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Randomized Controlled Trial
. 2021 Sep 1;78(9):1099-1107.
doi: 10.1001/jamaneurol.2021.2385.

Direct to Angiography Suite Without Stopping for Computed Tomography Imaging for Patients With Acute Stroke: A Randomized Clinical Trial

Manuel Requena  1   2 , Marta Olivé-Gadea  1   2 , Marian Muchada  1   2 , David Hernández  3 , Marta Rubiera  1   2 , Sandra Boned  1   2 , Carlos Piñana  3 , Matías Deck  1   2 , Álvaro García-Tornel  1   2 , Humberto Díaz-Silva  3 , Noelia Rodriguez-Villatoro  1   2 , Jesús Juega  1   2 , David Rodriguez-Luna  1   2 , Jorge Pagola  1   2 , Carlos Molina  1   2 , Alejandro Tomasello  3 , Marc Ribo  1   2
Affiliations
Randomized Controlled Trial

Direct to Angiography Suite Without Stopping for Computed Tomography Imaging for Patients With Acute Stroke: A Randomized Clinical Trial

Manuel Requena et al. JAMA Neurol. .

Abstract

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Tomasello reported receiving personal fees from Anaconda Biomed, Balt, Medtronic, Perflow, and Stryker outside the submitted work. Dr Ribo reported receiving personal fees from Anaconda Biomed, AptaTargets, Cerenovus, Johnson & Johnson, Medtronic, Methinks, Philips, Sanofi, Stryker, and Rapid AI outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. ANGIOCAT Trial Flow Diagram
DTCT indicates direct transfer to computed tomography; EMS, emergency medical services; ICH, intracranial hemorrhage; LVO, large vessel occlusion; and mITT, modified intention-to-treat.
Figure 2.
Figure 2.. Percent Distribution of Modified Rankin Scale (mRS) Scores at 90 Days by Treatment in the Modified Intention-to-Treat Population
Shown are mRS scales for patients in the direct transfer to angiography suite (DTAS) group and the direct transfer to computed tomography (DTCT) group who were evaluated by a central assessor blinded to group assignment. There was a significant difference between the DTAS group and the control DTCT group in the overall distribution of scores after adjustment for age, National Institutes of Health Stroke Scale score at baseline, time from stroke onset to admission, premorbid functional status, and atrial fibrillation (adjusted common odds ratio for improvement of 1 point on mRS, 2.2; 95% CI, 1.2-4.1).
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References

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