ANGEL-ASPECT Trial: Large Core Thrombectomy (China)
In Chinese patients with anterior LVO and large ischemic core (ASPECTS 3–5, OR ASPECTS 0–2 with core 70–100 mL), does endovascular thrombectomy improve the mRS distribution at 90 days compared with medical management?
Huo et al. (NEJM 2023;388(14):1272–1283) · doi:10.1056/NEJMoa2213379 · 456 patients
Population
Included
- Anterior LVO
- Age ≤80; NIHSS 6–30
- Pre-stroke mRS 0–1
- ASPECTS 3–5 (no core limit) OR ASPECTS 0–2 with core 70–100 mL OR ASPECTS >5 with core 70–100 mL (6–24h)
General
- Ages 18–80 years
- Symptoms consistent with acute ischemic stroke
- Pre-stroke mRS score 0–1
- NIHSS score 6–30 at randomization
- Randomization within 24 hours of stroke onset
- Informed consent signed
Neuroimaging
- CTA or MRA showing ICA terminal or M1 MCA occlusion
- NCCT ASPECTS combined with perfusion core volume meeting one criterion: ASPECTS 3–5; ASPECTS >5 (6h–24h) with core 70–100 ml; ASPECTS <3 with core 70–100 ml
Excluded
- ASPECTS ≥6 with smaller cores (use small-core evidence)
- Pre-stroke mRS ≥2
- Age >80
- NIHSS <6 or >30
- Significant mass effect
General
- Pregnancy or positive HCG in childbearing females
- Severe contrast allergy uncontrolled by medications
- Refractory hypertension (SBP >185 or DBP >110 mmHg)
- Hemorrhagic tendency (platelets <100×10⁹/L, APTT ≥35 s, INR >1.7)
- Recent organ surgery/biopsy (past month)
- Active/recent bleeding (past month)
- Hemodialysis/peritoneal dialysis or GFR <30 or creatinine >220 mmol/L
- Brain tumor with mass effect
- Expected survival <1 year
- Participation in confounding interventional trials
- Other investigator-deemed contraindications
Neuroimaging
- Midline shift, herniation, or mass effect with ventricular effacement
- Acute intracranial hemorrhage
- Bilateral strokes or multiple vessel occlusions
Source: ClinicalTrials.gov NCT04551664· Retrieved 2026-06-08
Primary Outcome — Ordinal mRS Shift
Ordinal-shift design: Primary is generalized OR for ordinal mRS shift (gOR 1.37, 95% CI 1.11–1.69, P=0.004). The mRS 0–2 binary (functional independence) shown below is a secondary outcome. Higher any-ICH rate than SELECT2 (49.1% vs 17.3%); careful BP management required.
mRS 0–2 at 90 Days (secondary)
Study Arms
- Agent
- Endovascular thrombectomy (stent retriever or contact-aspiration first-line; ± balloon angioplasty, stent implantation, or intraarterial thrombolysis as needed)
- Route
- Endovascular
- Frequency
- Single procedure
- Duration
- Within 24 h of stroke onset
- Co-interventions
- IV thrombolysis when eligible: alteplase 0.9 mg/kg or urokinase 1.0–1.5 million IU (~28% of patients in both groups); medical management per Chinese Stroke Association guidelines
Large-core selection broader than SELECT2: ASPECTS 3–5 (any core), ASPECTS >5 with core 70–100 ml (6–24 h), ASPECTS <3 with core 70–100 ml. ICA-terminal or M1 occlusion. Simple 1:1 randomization (Huo NEJM 2023 p.1274).
- Agent
- Standard medical management (no thrombectomy)
- Route
- Medical
- Duration
- Through hospitalization
- Co-interventions
- IV thrombolysis when eligible: alteplase 0.9 mg/kg or urokinase 1.0–1.5 million IU (~28% of patients in both groups); medical management per Chinese Stroke Association guidelines
Both arms received Chinese Stroke Association guideline-based management; ~28% in each group received IV thrombolysis. Full-dose alteplase (0.9 mg/kg), distinct from low-dose Japanese protocols. Substantive control (Huo NEJM 2023 p.1274).
Safety
Symptomatic ICH
6.1%
2.7%
6.1% EVT vs 2.7% medical (P=0.12, NS but trending higher). Higher than SELECT2. Careful BP management warranted.
90-day mortality
21.7%
20%
21.7% vs 20.0% (NS). No mortality penalty despite higher ICH rates.
Any ICH (radiographic + symptomatic)
49.1%
17.3%
49.1% EVT vs 17.3% medical (P<0.001). Most are asymptomatic but warrants vigilant monitoring.
Trial Design
Type
- Multicenter randomized open-label trial
- Conducted in China
- Large core selection (ASPECTS 3-5 or Core 70-100ml; also ASPECTS 0–2 with core 70–100mL)
- 1:1 allocation (Thrombectomy vs. Medical)
- Stopped early for efficacy (2nd interim)
Timeline
Enrolled 2020-2022
N
456
Enrollment
456 patients in China; age ≤80; NIHSS 6–30. Stopped early at 2nd interim. Published NEJM 2023;388(14):1272–1283.
ClinicalTrials.gov
NCT04551664Bedside Pearl
In a broader large-core population (China, includes ASPECTS 0–2 with core 70–100 mL), EVT improves ordinal mRS shift (gOR 1.37, P=0.004). Functional independence 30% vs 11.6% (NNT 5.4 from secondary). Higher ICH rates than SELECT2; BP management is critical.
See also