SWIFT DIRECT
Research type
Research Study
Full title
Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke
IRAS ID
278915
Contact name
Liqun Zhang
Contact email
Sponsor organisation
Universtiy Hospital Bern
Eudract number
2018-004464-57
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Summary of Research
Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke (SWIFT DIRECT)
Most strokes are caused by the blockage of one or more blood vessels in the brain, resulting in death of brain tissue due to lack of blood supply. A clot-busting (thrombolytic) drug was the only approved treatment for almost 20 years. Since December 2014, a new era in acute stroke treatment has begun: randomised controlled trials (RCTs) have consistently shown that direct removal of the blood clot in the brain by endovascular clot retrieval in addition to best medical treatment (with and without intravenous thrombolysis) improves functional outcome in stroke patients with proximal vessel occlusion compared to best medical treatment alone. No randomised controlled trial has ever assessed whether direct Mechanical Thrombectomy (MT) is equally effective as current standard treatment, i.e. patients treated with IV t-PA in combination with MT. Pooled patient data from clinical trials and registry data showed similar rates of functional independence and mortality at 90 days between patients who received thrombolytic drug before clot removal and those who received direct clot removal treatment without thrombolysis.
Therefore, SWIFT DIRECT has been designed as an international, multicentre, randomised controlled trial to ascertain whether immediate and direct MT is not inferior to bridging thrombolysis in patients directly referred to a stroke centre with rapid access to endovascular procedures.Summary of Results
Stroke study demonstrates excellent results with combination therapy
An international study led by the Inselspital, University Hospital Bern, demonstrates that in stroke patients with an occlusion of a large cerebral vessel, a combined procedure – first thrombolysis, then thrombectomy – shouldn’t be replaced by thrombectomy alone. Using combination therapy, the occluded cerebral vessel could be reopened in 96% of those affected. The researchers are therefore making an important contribution to clarifying an ongoing controversy amongst experts.
Around 80% of all strokes are caused by a hypoperfusion of the brain. The most common cause is a blood clot that blocks a cerebral vessel. This is referred to as a brain infarction or – using medical terminology – an ischaemic stroke. The clot stops the brain cells from receiving enough oxygen and nutrients, and therefore they die. To prevent permanent damage or even the death of the affected person is, the clot must be removed as quickly as possible.
Currently, the emergency treatment of cerebral infarction is based on two essential measures: thrombolysis, also known as lysis therapy, or lysis for short, and thrombectomy. Both pursue the same goal, namely the restoration of blood flow. Lysis therapy involves giving stroke patients a drug to dissolve the blood clot. Thrombectomy refers to the mechanical removal of the clot using catheters.Thrombectomy with or without prior thrombolysis?
As a rule, stroke patients who undergo thrombectomy, receive lysis first. However, as lysis treatment can increase the risk of bleeding, the question arises whether the combined procedure is necessary or whether thrombectomy alone – if performed immediately – can achieve equally good or even better results. Four recently published international studies came to contradictory conclusions, leading to uncertainty among experts.
A new international study led by the Stroke Center, Inselspital, University Hospital Bern, makes an important contribution towards settling this controversy. The study shows that the results of using thrombectomy alone are not as good as when the combined procedure – first lysis, then thrombectomy – is used. The results were published in the latest issue of the renowned medical journal "The Lancet".The chances of reopening the cerebral vessels are significantly higher with combination therapy
For the study, 408 patients with an acute stroke were recruited at 48 different stroke centres in Europe and Canada between 2017 and 2021. Half of the study participants were randomly assigned to un-dergo thrombectomy alone and the other half received a combination of thrombolysis and throm-bectomy.
With the combination therapy, blood flow to the blood vessels was restored in 96% of stroke patients, compared to only 91% of those treated with thrombectomy alone. The percentage of patients who were able to live independently again three months after the stroke was 65% if they had had combina-tion therapy and 57% if they had had thrombectomy alone. Patients’ risk of bleeding in the brain was not significantly higher after combination therapy than it was after thrombectomy alone (3% compared to 2%).REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0115
Date of REC Opinion
13 Jul 2020
REC opinion
Further Information Favourable Opinion