A national study led by Cedars-Sinai provides further support that a specialized stenting system for opening blocked brain arteries has a low rate of complications and may be as good or better than traditional medical therapy for certain patients with a stroke history.

The affected patients are those who have suffered one or more strokes caused by intracranial artery stenosis—a narrowing of the arteries in the brain caused by a buildup and hardening of fatty deposits called cholesterol plaque.

The study is a follow-up to The Wingspan® Stent System Post-Market Surveillance Study (WEAVE™), which was presented at the 2018 International Stroke Conference in Los Angeles. The 2018 study demonstrated that stenting of brain arteries in 152 patients resulted in a low complication rate—including stroke or death—of 2.6% within 72 hours of the procedure.

For their new study, published online in the Journal of NeuroInterventional Surgery, the investigators followed a group of 129 stented patients for one year. Their research found a rate of 8.5% for strokes and deaths in this group over that period.

The rate with stenting was favorable compared with the 12.2% one-year stroke and death rate for a similar cohort of patients in a 2011 study, reported by a different investigative team, who were treated with medical therapy alone, said Michael Alexander, MD, director of the Cedars-Sinai Neurovascular Center and professor of Neurosurgery.

"Our findings lend support, through real-world data, that stenting for intracranial atherosclerotic disease can be performed safely, if proper patient selection and guidelines are followed, and also that there appears to be clinical benefit at the one-year follow-up," Alexander said. He was the national principal investigator and corresponding author for the study, which was performed at 12 U.S. sites and involved 14 co-authors.

The investigators noted that their findings, based on a single-arm interventional study without a control medical arm, have limitations. They said the next step, to best establish efficacy, is to develop randomized clinical trials comparing best-practice stenting protocols with medical therapy.

Funding: The WOVEN Trial was a physician-initiated study without industry or public funding.

Competing interests: Michael Alexander, Alois Zauner, Rishi Gupta, AmeerHassan, Blaise Baxter, R. Charles Callison and Wengui Yu are scientific consultants for Stryker Neurovascular. No industry compensation was provided for this research or the production of this manuscript to any of the investigators.

DOI:10.1136/neurintsurg-2020-016208. National Clinical Trials Study No. NCT020234058