, the primary endpoint of cardiovascular mortality or nonfatal MI occurred in 37.7% of frail patients treated with the invasive strategy compared with 29.4% of those who were managed conservatively (HR 1.21; 95% CI 0.88-1.67), report Francesca Rubino, MD (Newcastle University, Newcastle upon Tyne, England), and colleagues this week in\u00a0JAMA Network Open<\/a>.<\/p>\n Procedural complications were numerically higher in frail patients than in robust patients, although the difference did not reach statistical significance. <\/p>\n SENIOR-RITA<\/a> showed that it is possible to routinely assess frailty in an acute setting, such as NSTEMI, and the new analysis \u201cemphasizes the fact that we do need to individualize care taking on board the frailty status of patients,\u201d senior investigator Vijay Kunadian, MD (Newcastle University), told TCTMD. \u201cPatients who are severely frail can be treated with medical therapy alone.\u201d <\/p>\n Kunadian noted that roughly one-third of NSTEMI patients were frail in SENIOR-RITA, with an equal split between men and women. While the study overall found no difference in the composite endpoint over more than 4 years of follow-up, \u201cwhat is interesting is that among patients who had the highest levels of frailty, there was a signal for harm with a routine invasive strategy,\u201d she said.<\/p>\n Abdulla A. Damluji, MD, PhD (Cleveland Clinic, OH), applauded the investigators for the original study, noting that it was a very difficult clinical trial to complete. However, he said, the new analysis is challenging to interpret given some of the limitations of the overall trial, including the high rate of crossover in the conservative-strategy arm, which disadvantaged the invasive approach, and the prolonged time from admission to invasive management (median time 5 days). <\/p>\n \u201cI still think we have a lot of questions,\u201d Damluji told TCTMD. \u201cWe are limited by this analysis. SENIOR-RITA is the largest clinical trial in older adults with non-ST-elevation myocardial infarction where they systematically collected frailty and multimorbidity [data]. . . . We really do need more trials in frail patients otherwise we’ll not have generalized evidence in the field.\u201d<\/p>\n Nonetheless, he stressed, an invasive approach isn\u2019t right for all frail patients. \u201cI certainly agree with that,\u201d said Damluji, lead author of a recent statement on managing ACS in older patients<\/a>. \u201cIf someone is 95 years old and wheelchair bound, has three-vessel disease and mild forms of cognitive impairment, medical therapy is not a bad idea.\u201d <\/p>\n The difficulty, he added, is that many fall into a gray zone where they\u2019re neither robust nor frail. \u00a0<\/p>\n Patients Typically Excluded From RCTs<\/p>\n The SENIOR-RITA trial, which was conducted at 48 sites in the United Kingdom and published in the New England Journal of Medicine in 2024, was unique in that researchers included patients who typically don\u2019t get enrolled into clinical trials given their age, frailty status, and comorbidities. In all, 1,518 patients (mean age 82 years; 45% women) were randomized to the invasive strategy of coronary angiography followed by revascularization, if necessary, or to medical therapy with aspirin plus a P2Y12 receptor antagonist, statin, beta-blocker, and ACE inhibitor or ARB.<\/p>\n The trial found no significant difference in the risk of cardiovascular mortality or nonfatal MI, but there was evidence of benefit with regard to nonfatal MI and repeat revascularization. <\/p>\n The new analysis focuses on 1,446 patients with a complete frailty assessment at baseline. Using the Fried criteria, 469 patients were classified as frail, 674 as prefrail, and 303 as robust. Frail patients were older and had a higher GRACE risk score, a greater burden of comorbidities, and a lower cognitive assessment score than the prefrail and robust patients. Among the 231 frail older patients randomized to the invasive strategy, 83.1% underwent coronary angiography. <\/p>\n Patients who are severely frail can be treated with medical therapy alone. Vijay Kunadian<\/p>\n Frail patients saw no benefit with the invasive strategy regarding the study\u2019s primary endpoint. Numerically, deaths from cardiovascular causes were higher with the invasive strategy (25.5% vs 18.5% with the conservative approach; P = 0.07), and there was no difference in the risk of recurrent MI (14.7% vs 13.9%; P > 0.99). The risks of recurrent coronary angiography and revascularization among frail patients managed invasively were also reduced.<\/p>\n The primary outcome did not differ between the invasive and conservative strategy in prefrail and robust patients, but the risk of recurrent coronary angiography and revascularization was significantly reduced in both groups. <\/p>\n When frailty was assessed as a continuous variable, there was a significant interaction for the study\u2019s primary endpoint (P = 0.04), which the investigators say suggests that clinical outcomes may differ by frailty status. Procedural complications occurred in 8.3% of frail patients, 3.9% of prefrail patients, and 3.4% of the robust group. Rates of the various complications were low among all three groups, except for type 2 bleeding in frail patients (2.6%). <\/p>\n Kunadian noted that these data highlight that not all older adults are the same. \u201cThey are very heterogeneous due to conditions such as frailty, comorbidity, cognitive impairment affecting their outcomes after NSTEMI,\u201d she said. <\/p>\n In Line With Other Data<\/p>\n Observational studies<\/a> have consistently shown that frail patients have higher risks of complications with an invasive approach, including more bleeding and vascular injury. These studies have also suggested such patients benefit from revascularization<\/a>, although those data are limited by selection bias despite adjusting for confounding variables. <\/p>\n Damluji\u2019s center has developed a geriatric cardiology service for managing older patients, a group that is growing in number as the population ages. <\/p>\n \u201cFor patients that are the highest risk, we have the geriatrician see them ahead of time and we have a standardized way of measuring age-associated risks, which we call geriatric syndromes,\u201d he said. \u201cThese are conditions that don\u2019t fall into one disease category, like frailty, multimorbidity, physical decline, and delirium. We have a standard way to approach these patients who are undergoing a high-risk procedure.\u201d <\/p>\n With that information available, the clinician is able to best make a judgement about whether they\u2019d benefit from a procedure, such as coronary revascularization, said Damluji. While SENIOR-RITA assessed frailty using the Fried criteria, he added, others using different metrics, which makes comparing frail patients from one trial to another difficult. <\/p>\n If someone is 95 years old and wheelchair bound . . . medical therapy is not a bad idea. Abdulla Damluji<\/p>\n