Carotid Stenting vs. Endarterectomy for Carotid Stenosis

(CREST-2 Trial)

No longer recruiting at 201 trial locations

Overseen By CREST-2 Administrative Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Antithrombotics

Disqualifiers: Stroke, Dementia, Atrial fibrillation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to prevent strokes in individuals with carotid stenosis, a narrowing of the neck arteries. It compares traditional surgery (carotid endarterectomy) and a less invasive procedure (carotid stenting with a protective device) against medication alone. The goal is to determine which approach best maintains health and prevents strokes. Suitable participants have significant narrowing of the neck arteries but have not experienced a recent stroke or mini-stroke. As an unphased trial, this study allows participants to contribute to important research that could enhance stroke prevention strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain anticoagulants like warfarin or have a history of intolerance to study medications, you may not be eligible to participate.

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

Research has shown that carotid stenting (CAS) is generally safe for individuals with carotid artery narrowing. Studies have found a low risk of major complications, such as stroke or heart attack, within 30 days after the procedure. CAS is as safe as carotid endarterectomy (CEA), another common treatment, and both procedures help prevent strokes caused by narrowed neck arteries.

The risks for CAS and CEA are similar, indicating that patients undergoing CAS are not more likely to encounter serious issues than those undergoing CEA. This information comes from real-world studies, reflecting actual patient experiences outside controlled lab settings.

In addition to CAS and CEA, the trial includes intensive medical management, which focuses on medication and lifestyle changes. This non-surgical option may be preferable for those concerned about surgery.

Overall, most patients tolerate both CAS and CEA well, with similar safety levels. The choice between them often depends on personal health factors and patient preference. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for carotid stenosis because they offer different approaches to reducing the risk of stroke. Carotid endarterectomy (CEA) involves a surgical procedure to physically remove plaque from the carotid artery, which has been the standard treatment for many years. Carotid stenting (CAS), on the other hand, uses a less invasive method by placing a stent to keep the artery open, potentially offering a quicker recovery. The trial also explores intensive medical management without surgery, focusing on medication and lifestyle changes to manage the condition. This variety in treatment options could provide more personalized care and potentially better outcomes for patients with carotid stenosis.

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

Research has shown that carotid stenting (CAS), one of the treatments in this trial, works well for people with narrowed carotid arteries. One study found that CAS succeeded 96% of the time, with very few deaths related to the procedure. Another study reported a 10.3% risk of stroke within five years after CAS. Patients who underwent CAS also spent less time in the hospital compared to those who had carotid endarterectomy (CEA), another treatment option in this trial. These results suggest that CAS is a promising method to help prevent strokes in people with narrowed carotid arteries. ^{1 2 6 7 8}

Who Is on the Research Team?

George Howard, DrPH

Principal Investigator

University of Alabama at Birmingham

Lloyd Edwards, PhD

Principal Investigator

University of Alabama at Birmingham

Brajesh K. Lal, MD

Principal Investigator

University of Maryland

James F. Meschia, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 35 with asymptomatic high-grade carotid stenosis, who haven't had a stroke or TIA related to the stenosis in the last 180 days. They must be able to follow the study schedule and not be pregnant if of childbearing potential. Exclusions include recent major surgery, severe kidney disease, planned major surgeries, certain cancers, and intolerance to study medications.

Inclusion Criteria

I am 35 years old or older.

Patients must agree to comply with all protocol-specified follow-up appointments

I have never had a stroke or symptoms of a stroke.

Exclusion Criteria

I have a cancer diagnosis other than non-melanoma skin cancer.

I haven't had any major surgery or serious heart issues in the last month.

I have a heart condition that could cause blood clots.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either carotid endarterectomy, carotid stenting, or intensive medical management

4 years

Follow-up

Participants are monitored for stroke and cognitive function outcomes

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Carotid endarterectomy (CEA)
• Carotid Stenting (CAS)
• Intensive Medical Management - no CAS
• Intensive Medical Management - no CEA

Trial Overview

The CREST-2 trial compares intensive medical management alone versus alongside either carotid endarterectomy (CEA) or carotid stenting (CAS) in preventing strokes. Participants are randomly assigned to one of these treatments and all receive uniform medical management directed by the study team.

How Is the Trial Designed?

Group I: Intensive Medical Management - no CEA Experimental Treatment 1 Intervention

Intensive Medical Management alone - no CEA

Group II: Intensive Medical Management - no CAS Experimental Treatment 1 Intervention

Intensive Medical Management alone - no CAS

Group III: Carotid Endarterectomy (CEA) Active Control 1 Intervention

Carotid Endarterectomy

Group IV: Carotid Stenting (CAS) Active Control 1 Intervention

Carotid Stenting

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Thomas G. Brott, M.D.

Lead Sponsor

Trials

1

Recruited

2,500+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a study of 10,958 Medicare patients aged 66 and older, carotid artery stenting (CAS) showed similar in-hospital and 1-year stroke rates compared to carotid endarterectomy (CEA), indicating comparable efficacy in preventing strokes.

However, CAS patients experienced significantly higher all-cause mortality at 1 year (9.9% for CAS vs. 6.1% for CEA), which may be attributed to their higher baseline risk factors, such as existing coronary and peripheral arterial disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after carotid artery stenting and endarterectomy in the Medicare population. Wang, FW., Esterbrooks, D., Kuo, YF., et al.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38749596/

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.

2.

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.

3.

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 ...

Technical success was 100%. The length of hospital stay was significantly shorter in asymptomatic patients treated with CAS compared to those treated with CEA ( ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8210939/

Six-year outcomes of carotid artery stenting performed with ...

The success rate of the CAS procedure was 96%. Procedure-related death was reported in 4 (0.6%) patients who successfully underwent the CAS procedure. Moreover, ...

5.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.121.036178

Comparative Effectiveness of Carotid Stenting to Medical ...

The observed unadjusted 5-year risk of fatal or nonfatal stroke among patients with carotid stenosis was 10.3% (95% CI, 7.8%–13.4%) in the CAS ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11958397/

30-Day Outcomes of Real-World Elective Carotid Stenosis ...

Dual-layer micromesh carotid artery stenting is safe, with a low 30-day major adverse event incidence in real-world asymptomatic and symptomatic ...

7.

jwatch.org

jwatch.org/na57514/2024/06/18/real-world-data-safety-carotid-artery-stenting

Real-World Data on the Safety of Carotid Artery Stenting

Trials show that carotid artery stenting (CAS) is noninferior to carotid endarterectomy in patients with carotid artery stenosis.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1878875023014596

Comparison of Perioperative Safety of Carotid Artery ...

Wang et al reported that CAS has risk comparable to CEA regarding composite outcome of any stroke, death, and myocardial infarction (MI) in perioperative and ...