A study co-led by neurologists at the UPMC Stroke Institute and Hospital Universitari Germans Trias i Pujol, a teaching hospital of the Universitat Autònoma de Barcelona in Spain, has shown for the first time that the benefits experienced by patients after a clot removal procedure to treat stroke are sustained at 12 months after treatment.
The study, a pre-specified secondary endpoint of a clinical trial called REVASCAT, whose main results were previously published, was conducted by UPMC Stroke Institute physicians Dr. Tudor Jovin, professor of neurology and neurological surgery at the University of Pittsburgh School of Medicine and director of the institute, and Dr. Brian Jankowitz, assistant professor of neurosurgery at Pitt’s School of Medicine, in collaboration with researchers at four large tertiary referral centers in Catalonia, Spain. The results were published this week in the journal Lancet Neurology.
The REVASCAT trial, along with other similar large trials, tested whether the procedure to remove clots in large brain blood vessels that cause a stroke, also known as thrombectomy, was better than the existing treatments that used clot-busting drugs. The video below describes the procedure in which surgeons insert a device (called a stent) through an artery in the groin and remove the clot from the affected blood vessel in the brain.
The REVASCAT trial showed that thrombectomy resulted in significant improvements in outcomes such as reduced disability at three months after treatment. However, it was not known whether the effectiveness of the treatments would be sustained over a longer period.
“Previous thrombectomy trials demonstrated that guidelines for stroke treatment needed to be reestablished to include endovascular therapy an important therapeutic option,” said Dr. Jovin, the study’s co-lead author. “Now, our findings from the extended study significantly reinforce this approach and show unequivocally that the benefit to patients is sustained over a longer period of time.”
For the original REVASCAT study, conducted between November 2012 and December 2014, the researchers treated and monitored 206 patients whose stroke symptoms began not more than eight hours earlier and who had evidence of vessel blockage on imaging studies.
In the 70 percent of patients who received an intravenous dose of the clot-busting drug tPA, or alteplase, imaging studies conducted at least 30 minutes after tPA administration had to confirm that the vessel was still blocked. Then, half of the patients were randomly assigned to receive medical therapy alone, and the other half received medical therapy and thrombectomy.
The researchers found a 1.7-fold reduction in disability and a 15.5 percent increase in the rate of return to functional independence in the endovascular therapy group compared to the medical intervention-alone group.
In the current study, researchers continued to monitor the same group of patients until 12 months after treatment, and found that the benefits, including reduced disability, better performance of daily living activities and better overall health-related quality of life, remained after a year. Importantly, the magnitude of the benefits had not decreased either.
“Several studies conducted after the REVASCAT trial to examine the cost-effectiveness of thromobolectomy assumed that the improved outcomes would be sustained, but the assumption had not actually been tested until now,” said co-principal investigator Dr. Antoni Dávalos, of Hospital Universitari Germans Trias i Pujol, and professor of neurology at the Universitat Autònoma de Barcelona.
By demonstrating sustained benefit, the study also showed that future trials to test treatments for acute strokes could be limited to 90 days and don’t need to extend for an entire year, Dr. Davalos said.
REVASCAT was funded by the Fundació Ictus Malaltia Vascular (Barcelona, Spain) through an unrestricted grant from the manufacturer of the device (Medtronic). The project was also partially supported by a grant from the Spanish Ministry of Health and a grant from the Generalitat de Catalunya.