Endovascular Treatment of Acute Ischemic Stroke in the Netherlands for Late Arrivals - MR CLEAN-LATE

May 18, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Collaboration for New Treatments of Acute Stroke consortium, Dutch Heart Foundation, Stryker, Medtronic, Cerenovus, Top Sector Life Sciences & Health, and the Netherlands Brain Foundation
Date Published:
04/22/2023
Original Posted Date:
05/18/2023
References

Contribution To Literature:

The MR CLEAN-LATE trial showed that endovascular therapy in addition to best medical treatment is superior to best medical treatment alone for functional neurological outcomes at 90 days in patients who had an ischemic stroke and presented 6–24 hours from stroke onset; these patients had evidence of an intracranial large-vessel occlusion in the anterior circulation and the presence of collateral flow on baseline CTA.

Description:

The goal of the trial was to compare the safety and efficacy of endovascular therapy in addition to best medical treatment compared with best medical treatment alone in patients who had an ischemic stroke and presented 6–24 hours from stroke onset with an intracranial large-vessel occlusion in the anterior circulation and the presence of collateral flow on baseline computed tomography angiography (CTA).

Study Design

Eligible patients with acute ischemic stroke at 18 sites in the Netherlands were randomized in a 1:1 ratio to undergo endovascular therapy (n = 255) or medical management (n = 247). All CE-marked endovascular treatment devices were allowed. Treatment technique and device choices were left to the discretion of the treating interventionalist.

  • Total number of enrollees: 535
  • Total number randomized: 502
  • Duration of follow-up: 90 days
  • Mean patient age: 74 years
  • Percentage female: 52%

Inclusion criteria:

  • Age ≥18 years
  • Ischemic stroke due to a proximal occlusion in the anterior circulation (distal intracranial internal carotid artery, first segment of the middle cerebral artery [M1], or the proximal second segment of the middle cerebral artery [M2]) as confirmed by CTA or magnetic resonance angiography (MRA)
  • Endovascular treatment could start within 6–24 hours from symptom onset or last seen well
  • Presence of collateral flow in the middle cerebral artery territory of the affected hemisphere on CTA

Exclusion criteria:

  • Intracranial hemorrhage on baseline imaging
  • Pre-stroke dependency defined as a modified Rankin Scale (mRS) score of 3 or higher
  • Ischemic stroke within the previous 6 weeks with persistent neurological symptoms
  • Clinical evidence of hemorrhagic diathesis
  • Clearly demarcated hypodensity of more than a third of the middle cerebral artery territory consistent with current symptoms

Other salient features/characteristics:

  • Median National Institutes of Health Stroke Scale (NIHSS) score: 10
  • Occlusion site: M1: 52%, M2: 31%
  • Median ASPECTS score: 9
  • Use of intravenous thrombolysis: 7%
  • Median time from symptom onset to randomization: 700 minutes

Principal Findings:

The primary endpoint, score on mRS at 90 days for endovascular therapy vs. medical management, was 3 vs. 4 (treatment effect odds ratio [OR] 1.67, 95% confidence interval [CI] 1.20-2.32).

Secondary outcomes for endovascular therapy vs. medical management:

  • mRS score 0-3 at 90 days: 51% vs. 42% (p < 0.05)
  • Recanalization at 24 hours after randomization on CTA or MRA: 81% vs. 53% (p < 0.05)
  • Follow-up infarct volume on noncontrast CT or MRI: 28 vs. 43 mL
  • All-cause mortality: 24% vs. 30% (p > 0.05)
  • Symptomatic intracranial hemorrhage: 7% vs. 2%, (OR 4.59, 95% CI 1.49-14.1)

Interpretation:

The results of this trial indicate that endovascular therapy in addition to best medical treatment is superior to best medical treatment alone for functional neurological outcomes at 90 days in patients who had an ischemic stroke and presented 6–24 hours from stroke onset; these patients had evidence of an intracranial large-vessel occlusion in the anterior circulation and the presence of collateral flow on baseline CTA. These findings are likely to impact clinical practice and potentially guidelines.

References:

Olthuis SG, Pirson FA, Pinckaers FM, et al., on behalf of the MR CLEAN-LATE Investigators. Endovascular treatment versus no endovascular treatment after 6–24 h in patients with ischemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands: a multicentre, open-label, blinded-endpoint, randomized, controlled, phase 3 trial. Lancet 2023;401:1371-80.

Editorial Comment: Wardlaw JM. Even more benefit with endovascular treatment for patients with acute ischemic stroke: MR CLEAN-LATE. Lancet 2023;401:1317-9.

Clinical Topics: Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Vascular Medicine, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Computed Tomography, Magnetic Resonance Imaging, Nuclear Imaging

Keywords: Computed Tomography Angiography, Coronary Occlusion, Endovascular Procedures, Infarction, Intracranial Hemorrhages, Ischemic Stroke, Magnetic Resonance Angiography, Stroke, Vascular Diseases


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