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DETERMINE

Individualized vs Standard Blood Pressure Control During Thrombectomy for Ischemic Stroke: The DETERMINE Randomized Clinical Trial

Year of Publication: 2026

Authors: Maïer B, Gory B, Chabanne R, et al; DETERMINE Investigators

Journal: Neurology

Citation: Neurology 2026;107(5):e218420. DOI: 10.1212/WNL.0000000000218420

Link: https://doi.org/10.1212/WNL.0000000000218420

PDF: https://www.neurology.org/doi/pdf/10.121...000000000218420


Clinical Question

In adults undergoing mechanical thrombectomy for anterior large-vessel-occlusion ischemic stroke, does an individualized blood pressure strategy (MAP within ±10% of the reference MAP measured pre-procedure) improve 90-day functional outcome compared with a standard SBP 140-180 mm Hg target?

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.

Design

Study Type: Multicenter, open-label, blinded-endpoint, randomized clinical trial (Class II)

Randomization: 1

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.

Enrollment Period: March 10, 2021 - September 18, 2023

Follow-up Duration: 90 days (±15 days)

Centers: 8

Countries: France

Sample Size: 432

Power Calculation: Assumed 54% poor-outcome rate in controls; conservative RR estimate 0.75; alpha 5%; interim efficacy analysis at 50% inclusion using O'Brien-Fleming alpha spending; target 432 randomized patients for 80% power (p < 0.049 for primary).

Analysis: Intention-to-treat; generalized linear mixed models (Bernoulli) for binary outcomes with intervention and stratification factors (age <70 vs ≥70 y, sedation modality, baseline NIHSS <17 vs ≥17, IV thrombolysis) as fixed effects and center as a random effect; ordinal mRS analyzed via mixed ordinal logistic regression; SITS-MOST sICH unadjusted (rare events); multiple imputation (10 datasets, chained equations, Rubin's rules) for missing primary outcomes; per-protocol sensitivity analysis performed.


Inclusion Criteria

  • Age ≥18 years
  • Acute ischemic stroke due to an anterior large vessel occlusion (intracranial internal carotid artery, M1 segment MCA, proximal M2 segment MCA, A1 segment ACA, or tandem occlusion)
  • Eligible for mechanical thrombectomy per European and North American guidelines
  • Perfusion imaging not mandatory in early time window (<6 h)

Exclusion Criteria

  • Intubation or induction of general anesthesia before randomization
  • Posterior circulation stroke
  • Pre-stroke modified Rankin Scale score >2

Baseline Characteristics

CharacteristicIndividualized BP (n=214)Standard BP (n=218)
Age, y (mean, SD)69.1 (15)69.6 (15.1)
Female sex111/214 (51.9%)117/218 (53.7%)
Hypertension130/214 (61.9%)133/218 (61.0%)
Diabetes mellitus29/209 (13.9%)33/218 (15.1%)
Dyslipidemia65/209 (31.1%)60/217 (27.6%)
History of ischemic stroke27/210 (12.9%)27/218 (12.4%)
History of myocardial infarction9/209 (4.3%)17/218 (7.8%)
Pre-stroke mRS >26/214 (2.8%)5/218 (2.3%)
Directly admitted to CSC78/214 (36.4%)77/218 (35.3%)
Antihypertensive treatment at admission127/211 (60.2%)124/218 (56.9%)
Antiplatelet therapy at admission50/211 (23.7%)50/218 (22.9%)
Anticoagulant therapy at admission38/211 (18.0%)30/218 (13.8%)
Median NIHSS (IQR)15 (11-19)15 (10-19)
Median ASPECTS (IQR)8 (7-9)8 (7-9)
IV thrombolysis121/213 (56.8%)126/218 (57.8%)
Intracranial ICA occlusion32/213 (15.0%)15/217 (6.9%)
M1 occlusion125/213 (58.7%)112/217 (51.6%)
Proximal M2 occlusion40/213 (18.8%)46/217 (21.2%)
Tandem lesion15/213 (7.0%)28/217 (12.9%)
A1 occlusion1/213 (0.5%)2/217 (0.9%)
Conscious sedation194/212 (91.5%)199/218 (91.3%)
General anesthesia15/212 (7.1%)13/218 (6.0%)
Conversion CS → GA3/212 (1.4%)6/218 (2.8%)
Onset to groin puncture, min (median IQR)346 (245-630)311 (227-468)
Onset to randomization, min344 (244-608)306 (220-459)
Onset to reperfusion, min388 (289-588)368 (274-560)
Puncture to reperfusion, min34.2 (22-50)36 (21-55)
Mean admission SBP, mm Hg (SD)149.1 (24.9)146.9 (24.2)
Mean admission DBP, mm Hg (SD)83.1 (16.1)83.1 (16.5)

Arms

FieldIndividualized BPControl
InterventionMAP maintained within ±10% of reference MAP (mean of first 2 non-invasive measurements on angiosuite arrival) throughout MT; continuous IV diluted norepinephrine (5 or 10 µg/mL) started before sedation to prevent hypotension; IV nicardipine or urapidil for hypertension >10% above reference MAP; no upper SBP limit imposed.Standard guideline-based BP control: SBP <180 mm Hg and DBP <105 mm Hg; hypotension treated only if SBP <140 mm Hg (SNACC recommendation); vasopressors (norepinephrine, ephedrine, phenylephrine) or nicardipine/urapidil at physician discretion.
N214218

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Favorable functional outcome at 90 days (±15 d), defined as modified Rankin Scale score 0-2, assessed by blinded certified neurologists or research nurses.Primary106/218 (48.8%)94/214 (44.2%)0.34
Ordinal mRS shift at 90 days (mixed ordinal logistic regression)Secondarymedian mRS 4 (IQR 2-5)median mRS 4 (IQR 2-6)
Excellent functional outcome (mRS 0-1) at 90 daysSecondary66/212 (31.1%)56/197 (28.4%)
Early neurologic improvement at 24 h (NIHSS reduction ≥8 pts or NIHSS 0-1)Secondary73/200 (36.5%)74/197 (37.6%)
Successful reperfusion (mTICI 2b-3) at end of MTSecondary189/218 (86.7%)187/214 (87.4%)
Mean intraprocedural MAP, mm HgSecondary100101.5
Time within ±10% of baseline MAP during MT, %Secondary53.758.1
All-cause mortality at 90 daysSafety35/213 (16.4%)37/197 (18.8%)
Symptomatic intracranial hemorrhage (ECASS-III definition)Safety14/203 (6.9%)16/203 (7.9%)
Symptomatic intracranial hemorrhage (SITS-MOST definition)Safety5/210 (2.4%)4/206 (2.4%)

Subgroup Analysis

No significant interactions were observed in any prespecified subgroup for the primary outcome, including age (<70 vs ≥70 y), sex, history of hypertension, baseline NIHSS (<17 vs ≥17), time from onset to treatment, sedation modality (conscious sedation vs general anesthesia), IV thrombolysis, occlusion site, baseline SBP and MAP, and center. Post hoc analyses of ΔMAP magnitude, AUC of BP deviations, and time within BP targets did not identify a subgroup that benefited.


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.

Funding

Investigator-initiated, funded by the French Health Ministry (Programme Hospitalier de Recherche Clinique, PHRC AOR 19-019 / AOR19069). No commercial involvement in the design, planning, analysis, or reporting.

Based on: DETERMINE (Neurology, 2026)

Authors: Maïer B, Gory B, Chabanne R, et al; DETERMINE Investigators

Citation: Neurology 2026;107(5):e218420. DOI: 10.1212/WNL.0000000000218420

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