Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core - ANGEL-ASPECT

Apr 18, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Covidien Healthcare International Trading (Shanghai), Johnson & Johnson MedTech, Genesis MedTech (Shanghai), and Shanghai HeartCare Medical Technology
Date Published:
02/10/2023
Date Updated:
04/18/2023
Original Posted Date:
04/18/2023
References

Contribution To Literature:

The ANGEL-ASPECT trial showed that an endovascular approach up to 24 hours after stroke onset results in improved neurological recovery compared with medical therapy among patients presenting with acute ischemic stroke with a large infarct core caused by large-vessel occlusion in the anterior circulation.

Description:

The goal of the trial was to compare the safety and efficacy of endovascular therapy compared with medical therapy among patients with ischemic stroke with a large infarct core caused by acute large-vessel occlusion in the anterior circulation.

Study Design

Eligible patients with acute ischemic stroke at 46 sites in China were randomized in a 1:1 ratio to undergo endovascular therapy (n = 230) or medical management (n = 225). Patients in the endovascular arm could undergo thrombectomy with a stent-retriever or contact-aspiration system and, if needed, balloon angioplasty, stent implantation, or intra-arterial thrombolysis and receive medical therapy as well.

  • Total screened: 1,504
  • Total number of enrollees: 455
  • Duration of follow-up: 90 days
  • Mean patient age: 68 years
  • Percentage female: 39%

Inclusion criteria:

  • Age 18-80 years
  • Acute ischemic stroke within the previous 24 hours with a score of 6-30 on the National Institutes of Health Stroke Scale (NIHSS)
  • Pre-stroke score of 0 or 1 on the modified Rankin scale (mRS) assessed retrospectively
  • Evidence of large-vessel occlusion of the initial segment of the middle cerebral artery or the intracranial segment of the distal internal carotid artery (or both) on computed tomography angiography (CTA)/magnetic resonance angiography (MRA) Alberta Stroke Program Early Computed Tomography Score (ASPECTS) value of 3-5 based on findings from noncontrast CT within 24 hours after stroke onset with no limitation with respect to infarct-core volume; or an ASPECTS value of 0-2 based on findings from noncontrast CT within 24 hours after stroke onset and an infarct-core volume between 70-100 mL; or an ASPECTS value >5 based on findings from noncontrast CT between 6-24 hours after stroke onset and an infarct-core volume of 70-100 mL

Exclusion criteria:

  • Midline shift or clinical signs of herniation
  • Mass effect
  • High risk of hemorrhage
  • Acute bilateral strokes
  • Multiple intracranial occlusions

Other salient features/characteristics:

  • Median NIHSS score: 16
  • Occlusion site: internal carotid artery: 36%, M1 segment: 63%
  • Median ASPECTS score: 3
  • Use of intravenous thrombolysis: 28%
  • Median time from stroke onset to randomization: 458 minutes (~36% were <6 hours)

Principal Findings:

The trial was terminated early due to efficacy of endovascular therapy after the second interim analysis. The primary endpoint, score on mRS at 90 days for endovascular therapy vs. medical management, was 4 vs. 4; treatment effect 1.37 (95% confidence interval 1.11-1.69, p = 0.004).

Secondary outcomes for endovascular therapy vs. medical management:

  • mRS 0-3 at 90 days: 47.0% vs. 33.3%
  • Change from baseline in infarct-core volume: 61.7 vs. 90.5 cc (p > 0.05)
  • Symptomatic intracranial hemorrhage (ICH) within 48 hours: 6.1% vs. 2.7% (p = 0.12)
  • Any ICH within 48 hours: 49.1% vs. 17.3% (p < 0.001)
  • All-cause mortality: 21.7% vs. 20.0% (p = 0.99)

Interpretation:

The results of this trial indicate that an endovascular approach up to 24 hours after stroke onset results in improved neurological recovery compared with medical therapy among patients presenting with acute ischemic stroke with a large infarct core caused by large-vessel occlusion in the anterior circulation. There was a higher incidence of ICH; nearly 50% of patients had evidence of some ICH within 48 hours. The window for receiving thrombolytics in this trial was longer than commonly used (<4.5 hours). These findings are likely to impact clinical practice and potentially guidelines.

References:

Huo X, Ma G, Tong X, et al., on behalf of the ANGEL-ASPECT Investigators. Trial of Endovascular Therapy for Acute Ischemic Stroke With Large Infarct. N Engl J Med 2023;388:1272-83.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Vascular Medicine, Aortic Surgery, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Computed Tomography, Nuclear Imaging

Keywords: Angiography, Angioplasty, Balloon, Computed Tomography Angiography, Coronary Occlusion, Diagnostic Imaging, Endovascular Procedures, Fibrinolytic Agents, Intracranial Hemorrhage, Traumatic, Ischemic Stroke, Stents, Stroke, Thrombectomy, Thrombolytic Therapy, Tomography, X-Ray Computed, Vascular Diseases


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