The Lancet: Urgent stroke guidelines changing


Results from an Australian-led international clinical trial, published in The Lancet, address intense debate around the best urgent stroke treatment. It confirms that bridging therapy (intravenous thrombolysis combined with endovascular thrombectomy), produces better patient outcomes than endovascular thrombectomy alone, and is safe.

Peter Mitchell Bernard Yan

The article, involving several Australian Stroke Alliance partners, is changing practice guidelines around the world. We spoke to lead authors Professor Peter Mitchell, the director of Neurointervention at Melbourne Health, and Professor Bernard Yan, Royal Melbourne Hospital neurologist and endovascular neurointerventionist,  to find out more.

The article, published in what is considered to be the #1 medical journal in the world, features the results of the DIRECT-SAFE study, and can be read here.

Why was the DIRECT-SAFE study undertaken?

For people experiencing an acute stroke, standard treatment involves the use of intravenous thrombolysis (to dissolve the clot) and endovascular thrombectomy (to remove the clot).  However, as joint lead author of the study Professor Peter Mitchell explains, there has been “increasing unease in giving patients intravenous thrombolytics due to fears of increasing haemorrhage and clot migration”.  

In order to address these concerns, DIRECT-SAFE (an international clinical trial involving acute-care hospitals across Australia, New Zealand, China and Vietnam) was designed to investigate whether “bridging therapy” (intravenous thrombolysis combined with thrombectomy) or thrombectomy alone delivered optimal outcomes for stroke patients.

What were the results of the DIRECT-SAFE study?

The trial looked at both the safety aspects and the effectiveness of the two treatment approaches.  The results showed that bridging therapy produced better outcomes than thrombectomy alone, as measured by functional independence at 90 days, post stroke.  Importantly, the safety outcomes were also shown to be similar between the two groups.

Discussing the results, joint lead author, Professor Bernard Yan, says the study “showed that bridging treatment was better, especially in Asian region patients. Patients in the bridging treatment arm had better outcomes across the entire study”.

Why are the findings of DIRECT-SAFE important?

DIRECT-SAFE has provided critical information on the optimal approach for the acute treatment of stroke, which has been a topic of intense debate in recent years.

This is ground-breaking and resolves the unease around the world about giving or not giving intravenous thrombolytics before thrombectomy. It will change practice and has already changed European stroke guidelines.
Professor Peter Mitchell

Professor Yan, adds that “as well as being the final piece of evidence confirming bridging therapy as optimal, the productive and seamless integration and collaboration of high level researchers and sites across Australia, New Zealand, China and Vietnam establishes a network well positioned to answer future research questions”.

As practice guidelines continue to evolve as a result of international collaboration, the Australian Stroke Alliance is committed to contributing to optimal urgent stroke care. A powerful “stroke ecosystem” is developing across the country, with international implications.

Read the published paper

“Endovascular thrombectomy versus standard bridging thrombolytic with endovascular thrombectomy within 4·5 h of stroke onset: an open-label, blinded-endpoint, randomised non-inferiority trial” can be viewed here.