ARTICLE IN BRIEF
Any initial differences in outcomes for stroke patients undergoing carotid artery stenting or carotid endarterectomy resolve after one-year follow-up.
LOS ANGELES — The quality of life for stroke patients one year after revascularization is similar — whether they undergo carotid artery stenting or carotid endarterectomy, according to a new analysis of results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).
“Carotid artery stenting is associated with less impairment of health status during the first two to four weeks of recovery than carotid endarterectomy, particularly with regard to physical limitations and pain, but these differences resolve completely during long-term follow-up,” said Joshua M. Stolker, MD, associate professor of medicine at St. Louis University School of Medicine.
Additionally, exploratory analyses suggest that periprocedural stroke — a risk associated with stenting — has a significant impact on one-year health status across multiple health-related quality of life measures, he reported here at the American Stroke Association International Stroke Conference 2011.
In the findings from CREST, first reported at last year's conference, 7.2 percent of patients randomized to stenting suffered stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke on follow-up, compared with 6.8 percent of surgery patients, a nonsignificant difference.
In the weeks after the procedure, however, patients who received stents suffered slightly but significantly more strokes, while those who underwent surgery had slightly but significantly more heart attacks. Specifically, the 30-day rate of stroke was 4.1 percent for stenting versus 2.3 percent with surgery. Conversely, the 30-day rate of MI was 2.3 percent for surgery versus 1.1 percent for stenting.
“Differences in the risk of periprocedural stroke and MI have led to considerable debate regarding optimal treatment strategy. As a result, other measures such as health status may help further inform individualized clinical decision-making,” said Dr. Stolker, explaining the rationale for the new analysis.
NEW STUDY ANALYSIS
The analysis involved over 85 percent of the 1321 symptomatic and 1181 asymptomatic patients who were randomized to receive either carotid artery stenting using the stent and distal protection devices (Acculink and Accunet devices) or carotid endarterectomy.
All were given the Medical Outcomes Study Short-Form 36 (SF-36), which evaluates eight dimensions of health status: physical functioning, physical role limitations, bodily pain, vitality, general health, perception, social functioning, emotional role limitations, and mental health. Scores range from 0 to 100 points, with higher scores corresponding to better health-related quality of life.
Assessments were made at baseline, and two weeks, one month, and 12 months after randomization.
At two weeks, patients in the stenting group had significantly better outcomes than those in the endarterectomy group on the physical function (an average of 59 vs. 64 points), pain (67 vs. 62 points), social functioning (76 vs. 72 points) and vitality (56 vs. 53 points) subscales.
“But there were clinically important differences only for physical function and pain,” said Dr. Stolker, noting that the minimal clinically important difference is thought to be 5 to 10 points.
At four weeks, patients in the stenting group still had slightly higher scores on the physical and social function subscales, he said.
“By one year, however, all between-group differences had resolved entirely,” Dr. Stolker said. Specifically, the average score for both groups was about 63 points on the physical functioning, 48 points on the physical role limitations, 66 points on the bodily pain, 58 points on the vitality, 63 points on the general health perception, 77 points on the social functioning, and 75 points on both the emotional role limitations and mental health subscales.
On modified Likert scales designed specifically for aspects of functional status related to recovery after carotid revascularization, patients in the stenting group reported less difficulty with driving, eating and swallowing, neck pain, and headaches at two weeks than patients in the surgery group. Patients in the surgery group reported less difficulty with walking and leg pain.
Again, the differences were less pronounced by four weeks and disappeared by one year.
Exploratory analyses showed that periprocedural stroke had a significant impact on one-year health status across multiple SF-36 domains, but periprocedural MI and cranial nerve palsy did not.
“However, there was no detectable difference in one-year health status between the two groups, likely reflecting the small absolute difference in stroke rates (about 2 percent) and the fact that most of this difference is from minor strokes,” Dr. Stolker said.
Asked to comment on the findings, Gregg C. Fonarow, MD, the Eliot Corday Chair in Cardiovascular Medicine and Science at the University of California- Los Angeles David Geffen School of Medicine and director of the Ahmanson-UCLA Cardiomyopathy Center, said that the new findings, in conjunction with evidence from CREST and other trials regarding important clinical events, will help guide individualized, patient-centered clinical decision making.
“This is a really important study that complements the overall CREST results. Here's the trade-off: Stenting may help you to avoid a little pain and discomfort early on, but if you have a periprocedural stroke, it could have a lasting impact on your health and quality of life,” he said.
“In CREST, patients under 70 tended to do better with stenting, while older patients did better with surgery,” Dr. Fonarow noted.
Most other studies show surgery has an edge over stenting. A meta-analysis published online last September in TheLancet showed that for patients younger than 70 years, there was no difference in the estimated 120-day risk of stroke or death between stenting and surgery, whereas for those older than 70 years, the risk associated with stenting was roughly twice that seen with endarterectomy.
In another large trial, (SPACE) investigators found that stenting failed to meet criteria for noninferiority versus surgery and had slightly higher rates of ipsilateral ischemic stroke and death at 30 days, according to a 2006 study in the Lancet. And in a 2006 paper in the New England Journal of Medicine, investigators also failed to show noninferiority for stenting versus surgery, and the death rate at 30 days was higher with surgery.
Interim safety results from the International Carotid Stenting Study (ICSS) showed 8.5 percent of stent patients had a stroke, death or MI in the first 30 days after surgery, compared with 5.2 percent of the surgery group, according to a March 2010 paper in The Lancet. Final results of ICSS, whose primary outcome is the rate of fatal or disabling stroke at three years, are expected in 2012.
CREST was supported by the NINDS, with supplemental funding from Abbott Vascular Solutions, including donations of the Accunet and Acculink stent systems used in the study.