First patients in France and the USA enrolled in global WE-TRUST trial to accelerate stroke diagnosis and treatment

The first patients in France and the USA have been enrolled into the large-scale WE-TRUST* multicenter randomized controlled clinical trial. This trial aims to evaluate whether a Direct to Angio Suite (DTAS) workflow can improve outcomes for early time-window stroke patients when compared to the conventional method where a diagnostic MR/CT scan is made before transfer to the angio suite. The Bicêtre Hospital in Paris (AP-HP**), France, has successfully recruited the first French patient in the WE-TRUST trial. The Baptist Stroke & Cerebrovascular Center, a comprehensive stroke center in Jacksonville (Florida, USA), has successfully enrolled the first patient in the USA. These steps are an important international expansion of the WE-TRUST trial, which is already running in several European and South American countries including Spain, Turkey, Germany, Brazil, The Netherlands, Argentina and France.

“Every second counts for acute stroke patients. It is critically important to act quickly and treat them as soon as possible for better results and a better quality of life,” said Ricardo Hanel, MD, PhD, neurosurgeon, Director of the Baptist Neurological Institute. “By incorporating US patients into the WE-TRUST trial, we aim to help provide data and outcomes that will inform clinical workflows, that in turn (and more importantly), benefit patients across the globe.”

The first patient that was treated in France had a severe stroke [1] and arrived directly at the hospital, going straight to the angio suite where within 30 minutes Dr Vanessa Chalumeau started the procedure to remove the blood clot in their brain. After the intervention, the patient’s condition improved significantly [2]. “By using the direct-to-angio approach we were able to diagnose and treat this patient faster than conventional methods,” said Laurent Spelle, MD, PhD, interventional neuroradiologist and Chairman at NEURI Brain Vascular Center at Bicêtre Hospital. “Our goal is to find more effective and efficient ways to diagnose, treat, and manage stroke, ultimately enhancing the quality of life for patients. By joining WE-TRUST we can help build the clinical evidence for the Direct to Angio Suite (DTAS) workflow, a new treatment approach that has great potential to improve patient outcomes.”

WE-TRUST

Every 30 minutes of delay before treatment reduces the chance of a good outcome by 14% [3], and every hour ages the brain by 3.6 years compared to a normally aging brain [4]. The WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment) trial investigates the clinical impact of the DTAS approach, which combines stroke diagnosis and treatment in a single angio suite session. Enabled by a cone-beam CT (CBCT) imaging tool already integrated into interventional angio suite systems such as Philips Image Guided Therapy System –  Azurion, the DTAS approach can potentially reduce the time to treatment for early time-window stroke patients (less than six hours after stroke onset).

“At Philips, we believe that implementing a Direct to Angio Suite workflow, where suspected stroke patients undergo diagnosis and treatment in a single room, holds the promise of saving critical minutes and preserving invaluable brain function," said Dr. Atul Gupta, Chief Medical Officer for Image Guided Therapy at Philips, who is also a practicing interventional radiologist. “While the outcomes of numerous single-center studies have already validated this belief, it is essential to conduct a multicenter clinical trial of the magnitude and scope of WE-TRUST to ascertain the DTAS approach as a benchmark in stroke care.”

WE-TRUST is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint trial that aims to engage 16 leading strokes sites and enroll a total of more than 500 patients across the United States, Brazil, Argentina, the Netherlands, Germany, France, Spain and Turkey. More information about the study can be found at wetrust-study.com.

Philips recently announced that the results of a health economics analysis published in the Journal of NeuroInterventional Surgery (JNIS) show that Philips’ direct-to-angio treatment pathway for stroke patients can save more than USD 3,000 per patient.

*The WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment) clinical trial is sponsored by Philips
**Assistance Publique–Hôpitaux de Paris (AP-HP) is the university hospital trust operating in Paris and the region Île-de-France.

[1] NIHSS of 19. The National Institutes of Health Stroke Scale (NIHSS) quantifies stroke severity based on weighted evaluation findings
[2] NIHSS of 4
[3] World Stroke Organization (WSO): Global Stroke Fact Sheet 2022 (https://www.world-stroke.org/assets/downloads/WSO_Global_Stroke_Fact_Sheet.pdf)
[4] U.S. National Stroke Association