NEW ORLEANS — Opening blocked neck arteries with a metal stent or surgery were equally durable, in research presented at the American Stroke Association’s International Stroke Conference 2012.
Two years after the procedures, less than 7 percent of patients had developed repeat blockages (restenosis), researchers said.
“Unlike bare metal stents placed in coronary arteries, where re-blockage occurs about 20 percent of the time, we found the re-blockage rates in the carotid artery were quite small,” said Brajesh K. Lal, M.D., lead author of this analysis and associate professor of vascular surgery at the University of Maryland School of Medicine in Baltimore. “Patients and physicians can be reassured that both procedures are durable and that re-blockage rates are equivalent, so they can use different criteria to determine which procedure is right for a patient.”
The study is the largest to look at restenosis rates after either procedure.
The study participants — part of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) — had partial blockages in a neck artery. Symptomatic patients had experienced a non-disabling stroke or transient ischemic attack (mini-stroke) because of the blockage, while asymptomatic patients had not.
Previously, this head-to-head comparison of the two procedures showed no difference in the combined rates of stroke, heart attack or death between patients undergoing surgical removal of a blockage (carotid endarterectomy) or stenting.
About 10 percent of strokes are caused by blockages in the neck arteries, which supply blood to the brain. Revascularization procedures preserve blood flow and lower the risk of stroke.
In the current study, 1,086 patients received stenting and 1,105 endarterectomy. All were assessed at one, six, 12 and 24 months after the procedure with an ultrasound to identify those who had developed a 70 percent or greater blockage in the treated section.
After two years, the researchers found:
- Identical rates of restenosis (5.8 percent) after stenting and endarterectomy.
- Complete blockage (occlusion) in 0.3 percent after stenting and 0.5 percent after endarterectomy.
- Combined restenosis/occlusion in 6 percent after stenting and 6.3 percent after endarterectomy.
- Twenty stent patients and 23 endarterectomy patients had undergone a second procedure to open a re-blocked carotid.
- Rates of restenosis were about double in women and patients with diabetes and abnormal lipid levels.
- Stroke rates were 4 times higher in patients who developed a restenosis compared to those that did not develop a restenosis during follow-up.
“These may be groups we need to focus more on by monitoring them closely and aggressively controlling risk factors after the procedures,” said Lal, who is also chief of vascular surgery at the Baltimore VA Medical Center in Maryland.
Physicians from different specialties perform revascularization procedures. In the study, results didn’t differ by specialty.
“CREST was unique in having a built-in training and credentialing process that mandated participating physicians perform 1,500 revascularization procedures before randomizing any patients,” Lal said. “These results provide hard data for the FDA and professional societies to use as they recommend a particular type or extent of training for performing these procedures.”
Monitoring of CREST participants will continue through 10 years.
Co-authors are: Kirk E. Beach, M.D., Ph.D.; Gary S. Roubin, M.D.; Helmi L. Lutsep, M.D.; Wesley S. Moore, M.D.; Mahmoud B. Malas, M.D.; David Chiu, M.D.; Nicole R. Gonzales, M.D.; James L. Burke, M.D.; Michael Rinaldi, M.D.; James R. Elmore, M.D.; Fred A. Weaver, M.D.; Craig R. Narins, M.D.; Malcolm Foster, M.D.; Kim Hodgson, M.D.; Alexander D. Shepard, M.D.; James F. Meschia, M.D.; Robert O. Bergelin, M.S.; Jenifer Voeks, Ph.D.; George Howard, Dr.P.H.; and Thomas G. Brott, M.D. Author disclosures are on the abstract.
The study is funded by the National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions (formerly Guidant), which included donations of the Acculink and Accunet stent systems to most of the CREST centers.
Statements and conclusions of study authors that are presented at American Stroke Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding.
NR12-1005 (ISC 2012/Lal)
Note: Abstract 3 will be presented in rooms 220-222.
FOR RELEASE: 7:54 a.m. CT/ 8:54 a.m. ET, Wednesday, Feb. 1, 2012
Men, women fare equally well with revascularization techniques
When deciding whether to open a blocked artery in the neck by surgically removing the blockage or placing a stent to hold the vessel open, doctors need not consider the patient’s gender, researchers said.
Results from the CREST trial suggested that the risks and benefits of the procedures might differ by gender. However, outcomes from the Nationwide Inpatient Sample on an estimated 673,170 patients who underwent either procedure between 2005 and 2009 showed:
- A higher rate of post-operative strokes in asymptomatic women undergoing carotid endarterectomy.
- A higher rate of cardiac complications for asymptomatic men undergoing carotid endarterectomy.
- No gender differences in symptomatic patients.
- No gender differences in asymptomatic women undergoing carotid angioplasty and stenting.
- After adjusting for cofactors, researchers found no difference between men and women in the occurrence of any complications (including stroke, heart complications or death) during the hospitalization following the procedure.
Note: Actual presentation is 5:45 p.m. CT Wednesday, Feb. 1, 201.
Patients given stents outside clinical trials fare worse
Patients who receive stents outside clinical trials fare worse than those who undergo the procedure in clinical trials, according to nationwide data.
Using Nationwide Inpatient Survey data between 2005 and 2008, researchers found that:
- In-hospital death was twice as high among patients treated outside of trials.
- The rate of adverse events, including stroke, cardiac events and death, during hospitalization after the procedure was significantly higher in patients treated outside of trials.
The findings highlight the need for strategies to successfully replicate the benefits of carotid arterial stent placement in clinical trials as the procedure enters wider practice.
Note: Actual presentation is 3:12 p.m. CT Thursday, Feb. 2, 2012.
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