Early Endovascular Therapy Beneficial for Acute Stroke With Large Infarction

Endovascular therapy within 24 hours of an acute ischemic stroke with a large infarct core is associated with a better functional outcome at 3 months compared with the use of medical management alone. These are the findings of a study published in The New England Journal of Medicine.

The use of endovascular therapy has become standard care among patients who experience an ischemic stroke due to cerebral large vessel occlusion. Current guidelines recommend that imaging selection criteria for endovascular therapy include 1 of the following 2 events:

• Alberta Stroke Program Early Computed Tomography Score (ASPECTS) value of ≥6 (which is a measure of infarct size on a scale of 0-10, in which lower values are indicative of a larger infarct); this measure typically suggests small- to medium-sized infarctions
• Mismatch between clinical state and perfusion imaging within 6-24 hours

Recognizing that both of the above criteria generally exclude large-sized infarcts, researchers sought to evaluate whether endovascular therapy is beneficial for patients with a large infarction.

They conducted the multicenter, prospective, open-label Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core trial (ANGEL-ASPECT; ClinicalTrials.gov Identifier: NCT04551664) in China. The study included patients with acute large vessel occlusion in the anterior circulation and an ASPECTS value of 3-5 or an infarct-core volume between 70-100 mL. All participants were randomly assigned, in a 1:1 ratio, “within 24 hours from the time they were last known to be well” to receive endovascular therapy plus medical management or medical management alone.

The primary study outcome was the score on the modified Rankin Scale (mRS) at 90 days.

The primary study objective was to establish whether an ordinal shift in the distribution of scores on the mRS at 90 days had transpired between the 2 treatment arms.

All imaging was conducted at baseline, at 36±12 hours, and at 7±1 days following randomization or at hospital discharge.

A total of 456 patients (median age, 68 years; 38.7% women) were enrolled in ANGEL-ASPECT, with 231 patients randomly assigned to the endovascular-therapy arm and 225 patients assigned to the medical-management-alone arm.

In the endovascular-therapy arm, 1 of the 231 patients was not included in the intention-to-treat analysis.

In both of the treatment arms, approximately 28% of participants received intravenous (IV) thrombolysis.

The trial was stopped early, since evidence of the efficacy of endovascular therapy was observed following the second interim analysis on May 17, 2022.

According to the primary outcome analysis, a shift in the distribution of scores on the mRS at 90 days in favor of significantly better outcomes with endovascular therapy compared with medical management alone was observed (generalized odds ratio, 1.37; 95% CI, 1.11-1.69; P =.004).

Based on the secondary outcome analysis, the proportion of patients with a score of 0-2 on the mRS at 90 days was 30.0% in the endovascular-therapy arm vs 11.6% in the medical-management-alone arm (relative risk [RR], 2.62; 95% CI, 1.69-4.06).

In addition, the percentage of patients with a score of 0-3 on the mRS at 90 days was 47.0% in the endovascular-therapy cohort compared with 33.3% in the medical-management cohort (RR, 1.50; 95% CI, 1.17-1.91).

The occurrence of symptomatic intracranial hemorrhage within 48 hours following randomization was reported in 6.1% of patients in the endovascular-therapy group vs 2.7% in the medical-management-alone group (RR, 2.07; 95% CI, 0.79-5.41; P =.12). The occurrence of any intracranial hemorrhage within 48 hours was reported in 49.1% of those who received endovascular therapy compared with 17.3% of those who received medical management alone (RR, 2.71; 95% CI, 1.91-3.84; P <.001).

Several limitations of the present study warrant mention. To begin, the percentage of patients who received IV thrombolysis was low, which may have negatively impacted the medical-management group. Additionally, urokinase instead of alteplase, which is likely more effective, was used as thrombolysis in a small proportion of patients. Further, no patients with an ASPECTS value of >5 and an infarct-core volume of 70 to 100 mL participated in the trial.

“Among patients in China with acute ischemic stroke and a large infarct core due to large-vessel occlusion in the anterior circulation, endovascular therapy within 24 hours after stroke onset resulted in a better functional outcome at 3 months than medical management alone,” the researchers explained. “Intracranial hemorrhages were more common with endovascular therapy,” they concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.