New results from the TENSION study—presented recently at the 15th World Stroke Congress (WSC; 10–12 October, Toronto, Canada) by Götz Thomalla (University Medical Center Hamburg-Eppendorf, Hamburg, Germany)—have demonstrated improved functional outcomes and reduced mortality rates among stroke patients treated via mechanical thrombectomy.
“TENSION shows that, just using a pragmatic, standard-of-care approach to acute stroke imaging, we can guide thrombectomy in stroke patients with a large core, improve outcomes, and save lives,” said Thomalla.
According to Thomalla and his colleagues’ publication of these findings in The Lancet, recent evidence—primarily from the RESCUE-Japan LIMIT, ANGEL-ASPECT and SELECT2 randomised trials—suggests a beneficial effect with thrombectomy in patients experiencing an acute ischaemic stroke caused by a large infarct.
“However, previous trials have relied on multimodal brain imaging, whereas non-contrast CT [computed tomography] is mostly used in clinical practice,” the authors note. As such, the generalisability of the three aforementioned trials is somewhat limited, and their results are yet to trigger a change in guidelines or clinical practice.
TENSION, a prospective, multicentre, open-label, randomised controlled study, was conducted at 40 hospitals in Europe and one site in Canada. Overall, 253 patients with acute ischaemic stroke due to a large vessel occlusion in the anterior circulation and a large, established infarct indicated by an Alberta stroke programme early computed tomographic score (ASPECTS) of 3–5, were randomly assigned (1:1) to receive either endovascular thrombectomy alongside standard of care, or standard of care alone, within an extended time window (up to 12 hours) from symptom onset.
The primary outcome was functional outcome across the entire range of modified Rankin scale (mRS) scores at 90 days—assessed by investigators masked to treatment assignment—in TENSION’s intention-to-treat population. Safety endpoints included rates of mortality and symptomatic intracranial haemorrhage (ICH).
While many of these aspects are similar to the other randomised trials supporting thrombectomy in large-core stroke patients to date, Thomalla et al emphasise that the modalities used in their study (82% non-contrast CT and 18% magnetic resonance imaging [MRI]) were based on standard-of-care stroke imaging and are therefore reflective of global clinical practice. This differs from the previous trials in which, by design, perfusion imaging or post-processing via commercial software was required.
TENSION was stopped early due to positive efficacy signals following its first preplanned interim analysis. As per the data presented by Thomalla at WSC 2023, there was a shift in the distribution of mRS scores towards better outcomes in favour of thrombectomy plus standard-of-care treatment as compared to standard of care alone at 90 days. In the trial, there was also a lower rate of mortality in the patients treated with thrombectomy, and comparable rates of symptomatic ICH between the two groups (6% for thrombectomy and 5% for standard of care).
“Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with [an] established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection,” Thomalla and colleagues write, concluding their paper in The Lancet.
In addition to the significance of the fact that TENSION utilised imaging modalities that are more widely accessible and commonly used in daily clinical practice than those employed by the other large-core trials published thus far, the authors highlight the lower 90-day mortality rate associated with thrombectomy in their study—a phenomenon that was not borne out in the results of RESCUE-Japan LIMIT, ANGEL-ASPECT, or SELECT2.