An international stroke study affiliated with the University of Pittsburgh once again has confirmed that a new procedure that surgically removes blood clots blocking large arteries in the brain can lower the levels of disability for stroke patients.
The technique, called endovascular surgery or stent retriever thrombectomy, was tested in the REVASCAT clinical trial based in four stroke centers in Catalonia, Spain. Because of its demonstrated success in preserving function in patients, the trial was ended after two years, having treated and monitored 206 patients.
Stroke patients who were found to continue to have vessels blocked after receiving the intravenous clot-busting drug tPA were eligible to be randomly separated into one of two groups: Half were to receive medical therapy alone; the other half had that therapy as well as surgery.
Co-principal investigator Tudor Jovin, director of the UPMC Stroke Institute, said the trial ended and the study results were reported early, before the expected 700 patients were enrolled.
“It was stopped mainly because it was very clear it was not ethical to randomize patients anymore,” he said, and all eligible patients could receive the surgical treatment.
A stent-tipped catheter is put into a groin artery and threaded through the body to the brain, where the clot has been detected. The mesh-like stent opens up and captures the clot; the pieces are drawn out as the catheter is retracted, restoring blood flow to the area.
Patients in the REVASCAT study who had the surgery were found overall to have almost twice the chance of achieving a level of function related to living independently, Dr. Jovin said.
Results were reported Friday at the annual meeting of the European Stroke Organisation in Glasgow, Scotland, and published online in the New England Journal of Medicine.
Another large stroke trial, called SWIFT PRIME, led at its Pitt location by Dr. Jovin, also reported successful results from endovascular treatment at the meeting and in the New England Journal of Medicine. That study found treatment within six hours of the stroke was linked to increased functional recovery and less disability after 90 days. Several studies reported in the past six months found similar results.
Dr. Jovin explained that the Spanish study was the first to have an open group of eligible patients, eliminating concerns that only a minority of eligible patients are benefiting from the treatment. It was found that nearly every eligible patient in the Catalan region, according to a Catalan health department registry of stroke patients treated with clot-busting therapy, was actually enrolled in REVASCAT.
The window of time in which this treatment will be effective needs to be studied further, Dr. Jovin said. He is co-principal investigator, with Emory University’s Raul G. Nogueira, in a new trial known as DAWN, which focuses on patients between six and 24 hours after their stroke symptoms appear. They have the same type of blockage as in the earlier trials, but by using the more advanced imaging of the SWIFT PRIME study, defining patients who will benefit most from the procedure may be possible, Dr. Jovin said.
“Now the challenge of endovascular therapy is how to allow access to the greatest number of people in the fastest possible way,” he said.
The endovascular surgery is now being done in Pittsburgh at UPMC Presbyterian and Allegheny General Hospital.
Jill Daly: firstname.lastname@example.org. or 412-263-1596.