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CREST Shows Similar Net Safety and Efficacy With Stenting vs Endarterectomy for Carotid Stenosis
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February 26, 2010 (San Antonio, Texas) — Final results of the long-awaited Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) show similar net outcomes with carotid artery stenting (CAS) and carotid endarterectomy (CEA) for the treatment of carotid stenosis, researchers report.
CREST is the largest prospective randomized trial to date comparing these 2 interventions, with 2502 patients from 117 US and Canadian centers.
On the composite primary endpoint of any stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke on follow-up, stenting was associated with a 7.2% rate of these events vs 6.8% with surgery, a nonsignificant difference.
However, individual risks varied, they found. At 30 days, the rate of stroke was significantly higher with stenting at 4.1% vs 2.3% with surgery. Major stroke, though, was not different, at less than 1% in both groups. Conversely, MI was higher with CEA at 2.3% vs 1.1% with CAS, again a statistical difference.
Patients who had an MI, though, reported a better quality of life after recovery than those who had a stroke, the study authors noted.
Rates of ipsilateral stroke during a mean follow-up of 2.5 years were equal between groups at 2.0% for stenting and 2.4% with surgery.
Wayne Clark, MD, from the Oregon Health Sciences University in Portland was principal investigator from the lead enrolling center for CREST and presented the findings here on behalf of the CREST investigators. He pointed out that the event rates in this trial were lower than have been seen in prior studies, something he credited to the rigorous credentialing process and lead-in phase for operators in this study.
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| Dr. Wayne Clark |
"I think both procedures are excellent, with low perioperative rates and apparently excellent clinical durability, so I'm excited to say that I think we have 2 good options to treat patients," Dr. Clark told reporters here.
The results were presented at the International Stroke Conference 2010. The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS), with supplemental funding by Abbott.
Differences in Outcomes by Age
Differences were also seen in outcome with age, the investigators reported. During the lead-in phase, it was noticed that there was a higher risk for events for older patients with stenting, said principal investigator Thomas G. Brott, MD, professor of neurology and director of research at the Mayo Clinic in Jacksonville, Florida.
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| Dr. Thomas Brott |
That higher event rate was also seen in the randomized trial, with those approximately 69 years and older having better outcomes with surgery and those younger than 69 years having slightly better outcomes with stenting.
"When we went into this, I think we thought the less invasive procedure would be best suited for the older patient," Dr. Brott said. "Now that we have data from studies in the United States and Europe, we have to question that."
Although they did not present the data in detail here, Dr. Clark did note that outcomes were also similar for symptomatic and asymptomatic patients and for men and women in this trial.
"CAS may offer a reasonable alternative to CEA, particularly in patients who prefer a less invasive procedure and in younger patients," Wesley S. Moore, MD, professor and chief, emeritus, Division of Vascular Surgery of the University of California at Los Angeles, and coprincipal investigator for surgery in the CREST trial, concluded in a statement from the National Institutes of Health (NIH).
"However, it should be kept in mind that for the endpoint of stroke CEA has been shown to be the safer procedure. It is when heart attacks are added that the results of the 2 procedures become similar," Dr. Moore added.
Lead-In Phase
CREST compared CAS and CEA for stroke prevention in patients with both asymptomatic and symptomatic extracranial carotid stenosis. The trial, as mentioned, was preceded by an NIH-funded lead-in phase meant to credential interventionalists in what was at the time the fairly new and evolving technology of carotid stenting.
Dr. Clark began his presentation by paying tribute to Robert Hobson, MD, the principal investigator of CREST until his death in 2007, who, Dr. Clark said, "had the outlandish vision that surgeons and interventionalists could work together to do something great."
The trial included 1321 symptomatic and 1181 asymptomatic patients who were randomized to receive either CAS using the same stent and distal protection devices (Acculink and Accunet devices) or CEA. Subjects were 35% female, and only 9.3% were minorities.
Patients with symptomatic stenosis had 50% or more stenosis by angiography, 70% or ore by ultrasonography, or 70% or more by computed tomography or magnetic resonance angiography, a newer imaging technique that was used later in the trial for enrollment purposes. Asymptomatic patients had 60% or more lesions by angiography, 70% or more by ultrasonography, or 80% or more on computed tomography or magnetic resonance angiography.
Again, the primary endpoint was a composite, including any clinical stroke, MI, or death during the periprocedural period plus ipsilateral stroke on the vessel that was treated with patients followed up for up to 4 years. Endpoints were blindly adjudicated by 2 independent neurologists.
Enrollment in CREST began with only symptomatic patients but was slow at the outset, Dr. Clark noted. "We started very slow there, and I think early on there were concerns that we'd ever finish," he said. "As we added more sites things got better, and at about the midpoint of the trial, we decided also to include asymptomatic patients."
The patients were well matched for age, risk factors, and degree of stenosis, he noted, with more than 85% of patients in both groups having stenoses of greater than 70%.
"Again, overall on the primary endpoint, stroke, MI, death periprocedure, plus ipsilateral stroke out to 4 years, no significant difference between the 2 treatment groups," he said. Kaplan-Meier curves confirmed most events were periprocedural.
Table. CREST: Primary, Secondary, and Safety Endpoints
| Endpoint | CAS | CEA | Hazard Ratio (95% CI) | P Value |
| Primary endpoint ≤4 years | 7.2 | 6.8 | 1.11 (0.81 – 1.51) | .51 |
| Primary endpoint: periprocedural components | 5.2 | 4.5 | 1.18 (0.82 – 1.68) | .38 |
| Periprocedural stroke and MI | ||||
| Any periprocedural stroke | 4.1 | 2.3 | 1.79 (1.14 – 2.82) | .01 |
| Periprocedural major stroke | 0.9 | 0.7 | 1.35 (0.54 – 3.36) | .52 |
| Periprocedural MI | 1.1 | 2.3 | 0.50 (0.26 – 0.94) | .03 |
| Cranial nerve palsies | 0.3 | 4.8 | 0.07 (0.02 – 0.18) | .0001 |
| Ipsilateral stroke after periprocedural period ≤4 years | 2.0 | 2.4 | 0.94 (0.50 – 1.76) | .85 |
CAS = carotid artery stenting; CEA = carotid endarterectomy; CI = confidence interval; CREST = Carotid Revascularization Endarterectomy Versus Stenting Trial; MI = myocardial infarction
Further analysis of the quality-of-life data and economic data from CREST is ongoing and will be presented in the future, Dr. Clark added.
"Now to paraphrase Marc Antony, I come here today not to bury carotid endarterectomy but to praise it," he concluded wryly. "As such, at experienced centers, I think our results show that both procedures have very low perioperative complication rates and excellent long-term results. I feel we now have 2 options that we can offer to our patients to prevent them having carotid artery strokes."
At Odds With ICSS?
During the question period, Dr. Clark was asked how the CREST researchers explain the difference between their findings and those published only yesterday in the Lancet from the International Carotid Stenting Study (ICSS). In that paper, interim safety results at 120 days appeared to favor CEA over CAS for patients with symptomatic carotid stenosis only.
The ICSS results showed higher rates of stroke, death, or periprocedural MI in patients treated with CAS vs CEA. The primary outcome of that study is the 3-year rate of fatal or disabling stroke in any territory, and results are expected in 2012.
"I think the Lancet results do point out that whether it's tPA [tissue plasminogen activator] past 3 hours or carotid artery stenting, different results and sometimes conflicting results can occur between European and US trials," Dr. Clark replied.
CREST had a very detailed credentialing process, he added, and the almost 1600 practice cases studied during this period, whether they were proctored or not, were not included in the randomized CREST trial. "So you can make your own inference on why I think the results might be different," he said.
In an interview with Medscape Neurology, ICSS principal investigator Martin M. Brown, MD, from University College London, Institute of Neurology, in the United Kingdom, acknowledged that the CREST investigators had stricter criteria for investigators to join the trial that might have made some difference but thought it was probably more likely to be related to the mix of patients. CREST had both symptomatic and asymptomatic patients, whereas ICSS included only symptomatic patients.
"We may need to wait until they do the analysis of just their symptomatic patients to know whether it closely matches our trial or not," he said.
"I think there'll be a lot more interesting analysis coming out of the trial, and we're hoping to combine all our data together with the CREST results in due course so that we can look at different risk factors," Professor Brown added.
"The CREST trial provides doctors and patients with much needed risk/benefit information to help choose the best carotid procedure based on an individual’s health history," said Walter J. Koroshetz, MD, deputy director of NINDS, in the NIH statement. "This personalized decision making should translate into improved patient outcomes."
The study was supported by NINDS, with supplemental funding by Abbott. The investigators have disclosed no relevant financial relationships.
International Stroke Conference (ICS) 2010: Abstract 197. Presented February 25, 2010.
Authors and Disclosures
Journalist
Susan Jeffrey
Susan Jeffrey is the news editor for Medscape Neurology & Neurosurgery. Susan has been writing principally for physician audiences for nearly 20 years. Most recently, she was news editor for thekidney.org and also wrote for theheart.org; both of these Web sites have been acquired by WebMD. Prior to that, she spent 10 years covering neurology topics for a Canadian newspaper for physicians. She can be contacted at SJeffrey@webmd.net.
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