Optimised medical therapy alone versus optimised medical therapy plus revascularisation for asymptomatic or low-to-intermediate risk symptomatic carotid stenosis (ECST-2): 2-year interim results of a multicentre randomised trial

As with coronary artery disease, revascularization of patients with carotid artery stenosis doesn't seem to prevent ischemic events. James W. Mold, MD, MPH

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Background: Carotid revascularisation, comprising either carotid endarterectomy or stenting, is offered to patients with carotid stenosis to prevent stroke based on the results of randomised trials conducted more than 30 years ago. Since then, medical therapy for stroke prevention has improved. We aimed to assess whether patients with asymptomatic and symptomatic carotid stenosis with a low or intermediate predicted risk of stroke, who received optimised medical therapy (OMT), would benefit from additional revascularisation.

Methods: The Second European Carotid Surgery Trial (ECST-2) is a multicentre randomised trial with blinded outcome adjudication, which was conducted at 30 centres with stroke and carotid revascularisation expertise in Europe and Canada. Patients aged 18 years or older with asymptomatic or symptomatic carotid stenosis of 50% or greater, and a 5-year predicted risk of ipsilateral stroke of less than 20% (estimated using the Carotid Artery Risk [CAR] score), were recruited. Patients were randomly assigned to either OMT alone or OMT plus revascularisation (1:1) using a web-based system. The primary outcome for this 2-year, interim analysis was a hierarchical outcome composite of: (1) periprocedural death, fatal stroke, or fatal myocardial infarction; (2) non-fatal stroke; (3) non-fatal myocardial infarction; or (4) new silent cerebral infarction on imaging. Analysis was by intention-to-treat using the win ratio-ie, each patient in the OMT alone group was compared as a pair with each patient in the OMT plus revascularisation group, with a win declared for the patient with a better outcome within the pair (a tie was declared if neither patient in the pair had a better outcome). The win ratio was calculated as the number of wins in the OMT alone group divided by the number of wins in the OMT plus revascularisation group. This trial is registered with the ISRCTN Registry (ISRCTN97744893) and is ongoing.

Findings: Between March 1, 2012, and Oct 31, 2019, 429 patients were randomly assigned to OMT alone (n=215) or OMT plus revascularisation (n=214). One patient allocated to OMT alone withdrew consent within 48 h and was not considered further. The median age of patients was 72 years (IQR 65-78); 296 (69%) were male and 133 (31%) female. No benefit was recorded in favour of either treatment group with respect to the primary hierarchical outcome assessed 2 years after randomisation, with 5228 (11·4%) wins for the OMT alone group, 5173 (11·3%) wins for the OMT plus revascularisation group, and 35 395 (77·3%) ties between groups (win ratio 1·01 [95% CI 0·60-1·70]; p=0·97). For OMT alone versus OMT plus revascularisation, four versus three patients had periprocedural death, fatal stroke, or fatal myocardial infarction; 11 versus 16 had non-fatal stroke; seven versus five had non-fatal myocardial infarction; and 12 versus seven had new silent cerebral infarction on imaging. One periprocedural death occurred in the OMT plus revascularisation group, which was attributed to decompensated aortic stenosis 1 week after carotid endarterectomy.

Interpretation: No evidence for a benefit of revascularisation in addition to OMT was found in the first 2 years following treatment for patients with asymptomatic or symptomatic carotid stenosis of 50% or greater with a low or intermediate predicted stroke risk (assessed by the CAR score). The results support treating patients with asymptomatic and low or intermediate risk symptomatic carotid stenosis with OMT alone until further data from the 5-year analysis of ECST-2 and other trials become available.

Funding: National Institute for Health and Care Research; Stroke Association; Swiss National Science Foundation; Dutch Organisation for Knowledge and Innovation in Health, Healthcare and Well-Being; Leeds Neurology Foundation.

Author/s:

Simone J A Donners, Twan J van Velzen, Suk Fun Cheng, John Gregson, Audinga-Dea Hazewinkel

Invasive Versus Conservative Treatment Strategy in Older Patients With Non-ST Segment Elevation Acute Coronary Syndromes: A Meta-Analysis of Randomized Controlled Trials

Alex Haga — Mon, 31 Mar 2025 13:51:29 +0000

Date Added:

March 31, 2025

Journal/Publication:

J Am Geriatr Soc .

Publication Date:

March 26, 2025

URL:

Invasive Versus Conservative Treatment Strategy in Older Patients With Non-ST Segment Elevation Acute Coronary Syndromes: A Meta-Analysis of Randomized Controlled Trials

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1111/jgs.19447

Keywords

NSTEMI

Conservative treatment

invasive treatment

revascularization

unstable angina pectoris

PMID (1):

40135822

MeSH

acute coronary syndrome

conservative treatment

myocardial infarction

stroke

Revascularization may reduce subsequent MI and invasive procedures but not mortality compared to conservative care in older patients following non-ST elevation MI. James W. Mold, MD, MPH

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Background
Non-ST segment elevation acute coronary syndromes (NSTE-ACS) are a common cause of hospital admission in older patients. Our study aims to synthesize the available evidence from randomized controlled trials (RCTs) to compare clinical outcomes with invasive versus conservative medical management in this population.

Methods
A literature search of online databases including PubMed/MEDLINE, Embase, and the Cochrane Library was conducted from inception to September 1, 2024. The search aimed to identify RCTs that reported clinical outcomes with invasive versus conservative strategies in older patients (≥ 70 years) with NSTE-ACS. The risk ratios (RRs) were used as summary estimates.

Results
Seven RCTs with 2998 patients were included; 1490 patients in the invasive group and 1508 patients in the conservatively managed group. The pooled analysis demonstrated no statistically significant difference between the two strategies for the risk of all-cause death (RR: 1.03, 95% CI: 0.92–1.15), cardiovascular death (RR: 1.04, 95% CI: 0.82–1.33), stroke (RR: 0.78, 95% CI: 0.53–1.15), and major bleeding (RR: 1.23, 95% CI: 0.90–1.69). However, the invasive strategy was associated with a significantly reduced risk of myocardial infarction (RR: 0.74, 95% CI: 0.57–0.96) and unplanned revascularization (RR: 0.29, 95% CI: 0.21–0.40) compared to the conservative strategy.

Conclusion
In older patients with NSTE-ACS, an invasive strategy reduces the risk of repeat myocardial infarction and unplanned revascularization without a significant increase in stroke or major bleeding. There was no associated reduction in all-cause or cardiovascular mortality with the invasive strategy compared to conservative management.

Author/s:

Mushood Ahmed, Areeba Ahsan, Aimen Shafiq, Tallal Mushtaq Hashmi