J Mocco, assistant professor of Neurosurgery, The University of Florida, Gainesville, USA, announced the investigational device exemption (IDE) approval and initiation of THERAPY during the opening session of the Society of NeuroInterventional Surgery (SNIS) Annual Meeting in Colorado on 25 July 2011. This randomised controlled trial could significantly impact the delivery of stroke treatment services in hospitals across the USA, investigators say.
Mocco, who is the principal investigator for the trial, told delegates that THERAPY was designed to prove the clinical benefit of interventional treatment of acute ischaemic stroke. “Currently, catheter-based intervention in acute stroke patients has only been indicated for the removal of the clot causing stroke,” Mocco said. “THERAPY, however, will assess the benefits of catheter-based intervention as a treatment standard for patients suffering stroke.
He also noted that “patient selection is the key to both clinical trial design and high quality patient care. The THERAPY trial focuses on patients who are potentially responsive to aspiration thrombectomy but resistant to intravenous tissue plasminogen activator (tPA). We believe this design can enable an efficient, cost-effective, and most importantly, realistic trial. Treating patients with stroke and providing medical evidence of benefit to those patients’ clinical outcome is the goal of the THERAPY trial.”
Stroke treatment has evolved significantly over the past two decades. The development of catheter-based intra-arterial therapeutic approaches to stroke has improved the ability to emergently open blocked arteries safely within 8 hours of stroke onset in single-arm studies.
Despite the great promise of catheter-based treatments for stroke, however, rigorous randomised prospective trials are necessary to prove their clinical efficacy. With the initiation of THERAPY, the opportunity now exists for the medical community to better assess whether interventional acute stroke treatment improves patients’ future clinical outcomes. The results of such a study, study authors say, could potentially re-frame the role of catheter-based stroke therapy in the near-term future.
“The THERAPY trial offers the opportunity to prove that embolectomy can improve clinical outcomes in a selective patient group. It complements the more general approach of the NIH-funded 900-subject IMS III Trial. As we pass the half-way point for IMS III, and look forward to its results, we will need further definition of subpopulations that will benefit from endovascular treatments. My hope is that the stroke community will move quickly to randomise patients in these studies and get our current stroke armamentarium established on firmer ground,” said Pooja Khatri, an associate professor of Neurology, University of Cincinnati, and director of Acute Stroke of the Greater Cincinnati/Northern Kentucky Stroke Team, who is the neurology principal investigator for the trial.