Performing an endovascular thrombectomy on the patient ischemic stroke Having a large ischemic core has proven beneficial in major international trials and is expected to lead to changes in clinical practice and the way stroke care systems are organized.
Results of the SELECT2 Trial Conducted at Centers in the United States, Canada, Europe, Australia, and New Zealand Show that Endovascular Thrombectomy and Medical Care Provide Better Clinical Outcomes Than Medical Care Alone in Patients With Large Ischemic Cores showed. Patients who presented within 24 hours of the last known good health.
Results from the SELECT2 trial were presented today by Amrou Sarraj, MD at the 2023 International Stroke Congress (ISC) in Dallas, Texas. Sarraj is a Professor of Neurology at the University Hospitals Cleveland Medical Center at the Reserve University in Ohio Case He Western.
that research too Simultaneous release online New England Journal of Medicine.
In a similar study conducted in China, ANGEL-ASPECT trialalso presented at the same ISC session, showed very similar results.
These two exams are in addition to another exam Japanese study The RESCUE-JAPAN LIMIT trial reported last year also showed benefits of thrombectomy in patients with large core stroke.
Sarraj concluded that the combined results of these three trials “clearly demonstrate the benefits of endovascular thrombectomy in patients with large ischemic cores.”
Approximately 20% of large vessel occlusive strokes have a large core, but these patients are not considered candidates for endovascular thrombectomy due to potential concerns. reperfusion injury Necrotic brain tissue increases the risk of bleeding, edema, disability, and death.
This creates uncertainty about how to manage these patients with core infarcts, Dr. Sarraj noted.
The SELECT2 trial enrolled patients with stroke as a result of occlusion of the first segment of the internal carotid artery or middle cerebral artery. Patients had a large ischemic core volume defined as 3–5 on ASPECTS (Alberta Stroke Program Early Computed Tomography Score) or a core volume of at least 50 mL on imaging. They were randomly assigned to endovascular thrombectomy plus medical care, or medical care only.
The trial aimed to enroll 560 patients, but was stopped early due to efficacy after 178 patients were assigned to the thrombectomy group and 174 to the medical group. .
Main Result — Generalized odds ratio for the shift in the distribution of Modified Rankine Scale The score for better outcome in favor of thrombectomy was 1.51 (P. < .001).
“This represents a 60% chance of achieving a better functional outcome in patients undergoing thrombectomy, and the number required for treatment is 5. , means that five patients will need to be treated with thrombectomy,” Sarraj said. .
The secondary outcome of functional independence (modified Rankin scale score 0–2) at 90 days was 20% of patients in the thrombectomy group and 7% of patients in the medical care group (relative risk, 2.97). has occurred. The number needed to process 7.
Independent ambulation (modified Rankin scale score of 0 to 3) occurred in 37.9% of patients in the thrombectomy group and 18.7% of patients in the medical care group at 90 days (relative risk, 2.06). The number needed to process 5.
Mortality was similar in the two groups.
The results of other secondary outcomes were generally in the same direction as the results of the primary analysis, except for the possibility of early neurological improvement, the authors report.
Symptomatic incidence intracranial hemorrhage It was low in both study groups, one in the thrombectomy group and two in the medical group.
The researchers note that previous studies have reported a higher incidence of symptomatic intracranial hemorrhage in patients with large ischemic core lesions than in this trial. “Thus, it was unexpected that the low proportion of patients with symptomatic intracranial hemorrhage observed in both study groups was unexpected.”
Approximately 20% of patients in the thrombectomy group had procedure-related complications. In the thrombectomy group, there were 5 arterial access site complications, 10 dissections, 7 cerebrovascular perforations, and 11 transient vasospasms.
Early neurological deterioration, defined as an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS), occurred in 24.7% in the thrombectomy group and 15.5% in the medical group (relative risk, 1.59).
In a post hoc analysis “no conclusions can be drawn from it,” the authors found that early neurological deterioration was associated with worse functional outcome at 90 days, and that patients with neurological deterioration were reported having a larger ischemic core lesion at baseline (median volume, 107 mL) vs. 77 mL in patients without neurological deterioration.
They noted that a potential cause of exacerbation in some of these patients was reperfusion-related cerebral edema. It highlights that it was associated with better outcomes than alone.
“Two-thirds of patients had a core infarct size greater than 70 mL and one-third of patients had a core infarct size greater than 100 mL, although large and very large Even in patients with core volume, thrombectomy was superior to medical care alone,” Saraji said.
This would “change convention”
comments on the study of theheart.org| Medscape CardiologyISC 2023 Chair Tudor Jovin, MD, Cooper Neurological Institute, Cherry Hill, New Jersey, said: And what is surprising is that the benefits are about the same as in patients with smaller core infarcts. This will change practice.
Jovin said these results should not only change the choice of patients undergoing thrombectomy, but also the treatment system. “Because the current treatment system is based on excluding these patients with large infarcts, there will be no need for that in the future.”
He elaborated: Outside hospitals had to perform advanced imaging studies before deciding whether to transfer patients for thrombectomy, all of which contributed to the delay.
“We are very pleased to see these results. We hope that patient triage will be much simplified and patients with large infarcts will be more tolerant,” he added.
also comment on theheart.org | Medscape Cardiology, Joseph Broderick, M.D., Ph.D., professor of neurology at the University of Cincinnati and director of the Institute for Neuroscience, said the results were “robust and important.”
He said the results of the SELECT2 trial, along with two other similar trials, “will change practice and extend endovascular treatment to more severe stroke patients.”
However, Broderick believes that imaging is still needed to exclude patients with ASPECTS scores between 0 and 2 who were not included in these trials. “These are patients with very large areas of low density that are well defined on baseline imaging (the brain is already dead or dead). I don’t get it,” he pointed out.
“Welcome News”
and NEJM Editorial companion Pierre Fayad, M.D., University of Nebraska Medical Center, Omaha, noted that all three trials of thrombectomy in patients with large core infarction stroke were affected by design, patient selection, thrombolytic therapy and dose, geographic location, and imaging criteria.
“These trials provide encouraging information from more than 1,000 patients who have suffered major ischemic stroke across healthcare systems and will likely lead to changes in care delivery patterns. ”
Fayad suggested that endovascular thrombectomy be offered to patients with major stroke if they arrive in a timely manner at a center where the procedure can be performed, and if the patient has an ASPECTS value of 3 to 5 or is ischemic. says it is reasonable to do so. -A core volume of 50 mL or more.
Despite the increased risk of symptomatic hemorrhage, edema, neurological deterioration, and unilateral craniectomy, a higher rate of favorable outcomes may be expected with this treatment, they said. he points out.
“Patients and families should be aware of treatment limitations and the expected residual neurological deficits resulting from large infarcts. Being able to perform other daily activities is welcome news for our patients, both for patients and the field of stroke care,” he concludes.
The SELECT2 trial was supported by researcher-led grants from Stryker Neurovascular to University Hospital Cleveland Medical Center and the University of Texas McGovern Medical School.
International Stroke Congress (ISC) 2023: Presentation LB21. Presented February 10, 2023.
N Eng J MedPublished online on February 10, 2023. full text, editorial
For more information, theheart.org | | Medscape Cardiology, follow me twitter and Facebook
