Endovascular thrombectomy for acute ischemic stroke with large infarct in randomized trials versus clinical practice: Comparison of the TENSION trial and the German Stroke Registry.

Randomized trials have shown that endovascular thrombectomy improves functional outcomes in patients with acute ischemic stroke and large infarct. However, there is continued debate about the generalizability of these results to routine clinical practice. To investigate whether functional outcomes reported in the randomized TENSION trial can be achieved in routine clinical practice. TENSION was a prospective, multicenter, randomized trial that enrolled patients with acute ischemic stroke and large infarct at 41 centers across Europe and Canada. Patients were randomized to endovascular thrombectomy or best medical treatment. The main inclusion criteria of TENSION were defined as pre-stroke mRS 0-2, randomization within 11 hours of symptom onset, occlusion of the intracranial ICA or M1 segment of the MCA, ASPECTS 3-5, and baseline NIHSS score 0-25. Patients from the thrombectomy arm of TENSION (TENSION-RCT) were compared to patients from the German Stroke Registry meeting the main inclusion criteria of TENSION (TENSION-GSR) using 1:1 propensity score matching. Primary outcome was the 90-day mRS score (shift analysis). Of 308 patients who met the inclusion criteria, 198 were matched (median age, 74 [IQR, 64-81]; 98 [49.5%] female; median 90-day mRS, 5 [IQR, 3-6]). There was no significant shift in 90-day mRS scores between TENSION-RCT and TENSION-GSR (acOR, 1.19; 95% CI, 0.70-2.02; p = 0.52). The proportions of independent ambulation (90-day mRS 0-3; 33.3% vs 31.3%, p = 0.76) and severe disability or death (90-day mRS 5-6; 50.5% vs 52.5%, p = 0.78) did not differ between TENSION-RCT and TENSION-GSR. Functional outcomes of the TENSION thrombectomy arm are achievable within comprehensive stroke centers in Germany. These findings support endovascular thrombectomy for acute ischemic stroke with large infarct and its broad implementation in routine care. The data that support the findings of this study are available upon reasonable request after approval of the steering committees of the TENSION trial and the GSR-ET.