University Hospitals (UH) Cleveland Medical Center in Cleveland, USA has been awarded US$7 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to evaluate endovascular thrombectomy in patients presenting more than 24 hours from time last known well via the global SELECT LATE clinical trial. Amrou Sarraj (UH Neurological Institute, Cleveland, USA) will lead the study, which aims to provide deterministic evidence of a clinical benefit with the addition of thrombectomy to standard medical care in this patient population.
Sarraj and colleagues will conduct the study across sites in the USA, Canada, Europe, Australia and New Zealand, assessing the benefits and risks of thrombectomy for patients who present to the hospital beyond the usual 24-hour timeframe for treatment by randomly assigning them to receive either thrombectomy or standard medical care. The researchers will compare how well patients in each group respond in terms of functional independence—as per ability to perform day-to-day tasks without help from others—and quality of life as identified by the patients.
Based on Get With The Guidelines data, only about 10% of patients presenting with a large vessel occlusion later than 24 hours currently receive thrombectomy treatment.
“[The] thrombectomy procedure has revolutionised how we treat patients with acute ischaemic stroke due to occlusion in one of the larger brain vessels,” said Sarraj, principal investigator for the SELECT LATE trial. “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. For patients who present beyond this timeframe, a lack of randomised 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 centres.”
The trial aims to reduce treatment disparities in elderly patients who live alone, and also 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.
Following the recent success of Sarraj and colleagues’ SELECT2 trial—which established efficacy and safety of thrombectomy in patients presenting with large strokes—Nicholas Bambakidis (UH Neurological Institute, Cleveland, USA) feels this is the next step in the evolution of acute stroke management.
“University Hospitals and Case Western Reserve University [Cleveland, USA] have always been at the forefront of medical advances,” Bambakidis stated. “The SELECT LATE global trial will have a tremendous impact on acute stroke management, not only individually but also in terms of how we organise stroke systems of care.”
“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 [to a] higher level of care and consideration of thrombectomy,” Sarraj added.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other healthcare stakeholders, but also for its conduct in real-world settings,” said PCORI executive director Nakela Cook. “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. We look forward to following the study’s progress and working with University Hospitals Cleveland Medical Center to share its results.”
The SELECT LATE study was selected through PCORI’s competitive review process in which patients, caregivers and other stakeholders join scientists to evaluate proposals. Sarraj and colleagues’ award has been approved pending completion of PCORI’s business and programmatic review, and issuance of a formal award contract.
