Surgery vs Stenting for Carotid Artery Stenosis

(ACST-2 Trial)

Not currently recruiting at 134 trial locations

Overseen By Richard Bulbulia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oxford

Must be taking: Statins, Aspirin

Disqualifiers: Advanced cancer, Major co-morbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat carotid artery stenosis, a condition where the neck artery narrows and can lead to stroke. The researchers compare two treatments: surgery (carotid endarterectomy) and stenting (carotid artery stenting). They aim to determine which method is safer in the short term and more beneficial over the long term for individuals with this condition who haven't had recent symptoms or treatments. Those who have already started medications like statins or aspirin and have undergone necessary heart procedures might be suitable if there's uncertainty about the best treatment for them. Participants must be willing and able to follow up in person and through annual communication for several years. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve future treatment options for carotid artery stenosis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have already started any appropriate medical treatment, like statins or aspirin, before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that carotid artery stenting (CAS) is generally safe and effective for people with narrowed carotid arteries. Studies indicate that the risk of stroke or death within 30 days is less than 3% for those without symptoms, meaning most people recover well after the procedure. However, complications can occur, such as changes in blood flow that might lead to serious problems.

Carotid endarterectomy (CEA) is a surgical option that has been used for a long time and is also considered safe. This procedure involves directly removing plaque from the artery and serves as a standard treatment for many with carotid artery blockage.

Both treatments are known for their safety and are common procedures with well-understood risks and benefits. Doctors have extensive experience performing them. Always consult your healthcare provider to understand personal risks and options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Carotid Artery Stenting (CAS) and Carotid Endarterectomy (CEA) because they offer distinct approaches to treating carotid artery stenosis, a condition where the arteries in the neck narrow, increasing stroke risk. CEA is a surgical procedure that physically removes plaque from the artery, while CAS involves placing a stent to keep the artery open. These treatments provide different options for patients based on their health profiles and preferences. Stenting is less invasive and may have a quicker recovery time, whereas endarterectomy has a long track record of effectiveness. The comparison of these two methods could lead to more personalized treatment options for patients with this condition.

What evidence suggests that this trial's treatments could be effective for carotid artery stenosis?

This trial will compare carotid artery stenting (CAS) and carotid endarterectomy (CEA) for treating carotid artery stenosis, the narrowing of the neck arteries. Studies have shown that both CAS and CEA are effective treatments. Research indicates that CAS has a low complication rate within 30 days, similar to CEA, especially when performed by experienced doctors. A large study with over 1,700 patients found that CAS is as effective as CEA in the long term, with follow-ups showing similar results. Another study found that both treatments have similar short-term success in reducing the risk of stroke and heart attack. Overall, both methods show promise for effectively managing carotid artery stenosis. ^{1 2 3 6 7}

Who Is on the Research Team?

Alison Halliday

Principal Investigator

University of Oxford

Are You a Good Fit for This Trial?

This trial is for patients with asymptomatic carotid artery narrowing who haven't had symptoms or previous procedures on the affected artery. They must be on medical treatment like statins, have completed any heart procedures, and be able to attend follow-ups. Both surgery (CEA) and stenting (CAS) should be possible options without a clear preference for either.

Inclusion Criteria

Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA and CAS would both be anatomically practicable.

Tests show both CEA and CAS procedures are suitable for me.

I have a narrowed carotid artery without symptoms or previous treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either carotid endarterectomy or carotid artery stenting to address asymptomatic carotid artery narrowing

1 month

Follow-up

Participants are monitored for immediate risks and long-term benefits, including stroke prevention and quality of life

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Carotid Artery Stenting
• Carotid Endarterectomy

Trial Overview The study compares two treatments for carotid artery narrowing: Carotid Endarterectomy (CEA), which is surgery to remove plaque from inside the carotid artery, and Carotid Artery Stenting (CAS), where a mesh tube is inserted to widen the narrowed part of the artery. It assesses immediate risks and long-term benefits.

How Is the Trial Designed?

Group I: CEA Active Control 1 Intervention

Carotid endarterectomy

Group II: CAS Active Control 1 Intervention

Carotid Artery Stenting

Carotid Artery Stenting is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Carotid Artery Stenting for:

• Symptomatic carotid stenosis ≥70%
• Asymptomatic carotid stenosis >60%
• Symptomatic carotid stenosis 50-69%

Approved in United States as Carotid Artery Stenting for:

• Symptomatic carotid stenosis ≥70%
• Asymptomatic carotid stenosis >60%
• Symptomatic carotid stenosis 50-69%

Approved in Canada as Carotid Artery Stenting for:

• Symptomatic carotid stenosis ≥70%
• Asymptomatic carotid stenosis >60%
• Symptomatic carotid stenosis 50-69%

Who Is Running the Clinical Trial?

University of Oxford

Lead Sponsor

Trials

1,113

Recruited

21,220,000+

NHS Health Technology Assessment Programme

Collaborator

Trials

7

Recruited

5,700+

BUPA Foundation

Collaborator

Trials

4

Recruited

4,300+

British Heart Foundation

Collaborator

Trials

158

Recruited

2,648,000+

Published Research Related to This Trial

In a study of 101 high surgical risk patients undergoing carotid artery stenting (CAS), the procedure demonstrated a low 30-day complication rate of 4.6%, indicating it is a safe option for patients with significant carotid artery disease.

The study found that CAS was successful in 99% of cases, with a notable 8.3% rate of in-hospital adverse events, primarily minor, suggesting that CAS can be an effective alternative to carotid endarterectomy for both symptomatic and asymptomatic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of carotid artery stenting in high-risk patients with carotid artery stenosis: a single neurovascular center retrospective review of 101 consecutive patients. Meyer, SA., Gandhi, CD., Johnson, DM., et al.[2010]

In a study of 48 patients undergoing carotid angioplasty with stent implantation (CAS), the use of various cerebral protection devices significantly reduced procedural risks, with only one stroke occurring during the procedure.

Over a 6-month follow-up period, there were no deaths or strokes among 40 patients, indicating that CAS procedures are generally safe and have a low incidence of major cerebrovascular complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Carotid artery stenting with different cerebral protection systems]. Bartuś, S., Dudek, D., Rakowski, T., et al.[2010]

Carotid angioplasty and stenting (CAS) has a slightly higher risk of periprocedural strokes compared to carotid endarterectomy (CEA), particularly in patients over 70 and those who have recently experienced symptoms, but it has a lower incidence of cardiac events and cranial nerve palsies.

Both CAS and CEA are equally effective in preventing future strokes, and while CAS is a valid alternative for symptomatic patients, in asymptomatic patients, modern medical therapy may be as effective as either procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carotid Angioplasty and Stenting and Embolic Protection. Giordan, E., Lanzino, G.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10318231/

Long-term outcomes of carotid artery stenting in patients ... International Carotid Stenting Study (ICSS) has compared outcomes of a total 1,713 carotid artery stenosis patients with a median follow-up of 4.2 years. The 5- ...

2. ahajournals.org ahajournals.org/doi/10.1161/SVIN.124.001459

Carotid Artery Stenting Outcomes by Neurointerventional ... Fellowship‐trained neurointerventionalists in comprehensive stroke centers, achieved a notably low 30‐day complication rate in carotid artery ...

3. jacc.org jacc.org/doi/10.1016/j.jcin.2024.03.014

Real-World Outcomes of Carotid Artery Stenting in ... The purpose of this study was to investigate the real-world clinical outcomes of CAS in symptomatic and asymptomatic patients with carotid artery stenosis.

4. eurointervention.pcronline.com eurointervention.pcronline.com/article/thirty-day-outcomes-of-carotid-endarterectomy-versus-carotid-artery-stenting-in-asymptomatic-and-symptomatic-patients-a-propensity-score-matched-analysis

Thirty-day outcomes of carotid endarterectomy versus ... CONCLUSIONS: Propensity-matched analysis suggests that CAS has similar postprocedural outcomes for stroke, AMI and death at 30 days compared to CEA.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa0708028

Long-Term Results of Carotid Stenting versus ... The trial showed that carotid artery stenting was not inferior to carotid endarterectomy in this population at 1 year. Subsequently, reports of several ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9800945/

The Safety and Long-Term Efficacy of Carotid Artery Stenting CAS is a safe and less invasive intervention in patients with significant carotid artery stenosis and is equally effective in preventing future strokes.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S105230572300352X

Complications and outcomes of carotid artery stenting in ... Among patients, 107 (70.4%) had a carotid artery stenting risk. In high-risk carotid artery stenting cases, symptomatic complications occurred in 32 (30.0%), ...