In recent years, there has been dramatic progress in the treatment of stroke—with significant contributions made by Icahn School of Medicine at Mount Sinai researchers— especially in the development of endovascular therapy that quickly and safely removes the stroke-causing blood clots that form in an artery that supplies blood to the brain.
In January, at the International Stroke Conference 2018 in Los Angeles, Mount Sinai researchers unveiled preliminary clinical trial data that further advance the effectiveness of a new clot-aspiration treatment as a first-line approach for retrieving and removing these blood clots from arteries.
The findings, which were presented by J Mocco, MD, MS, Professor of Neurosurgery, and Vice Chair of Neurosurgery and Director of the Cerebrovascular Center at the Mount Sinai Health System, showed that using, as a first-line approach, a clot-aspiration system that acts like a “vacuum” to retrieve and remove the clot was not inferior to using a stent, the current standard of care. Over the years, research conducted by Dr. Mocco was instrumental in developing both approaches.
“Our data strongly demonstrate that the two approaches are clinically equivalent, meaning that patients do just as well when you start with aspiration, or clot suction, as when you start with a stent retriever to trap and pull out the clot,” says Dr. Mocco, who designed the still-to-be-published study in collaboration with two leading stroke experts from other institutions. “Ours is the first trial designed to compare patient functional outcomes between these treatment approaches.”
Both the aspiration and stent retriever techniques are initiated by inserting a guide catheter into the femoral artery in the groin and moving it up into the brain under image guidance. The aspiration approach involves passing a specialized aspiration catheter through the guide catheter, the first step in a system that allows the clot to be suctioned from the artery. The stent retriever approach involves introducing a stent retriever, which resembles a tiny wire cage, through the guide catheter and moving it to the clot, where it opens up and traps the clot. The stent that contains the clot is then removed through the guide catheter.
Specifically, the study enrolled 270 stroke patients at 15 centers into a prospective, multicenter, randomized trial to assess how functional they were after treatment using either a large-diameter aspiration catheter system, made by Penumbra, Inc., or a stent retriever, as a first approach. To compare clinical outcomes, researchers used the modified Rankin Scale for neurologic activity, (mRS), a standard measurement of the degree of disability or dependence in the daily activities of people who have had a stroke. The scale runs from 0 (no symptoms at all) to 6 (death).
The data showed that 52 percent of patients treated with Penumbra’s aspiration system achieved the primary endpoint of functional independence (mRS 0-2) at 90 days compared with 49 percent of patients treated with stent retrievers.
“This study is very exciting because it shows that there are other ways to open the arteries that are just as effective and perhaps may be even faster, safer, and less expensive,” says Dr. Mocco.
The clinical trial was funded by Penumbra, Inc., but was conducted independently by Dr. Mocco and his collaborators, who also handled all data analysis. Dr. Mocco does not have a financial interest with Penumbra. Dr. Mocco serves as a consultant and has equity in companies that develop and manufacture devices for the treatment of neurologic diseases and is a manager for Neurotechnology Investors.