LASTE
Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size
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
PDF: 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
| Characteristic | Control | Active |
|---|---|---|
| Age - Median (IQR) - yr | 74 (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) - ml | 137 (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
| Field | Thrombectomy Group | Control |
|---|---|---|
| Intervention | Endovascular thrombectomy using approved devices plus standard medical care | Standard medical care alone |
| Duration | 90 days (primary), 180 days (secondary) | 90 days (primary), 180 days (secondary) |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Distribution of mRS score at 90 days (ordinal shift analysis; scores 5–6 combined) | Primary | Median mRS: 6 (IQR 4–6) | Median mRS: 4 (IQR 3–6) | 1.63 | <0.001 |
| Death from any cause at 90 days | Secondary | 55.5% | 36.1% | 0.65 | <0.001 |
| Symptomatic intracerebral hemorrhage within 24 hr | Secondary | 5.7% | 9.6% | 1.73 | |
| Functional independence (mRS 0–2) at 90 days | Secondary | 4.9% | 13.3% | 2.39 | <0.001 |
| Functional independence (mRS 0–2) at 180 days | Secondary | 4.9% | 18.5% | 3.26 | |
| Death from any cause at 90 days | Adverse | 55.5% | 36.1% | 0.65 | <0.001 |
| Symptomatic intracerebral hemorrhage within 24 hr | Adverse | 5.7% | 9.6% | 1.73 | |
| Parenchymal hematoma type 2 | Adverse | 2.5% | 0.6% | 0.25 | |
| Procedure-related complications | Adverse | 11 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
Content summarized and formatted by NeuroTrials.ai.