OPTIMAL-BP 1-Year
(2026)Objective
Test whether intensive blood pressure lowering (SBP <140 mm Hg) for 24 hours after successful endovascular thrombectomy in acute ischemic stroke has durable effects on functional outcome and mortality at 1 year, compared with conventional management (SBP 140–180 mm Hg).
Study Summary
• Excellent recovery (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 more frequent (40.5% vs 27.4%; adj OR 1.93, 95% CI 1.10–3.45, P=0.024)
• One-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); no divergence in mRS trajectories between 3 months and 1 year, indicating early harm persists rather than accrues
Intervention
Intensive BP management targeting SBP <140 mm Hg vs conventional BP management targeting SBP 140–180 mm Hg for 24 hours after successful endovascular thrombectomy; first-line agent nicardipine
Inclusion Criteria
Adults ≥20 years with acute ischemic stroke due to large vessel occlusion who underwent endovascular thrombectomy with successful reperfusion (mTICI ≥2b) and had SBP ≥140 mm Hg on two measurements within 2 hours after recanalization
Study Design
Arms: Intensive BP management (SBP <140) vs conventional BP management (SBP 140–180) for 24 hours
Patients per Arm: Intensive 155 vs Conventional 151 (randomized); 294/306 (96.1%) completed 1-year follow-up
Outcome
• Primary: 1-year all-cause mortality 23.0% vs 18.5% (adj OR 1.31, 95% CI 0.70–2.46, P=0.394) – no difference
• Secondary: mRS 0–1 at 1 year 31.1% vs 43.2% (adj OR 0.55, P=0.042); mRS 5–6 at 1 year 40.5% vs 27.4% (adj OR 1.93, P=0.024)
Clinical Question
Among patients with acute ischemic stroke and successful endovascular thrombectomy, does intensive blood pressure lowering (SBP <140 mm Hg) for the first 24 hours produce different long-term (1-year) functional outcomes and mortality compared with conventional BP management (SBP 140–180 mm Hg)?
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.
Study Design
- Study Type
- Randomized Controlled Trial (1-year follow-up extension of a phase 3 trial)
- Randomization
- Yes
- Blinding
- Open-label, blinded end point (PROBE); outcome assessors blinded to allocation
- Sample Size
- 306
- Follow-up
- 1 year
- Centers
- 19
- Countries
- South Korea
Primary Outcome
Definition: Functional independence (modified Rankin Scale score 0–2) at 1 year and all-cause mortality within 1 year (intention-to-treat)
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 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 0.34–1.00; Mortality 0.70–2.46) | 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 |
Limitations & 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).
Citation
Stroke. Published online May 29, 2026. doi:10.1161/STROKEAHA.126.055632