medwireNews: Two-year interim analysis of the Second European Carotid Surgery Trial (ECST-2) has found no evidence to support the use of revascularization in addition to optimal medical therapy (OMT) for patients with symptomatic and asymptomatic carotid stenosis of 50% or greater and an intermediate-to-low risk for stroke.
There were no significant differences between OMT plus revascularization and OMT alone in relation to periprocedural death, stroke, or myocardial infarction, report the researchers in The Lancet Neurology.
In a comment related to the study, Jan Ho and Graeme Hankey, both from the Perron Institute for Neurological and Translational Science in Perth, Western Australia, say that ECST-2 “is the first contemporary clinical trial to investigate the risks and benefits of carotid revascularisation in patients with carotid stenosis who were selected according to their predicted absolute risk of stroke, calculated by the Carotid Artery Risk [CAR] score.” All the patients had a CAR score of less than 20%.
They add that given recent improvements in the surgical techniques used in revascularization and the perioperative management of patients undergoing such procedures, along with a decrease in associated stroke risk, it is “pertinent” for stroke neurologists to know the potential benefit of adding revascularization to OMT in patients with carotid stenosis, “particularly those who have a predicted absolute risk of ipsilateral stroke of less than 20% over 5 years.”
The 5-year noninferiority trial recruited 429 patients with a median age of 72 years, 69% of whom were men. They were randomly allocated to receive either OMT with revascularization (n=214) or OMT alone (n=215).
OMT included a low cholesterol diet, target-adjusted cholesterol-lowering medication, antihypertensive medication, and guideline-based antithrombotic therapy, which included combination antiplatelet therapy with aspirin and clopidogrel. For the revascularization group, carotid endarterectomy or carotid artery stenting was performed not more than 2 weeks after randomization for patients with symptomatic carotid stenosis, and not more than 4 weeks after randomization for patients with asymptomatic carotid stenosis.
The primary outcome was a hierarchical composite of periprocedural death (<90 days after randomization), fatal stroke, or fatal myocardial infarction; nonfatal stroke; nonfatal myocardial infarction; or new silent cerebral infarction on imaging, within 2 years of randomization. The primary analysis, based on intention to treat, used the win ratio method, where every patient in the OMT plus revascularization group was paired with every patient in the OMT only group. A win was declared for the patient with a better outcome, or a tie if neither patient had a better outcome. The total number of wins for each treatment group was compared to give a win ratio.
“ECST-2 is the first stroke trial to use the win ratio for its primary analysis,” say Martin Brown, from University College London, UK, and co-investigators, pointing out that, compared with a standard time-to-event analysis, the win ratio method enables greater emphasis on more severe events and allows the inclusion of magnetic resonance imaging-detected infarction as an outcome event, which in turn “allows a smaller sample size to reach conclusions about treatment effects.”
For the primary outcome, there were 5173 (11.3%) wins in the OMT plus revascularization group, 5228 (11.4%) wins in the OMT alone group, and 35,395 (77.3%) ties between the groups, giving a nonsignificant win ratio of 1.01. The number of outcome events was small in each group, note the researchers.
For OMT plus revascularization versus OMT alone there were three versus four instances of periprocedural death, fatal stroke, or fatal myocardial infarction; 16 versus 11 instances of nonfatal strokes; five versus seven instances of nonfatal myocardial infarction; and seven versus 12 instances of new silent cerebral infarction on imaging.
“The results demonstrate that symptomatic patients at low risk of stroke treated with OMT alone can be reliably identified using the CAR score,” conclude the researchers. They note that “[t]he risks of stroke associated with carotid stenosis treated with OMT in ECST-2 were substantially lower than recorded in similar patients during previous carotid stenosis trials.”
Ho and Hankey conclude that the results should “encourage larger trials of carotid revascularisation in patients with a predicted low to moderate risk of stroke.”
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Lancet Neurol 2025; 24: 389–399
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