Large Core Stroke Thrombectomy Is Safe and Effective Regardless of Prior Antithrombotic or Thrombolytic Treatment: A Secondary Analysis of the Randomized TENSION Trial

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BACKGROUND: The relevance of prior antithrombotic and thrombolytic treatment for decision-making regarding endovascular thrombectomy (EVT) for acute ischemic stroke due to large vessel occlusion with established large infarcts is uncertain. This study investigates associations of prior antithrombotic medication and thrombolysis with the efficacy and safety of EVT for acute ischemic stroke due to large vessel occlusion with established large infarct. METHODS: TENSION (Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window) was a prospective randomized open-label blinded-end point clinical trial. Patients with acute ischemic stroke due to large vessel occlusion and established large infarct were randomized to EVT with medical therapy or medical therapy alone. Exposures were preadmission antithrombotic treatment with antiplatelet agents or anticoagulants and intravenous thrombolysis. The primary efficacy end point was functional outcome at 90 days. Safety outcomes included death and symptomatic intracranial hemorrhage. RESULTS: The study included 246 patients (median age, 74 years; interquartile range, 65 to 80 years; 49% women); 124 (50%) were assigned to EVT. Of 176 patients (72%) with prior antithrombotic therapy, 75 (31%) received antiplatelets, 56 (23%) anticoagulants, and 89 (36%) intravenous thrombolysis. EVT was associated with better functional outcome in patients with (common odds ratio [cOR], 2.40 [95% CI, 1.22-4.99]) and without (cOR, 2.29 [95% CI, 1.53-3.46]) antiplatelet therapy; with (cOR, 2.45 [95% CI, 1.17-5.28]) and without (cOR, 2.12 [95% CI, 1.44-3.15]) anticoagulation; as well as receiving (cOR, 1.46 [95% CI, 0.83-2.61]) and not receiving (cOR, 2.89 [95% CI, 1.87-4.51]) thrombolysis. Interaction analyses were consistent with similar treatment effects across subgroups. Mortality and rates of symptomatic intracranial hemorrhage were similar between groups. CONCLUSIONS: Benefit and safety of EVT were not modified by prior antithrombotic/thrombolytic therapy. Preadmission exposure to antiplatelets or anticoagulants or use of intravenous thrombolysis should not exclude eligible patients with stroke from EVT. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03094715.

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