OPTIMAL-BP 1-Year
Intensive Versus Conventional Blood Pressure Lowering After Successful Endovascular Thrombectomy: OPTIMAL-BP 1-Year Outcomes
Bottom Line
Intensive BP lowering (<140 mm Hg) during the first 24 hours after successful endovascular thrombectomy produces durable harm on 1-year functional recovery — significantly lower functional independence and excellent outcome and higher severe disability/death — without a difference in mortality, supporting current guideline recommendations against intensive post-EVT BP lowering.
Major Points
- 1-year follow-up extension of the multicenter Korean OPTIMAL-BP RCT (306 randomized; 96.1% 1-year follow-up completeness).
- Functional independence (mRS 0–2) at 1 year was lower with intensive vs conventional management: 40.5% vs 52.7% (ITT adj OR 0.59, 95% CI 0.34–1.00, P=0.051; per-protocol adj OR 0.56, 95% CI 0.32–0.97, P=0.040).
- Excellent functional outcome (mRS 0–1) at 1 year was significantly lower with intensive management (31.1% vs 43.2%; adj OR 0.55, 95% CI 0.31–0.97, P=0.042); severe disability/death (mRS 5–6) was significantly higher (40.5% vs 27.4%; adj OR 1.93, 95% CI 1.10–3.45, P=0.024).
- 1-year all-cause mortality did not differ (23.0% vs 18.5%; adj OR 1.31, 95% CI 0.70–2.46, P=0.394); Kaplan-Meier time-to-death was not different (adjusted HR 1.30, 95% CI 0.89–2.17, P=0.307).
- mRS trajectories from 3 months to 1 year were similar between groups (P=0.609), indicating that the harm from intensive BP lowering is established in the hyperacute/early subacute phase and persists, rather than emerging late.
- 24-hour mean SBP was 129.4 vs 138.0 mm Hg; intravenous antihypertensive use 73.0% vs 19.2% (P<0.001).
- No prespecified subgroup showed a significant interaction; effect estimates favored conventional management across strata.
- Findings reinforce prior BP-TARGET, ENCHANTED2/MT and OPTIMAL-BP 3-month results and support the 2024 hypertension guideline class III (harm) recommendation against SBP <140 mm Hg for 24–72 h after successful reperfusion.
Design
Study Type: Randomized Controlled Trial (1-year follow-up extension of a phase 3 trial)
Randomization: 1
Blinding: Open-label, blinded end point (PROBE); outcome assessors blinded to allocation
Enrollment Period: June 18, 2020 – November 29, 2022
Follow-up Duration: 1 year
Centers: 19
Countries: South Korea
Sample Size: 306
Analysis: Intention-to-treat (primary) and per-protocol; multivariable logistic regression adjusted for age, sex, onset-to-randomization time, and admission NIHSS; Cox proportional hazards for mortality; ordinal logistic regression for mRS shift; missing 1-year mRS not imputed
Inclusion Criteria
- Adults age ≥20 years
- Acute ischemic stroke caused by large vessel occlusion
- Underwent endovascular thrombectomy
- Successful reperfusion of the occluded artery (mTICI score ≥2b)
- Elevated SBP ≥140 mm Hg on ≥2 measurements 2 minutes apart within 2 hours after successful reperfusion
- EVT performed per Korean Clinical Practice Guidelines
- Written informed consent from patient or legal representative
Exclusion Criteria
- SBP <140 mm Hg following EVT
- Any contraindication to antihypertensive therapy
- Symptomatic intracerebral hemorrhage evident during or immediately after EVT
- Serious medical or surgical illness (e.g., terminal cancer, severe cardiac/aortic disease, severe anemia, chronic kidney disease, active pneumonia/sepsis)
- Prestroke disability (modified Rankin Scale score 3–5)
- Investigator/administrative reasons (e.g., COVID-19 infection, transfer to another hospital, non-Korean citizenship, advanced dementia)
Arms
| Field | Intensive BP management | Control |
|---|---|---|
| Intervention | Target SBP <140 mm Hg for 24 hours after enrollment; IV nicardipine first-line (used in 73.0% within 24 h); goal reached within 1 hour of randomization | Target SBP 140–180 mm Hg for 24 hours after enrollment; IV antihypertensives used in 19.2% within 24 h; no vasopressors to raise SBP to target unless clinically significant hypotension |
| Duration | 24 hours (BP protocol); 1-year outcome assessment | 24 hours (BP protocol); 1-year outcome assessment |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Functional independence (modified Rankin Scale score 0–2) at 1 year and all-cause mortality within 1 year (intention-to-treat) | Primary | mRS 0–2 at 1 y: 77/146 (52.7%); 1-y mortality: 27/146 (18.5%) | mRS 0–2 at 1 y: 60/148 (40.5%); 1-y mortality: 34/148 (23.0%) | Functional independence adj OR 0.59; Mortality adj OR 1.31 | Functional independence P=0.051 (ITT); P=0.040 (per-protocol adj OR 0.56, 95% CI 0.32–0.97). Mortality P=0.394 |
| Excellent functional outcome (mRS 0–1) at 1 year (ITT) | Secondary | 63/146 (43.2%) | 46/148 (31.1%) | adj OR 0.55 | 0.042 |
| Moderate functional outcome (mRS 0–3) at 1 year (ITT) | Secondary | 92/146 (63.0%) | 77/148 (52.0%) | adj OR 0.63 | 0.093 |
| Severe disability or death (mRS 5–6) at 1 year (ITT) | Secondary | 40/146 (27.4%) | 60/148 (40.5%) | adj OR 1.93 | 0.024 |
| mRS shift analysis at 1 year (ordinal, ITT) | Secondary | median mRS 2 (IQR 1–5) | median mRS 3 (IQR 1–5) | adjusted common OR 1.52 (higher = worse) | 0.057 |
| Time-to-death within 1 year (Kaplan-Meier, ITT) | Secondary | 27/146 deaths | 34/148 deaths | adjusted HR 1.30 | 0.307 |
| Functional independence (mRS 0–2) at 1 year — per-protocol | Secondary | 76/139 (54.7%) | 58/141 (41.1%) | adj OR 0.56 | 0.040 |
| Note | Adverse | This 1-year extension paper reports long-term outcomes rather than a standard AE table. Safety-related findings: 1-year all-cause mortality 23.0% intensive vs 18.5% conventional (adj OR 1.31, 95% CI 0.70–2.46, P=0.394); ischemic stroke was the leading cause of death in both groups (58.8% vs 59.3% of deaths). Severe disability or death (mRS 5–6) at 1 year 40.5% vs 27.4% (adj OR 1.93, P=0.024) — signal of durable functional harm from intensive lowering. The primary safety outcomes (24-hour hypotension, hemorrhagic transformation, symptomatic ICH) were reported in the original 3-month OPTIMAL-BP publication (JAMA 2023). | |||
Subgroup Analysis
No prespecified subgroup (age, sex, admission NIHSS, IV tPA, occlusion site, TOAST subtype, onset-to-randomization time) showed a significant treatment-by-subgroup interaction for 1-year functional independence; effect estimates were consistently in favor of conventional management across all strata.
Criticisms
- Trial was terminated earlier than planned, reducing statistical power and contributing to marginal significance in the ITT primary outcome (P=0.051).
- Enrolled exclusively at 19 South Korean centers — limits generalizability to other ethnic and healthcare-system contexts.
- Open-label design (though with blinded outcome assessment); post-discharge care, rehabilitation intensity, and long-term BP control were not standardized, allowing unmeasured confounding of long-term recovery.
- Missing 1-year mRS data were not imputed; 12/306 (3.9%) lost to 1-year follow-up may bias effect estimates, particularly in ITT analysis.
- BP management was protocolized only for the first 24 hours; the optimal duration (24 vs 72 hours) and whether harm extends to less intensive targets remain uncertain.
- Intraprocedural BP and pre-randomization BP management were not systematically collected, limiting evaluation of periprocedural hemodynamic effects.
- Baseline infarct core and core-penumbra mismatch not collected because imaging protocols varied across centers.
- Clinically significant hypotension was not defined by a prespecified numerical threshold, introducing inter-center variability.
- No difference in 1-year mortality despite meaningful functional harm — pathophysiological mechanism of the durable functional gap remains hypothesis-generating (impaired collateral perfusion, reperfusion injury, penumbral compromise).
Funding
Korean Ministry of Health and Welfare / Korea Health Industry Development Institute; institutional support from Yonsei University College of Medicine (see original OPTIMAL-BP disclosures)
Based on: OPTIMAL-BP 1-Year (Stroke, 2026)
Authors: Jae Wook Jung, Young Dae Kim, JoonNyung Heo, ..., et al.; Hyo Suk Nam (corresponding author)
Citation: Stroke. Published online May 29, 2026. doi:10.1161/STROKEAHA.126.055632
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