Surgery vs Stenting for Carotid Artery Stenosis

(ACST-2 Trial)

Recruiting at 124 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

3638 Participants Needed

Trial Summary

What is the purpose of this trial?

The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt physical intervention is thought to be needed, but there there is still substantial uncertainty shared by patient and doctor about whether surgery or stenting is the more appropriate choice. The study is looking at immediate risks (within one month)and at long term benefits

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.

What data supports the effectiveness of the treatment Carotid Artery Stenting for Carotid Artery Stenosis?

Research shows that Carotid Artery Stenting (CAS) is a viable option for treating carotid artery stenosis, especially for patients who are at high risk for surgery. Studies indicate that CAS can provide similar outcomes to the surgical option, Carotid Endarterectomy (CEA), particularly in patients with high surgical risk. ^{1 2 3 4 5}

Is carotid artery stenting generally safe for humans?

Carotid artery stenting (CAS) is considered a safe alternative to carotid endarterectomy (CEA) for treating carotid artery stenosis, especially in high-risk patients. While CAS is less invasive and may reduce risks like wound complications, it can have higher complication rates, but the use of cerebral protection devices has improved its safety. ^{6 7 8 9 10}

How does the treatment for carotid artery stenosis differ from other treatments?

Carotid artery stenting (CAS) is a less invasive alternative to carotid endarterectomy (CEA) for treating carotid artery stenosis, especially suitable for patients at high surgical risk. Unlike CEA, which involves open surgery to remove plaque, CAS uses a small tube (stent) to widen the artery, potentially offering a safer option for certain patients. ^{2 11 12 13 14}

Research Team

Alison Halliday

Principal Investigator

University of Oxford

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes after Carotid Endarterectomy and Carotid Artery Stenting for Carotid Stenosis in the ACS-NSQIP Database. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Carotid angioplasty and stenting, success relies on appropriate patient selection. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of nonneurological events in high-risk patients treated by carotid angioplasty versus endarterectomy. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Carotid angioplasty stenting revisited: clinical and radiological (MRI) outcome. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Results of carotid angioplasty and stenting are equivalent for critical versus high-grade lesions in patients deemed high risk for carotid endarterectomy. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Carotid Angioplasty and Stenting and Embolic Protection. [2018]

7. United States 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. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

A review of the trials comparing carotid endarterectomy and carotid angioplasty and stenting. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for medical complications after carotid artery stenting. [2012]

10. Poland pubmed.ncbi.nlm.nih.gov

[Carotid artery stenting with different cerebral protection systems]. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Carotid Artery Stenting Versus Carotid Endarterectomy: Post CREST. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Carotid Artery Angioplasty and Stenting: 2-Dimensional Operative Video. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Carotid artery stenting may be losing the battle against carotid endarterectomy for the management of symptomatic carotid artery stenosis, but the jury is still out. [2017]

14. England pubmed.ncbi.nlm.nih.gov

Carotid endarterectomy versus carotid stenting: an updated review of randomized trials and subgroup analyses. [2007]