By Lorraine L. Janeczko
NEW YORK (Reuters Health) - Drug-eluting stents may do a better job reducing in-stent restenosis and stroke recurrence compared with bare-metal stents in patients with symptomatic high-grade intracranial atherosclerotic stenosis, a randomized trial conducted in China shows.
"Intracranial atherosclerotic stenosis remains a major cause of acute ischemic stroke despite best medical therapy," Dr. Wengui Yu of the University of California, Irvine, told Reuters Health by email.
"One of the obstacles for intracranial stenting with uncoated stents is the high risk of in-stent restenosis and stroke recurrence," he added. "This study has demonstrated significant benefit of drug-eluting stents over standard uncoated stents."
Dr. Yu and his colleagues conducted an open-label randomized clinical trial over three and a half years at 16 medical centers in China that specialize in intracranial stenting. They followed participants for one year.
The median age of the 263 participants was 58 years and almost three-quarters were male, the researchers report in JAMA Neurology. Overall, 132 patients received a drug-eluting stent (NOVA intracranial sirolimus-eluting stent system) and 131 received a bare-metal stent (Apollo intracranial stent system).
At one year, the in-stent restenosis rate was lower with the drug-eluting stent (9.5% vs. 30.2%; odds ratio, 0.24; P<0.001). Patients with the drug-eluting stent also had a significantly lower rate of recurrent ischemic stroke from day 31 to year 1 (0.8% vs. 6.9%; hazard ratio, 0.10; P=0.03).
The research team found no significant difference in the rate of stroke or death within 30 days between the groups (7.6% vs. 5.3%; odds ratio, 1.45; P=0.46).
Dr. Yu said the lack of a medical-treatment arm was a weakness of the study, and he and his co-authors recommend further related research.
Three experts who were not involved in the trial also emphasized the need for more research in emails to Reuters Health.
Dr. Gabor Toth, a neurosurgeon at Cleveland Clinic in Ohio, said, "It is interesting and exciting to see new data come out on intracranial atherosclerosis and its treatment options."
"Physicians may take the results of this study into consideration in their decisions about treatment options and recommendations to patients. But further data and confirmation are needed," added Dr. Toth. "The intracranial DES (drug-eluting stent) option currently is off-label in the U.S., and there are no specific neurovascular DES stents available here."
"Many questions remain, including how DES would perform against aggressive medical therapy alone," he said.
Dr. Michael Levitt, an associate professor of neurological surgery and radiology at the University of Washington School of Medicine in Seattle, cautioned that "it is unclear how these results translate to patients in other parts of the world or of other ethnic backgrounds."
Dr. Helmi Lutsep, a professor of neurology at Oregon Health & Science University in Portland, said, "The safety of using drug-eluting stents in the brain will require more study, as will confirmation of the results in a larger group of patients."
"However," she added, "the findings could reinvigorate the use of stents in patients with intracranial stenosis, which is associated with a high risk of recurrent stroke."
The authors declare no conflicts of interest and the study did not receive commercial funding.
SOURCE: https://bit.ly/3GiHDiT JAMA Neurology, online January 4, 2022.