TENSION Trial: EVT for Large-Core Stroke Selected Mainly by Non-Contrast CT
In patients with anterior circulation LVO and ASPECTS 3 to 5 selected predominantly by non-contrast CT treated within 12 hours, does endovascular thrombectomy plus medical treatment shift the mRS distribution toward better outcomes at 90 days compared with medical treatment alone?
Bendszus et al. (Lancet 2023) · 253 patients
Population
Included
- Age 18 years or older, with a pre-specified upper bound of 80 years per protocol
- Acute ischemic stroke from anterior circulation large vessel occlusion (intracranial ICA or M1)
- Large established infarct defined as ASPECTS 3 to 5 on non-contrast CT or DWI; perfusion imaging not required
- Treatment feasible within 12 hours of stroke onset or last-known-well
- NIHSS less than 26
- Pre-stroke mRS 0 or 1
- Randomization within 11 hours after stroke onset (if known) or last seen well
- Endovascular treatment is expected to be finished within 12 hours after known symptom onset
- Clinical signs and symptoms attributable to target occlusion with impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes
- NIHSS Score of <26
- Signed informed consent (IC) form by patient or legal guardian
- Prior to new focal neurological deficit, mRS score was ≤2
- A new focal occlusion confirmed by imaging (MRA/CTA) of the M1 segment of the middle cerebral artery or the intracranial segment of the distal internal carotid artery
- CT (non-contrast CT) or DWI with an ASPECT score of 3-5
Excluded
- Pre-stroke mRS greater than 1
- High-grade extracranial stenosis requiring stent placement during EVT
- Vascular access or anatomy precluding endovascular thrombectomy
- Acute intracranial hemorrhage or significant mass effect
- Standard contraindications to endovascular thrombectomy
- Active participation in another clinical trial
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- Known vascular disease preventing endovascular treatment
- Contraindication for contrast medium
- Patient is known to have infective endocarditis
- Anticipated life expectancy of less than 12 months
- Extracranial high-grade stenosis requiring acute stent placement
- Mass effect, intracranial tumor, or evidence of acute hypodensity on CT consistent with established infarction beyond eligibility
- CBV/DWI abnormalities with an ASPECT score of 0-2
Source: ClinicalTrials.gov NCT03094715· Retrieved 2026-06-08
Primary Outcome — mRS Ordinal Shift at 90 Days
All randomized patients (anterior circulation LVO, ASPECTS 3 to 5)
mRS Ordinal Shift at 90 Days
cOR 2.58
95% CI 1.6 to 4.15 · P <0.001
Median mRS — EVT
4
Median mRS — Medical Treatment
5
Mortality: 40% (EVT) vs 51% (medical treatment) · sICH: 5% both arms
Study Arms
- Agent
- Mechanical thrombectomy (stent retriever and/or aspiration, with or without balloon protection)
- Route
- Endovascular
- Frequency
- Single procedure; technique/device at operator discretion
- Duration
- Initiated within 11 h of onset/LKW; expected completion within 12 h of onset
- Co-interventions
- Standard medical management per national and international guidelines, including IV thrombolysis (alteplase) when indicated. IV alteplase given in 49/125 (39%) of EVT-arm patients (Table 1, p.1757).
Stent retriever, aspiration, or both, with/without balloon protection; operator choice (Procedures, p.1755). Successful reperfusion = mTICI 2b+.
- Agent
- Best medical management per national/international guidelines
- Route
- Medical
- Duration
- Acute hospitalization
- Co-interventions
- IV thrombolysis (alteplase) when indicated. IV alteplase given in 44/128 (34%) of medical-treatment-arm patients (Table 1, p.1757).
No endovascular thrombectomy. Substantive control = guideline-based medical management incl. thrombolysis where eligible (Methods, p.1755).
Trial Design
Type
- Prospective multicenter randomized large-core trial
- EVT plus medical treatment vs medical treatment alone
- Anterior circulation LVO with ASPECTS 3-5
- Predominantly non-contrast CT selection up to 12 hours
Timeline
Enrolled 2018-2023; stopped early for efficacy
N
253
Enrollment
European multicenter RCT enrolling 253 patients between 2018 and 2023 (Bendszus Lancet 2023). Stopped early at the first interim analysis for efficacy.
ClinicalTrials.gov
NCT03094715Bedside Pearl
For an anterior circulation LVO patient with ASPECTS 3 to 5 inside 12 hours, TENSION supports proceeding to thrombectomy on non-contrast CT alone; you do not need to wait for perfusion imaging to make the decision. Frame the discussion around mortality reduction (51% to 40%) and median mRS shift from 5 to 4, not around independence.
See also