1. In frail, elderly patients with non-ST-segment elevation myocardial infarction (NSTEMI), invasive management with coronary angiography did not improve mortality and cardiovascular outcomes compared to conservative management.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Frailty is becoming an increasingly important consideration in patient management as the global population continues to age. Frailty is an independent, negative prognostic factor in patients with acute coronary syndrome (ACS), associated with an increased risk of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, and major bleeding. While frail patients with ACS less frequently receive invasive management and optimal medical therapy, they are underrepresented in randomized clinical trials. The SENIOR-RITA found that in older adults with NSTEMI, an invasive strategy did not result in a significantly lower risk of cardiovascular death or nonfatal myocardial infarction than a conservative strategy. This prespecified subgroup analysis focuses on frail patients.
SENIOR-RITA was a prospective, open-label, randomized clinical trial conducted in the United Kingdom across 48 sites from November 2016 through March 2023. Participants included adults aged at least 75 years with NSTEMI. These patients were randomized 1:1 to receive invasive treatment (coronary angiography and coronary revascularization, if appropriate, plus best available medical therapy) or conservative treatment (best available medical therapy). Best available medical therapy included aspirin, a P2Y12 receptor antagonist, statin therapy, a beta-blocker (to reach a target heart rate of 60 to 70 beats per minute), an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and management of hypertension, diabetes, and hypercholesterolemia. Frailty was assessed using the Fried Frailty Index (frail: ≥3 criteria present; intermediate or prefrail: 1 or 2 criteria present; robust [nonfrail]: 0 criteria present) and the modified Rockwood Clinical Frailty Score.
Overall, this study found that there was no significant difference in time to cardiovascular death or nonfatal myocardial infarction between the invasive and conservative treatment groups. Furthermore, when frailty was assessed as a continuous variable, it was significantly associated with a higher risk of the primary outcome, suggesting that invasive management may be harmful among the most frail patients. There were no significant differences in procedural complications.
Click here to read this study in JAMA Network Open
Relevant reading: Invasive Treatment Strategy for Older Patients with Myocardial Infarction
In-Depth [randomized clinical trial]:
Frailty is becoming an increasingly important factor when considering pursuing invasive or conservative management of NSTEMI. This subgroup analysis of a randomized controlled trial compared cardiovascular and mortality outcomes in elderly, frail patients with NSTEMI treated with coronary angiography and best medical therapy vs. best medical therapy alone. The primary outcome was a composite of time to cardiovascular death or nonfatal myocardial infarction.
The original SENIOR-RITA trial included 1518 patients, of whom Fried frailty criteria were available for 1446. 469 patients (32.4%; median [IQR] age, 83 [80-86] years; 51.2% female) were categorized as frail, 674 (46.6%; median [IQR] age, 82 [79-86] years; 43.2% female) as prefrail, and 303 (21.0%; median [IQR] age, 80 [78-83] years; 38.6% female) as robust. Frail patients were significantly older, had a higher burden of comorbidities, a lower Montreal Cognitive Assessment score, and a higher Global Registry of Acute Coronary Events risk score. Of the 469 frail patients, 231 (median [IQR] age, 83 [80-87] years; 49.8% female) were randomized to invasive treatment and 238 (median [IQR] age, 83 [80-86] years; 52.5% female) were randomized to conservative treatment. The primary outcome occurred in 87 patients (37.7%) in the invasive group and in 70 patients (29.4%) in the conservative group (hazard ratio [HR], 1.21; 95% CI, 0.88-1.67; P = .20) over a median follow-up of 4.1 years (IQR, 2.8-4.6 years). Cardiovascular death occurred in 59 patients (25.5%) in the invasive group and 44 patients (18.5%) in the conservative group (HR, 1.44; 95% CI, 0.97-2.10; P = .07). Nonfatal myocardial infarction occurred in 34 patients (14.7%) in the invasive group and in 33 patients (13.9%) in the conservative group (HR, 1.00; 95% CI, 0.61-1.63; P > .99). There was not a significant difference in the rate of procedural complications (frail, 16 of 192 patients [8.3%] vs prefrail, 12 of 310 [3.9%] and robust, 5 of 146 [3.4%]).
Image: PD
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