DETERMINE
(2026)Objective
Test whether individualized blood pressure control (MAP within 10% of the reference MAP measured before thrombectomy) improves 90-day functional outcome versus standard BP control (SBP 140-180 mm Hg) during mechanical thrombectomy for acute ischemic stroke due to anterior large vessel occlusion.
Study Summary
• Ordinal mRS shift at 90 days did not favor individualized BP (adjusted OR 0.84, 95% CI 0.59-1.18); mRS 0-1: 28.4% vs 31.1% (aOR 0.87, 0.56-1.35).
• 90-day all-cause mortality 18.8% vs 16.4% (aOR 1.19, 95% CI 0.70-2.03); symptomatic ICH (ECASS-III) 7.9% vs 6.9% (aOR 1.17, 95% CI 0.55-2.47).
Intervention
Individualized BP control during MT (MAP maintained within ±10% of reference MAP measured on angiosuite arrival) using continuous IV diluted norepinephrine, vs standard BP control (SBP 140-180 mm Hg per SNACC/AHA/ESO guidelines).
Inclusion Criteria
Age ≥18 y with acute ischemic stroke due to anterior LVO (intracranial ICA, M1 or proximal M2, A1, or tandem occlusion) eligible for mechanical thrombectomy per European/North American guidelines; perfusion imaging not required in the early time window (<6 h).
Study Design
Arms: Individualized BP (n=214) vs Standard BP (n=218)
Patients per Arm: 214 vs 218 (433 randomized, 1 excluded for consent withdrawal; ITT analysis)
Outcome
• Secondary — ordinal mRS shift aOR 0.84 (0.59-1.18); mRS 0-1: 28.4% vs 31.1% (aOR 0.87, 0.56-1.35); early neuro improvement at 24 h: 37.6% vs 36.5% (aOR 1.05, 0.69-1.57); mTICI 2b-3: 87.4% vs 86.7% (aOR 1.10, 0.62-1.95).
• Safety — 90-d mortality 18.8% vs 16.4% (aOR 1.19, 0.70-2.03); sICH ECASS-III 7.9% vs 6.9% (aOR 1.17, 0.55-2.47); sICH SITS-MOST 2.4% vs 2.4% (OR 0.81, 0.20-3.11).
• Class II evidence — no significant subgroup interactions.
Bottom Line
Individualized BP control (MAP within 10% of the reference MAP measured on angiosuite arrival) during thrombectomy for anterior LVO stroke did not improve 90-day functional independence compared with standard BP management (aOR 0.82, 95% CI 0.54-1.24; p = 0.34), with no safety concerns. Between-arm BP separation was minimal, likely reflecting the challenge of implementing narrow BP targets in real-world acute-stroke conditions.
Major Points
- Multicenter, open-label, blinded-endpoint RCT at 8 comprehensive stroke centers in France; 433 randomized, 432 analyzed (214 individualized vs 218 standard) in ITT.
- Individualized arm: MAP maintained within ±10% of reference MAP (mean of first 2 non-invasive measurements on angiosuite arrival) using continuous diluted IV norepinephrine, with nicardipine/urapidil for hypertension; no upper SBP limit.
- Standard arm: SBP 140-180 mm Hg (SNACC guidance), with pharmacotherapy at physician discretion for excursions.
- Primary outcome (mRS 0-2 at 90 d): 44.2% vs 48.8%, adjusted OR 0.82 (95% CI 0.54-1.24, p = 0.34) — numerically favoring standard care but non-significant.
- Ordinal mRS shift and all secondary efficacy endpoints (excellent outcome, early neuro improvement, reperfusion) were consistent with no benefit.
- Safety was similar: 90-d mortality 18.8% vs 16.4%; symptomatic ICH by ECASS-III 7.9% vs 6.9%; by SITS-MOST 2.4% vs 2.4%.
- Achieved BP separation between arms was minimal: mean intraprocedural MAP 101.5 vs 100 mm Hg; coefficient of variation of SBP identical (7.6); time within individualized target 58% vs 54%.
- No significant interactions across prespecified subgroups (age, sex, hypertension, NIHSS, time-to-treatment, sedation modality, IV thrombolysis, occlusion site, baseline SBP/MAP, center).
- MT was performed under conscious sedation in 91% of patients — the results may not generalize to general-anesthesia populations.
- Class II evidence: individualized BP management provides no functional-outcome benefit over standard BP control during MT for anterior LVO.
Study Design
- Study Type
- Multicenter, open-label, blinded-endpoint, randomized clinical trial (Class II)
- Randomization
- Yes
- Blinding
- Open-label to patients, investigators, and treating physicians; primary outcome (mRS at 90 d) and radiologic endpoints assessed by blinded assessors / central core lab.
- Sample Size
- 432
- Follow-up
- 90 days (±15 days)
- Centers
- 8
- Countries
- France
Primary Outcome
Definition: Favorable functional outcome at 90 days (±15 d), defined as modified Rankin Scale score 0-2, assessed by blinded certified neurologists or research nurses.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 106/218 (48.8%) | 94/214 (44.2%) | - (0.54-1.24) | 0.34 |
Limitations & Criticisms
- Minimal between-arm physiologic separation (mean MAP 101.5 vs 100 mm Hg; identical SBP coefficient of variation) undermines the ability to detect a true benefit of individualization — possible contamination as the same investigators managed both arms.
- Non-invasive intermittent BP monitoring every 2.5 minutes may miss short-lived excursions and forces reactive rather than proactive titration; only 58% of individualized-arm procedural time was within target.
- Conscious sedation used in 91% of cases limits generalizability to general-anesthesia populations — which are at higher risk of hypotension and where individualized BP control might plausibly matter more.
- Reference MAP was defined on angiosuite arrival rather than on hospital admission; pre-hospital and inter-hospital antihypertensive treatments were not systematically recorded.
- Open-label design with no upper SBP limit in the individualized arm and physician-discretion vasopressor choice in the control arm.
- 8 high-volume French comprehensive stroke centers with dedicated neuroanesthesiology teams — limits external validity.
- No screening log — selection bias cannot be excluded.
- Norepinephrine as the sole vasopressor may carry paradoxical deleterious effects in some patients; other agents were not tested.
Citation
Neurology 2026;107(5):e218420. DOI: 10.1212/WNL.0000000000218420