With the publication of two more stroke trials, the evidence in favour of endovascular treatment in patients with acute ischaemic stroke has reached new heights. Data from SWIFT PRIME (Solitaire with the intention for thrombectomy as primary endovascular treatment) and REVASCAT (Randomized trial of revascularization with Solitaire FR device versus best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight hours of symptom onset), published online first in the New England Journal of Medicine (NEJM) and presented at the European Stroke Organisation conference (17–19 April, Glasgow, UK), add to that of three other trials—MR CLEAN, EXTEND-IA and ESCAPE—that have begun to change the face of ischaemic stroke treatment.
Both SWIFT PRIME and REVASCAT assessed if patients experiencing an acute ischaemic stroke and treated with a stent retriever (Solitaire, Covidien/Medtronic) in addition to current medical therapy, including IV t-PA when patients were eligible, had less stroke-related disability than patients treated with IV t-PA or medical therapy alone.
SWIFT PRIME assessed 196 patients and found that the addition of the Solitaire device significantly decreased post-stroke disability and increased the number of patients who were independent within 90 days after a stroke. The trial found that the addition of the Solitaire device significantly increased patients’ rate of return to functional independence compared to IV t-PA alone (60.2% vs. 35.5%, p=0.0002).
“SWIFT PRIME showed that treatment with the Solitaire device is safe, technically successful and substantially reduces long-term disability levels,” said Jeffrey L Saver, professor of Neurology, Geffen School of Medicine at the University of California, Los Angeles (UCLA) and director, UCLA Comprehensive Stroke Center, USA. “This treatment marks the beginning of a new era in stroke care.”
He further told NeuroNews, “This is a once in a generation advance in stroke care. The paradigm is changing. The best treatment for patients who have blockages in the large arteries in the brain is going to be to get t-PA and the clot retriever. Together they work much better than t-PA alone and that means that we have to change the medical system to ensure that patients are brought first to the sites where they can rapidly get t-PA started, but also to the specialised sites where they can do this procedure in the cath lab.”
Similarly, REVASCAT (206 patients), conducted at four comprehensive stroke centres in Catalonia, Spain, showed that patients treated with the Solitaire device in addition to medical therapy (which included IV t-PA in eligible patients that comprised 70% of subjects enrolled) up to eight hours from onset of symptoms, experienced a statistically significant improvement in the rate of return to functional independence (43.7% vs. 28.2%) in favour of patients treated with the Solitaire device when compared to medical therapy alone.
All five of the now-published trials have shown that the amount of time to treatment has a significant impact on outcomes. SWIFT PRIME demonstrated dramatic improvements in workflow (the complete cycle of care from diagnosis through treatment) compared to previous trials. The trial was conducted at 39 centres across seven countries, demonstrating broad applicability in different health systems and the achievability of fast, efficient stent thrombectomy care.
“We now have five global trials that provide an overwhelming body of clinical evidence in support of [stent retriever] thrombectomy,” said Antoni Davalos, director, Department of Neurosciences, Hospital Universitari Germans Trias i Pujol. “Based on these findings, it is time for the stroke community to come together to re-evaluate stroke treatment guidelines and to look for systems to facilitate the access of treatable patients to specialised centres.”