University Hospitals Awarded $7 Million by PCORI to Study Endovascular Thrombectomy in Patients Presenting Beyond 24 Hours

CLEVELAND--University Hospitals was awarded $7 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to study Endovascular Thrombectomy in Patients Presenting beyond 24 Hours of Last-Known-Well. Amrou Sarraj, MD,FAHA, FSVIN,director of Stroke Center and Stroke Systems at the UH Neurological Institute,will lead the study, which aims to provide deterministic evidence of clinical benefit due to addition of endovascular thrombectomy to standard medical care in this population.

One of the main treatments for acute stroke is called endovascular thrombectomy (EVT), a procedure that involves removing a blood clot from the brain using a catheter. EVT has been shown to be effective for certain types of strokes when performed within 24 hours of when the patients were last known to be symptom-free. However, many stroke patients present to the hospital beyond the 24-hour time window, which limits their options for treatment.

Dr. Sarraj and University Hospitals will conduct a new study across sites in the U.S., Canada, Europe, Australia and New Zealand that aims to evaluate the benefits and risks of EVT for patients who present to the hospital beyond this usual time frame for treatment by randomly assigning them to receive either EVT or standard medical care. The researchers will compare how well patients in each group respond in terms of functional independence (ability to perform day-to-day tasks without help from others) and quality of life as identified by the patients. Only about 10% of patients presenting with a large vessel occlusion after 24 hours currently receive EVT, based on the Get-with-the-Guidelines data.

"Thrombectomy procedure has revolutionized how we treat patients with acute ischemic stroke due to occlusion in one of the larger brain vessels. However, the current evidence of efficacy and safety is limited to those presenting within 24 hours of when they were last known to be without symptoms," said Dr. Sarraj, who is principal investigator of the trial, the George M. Humphrey II Chair in Neurology at UH and Professor of Neurology at Case Western Reserve University School of Medicine. "For patients who present beyond this timeframe, a lack of randomized evidence prevents us from treating them universally with this state-of-the-art technology that is shown to improve stroke outcomes by two to three folds. We expect this to help many patients; those who live alone without early recognition of their symptoms, especially the elderly, and patients who do not have prompt access to thrombectomy centers."

The trial also aims to reduce treatment disparities in elderly patients who live alone and those living in rural and remote communities. These patients often do not have timely access to healthcare, resulting in delayed presentation and potential disqualification from receiving this treatment.

After recent success of Dr. Sarraj's SELECT2 trial that established efficacy and safety of thrombectomy procedure in patients presenting with large strokes, Nicholas Bambakidis, MD, Vice President and Director of the UH Neurological Institute and Chair of the Department of Neurosurgery, feels this is the next step of evolution for acute stroke management.

"University Hospitals and Case Western Reserve University have always been at the forefront of medical advances. The SELECT Late global trial will have a tremendous impact on acute stroke management, not only individually but also in terms of how we organize stroke systems of care," he said. Dr. Bambakidis also holds the Harvey Huntington Brown, Jr., Chair in Neurosurgery and is a Professor of Neurological Surgery at Case Western Reserve School of Medicine.

"We expect a major impact on systems of care and the current patients' transfer practice since these patients are vastly not being considered for transfer for higher level of care and consideration of thrombectomy," Dr. Sarraj added.

"This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health care stakeholders, but also for its conduct in real-world settings. It has the potential to answer an important question about the utility of endovascular thrombectomy in this vulnerable patient population and fill a crucial evidence gap," said PCORI Executive Director Nakela L. Cook, MD, MPH. "We look forward to following the study's progress and working with University Hospitals Cleveland Medical Center to share its results."

This study was selected through PCORI's highly competitive review process in which patients, caregivers and other stakeholders join scientists to evaluate proposals.

Many clinical studies test under carefully controlled conditions in specialized research centers whether an approach to care works, but healthcare is rarely delivered in such optimized situations and settings. Pragmatic clinical studies such as this test a treatment's effectiveness in "real-world" clinical situations such as standard hospitals and outpatient clinics, and can include a wider range of study participants, making their findings more generally applicable.

Dr. Sarraj's award has been approved pending completion of PCORI's business and programmatic review and issuance of a formal award contract.

PCORIis an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers and clinicians with the evidence-based information they need to make better-informed health and health care decisions.

The study abstract can be found here:Endovascular Thrombectomy in Patients Presenting Beyond 24 Hours of Last-Known Well (SELECT LATE) | PCORI

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