JMIR Publications

ABSTRACT

Background:

Endovascular thrombectomy (ET), if possible combined with intravenous thrombolysis (IVT), has been shown to be an effective treatment option for stroke patients with confirmed anterior large vessel occlusion (aLVO). However, ET is mainly limited to comprehensive stroke centers, resulting in a lack of ET capacity in remote, sparsely populated areas. Most stroke networks use the "Drip and Ship" or "Mothership" strategy, resulting in either delayed ET or IVT, respectively.

Objective:

This study aims to evaluate the LESTOR strategy, developed for optimizing the preclinical part of the stroke chain of survival to improve clinical outcome. This includes refinement of dispatching strategy as well as allocation strategy after identification of acute aLVO stroke patients using a telephone aLVO-query or a structured aLVO examination at the emergency scene, respectively.

Methods:

This is a controlled, non-randomized study implementing the LESTOR strategy with a stepped-wedge, cluster trial design in six districts in southwest Germany. LESTOR started in April 2020 and will end in February 2024. An aLVO-query/dispatch protocol and a structured aLVO examination is developed, evaluated and tested. After the training of all participating healthcare professionals, the LESTOR strategy is implemented stepwise. Patients otherwise receive usual stroke care in both the control and intervention groups. The primary outcome is the modified Rankin Scale at 90 days in stroke patients receiving endovascular treatment. We use a generalized linear mixed model for data analysis. The study is accompanied by a cost-effectiveness analysis and a qualitative process evaluation.

Results:

Enrollment was completed in June 2023. Data analysis is ongoing and first results are expected to be submitted for publication in 2024.

Conclusions:

We expect that the intervention will improve the clinical outcome of patients with aLVO stroke, especially outside the catchment areas of CSCs. The results of the accompanying process evaluation and the cost-effectiveness analysis will provide further insights into the implementation process and allow for a better interpretation of the results. Clinical Trial: DRKS (German Clinical Trials Register) DRKS00022152. Registered 19th October 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022152. WHO UTN U1111-1253-5758.