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Carotid artery stenting (CAS) and carotid endarterectomy (ACE) have provided comparable results over time in asymptomatic patients receiving good medical treatment in the largest trial to date of what to do do with a severe narrowing of the carotid artery that has not yet caused a stroke.
Among more than 3,600 patients, stenting and surgery by experienced physicians had a 1.0% risk of causing disabling stroke or death within 30 days.
The annual rate of fatal or disabling strokes was around 0.5% with either procedure over an average 5-year follow-up – according to Alison Halliday, MD, principal investigator of Carotid Asymptomatic, the annual risk of stroke was halved. Surgery trial-2 (ACST-2).
The results were reported today in a Hot Line session at the European Society of Cardiology (ESC) Virtual Congress 2021 and simultaneously published online in The Lancet.
Session chair Gilles Montalescot, MD, Sorbonne University, Paris, France, noted that ACST-2 doubled the number of randomized patients with asymptomatic carotid stenosis studied in previous trials, “therefore, a huge contribution to the base evidence in this area and apparently good news for both revascularization techniques. “
Results at 30 days and at 5 years
The trial was conducted in 33 countries between January 2008 and December 2020, involving 3,625 patients (70% male; mean age, 70 years) with at least 60% carotid stenosis on ultrasound, in which stenting or surgery was appropriate but the physician and patient were “substantially unsure” which procedure to prefer.
Of the 1,811 patients assigned to stenting, 87% underwent the procedure at a median of 14 days; 6% went for surgery, usually due to a heavily calcified lesion or a more tortuous carotid artery than expected; and 6% had no intervention.
Of the 1,814 patients assigned for surgery, 92% had the procedure at a median of 14 days; 3% switched to stenting, usually due to the patient’s or physician’s preference or reluctance to undergo general anesthesia; and 4% had no intervention.
The uncomplicated patients who had stenting stayed an average of 1 day less than those operated on.
In a previous press briefing, Halliday stressed the need for procedural skills and said doctors must submit a dossier of their CEA or CAS experience and, according to current guidelines, must demonstrate a stroke or death rate. independently verified 6% or less for symptomatic patients and 3% or less for asymptomatic patients.
The results showed that the 30-day risk of death, myocardial infarction (MI), or any stroke was 3.9% with carotid stenting and 3.2% with surgery (P = 0.26).
But with stenting, there was a slightly higher risk of non-disabling procedural stroke (48 vs 29; P = 0.03), including 15 strokes vs 5 strokes, respectively, which left the patients no residual symptoms. This is “consistent with important and recent nationally representative registry data,” observed Halliday, University of Oxford, UK.
For the operated patients, cranial nerve palsies were reported in 5.4% against any patient having undergone a stent.
At 5 years, the rate of fatal or disabling non-procedural strokes was 2.5% in each group (rate ratio [RR], 0.98; P = 0.91), with any non-procedural stroke occurring in 5.3% of patients with stents versus 4.5% with surgery (RR: 1.16; P = 0.33).
The researchers performed a meta-analysis combining the results of ACST-2 with those of eight previous trials (four in asymptomatic patients and four in symptomatic patients) that yielded a similar non-significant result for any non-procedural stroke ( RR: 1.11; P = .21).
Based on the results of ACST-2 and the main trials, stenting and surgery involve “similar risks and similar benefits,” Halliday concluded.
Presenter Marco Roffi, MD, University Hospital of Geneva, Switzerland, said: “In centers with documented expertise, carotid artery stenting should be offered as an alternative to carotid endarterectomy in patients with asymptomatic stenosis and appropriate anatomy.
Although the trial provided “good news” for patients, it pointed out that a reduction in the sample size from 5,000 to 3,625 limited statistical power and that recruitment over a long period may have introduced. confounding factors, such as changes in equipment technique, and medical therapy.
Additionally, many centers have recruited few patients, raising concerns about low-volume centers and operators, Roffi said. “We know that 8% of centers recruited 39% of patients” and “information on the qualifications and experience of interventionists was limited”.
Additionally, a lack of systematic evaluation of MI may have favored the surgery group, and more recent developments in stenting with the potential to reduce perioperative stroke have rarely been used, such as protection against proximal embolism in only 15% and double-layered stents in 11%.
Friedhelm Beyersdorf, MD, University Hospital Freiburg, Germany, said that as a vascular surgeon he finds it understandable why there might be a higher incidence of non-fatal strokes when treating carotid stenosis with stents, given the vulnerability of these lesions.
“Nonetheless, the main conclusion of the whole study is that carotid artery treatment is extremely safe, it must be done in order to avoid stroke, and obviously there seems to be a benefit to the surgery. in terms of non-disabling stroke, ”he said. noted.
Session chair Montalescot, however, said what the study cannot address – and has been the subject of much public comment online – is whether either intervention should be performed in these patients.
Unlike previous trials comparing interventions to medical treatment, Halliday said ACST-2 recruited patients for whom a decision had been made that revascularization was needed. Additionally, 99% to 100% were receiving antithrombotic therapy initially, 85% to 90% were receiving antihypertensive drugs, and approximately 85% were taking statins.
Longer-term follow-up should provide a better picture of non-procedural stroke risk, with patients being asked each year about the exact medications and doses they are taking, she said.
“We will have a huge list of what exactly happened and the intensity of this therapy, which is, of course, much more intense than when we did our first try. But these were people in whom a procedure was deemed necessary, she noted.
When asked at the press conference which procedure she would choose, Halliday, a surgeon, observed that patient preference matters but the nature of the lesion itself often determines the optimal choice.
“If you know that the competence of the people who perform it is equal, then the least invasive procedure – provided it has good long-term viability, and this is why we have been following for 10 years – is the most important. “, she added.
The study was funded by the Medical Research Council and the UK Health Technology Assessment Program. Halliday does not report any relevant financial relationship.
Lancet. Published online August 29, 2021. Full text
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