TENSION RCT – Thrombectomy for Large-Infarct Volume Strokes
January 9, 2024
Written by Laura Murphy
Spoon Feed
Endovascular thrombectomy plus medical care is better than medical care for patients with large vessel occlusion (LVO), even with established large infarcts.
Who gets a thrombectomy? Putting some TENSION on the guidelines
The TENSION trial was a prospective, multicenter, open-label, randomized trial in Europe and Canada that enrolled 253 patients between July 2018 and February 2023 with acute ischemic stroke due to LVO in anterior circulation and a large established infarct (ASPECTS score of 3-5) and NIHSS less than 26. Patients were randomized to endovascular thrombectomy with medical treatment or medical treatment alone up to 12h from stroke onset. Primary outcome was functional outcome across range of modified Rankin Scale (mRS) at 90 days, and primary analysis was done in intention-to-treat population.
The trial was stopped early for efficacy after the first interim analysis. At 90 days, endovascular thrombectomy was associated a shift in distribution of scores on mRS toward better outcome – adjusted common OR 2.58 (95%CI 1.60-4.15, p=0.0001) and with lower mortality – HR 0.67 (95%CI 0.46-0.98, p=0.038). There was also an increase in patients with independent neurologic outcome (mRS≤2) at 90 days (17% vs 2%, OR 7.16, 95%CI 2.12-24.21, p=0.0016). Analysis of patient-reported outcomes for physical and mental health at 90 days showed improvement in the endovascular thrombectomy compared to medical group. Results of per-protocol as well as subgroup analyses were similar, though the study was not powered for subgroup analyses due to being stopped early. Rates of intracranial hemorrhage were similar between the two groups.
The results of this study supported findings of other studies that have suggested improved functional outcomes with endovascular thrombectomy. However, this study utilized mostly unenhanced CT imaging (82%) rather than advanced imaging techniques, which differentiates it from prior studies. Authors noted that the rate of good functional outcomes in the medical group was lower in this trial despite similar NIHSS scores; they postulate that this may have been due to underestimation in ischemic lesion size due to predominance of non-contrast CT use. Lastly, it is the first study to demonstrate a mortality benefit to endovascular thrombectomy of large core strokes, though this should be interpreted with caution since the study was not powered to assess this due to early cessation.
How will this change my practice?
Current guidelines recommend endovascular thrombectomy in patients with ASPECTS score of 6 or greater, correlating to a minimal or moderate infarct size. This and other studies suggest clinical benefit to thrombectomy even for patients with lower ASPECTS scores and larger infarcts. I will be keeping an eye out for a guideline change and discussing possibility of thrombectomy with colleagues at my stroke center for patients with LVO and established infarcts.
Another spoonful: SELECT2 RCT – Endovascular Thrombectomy for Large Ischemic Strokes
Source
Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. Lancet. 2023 Nov 11;402(10414):1753-1763. doi: 10.1016/S0140-6736(23)02032-9. Epub 2023 Oct 11. PMID: 37837989.