Key PointsQuestion
Does direct transfer to angiography suite (DTAS) improve
functional outcomes compared with usual imaging workflow for patients
within 6 hours of onset of symptoms for large vessel occlusion ischemic
stroke?
Findings
In this randomized clinical trial including 174 patients with
suspected large vessel occlusion stroke on admission, large vessel
occlusion was confirmed in 147. The use of a DTAS protocol improved
in-hospital workflow times, increased the rate of endovascular
treatment, and decreased the severity of disability across the range of
modified Rankin Scale scores.
Meaning
For patients with acute ischemic stroke due to large vessel
occlusion within 6 hours of symptom onset, compared with usual imaging,
the use of DTAS led to safe patient triage for acute stroke endovascular
treatment, decreased workflow times, and improved outcomes; ongoing
international, multicenter clinical trials are exploring the
generalizability of these results.
Importance
Direct transfer to angiography suite (DTAS) for patients with
suspected large vessel occlusion (LVO) stroke has been described as an
effective and safe measure to reduce workflow time in endovascular
treatment (EVT). However, it is unknown whether DTAS improves long-term
functional outcomes.
Objective
To explore the effect of DTAS on clinical outcomes among patients with LVO stroke in a randomized clinical trial.
Design, Setting, and Participants
The study was an investigator-initiated, single-center,
evaluator-blinded randomized clinical trial. Of 466 consecutive patients
with acute stroke screened, 174 with suspected LVO acute stroke within 6
hours of symptom onset were included. Enrollment took place from
September 2018 to November 2020 and was stopped after a preplanned
interim analysis. Final follow-up was in February 2021.
Interventions
Patients were randomly assigned (1:1) to follow either DTAS
(89 patients) or conventional workflow (85 patients received direct
transfer to computed tomographic imaging, with usual imaging performed
and EVT indication decided) to assess the indication of EVT. Patients
were stratified according to their having been transferred from a
primary center vs having a direct admission.
Main Outcomes and Measures
The primary outcome was a shift analysis assessing the
distribution of the 90-day 7-category (from 0 [no symptoms] to 6
[death]) modified Rankin Scale (mRS) score among patients with LVO
whether or not they received EVT (modified intention-to-treat
population) assessed by blinded external evaluators. Secondary outcomes
included rate of EVT and door-to-arterial puncture time. Safety outcomes
included 90-day mortality and rates of symptomatic intracranial
hemorrhage.
Results
In total, 174 patients were included, with a mean (SD) age of
73.4 (12.6) years (range, 19-95 years), and 78 patients (44.8%) were
women. Their mean (SD) onset-to-door time was 228.0 (117.9) minutes, and
their median admission National Institutes of Health Stroke Scale score
was 18 (interquartile range [IQR], 14-21). In the modified
intention-to-treat population, EVT was performed for all 74 patients in
the DTAS group and for 64 patients (87.7%) in the conventional workflow
group (P = .002). The DTAS protocol decreased the median
door–to–arterial puncture time (18 minutes [IQR, 15-24 minutes] vs 42
minutes [IQR, 35-51 minutes]; P < .001) and door-to-reperfusion time (57 minutes [IQR, 43-77 minutes] vs 84 minutes [IQR, 63-117 minutes]; P < .001).
The DTAS protocol decreased the severity of disability across the range
of the mRS (adjusted common odds ratio, 2.2; 95% CI, 1.2-4.1; P = .009). Safety variables were comparable between groups.
Conclusions and Relevance
For patients with LVO admitted within 6 hours after symptom
onset, this randomized clinical trial found that, compared with
conventional workflow, the use of DTAS increased the odds of patients
undergoing EVT, decreased hospital workflow time, and improved clinical
outcome.
Trial Registration
ClinicalTrials.gov Identifier: NCT04001738
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