A large new international study hoping to extend the benefits of mechanical thrombectomy has been launched.
Thrombectomy is a treatment for certain types of acute ischaemic stroke that can use mechanical devices to drastically reduce the effects of an ongoing stroke. Very small devices are used to break and remove the clot from the blood vessel in the brain. This procedure is carried out by highly skilled neuro-radiologists and requires special hospital facilities.
Recent thrombectomy trials have included highly selected groups of stroke patients. They showed that if used in stroke patients with only small brain lesions, thrombectomy significantly reduces the level of post-stroke disability by restoring blood flow and therefore limiting brain damage.
The new study, part of the EU funded TENSION project, will examine the effects of mechanical clot retrieval in a large group of patients in whom the benefit of thrombectomy is uncertain. TENSION will study if it is safe and effective to do thrombectomy in patients with so-called ‘extended lesions’, that is, larger areas of damaged brain when compared to the previous studies. Patients will also be able to enrol in the trial up to 12 hours after their symptoms first showed. This will extend the treatment to a larger group of patients: including, for instance, more of those who have a stroke during the night-time and are more likely to be delayed in getting to hospital.
TENSION is careful to include the patient perspective on the evaluation of the outcome of the trial and its treatment effects. Importantly, the trial will also provide evidence for the socio-economic benefits of increasing the use of mechanical thrombectomy.
The trial will enrol up to 714 patients in eight European countries and the project will run for 5 years from February 2018. TENSION is co-ordinated by Prof. Dr. Götz Thomalla of the Universitätsklinikum Hamburg-Eppendorf in Hamburg and Prof. Dr. Martin Bendszus of the Universitätsklinikum Heidelberg and has received funding from the EU Horizon 2020 programme. Prof. Thomalla said “TENSION addresses a major health problem and will provide evidence for an effective therapeutic intervention for patients with severe stroke. This means we will get better individual patient outcomes and avoid stroke-related disability in a large number of patients. At the societal level, the new treatment will help in reducing stroke-related costs.”
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International project launches to prevent stroke in patients with brain bleeding
A new multi-million Euro initiative funded by the European Commission has been set up to help prevent stroke in patients with existing conditions.
The €6.9m project is aimed at patients with atrial fibrillation (AF), a common heart condition which causes irregular and abnormally fast heartbeat, who have previously had a stroke caused by bleeding in the brain (termed intracerebral haemorrhage or ICH). The Prevention of Stroke in intracerebral hemorrhage survivor with Atrial Fibrillation (PRESTIGE-AF) brings together scientists and clinicians across Europe with the goal of reducing the risk of further stroke in this group of patients.
Stroke is one of the largest public health challenges around the world, and occur when the blood supply to the brain is interrupted, such as through a clot or a brain bleed. It is the most common cause of adult-acquired disability, the second leading cause of death globally and the second most frequent cause of dementia. In addition, its impact is expected to further increase in the coming decades due to the ageing population.
At the core of the PRESTIGE-AF project will be a clinical trial to gather evidence around recommended medication for stroke prevention in patients with AF. Several sub-studies will explore individual predictive risk modelling using brain imaging, genetic testing and other biological markers. Other aspects of the project will include exploring cognitive and psychological factors and drug adherence by patients.
The five-year project will be led by Professor Roland Veltkamp from the Department of Medicine at Imperial College London and involves 11 other partner institutions throughout the UK and across Europe. Professor Veltkamp said: “Prevention of stroke is challenging in vulnerable stroke patients with multiple disorders and interacting risks. It’s this complexity that makes it difficult to work out the best individual preventive strategy for a particular patient. Working with our international partners through the PRESTIGE-AF initiative we hope to tackle some of the unmet needs of these patients and develop more personalised treatments. Prevention is key, and ultimately we aim to prevent stroke and the impact it has on patients’ lives.”
The Stroke Alliance for Europe (SAFE) has responsibility in the project for disseminating information about TENSION to the stroke community. For more information, please contact email@example.com.
PRESTIGE-AF has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 754517.