EVT improves outcomes in large vessel occlusion with large cerebral infarction
Click Here to Manage Email Alerts
Endovascular therapy for patients with acute large vessel occlusion with large ischemic core improved their likelihood of achieving a favorable outcome at 90 days by more than twofold vs. medical therapy alone, a speaker reported.
According to the results of the RESCUE-Japan LIMIT trial presented at the International Stroke Conference, although endovascular therapy (EVT) increased the risk for any intracranial hemorrhage within 48 hours, the risk for symptomatic hemorrhage was similar between those who underwent EVT for acute large vessel occlusion compared with medical therapy.
According to the presentation, American Heart Association guidelines recommend EVT for acute large vessel occlusion when patients meet the following criteria:
- pre-stroke modified Rankin Scale score 0 to 1;
- occlusion of internal carotid artery or proximal middle cerebral artery;
- age 18 years or older;
- NIH Stroke Scale (NIHSS) score of 6 or more;
- Alberta stroke program early CT score (ASPECTS) of 6 or more; and
- ability to initiate treatment within 6 hours of symptom onset.
“Endovascular therapy may improve outcomes of patients with acute large vessel occlusion with large infarctions,” Shinichi Yoshimura, MD, PhD, professor and chairman in the department of neurosurgery at Hyogo College of Medicine, Japan, said at a press conference. “However, in a real-world study, that is RESCUE-Japan Registry 2, many patients did not meet this guideline’s criteria ... so, we aimed to evaluate the effectiveness of EVT in acute [ischemic stroke] patients with a large ischemic region and ASPECTS score of 3 to 5.”
The randomized, open-label, parallel-group RESCUE-Japan LIMIT trial was conducted at 45 hospitals in Japan. Two hundred adult patients with large vessel occlusion stroke and ASPECTS score of 2 to 5 were randomly assigned to EVT (including thrombectomy, percutaneous transluminal angioplasty and stenting) plus standard medical therapy or standard medical therapy alone.
The primary outcome was modified Rankin Scale score of 0 to 3 at 90 days. Secondary outcomes included modified Rankin Scale score of 0 to 2 at 90 days; modified Rankin Scale score of 0 to 1 at 90 days; ordinal shift across modified Rankin Scale score at 90 days; and NIHSS score improvement of 8 points or more at 48 hours. Safety outcomes included symptomatic intracranial hemorrhage within 48 hours; any intracranial hemorrhage within 48 hours; death within 90 days; recurrence of cerebral infarction within 90 days; and decompressive craniectomy within 7 days.
For the primary outcome, 31% of patients with large vessel occlusion who underwent EVT had a modified Rankin Scale score of 0 to 3 at 90 days compared with 12.8% of patients who received standard medical therapy alone (RR = 2.43; 95% CI, 1.35-4.37; P = .002).
Although the proportion of patients with a modified Rankin Scale score of 0 to 2 or 0 to 1 was similar between those who underwent EVT compared with standard medical therapy, the ordinal shift across modified Rankin Scale scores favored EVT (common OR = 2.42; 95% CI, 1.46-4.01).
In addition, 31% of participants assigned to EVT experienced an 8 point or greater improvement in NIHSS score at 48 hours compared with 8.8% of those in the medical therapy group (RR = 3.51; 95% CI, 1.76-7).
The occurrence of symptomatic intracranial hemorrhage within 48 hours was similar between the EVT and medical therapy groups (RR = 1.84; 95% CI, 0.64-5.29; P = .25); however, any intracranial hemorrhage within 48 hours occurred in 58% of the EVT group compared with 31.4% of the medical therapy group (RR = 1.85; 95% CI, 1.33-2.58; P < .001).
None of the remaining safety outcomes differed between the groups.
“This is the first randomized clinical trial showing effectiveness of EVT for large ischemic region. EVT increased the favorable outcome by 2.43 times medical therapy alone in acute large vessel occlusion patients with large ischemic regions,” Yoshimura said at the press conference. “EVT increased any intracranial hemorrhage within 48 hours but the occurrence of symptomatic intracranial hemorrhage was similar between groups.”
During the press conference, discussant Tudor G. Jovin, MD, FAHA, chairman and chief of neurology at Cooper University Health Care in Camden, New Jersey, and medical director of Cooper Neurological Institute, shared his thoughts on the RESCUE-Japan LIMIT trial and its implications for clinical practice.
“The question of large cores, large baseline infarcts as an exclusion criterion for thrombectomy or endovascular therapy for stroke is arguably the most important question the field is facing,” Jovin said. “There are several ongoing randomized trials as a testament to the importance of this question. The RESCUE-Japan LIMIT is the first one to shed some light on this question. [Patients with large ischemic region] looked like they benefited just as much as patients with smaller baseline infarcts. ... What was surprising was the magnitude of the benefits. It begs the question whether we should really care about the size of the infarct when we take these patients in for thrombectomy. Of course, this study did not include the largest of the largest infarcts, but I would submit that the 0 to 1s are particularly rare.”
Reference:
- Yoshimura S, et al. N Engl J Med. 2022;doi:10.1056/NEJMoa2118191.
- Mechanical clot removal may restore more function than medication alone after severe stroke. https://newsroom.heart.org/news/mechanical-clot-removal-may-restore-more-function-than-medication-alone-after-severe-stroke. Published Feb. 9, 2022. Accessed Feb. 9, 2022.
Perspective
Back to Top
Larry B. Goldstein, MD, FAAN, FANA, FAHA
There is general concern that patients with a large core of irreversible brain injury may not benefit from reperfusion therapy and would be at higher risk for bleeding complications.
Overall, patients with a large volume of injured brain also benefit from mechanical clot removal plus medical therapy compared to medical therapy alone. EVT was associated with a higher risk for brain hemorrhages, but not a higher risk of brain hemorrhages associated with neurological symptoms. The benefit was found including these adverse events.
The authors list the limitations of the study, including that it was conducted exclusively in Japan. It likely will, nonetheless, be considered when deciding whether to proceed with EVT. Generalization of the results with replication in other patient populations and incorporation into evidence-based treatment guidelines would lead to a larger impact on practice.
Collapse
Yoshimura S, et al. LB1. Presented at: International Stroke Conference; Feb. 9-11, 2022; New Orleans (hybrid meeting).
Click Here to Manage Email Alerts