Laino, CharleneBack to top
A follow-up analysis of the CREST trial showed that over two years, the rate of restenosis or occlusion was 6.0 percent in patients who underwent stenting and 6.3 percent in the endarterectomy group, a nonsignficant difference. Given the findings, experts offer input on factors to consider when choosing one therapeutic option or the other.
OUTCOMES for carotid stenting (left) and carotid endarterectomy (right) were similar after a two-year, phase 3 trial.
NEW ORLEANS—For patients with carotid stenosis, stenting and endarterectomy are associated with the same low rates of restenosis through two years of follow-up, according to new results from the landmark Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).
Over two years, the rate of restenosis or occlusion was 6.0 percent in patients who underwent stenting and 6.3 percent in the endarterectomy group, a nonsignficant difference, reported Brajesh K. Lal, MD, associate professor of vascular surgery at the University of Maryland School of Medicine in Baltimore.
The new analysis involved 2,191 patients who received their assigned treatment within 30 days of randomization and had an ultrasound reviewed at the CREST Ultrasound Core Laboratory; 1086 patients received stenting and 1105 received surgery. Through two years of follow-up, hemodynamically significant restenosis (70 percent or greater blockage) occurred in 5.8 percent of the patients in both groups.
The rate of occlusion was 0.3 percent in the stenting group and 0.5 percent in the endarterectomy group. Patients who developed a restenosis had 4.37 times the risk of developing an ipsilateral stroke. Overall, 13 of the 120 patients with restenosis or an occlusion had a stroke: four in the stenting group and nine in the endarterectomy group.
Primary results of the CREST trial of over 2,500 patients with asymptomatic and symptomatic carotid stenosis showed no significant difference in the rate of stroke, myocardial infarction (MI), or death within the first 30 days — 7.2 percent for patients randomized to stenting and 6.8 percent for those given endarterectomy. However, the rate of stroke was higher in the stenting arm and the rate of MI was higher in the surgery arm, the investigators had reported in 2010 in the New England Journal of Medicine.
The primary findings did not fully allay physicians' fears concerning stenting, Dr. Lal said here at the American Stroke Association's International Stroke Conference.
“One of the most common arguments against stenting was the fact that the rate of restenosis associated with bare metal stents in coronary arteries is extremely high: almost 20 percent over two years. So there were worries that it would be high in the carotid arteries, too, and physicians were reluctant to do stenting,” he said.
“The durability of revascularization became an important issue, and in the new report, we found no difference between the two procedures.”
However, there were subgroups of patients that were about twice as likely to develop restenosis regardless of which procedure they underwent — females, diabetics, and those with dyslipidemia, Dr. Lal said. In patients who underwent surgery, there was a fourth risk factor — smoking, he said. In the endarterectomy arm, current smokers were 2.26 times more likely to develop restenosis than nonsmokers. [For more detailed data, see “Risk Factors for Restenosis.”]
RISK FACTORS FOR RESTENOSIS
“These risk factors will play an important role in how we follow patients, but, with the exception of smoking, would not affect which procedure we perform,” Dr. Lal said.
Now that stenting has been shown to be equally durable to surgery, how does the physician decide which to perform? “Some factors would clearly steer physicians to one procedure over another,” Dr. Lal said.
Among them is the issue of reimbursement, he said. From a practical point of view, “I would be forced to follow the directive of CMS [Centers for Medicare & Medicaid Services],” which only reimburses high-risk symptomatic patients for stenting.
A 2010 cost-effectiveness analysis in the Journal of Endovascular Therapy found the mean costs of stenting and surgery to be $12,782 and $8,916, respectively, said CREST investigator Larry B. Goldstein, MD, professor of medicine (neurology) and director of the Duke Stroke Center at Duke University Medical Center in Durham, NC.
Age is a factor too. The previously published findings showed that patients under age 70 appeared to benefit slightly more from stents, while their older counterparts benefited more from surgery, said Ralph L. Sacco, MD, Olemberg Family Chair in the Neurosciences and chairman of neurology at the Miller School of Medicine of the University of Miami.
Arterial health should also be considered. Stenting might be a better option for patients who have scar tissue in the neck from prior surgery or radiation therapy, said Philip B. Gorelick, MD, MPH, John S. Garvin Professor and head of the department of neurology and rehabilitation and director of stroke research at the University of Illinois College of Medicine in Chicago. Carotid artery bifurcation can make the artery hard to access surgically without breaking the jawbone, he said.
On the other hand, it may be difficult to place a stent in carotid arteries that are tortuous or heavily calcified, Dr. Gorelick said. For these patients, surgery may be the better choice, he said.
“Know your local expertise,” Dr. Sacco said. “If there's a great surgeon at your institution, you may choose endarterectomy. Similarly, if you have a terrific stenter, with low rates of complications, you may choose stenting.”
How about medical management alone? “Observational data has suggested that medical therapy alone now may be sufficient for patients with narrowing in a carotid artery who have not had referable symptoms,” Dr. Goldstein said. There are plans to conduct CREST 2, a trial that will compare best medical management with carotid revascularization to determine whether surgery or stenting is necessary at all.
In 2007, the rate of endarterectomy was 2.5 per 1000 Medicare beneficiaries versus 0.6 per 1000 for angioplasty/stenting. Since 1998, that represented a 31 percent decrease in surgery and a 450 percent increase in stenting, according to a 2010 report in the journal Circulation: Cardiovascular Quality and Outcomes, Dr. Goldstein said. Carotid stenosis causes about 10 percent of strokes, according to Dr. Lal.
CREST was funded by the NINDS with supplemental funding from stent manufacturer Abbott Vascular. The participants will continue to be followed through 10 years.
DR. BRAJESH K. LAL: “One of the most common arguments against stenting was the fact that the rate of restenosis associated with bare metal stents in coronary arteries is extremely high: almost 20 percent over two years. So there were worries that it would be high in the carotid arteries, too, and physicians were reluctant to do stenting. The durability of revascularization became an important issue, and in the new report, we found no difference between the two procedures.”