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LASTE

Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size

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Year of Publication: 2024

Authors: V. Costalat, T.G. Jovin, J.F. Albucher, ..., and C. Arquizan

Journal: The New England Journal of Medicine

Citation: N Engl J Med 2024;390:1677-89. DOI: 10.1056/NEJMoa2314063

Link: https://www.nejm.org/doi/10.1056/NEJMoa2314063

PDF: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2314063

Clinical Question

In patients with acute ischemic stroke due to occlusion of a proximal artery in the anterior circulation and a large baseline infarct with no restriction in maximum size, does endovascular thrombectomy plus medical care improve functional outcomes and mortality compared to medical care alone?

Bottom Line

In patients with acute ischemic stroke and a large infarct, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone, despite a higher incidence of symptomatic intracerebral hemorrhage.

Major Points

  • Multicenter RCT assessing thrombectomy in patients with large infarct cores (ASPECTS ≤5), without upper limit on infarct size.
  • Trial stopped early due to results from other trials supporting thrombectomy in similar populations.
  • 324 patients included in primary analysis (158 thrombectomy, 166 control).
  • Thrombectomy improved 90-day mRS (generalized odds ratio 1.63; 95% CI 1.29–2.06; P<0.001).
  • 90-day mortality was lower in thrombectomy group (36.1% vs. 55.5%; adjusted RR 0.65; 95% CI 0.50–0.84).
  • Symptomatic ICH was more frequent with thrombectomy (9.6% vs. 5.7%).
  • Functional independence (mRS 0–2) at 90 and 180 days was significantly higher with thrombectomy.

Design

Study Type: Multicenter, prospective, open-label, randomized, controlled trial with blinded outcome evaluation

Randomization: 1

Blinding: Blinded outcome evaluation by independent investigators; imaging assessed centrally by masked readers.

Enrollment Period: April 2019 through March 2022

Follow-up Duration: 90 days (primary), 180 days (secondary)

Centers: 30

Countries: France, Spain

Sample Size: 324

Analysis: Intention-to-treat; Wilcoxon–Mann–Whitney test for primary outcome; secondary analyses adjusted for prespecified covariates using multivariable models; missing data imputed; no adjustment for multiplicity

Inclusion Criteria

  • Age >18 years
  • Occlusion of intracranial ICA or M1 segment of MCA
  • ASPECTS ≤5 on CT/MRI (4–5 if age >80)
  • NIHSS ≥6
  • mRS 0–1 before stroke
  • Randomization within 6.5 hours from onset (or within 24h if MRI DWI/FLAIR mismatch present)

Exclusion Criteria

  • Intracerebral hemorrhage on imaging
  • ASPECTS 0–1 for patients >80 years

Baseline Characteristics

CharacteristicControlActive
Age - Median (IQR) - yr74 (65–80)73 (66–79)
Age >80 yr - no. (%)38 (23.0)34 (21.4)
Male sex - no. (%)88 (53.3)82 (51.6)
Transferred to thrombectomy-capable center - no. (%)94 (57.0)89 (56.0)
Modified Rankin scale score before stroke - 0 - no. (%)129 (78.2)130 (81.8)
Modified Rankin scale score before stroke - 1 - no. (%)34 (20.6)27 (17.0)
Median NIHSS score on admission (IQR)21 (18–24)21 (18–24)
Qualifying imaging method - MRI - no. (%)140 (84.8)131 (82.4)
ASPECTS - Median (IQR)2 (1–3)2 (1–3)
Median infarct volume at baseline (IQR) - ml137 (106–187)132 (104–185)
Occlusion site - ICA - no. (%)74 (44.8)69 (43.4)
Occlusion site - M1 - no. (%)91 (55.2)88 (55.3)
IV thrombolysis - no. (%)58 (35.2)55 (34.6)
Unknown time of onset - no. (%)47 (28.5)48 (30.2)

Arms

FieldThrombectomy GroupControl
InterventionEndovascular thrombectomy using approved devices plus standard medical careStandard medical care alone
Duration90 days (primary), 180 days (secondary)90 days (primary), 180 days (secondary)

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Distribution of mRS score at 90 days (ordinal shift analysis; scores 5–6 combined)PrimaryMedian mRS: 6 (IQR 4–6)Median mRS: 4 (IQR 3–6)1.63<0.001
Death from any cause at 90 daysSecondary55.5%36.1%0.65<0.001
Symptomatic intracerebral hemorrhage within 24 hrSecondary5.7%9.6%1.73
Functional independence (mRS 0–2) at 90 daysSecondary4.9%13.3%2.39<0.001
Functional independence (mRS 0–2) at 180 daysSecondary4.9%18.5%3.26
Death from any cause at 90 daysAdverse55.5%36.1%0.65<0.001
Symptomatic intracerebral hemorrhage within 24 hrAdverse5.7%9.6%1.73
Parenchymal hematoma type 2Adverse2.5%0.6%0.25
Procedure-related complicationsAdverse11 total events: arterial perforation (2), dissection (2), embolization (1), other (6)

Subgroup Analysis

No heterogeneity of treatment effect was observed across prespecified subgroups (e.g., age, ASPECTS, IVT use, occlusion site, NIHSS). Study was not powered for these analyses.

Criticisms

  • Trial was stopped early, reducing statistical power for some secondary outcomes.
  • Open-label design introduces potential for performance bias, though outcomes were adjudicated blinded.
  • Homogeneous study population from high-volume centers in France and Spain may limit generalizability.
  • Confidence intervals for secondary outcomes and subgroup analyses not adjusted for multiplicity.

Funding

Montpellier University Hospital through an unrestricted grant from an industry consortium (no involvement in trial design or execution).

Based on: LASTE (The New England Journal of Medicine, 2024)

Authors: V. Costalat, T.G. Jovin, J.F. Albucher, ..., and C. Arquizan

Citation: N Engl J Med 2024;390:1677-89. DOI: 10.1056/NEJMoa2314063

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