Patients who are treated with a new clot-removal device after suffering an acute ischemic stroke have significantly reduced disability levels after the event, according to new research led by Dr. Jeffery Saver of the UCLA Stroke Center and the David Geffen School of Medicine.
Dr. Saver, a professor of neurology at the California-based university, and his colleagues report in Friday’s edition of the New England Journal of Medicine that combining use of a clot-busting drug with that of a stent retriever device significantly increased the number of patients who were capable of independent daily function after three months.
According to the study authors, the findings represent the first new treatment of acute ischemic strokes since the development of the clot-busting drug tissue plasminogen activator (tPA) some 20 years ago, and could lead to a new era in the care of a condition characterized by the sudden loss of blood circulation to a part of the brain caused by the blockage of a blood vessel.
“These findings are a paradigm shift, a new era in stroke care and we are ecstatic. We will be able to treat many more patients, who will have much better outcomes,” Dr. Saver explained in an emailed statement Thursday. “This is a once-in-a-generation advance in acute stroke care.”
“While these findings won’t help all stroke patients, it will help those who have the most disabling strokes,” added Dr. Sidney Starkman, co-director of the UCLA Stroke Center and a professor of emergency medicine and neurology at the university. “Right now, they get tPA and it helps a third of them, but the other two thirds end up disabled or don’t survive the stroke.”
The research was conducted at 39 hospitals throughout the US, Canada and Europe and involved 196 patients, though it was originally scheduled to involve 833 before being halted early due to the early positive results, according to Dr. Saver. The study was examining a second-generation stent clot retrieval device known as Solitaire, which is manufactured by Medtronic.
Dr. Saver said that the first-generation devices had been tested previously and showed no benefit over medical therapy alone, which he called disappointing. The new device was used on patients within six hours of the first symptoms, and participants were divided into two groups of 98, each randomly receiving either tPA alone or tPA with stent retrieval of the clot.
Three months after experiencing their strokes, 60 percent of the patients that received tPA along with clot retrieval were said to be functionally independent and free from disability, compared to just 35 percent of the patients receiving only tPA. While tPA is effective, it only reopens blood vessels approximately 30 percent of the time, Dr. Saver said, while the stent retriever device used in the trial was able to open the arteries 88 percent of the time.