Carotid Artery Surgery in Dead Heat with Angioplasty and Stenting

By John Gever
PARIS, 06 sept 2008-- Medium-term efficacy is about the same for carotid endarterectomy versus angioplasty and stenting, said researchers here and in Germany. In two randomized studies involving nearly 1,500 patients and two to four years of follow-up, rates of ipsilateral stroke and death were nearly equal when events within the first month were excluded. The four-year risk of ipsilateral stroke after the first 30 days was 1.26% (95% CI 0% to 3%) for stented patients compared with 1.97% (95% CI 0% to 4%) for patients undergoing endarterectomy, reported Jean-Louis Mas, M.D., of the Hôpitaux Sainte-Anne, and colleagues online in Lancet Neurology. They were reporting final results from the EVA-3S (Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis) trial, in which 262 patients with recent-onset symptoms were randomized to one of the two procedures.
Reported simultaneously was a study by Peter Ringleb, M.D., of the University of Heidelberg, Germany, and his colleagues in the international SPACE (Stent-Protected Angioplasty versus Carotid Endarterectomy) collaboration.
In their 1,214-patient randomized trial, 12 stented patients and 10 receiving surgery suffered ipsilateral strokes after day 30, with two years of follow-up. They calculated a hazard ratio for non-periprocedural ipsilateral stroke of 1.17 (95% CI 0.51 to 2.70) on an intent-to-treat basis.
Both groups had previously reported 30-day results in which rates of death and stroke were significantly higher for angioplasty and stenting than for endarterectomy. In their current report, Dr. Mas and colleagues acknowledged that "the safety of carotid stenting needs to be improved before it can be used as an alternative to carotid endarterectomy."
But for patients who avoid the short-term hazards, they added, "carotid stenting is as effective as carotid endarterectomy for medium-term prevention of ipsilateral stroke, at least for the first 4 years after the perioperative period."
Dr. Ringleb and colleagues found that even when the higher periprocedural rates of death and stroke were included in the results, there was no significant difference in outcomes for the two procedures.
They calculated intent-to-treat hazard ratios for periprocedural events plus late ipsilateral strokes of 1.10 (95% CI 0.75 to 1.61) for stenting relative to endarterectomy.
Cumulative two-year risks on the same basis were 9.5% for stenting versus 8.8% for endarterectomy.
Despite the similarities in rates of late strokes, the SPACE investigators found restenosis in 10.7% of stented patients compared with 4.6% of the endarterectomy group (P=0.0009).
But only two of the stented patients with restenosis showed neurological symptoms, the researchers said.
They also argued that the ultrasound technology they used to measure the vascular lumen may overestimate stenosis in stented vessels.
In an accompanying editorial, A. Ross Naylor, M.D., M.B.Ch.B., of the University of Leicester, England, noted that most previous studies have found in favor of endarterectomy over angioplasty and stenting.
The SPACE and EVA-3S results are unlikely to overturn that judgment, he said, but they do offer some intriguing new insights.
"The most important finding ... is recognition that the average annual risk of ipsilateral stroke is 1% or less, irrespective of whether the patient was treated by carotid endarterectomy or [stenting]," Dr. Naylor wrote.
He also found it notable that the SPACE study found equivalent late stroke rates despite the higher apparent incidence of restenosis in the stented patients. Dr. Naylor said the finding suggested restenosis "is a relatively benign pathology."
A third major result from the studies, according to Dr. Naylor, was that outcomes for angioplasty and stenting seemed to be strongly influenced by age, with older patients faring less well.
He said the next step should be a pooled analysis of data from all the large randomized trials, including two still underway. The goal would be to identify subgroups who benefit the most, and least, from the two procedures, as well as other aspects of treatment that affect outcomes.

Primary source: Lancet NeurologySource reference:Mas J-L, et al "Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial" Lancet Neurology 2008; DOI: 10.1016/S1474-4422(08)70195-9.

Additional source: Lancet NeurologySource reference: Eckstein H-H, et al "Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial" Lancet Neurology 2008; DOI: 10.1016/S1474-4422(08)70196-0. Additional source: Lancet NeurologySource reference: Naylor A "Stenting versus endarterectomy: the debate continues" Lancet Neurology 2008; DOI: 10.1016/S1474-4422(08)70197-2.