EVA-3S: Carotid Stenting, Endarterectomy Show Comparable Long-term Efficacy

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In the long run, carotid artery stenting (CAS) and endarterectomy (CEA) provide similar stroke protection, according to follow-up of the randomized EVA-3S trial published online July 31, 2014, ahead of print in Stroke. The results show that while the risk-benefit equation favors surgery, driven by less procedural stroke, the difference between the 2 therapies is marginal at 10 years. 

Methods
For the main trial, 527 patients with symptomatic severe carotid stenosis were randomized to CAS (n = 265) or CEA (n = 262) at 30 French centers from November 2000 to September 2005. As reported in the New England Journal of Medicine in October 2006, the trial was prematurely stopped after researchers determined an excess 30-day incidence of stroke or death in the CAS group compared with the CEA group (9.6% vs 3.9%; P = .01).
For the current analysis, researchers led by Jean-Louis Mas, MD, of Hôpital Sainte-Anne (Paris, France), looked at long-term outcomes out to 12.4 years (median 7.1 years; interquartile range 5.1-8.8 years) in survivors from the original cohort. In 2011-2012 patients were asked to have an additional duplex ultrasound, including measurement of peak systolic velocities in carotid arteries and degree of stenosis.


Comparable Outcomes

At 5-year follow-up, the risk of any ipsilateral stroke, procedural stroke or death (primary endpoint) was higher in the stenting group than in those assigned to CEA. However, this difference was marginal by the 10-year mark. Other combinations of death and stroke outcomes also were similar between the 2 groups (table 1).

Table 1. Outcomes at 5 and 10 Years

 

CAS

CEA

P Value

5-Year Follow-up

Any Ipsilateral Stroke or Procedural Stroke or Deatha

11.0%

6.3%

.04

Any Stroke or Procedural Death

14.7%

11.4%

.17

Any Fatal or Disabling Stroke or Procedural Death

6.7%

4.9%

.35

Death

22.1%

20.8%

.69

10-Year Follow-up

Any Ipsilateral Stroke, Procedural Stroke or Deatha

11.5%

7.6%

.07

Any Stroke or Procedural Death

17.4%

15.4%

.24

Any Fatal or Disabling Stroke or Procedural Death

9.4%

8.5%

.41

Death

39.0%

38.7%

.97

aPrimary endpoint.

Additionally, in the per-protocol analysis (n = 504), no differences between the 2 groups were seen for ipsilateral stroke beyond the procedural period (P = .67), or for nonipsilateral stroke, stroke in any territory, or for disabling or fatal stroke. At 10-year follow-up, the risk of carotid restenosis of at least 70% or occlusion was similar in CEA and CAS patients (P = .26).

The study authors say the data are needed since “little is known on the long-term efficacy of carotid stenting beyond the first few years after the procedure.” Overall, the results are comparable to those of previous randomized trials, including the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which reported similar 2-year rates of restenosis in its CAS and CEA cohorts.

“Our results provide reassurance that carotid stenting is as durable as carotid endarterectomy, by showing similar low rates of severe restenosis in both groups 10 years after  revascularization, whatever the threshold used to define carotid restenosis,” Dr. Mas and colleagues write.

Furthermore, they say, given the low rates of ipsilateral stroke after successful revascularization with both procedures, “stenting could become an alternative to endarterectomy in patients with symptomatic stenosis who have similar procedural risk after stenting or endarterectomy (eg, patients <70 years), at centers in which procedures are performed by board-certified endovascular specialists.”

EVA-3S’s Flaws Balanced by Value of Long-term Data

In a telephone interview with TCTMD, William A. Gray, MD, of Columbia University Medical Center (New York, NY), noted that the EVA-3S trial is well known for having used inexperienced operators and for having a 1 in 20 rate of emergent surgery in the CAS group.

“In this trial you could have never performed carotid stenting before, be proctored by someone who had done no more than 5 [procedures], and [still] randomize your first patient,” he said. “That’s why their acute outcomes were terrible.”

Nevertheless, Dr. Gray said “this is probably the longest set of data we have on patients with carotid stenting compared with carotid endarterectomy, and the relative efficacy of both, so for that reason they are valuable.” What is needed, though, is a landmark analysis, he added, to eliminate the early period of hazard from the inexperienced operators.   

“There really doesn’t seem to be a difference at 5 years between these 2 therapies in terms of long-term stroke prevention or any death,” he said, noting the value of the 10-year data are more difficult to interpret since the patient numbers are small.   

But in a telephone interview with TCTMD, Christopher K. Zarins, MD, of Stanford University School of Medicine (Stanford, CA), contended that discounting procedural stroke and focusing only on what happens to patients in the postprocedural period is misleading and self-serving. 

“The CREST trial and others have shown that the risk of periprocedural stroke is higher with stenting than with surgery and anything else is just an effort to explain away results you don't like,” he said. 

However, he added, “it's rare that you get 5- and 10-year follow-up, and so it's a level of comfort for patients who have been treated that once their carotid has been fixed they should be good for the long haul.”

 


Source: 
Mas J-L, Arquizan C, Calvet D, et al. Long-term follow-up study of Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial. Stroke. 2014;Epub ahead of print.  

Disclosures:

  • The EVA-3S study was funded by the French Ministry of Health. 
  • Drs. Mas, Gray, and Zarins report no relevant conflicts of interest. 

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