Large Stroke Therapy Evaluation - LASTE

May 31, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Montpellier University Hospital
Date Published:
05/08/2024
Date Updated:
05/31/2024
Original Posted Date:
05/31/2024
References

Contribution To Literature:

The LASTE trial demonstrated that in patients with acute ischemic stroke and large infarcts of unrestricted size, endovascular thrombectomy was associated with less severe long-term disability compared with medical therapy alone.

Description:

The goal of the trial was to determine the efficacy and safety of endovascular thrombectomy for acute ischemic stroke with large baseline infarct size compared with medical therapy alone.

Study Design

  • Multicenter
  • Randomized
  • Open-label
  • Adjudicator-blinded

Patients with acute ischemic stroke and large infarct size were randomized in a 1:1 fashion to undergo endovascular thrombectomy with medical therapy (n = 159) or medical therapy alone (n = 165). Infarct size was assessed using the semiquantitative Alberta Stroke Program Early Computed Tomographic Score (ASPECTS).

  • Total number of enrollees: 324
  • Duration of follow-up: 180 days
  • Mean patient age: 74 years
  • Percentage female: 48%

Inclusion criteria:

  • Age ≥18 years
  • Presentation concerning for acute ischemic stroke with time last known well ≤6.5 hours or ≤24 hours with negative FLAIR MRI (magnetic resonance imaging)
  • Noncontrast CT or diffusion-weighted MRI ASPECTS ≤5 (and >3 if age >80 years)
  • Occlusion of intracranial internal carotid artery (ICA) or M1 segment of middle cerebral artery
  • Prestroke modified Rankin scale (mRS) score ≤1
  • National Institutes of Health Stroke Scale (NIHSS) score ≥6

Exclusion criteria:

  • Intracerebral hemorrhage or midline shift
  • Cervical ICA disease requiring stent placement
  • Creatinine >4.0 mg/dL unless on dialysis
  • Platelet count <50,000/µL or international normalized ratio (INR) >3.0

Other salient features/characteristics:

  • Median NIHSS score: 21
  • Median ASPECTS: 2
  • Percentage receiving thrombolytic therapy: 35%
  • Median time from symptom onset to thrombectomy: 305 minutes

Principal Findings:

The primary efficacy outcome, median mRS score at 90 days for thrombectomy vs. medical therapy, was: 4 vs. 6 (odds ratio [OR] 1.63, 95% confidence interval [CI] 1.29-2.06, p < 0.001).

Secondary efficacy outcomes for thrombectomy vs. medical therapy:

  • mRS score at 180 days: 4 vs. 6 (OR 1.71, 95% CI 1.35-2.18)
  • Decrease in NIHSS score ≥8 points from baseline or score ≤1 at 7 days or discharge: 30.7% vs. 11.4% (OR 2.62, 95% CI 1.70-4.56)
  • Mean increase in infarct volume at 24 hours: 51.6 vs. 119.5 mL, mean difference -67.9 mL (95% CI -84.1 to -51.6)

The primary safety outcome, all-cause death at 90 days for thrombectomy vs. medical therapy, was: 36.1% vs. 55.5% (relative risk [RR] 0.65, 95% CI 0.50-0.84, p < 0.001).

Secondary safety outcomes:

  • Symptomatic intracerebral hemorrhage within 24 hours for thrombectomy vs. medical therapy: 9.6% vs. 5.7% (RR 1.73, 95% CI 0.78-4.68)
  • Thrombectomy procedure-related adverse event: 6.9%

Interpretation:

The LASTE trial was terminated early after several interim studies showed benefit associated with thrombectomy in acute ischemic stroke with large infarct size. The current data similarly demonstrate sizable improvement in post-infarct disability, an effect which persisted to at least 6 months. All-cause death, which occurred in over half of the medical therapy arm, was also significantly lower post-thrombectomy. These findings persisted despite a somewhat higher incidence of intracerebral hemorrhage in the thrombectomy arm.

Particularly noteworthy was the inclusion of patients with ASPECTS <3, who were excluded in other studies due to theoretical risk of reperfusion injury in the most extensive infarcts. In contrast, although no subgroup interactions were observed, patients <80 years of age with ASPECTS of 1 or 2 may have derived even greater clinical benefit from thrombectomy. Future investigation may clarify whether this extends to more elderly patients with extensive infarcts.

References:

Costalat V, Jovin TG, Albucher JF, et al., on behalf of the LASTE Trial Investigators. Trial of Thrombectomy for Stroke With a Large Infarct of Unrestricted Size. N Engl J Med 2024;390:1677-89.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Aortic Surgery, Interventions and Vascular Medicine

Keywords: Endovascular Procedures, Ischemic Stroke, Thrombectomy


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