CREST Analysis: Restenosis Rates Similar at 2 Years for Carotid Stenting, Surgery

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Carotid endarterectomy (CEA) and carotid artery stenting (CAS) produce equivalent levels of restenosis out to 2 years following intervention, according to data from the CREST study presented at the American Stroke Association’s International Stroke Conference in New Orleans, LA, on February 1, 2012.

The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), originally published in the July 1, 2010, issue of the New England Journal of Medicine, randomized 2,502 symptomatic and asymptomatic patients with significant carotid stenosis (≥ 50% on angiography) to undergo CAS (n = 1,262) or CEA (n = 1,240). There was no difference between the treatment groups in rates of the primary composite endpoint of death, MI, or stroke at 4 years. However, periprocedural stroke was more common with CAS, while periprocedural MI was more frequent with CEA.

For the new analysis, Brajesh K. Lal, MD, of the University of Maryland School of Medicine (Baltimore, MD), and colleagues focused on hemodynamically significant restenosis in patients who received their assigned treatment within 30 days of randomization and had a core lab-reviewed duplex ultrasound (n = 1,086 for CAS and n = 1,105 for CEA). The endpoint was defined as 70% or greater diameter reduction with peak systolic velocity of at least 300 cm/sec, occlusion by absence of flow within the target artery, and repeat revascularization of the index artery.

At 2 years, restenosis had occurred at a rate of 5.8% in each of the treatment groups, while occlusion was observed in 0.3% of CAS patients and 0.5% of CEA patients. The combined restenosis/occlusion rate was nearly equivalent at 6.0% for CAS and 6.3% for CEA (P = 0.58). Repeat revascularization rates also were similar, with 1.8% of the CAS group and 2.1% of the CEA group undergoing repeat treatment with either surgery, angioplasty alone, or stenting.

Multivariate analysis found that several factors independently predicted increased restenosis at 2 years:

• Female sex: adjusted HR 1.83, 95% CI 1.3-2.7
• Diabetes: adjusted HR 2.22; 95% CI 1.5-3.3
• Dyslipidemia: adjusted HR 1.97; 95% CI 0.9-4.3

Restenosis resulted in stroke for 10.8% of the 120 patients who had restenosis or occlusion. Nearly half of the strokes occurred after restenosis was detected.

Restenosis Not a Factor to Influence Decision Making

In a telephone interview with TCTMD, Dr. Lal explained the current study—the largest to date comparing restenosis rates between the 2 carotid interventions—is important for several reasons.

For one, a substantial portion of clinicians have been concerned that “like the coronary experience, bare-metal stenting in the carotid artery would result in significantly high restenosis rates,” something that had not been seen historically with endarterectomy, Dr. Lal reported. Moreover, “with the primary composite endpoint of CREST demonstrating no difference between the 2 procedures, restenosis became a critically important factor in helping to make the decision,” he said, adding that other randomized trials looking at the question of restenosis in this population have been underpowered and reached different conclusions.

William A. Gray, MD, of Columbia University Medical Center (New York, NY), characterized the analysis as the “most carefully done, most systematic [comparison] of long-term outcomes in terms of patency.”

Dr. Gray told TCTMD in a telephone interview that the results are useful because they demonstrate that restenosis should not be a deciding factor for whether carotid disease patients undergo stenting or surgery. “The therapies continue to be equivalent as other secondary measures come out as well,” he said.

In a prepared statement, Dr. Lal said that the groups identified at high risk of restenosis by multivariate analysis may be ones “we need to focus more on by monitoring them closely and aggressively controlling risk factors after the procedures.”

Dr. Gray disagreed, cautioning that because the absolute numbers of patients developing restenosis in the study were quite small, it is hard to tease out the clinical importance of such factors.

Moreover, he added, the “authors should probably be circumspect about the larger conclusions” because the findings “apply only to one stent design and we don’t know whether other stents are better or worse. We think they’re the same, but scientifically you can only say it’s specific to RX Acculink [Abbott; Abbott Park, IL], which was used in this trial. Other stents have shown similar patency rates, so I don’t think there is a material difference.”

Dr. Lal also commented that the results are fairly representative of what is obtained today. “I don’t think there has been generational change in carotid stenting technology or technique. The concepts of putting a filter and a nitinol stent still remain the same,” despite the introduction of newer devices, he said.

 

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Source:
Lal BK. Restenosis following carotid artery stenting and endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial. Presented at: International Stroke Conference; February 1, 2012; New Orleans, LA.

 

 

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