The Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window - TENSION

Nov 22, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Trial Sponsor:
EU Horizon 2020
Date Published:
10/11/2023
Date Updated:
11/22/2023
Original Posted Date:
11/22/2023
References

Contribution To Literature:

The TENSION trial showed that endovascular thrombectomy improves functional outcomes and reduces mortality compared with medical treatment alone.

Description:

The goal of the trial was to evaluate endovascular thrombectomy compared with medical treatment alone among patients with large vessel acute ischemic stroke.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Open-label

Patients with acute ischemic stroke due to large vessel occlusion were randomized to endovascular thrombectomy (n = 125) versus medical treatment alone (n = 128).

All patients underwent computed tomography (CT)/CT angiography or magnetic resonance imaging/magnetic resonance angiography according to institutional preference. Eligible strokes included occlusion of the M1 segment of the middle cerebral artery or occlusion of the distal internal carotid artery. Infarct size was determined by visual image assessment, rather than advanced imaging techniques or post-processing tools.

  • Total number of enrollees: 253
  • Duration of follow-up: 90 days
  • Median patient age: 73 years
  • Percentage female: 45%
  • Percentage with diabetes: 23%

Inclusion criteria:

  • Acute ischemic stroke due to large vessel occlusion
  • Ability to complete endovascular therapy within 12 hours of symptom onset
  • ≥18 years of age
  • National Institutes of Health Stroke Scale score <26

Exclusion criteria:

  • Vascular disease precluding endovascular thrombectomy
  • High-grade extracranial stenosis requiring stent placement
  • Acute intracranial hemorrhage or mass effect

Other salient features/characteristics:

  • Intravenous alteplase used in 39%
  • Median time between symptom onset and groin puncture was 4.2 hours
  • Endovascular thrombectomy consisted of aspiration thrombectomy and stent retriever in 60%, stent retriever alone in 23%, and aspiration thrombectomy alone in 17%

Principal Findings:

The primary outcome, median score on modified Rankin Scale (lower is better) was 4 in the endovascular thrombectomy group vs. 6 in the medical treatment alone group (p = 0.0001).

Secondary outcomes:

  • Mortality at 90 days: 40% in the endovascular treatment group vs. 51% in the medical treatment alone group (p = 0.038)
  • Symptomatic intracranial hemorrhage at 90 days: 5% in the endovascular treatment group vs. 5% in the medical treatment alone group (p = 1.0)

Interpretation:

Among patients with acute ischemic stroke due to large vessel occlusion, endovascular treatment was superior to medical treatment alone. Endovascular treatment improved functional outcome, which was demonstrated by a lower modified Rankin Scale score at 90 days. Endovascular treatment was also associated with lower mortality compared with medical treatment alone. Symptomatic intracranial hemorrhage was similar between the treatment groups. Patients assigned to endovascular treatment received this therapy within 12 hours of symptom onset. Infarct size was determined by visual image assessment of brain imaging, which should improve generalizability.

References:

Bendszus M, Fiehler J, Subtil F, et al., on behalf of the TENSION Investigators. Endovascular thrombectomy for acute ischemic stroke with established large infarct: multicenter, open-label, randomized trial. Lancet 2023;402:1753-63.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Aortic Surgery, Interventions and Vascular Medicine

Keywords: Endovascular Procedures, Ischemic Stroke, Thrombectomy


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