A new analysis from a two-year follow up of participants in the CREST (Carotid revascularization endarterectomy versus stenting) trial show that carotid artery stenting and carotid endarterectomy are equally effective at halting carotid restenosis in stroke prevention. Results of the analysis were detailed in a presentation at the American Stroke Association’s International Stroke Conference (New Orleans, USA, 1–3 February 2012).
Two years after treatment with either surgery or stenting, the restenosis rate remained the same, approximately 6%.
“This was a huge surprise,” said Brajesh K Lal, lead author and associate professor of vascular surgery at the University of Maryland School of Medicine, Baltimore, USA.
“For years, surgery has been the standard of care to unclog the carotids,” said Lal, who is also chief of vascular surgery at the Baltimore VA Medical Center. “Physicians have been reluctant to utilise carotid artery stenting because of lessons learned from stenting in the coronary arteries, which lead to the heart. Coronary blockages recurred 20-30% of the time after one-to-three years. The results of our study may help physicians and patients weigh the risks and benefits of these two carotid procedures along with medical management to come up with the best treatment options.”
A previous CREST analysis showed no difference in the rates of stroke, heart attack or death among patients undergoing carotid endarterectomy or stenting.
In this new multicentre analysis, the largest to compare re-blockage rates after either procedure, 1,086 patients received stenting and 1,105 received 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% or greater blockage in the treated section.
After two years, the researchers found:
- Identical rates of restenosis at 5.8% after stenting and endarterectomy.
- Complete occlusion in 0.3% after stenting and 0.5% after endarterectomy.
- Combined restenosis/occlusion in 6% after stenting and 6.3% 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.
Lal said this analysis is prompting physicians to re-think the role of stents to prevent stroke. Based on the coronary artery experience, a much higher rate of restenosis with stents had been expected. “Because you are leaving a foreign body behind in the artery and the artery is pulsating with every heartbeat, the belief was that with each of these pulsations the stent would perhaps irritate the artery and cause a reaction and restenosis.”
Prior to this study, Lal said the US Food and Drug Administration (FDA) had approved stenting for patients who were not good candidates for surgery. The FDA cited CREST in its approval of an expanded indication for use of the stent to include all patients with clogged carotid arteries who are at risk for stroke.
Funds for the study came from 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 study sites.
Monitoring of CREST participants will continue for 10 years.