Once again completely the wrong endpoints measured. Are you that much of blithering idiots that you don't realize the only goal in stroke is 100% recovery and everything is measured against that? Someday a stroke medical 'professional' will criticize me for suggesting they know nothing about stroke. I look forward to that discussion. Will reprint it verbatim!
Evaluation of acute mechanical revascularization in large stroke (ASPECTS ⩽5) and large vessel occlusion within 7 h of last-seen-well: The LASTE multicenter, randomized, clinical trial protocol
Abstract
Rationale:
Mechanical
thrombectomy (MT), the standard of care for acute ischemic stroke (AIS)
secondary to large vessel occlusion (LVO), is generally not offered to
patients with large baseline infarct (core). Recent studies demonstrated
MT benefit in patients with anterior circulation stroke and large core
(i.e. Alberta Stroke Program Early Computed Tomography Score, ASPECTS
3–5). However, its benefit in patients with the largest core (ASPECTS
0–2) remains unproven.
Aim:
To
compare the efficacy and safety of MT plus best medical treatment (BMT)
and of BMT alone in patients with ASPECTS 0–5 (baseline computed
tomography (CT) or magnetic resonance imaging (MRI)) and anterior
circulation LVO within 7 h of last-seen-well.
Sample size estimate:
To
detect with a two-sided test at 5% significance level (80% power) a
common odds ratio of 1.65 for 1-point reduction in the 90-day modified
Rankin Scale (mRS) score in the MT + BMT arm versus BMT arm and to
anticipate 10% of patients with missing primary endpoint, 450 patients
are planned to be included by 36 centers in France, Spain, and the
United States.
Methods and design:
LArge
Stroke Therapy Evaluation (LASTE) is an international, multicenter,
Prospectively Randomized into two parallel (1:1) arms, Open-label, with
Blinded Endpoint (PROBE design) trial. Eligibility criteria are
diagnosis of AIS within 6.5 h of last-seen-well (or negative
fluid-attenuated inversion recovery (FLAIR) if unknown stroke onset
time), ASPECTS 0–5 (ASPECTS 4–5 for ⩾80-year-old patients), and LVO in
the anterior circulation (intracranial internal carotid artery (ICA) and
M1 or M1–M2 segment of the middle cerebral artery (MCA)).
Study outcomes:
The
primary endpoint is the day-90 mRS score(WRONG, WRONG, WRONG!) distribution (shift analysis)
with mRS categories 5 and 6 coalesced into one category. Secondary
endpoints include day-180 mRS score, rates of 90-day and 180-day mRS
score = 0–2 and 0–3, rate of decompressive craniectomy, the National
Institutes of Health Stroke Scale (NIHSS) score change,
revascularization and infarct volume growth at 24 h, and quality of life
at day 90 and 180. Safety outcomes (90-day all-cause mortality,
procedural complications, symptomatic intracerebral hemorrhage, and
early NIHSS score worsening) are recorded. A dynamic balanced
randomization (1:1) is used to distribute eligible patients into the
experimental arm and control arm, by incorporating the center and these
pre-specified factors: baseline ASPECTS (0–3 vs 4–5), age (⩽70 vs
>70 years), baseline NIHSS (<20 vs ⩾20), intravenous thrombolysis
(no vs yes), admission mode (Drip-and-Ship vs Mothership), occlusion
site (intracranial ICA vs MCA—M1 or M1–M2), intravenous fibrinolysis (no
vs yes), and last-seen-well to randomization time (0–4.5 vs
>4.5–6.5 h).
Discussion:
The LASTE trial will determine MT efficacy and safety in patients with ASPECTS 0–5 and LVO in the anterior circulation.
Trial registration:
LASTE Trial NCT03811769.
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