Finding a Faster Path to Treatment for Stroke

100th Patient Enrolled in WE-TRUST Clinical Trial

Milestone enrollment marks major progress in Philips-sponsored WE-TRUST clinical trial assessing the patient benefits of the ‘Direct to Angio Suite’ treatment pathway

December 12, 2023  - On November 29, the WE-TRUST* study – a large-scale clinical trial investigating a faster path to treatment for stroke – enrolled its 100th patient, marking an important milestone in the target of enrolling more than 500 stroke patients by the end of 2024. The 100th patient, a +70-year-old female admitted less than three hours after symptom onset, was enrolled at the Hospital Geral de Fortaleza in Brazil by the clinical team of Dr. Francisco Mont'Alverne and Dr. Fabricio Oliveira Lima.  

  
Through the WE-TRUST study, Philips is driving innovation in stroke treatment. With 16 leading stroke centers and hospitals around the world involved in the trial and 100 patients enrolled, the WE-TRUST study has already achieved the scale and momentum needed to deliver a reliable evidence base on the potential benefits of the ‘Direct to Angio Suite’ (DTAS) pathway for patients suspected of having a large vessel occlusion (LVO) ischemic stroke – a treatment pathway that focuses squarely on addressing the fact that the faster a patient is treated, the more likely they are to recover. 
  
Principal investigator Professor Raul Nogueira, Director of the UPMC Stroke Institute (Pittsburgh, USA), on the WE-TRUST study 

“We believe the main benefit the WE-TRUST study will bring to patients and society is that if we can treat patients on average 30 to 45 minutes faster [1] [2], we are going to rescue more brain tissue, and therefore improve outcomes. When we designed the study, it was based on the premise that the CT or MR images for about 85% of stroke patients that present within the first six or eight hours after symptom onset indicate that the patients are suitable for thrombectomy treatment to remove the blood clot in their brain. So in the conventional treatment pathway, we are doing CT or MR imaging to potentially exclude 15% of the patients who don’t have a favorable imaging profile for thrombectomy. However, we suspected that even those patients could still benefit from treatment. As six large randomized clinical trials have now confirmed that this is the case, we have an even stronger reason to pursue this trial.” 
  
Principal investigator Dr. Marc Ribó, interventional neurologist at Vall d'Hebron University Hospital (Barcelona, Spain), on the significance of reaching the 100th patient enrolled in the trial and on the health economic benefits of DTAS 

“When you begin clinical studies, you typically struggle with recruitment at first and it seems like you are never going to get to the finish line. However, once you get to a critical mass of participating centers with well-trained people then recruiting usually flies. So it appears that we've gone through the most difficult part of WE-TRUST and now we have a consistent number of participating centers that are screening and recruiting patients every week. As a result, recruitment for WE-TRUST is growing quickly and steadily, which we are very happy about. The sites that are active now are really promising, with nearly all of them heavily involved in recruitment.” 
  
Implementing direct transfer to the angio suite will hopefully show that we are not only helping patients, but also reducing societal costs and economic costs for hospitals. We are not only reducing disability, we're reducing length of stay and reducing the cost to hospitals. These savings can then be used to implement new angio suites dedicated to stroke admissions, because if you want to consistently implement direct transfer to the angio suite every hour of the day, you need to think about having a dedicated space for these patients.

Professor Serdar Geyik, Professor of Interventional Neuroradiology, and Dr. Arsida Bajrami, interventional stroke neurologist at Florya Medicalpark Hospital, Istanbul Aydin University Stroke Center (Istanbul, Turkey) on the reason they joined the WE-TRUST study and on enrolling the highest number of WE-TRUST patients 

“We needed to answer the question: which pathway is better for triaging the patient in our hospital – direct-to-angiography or conventional imaging? There are three main reasons why we are the top enroller in WE-TRUST. The first is that we are a high-volume stroke center. We perform around 400 thrombectomies a year, which gives us the capability to enroll more patients. The second is the organization of our center, which involves a group of dedicated stroke physicians and dedicated stroke technicians, plus two angio suites. We don't have separate teams. There is no emergency room or separate neuro team in our scenario. There is just one dedicated stroke team. They take the patient and then decide to enroll or not to enroll. And that's it. All of which means we are ready to accept direct to angio patients most times of the day. The third reason is our firm commitment to enroll patients to see how beneficial this study will be, because we believe very much in WE-TRUST and the direct-to-angio approach. It promises to be a whole new revolution, because everyone right now is trying to shorten the triage time and do fast thrombectomy. If we can prove that the DTAS pathway achieves better outcomes for patients compared to the conventional pathway, it will be beneficial for the whole world.” 
  
For more information on the WE-TRUST clinical trial, visit wetrust-study.com 

* WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast StrokeTreatment) https://www.clinicaltrials.gov/study/NCT04701684

[1] ANGIOCAT: 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)

[2] Psychogios, M.-N., et al.: The DTAS protocol decreased the median door–to–arterial puncture time (68 minutes [IQR, 53-89 minutes] vs 102 minutes [IQR, 85-117 minutes]; P < .001)