OPTIMAL-BP Trial: Intensive vs Conventional BP Lowering After EVT
In patients with LVO stroke who achieved successful recanalization after EVT, does intensive systolic BP management targeting SBP less than 140 mm Hg improve functional independence at 3 months compared with conventional management targeting SBP 140-180 mm Hg? (Stopped by DSMB for harm.)
Nam et al. (JAMA 2023) · doi:10.1001/jama.2023.14590 · 306 patients
Population
Included
- Age 20 or older
- LVO stroke with successful EVT (mTICI 2b or better)
- SBP 140 mm Hg or greater on two measurements within 2 hours of final reperfusion
- Randomization within 2 hours of final reperfusion
- Pre-stroke mRS 0 to 2
- Adults aged 20 years or older
- Acute ischaemic stroke due to large-vessel occlusion who underwent endovascular thrombectomy (EVT)
- Successful reperfusion of the occluded artery, defined as modified Thrombolysis in Cerebral Infarction 2b or greater
- Elevated systolic blood pressure of 140 mm Hg or more on at least 2 measurements taken at a 2-minute interval within 2 hours of successful reperfusion
Excluded
- SBP below 140 mm Hg at eligibility
- Symptomatic ICH after EVT
- Serious concurrent illness
- Pre-stroke mRS 3 to 5
- Planned hemicraniectomy
Key exclusion criteria
- Systolic blood pressure less than 140 mm Hg after EVT
- Any contraindication to the use of antihypertensive medications
- Symptomatic intracerebral haemorrhage evident during or immediately after EVT
- Serious medical or surgical illness
- Prestroke disability (modified Rankin Scale score 3 to 5)
Source: Nam et al., JAMA 2023;330(9):832–842 (OPTIMAL-BP)· Retrieved 2026-06-09
Primary Outcome — Functional Independence (mRS 0-2) at 3 Months
STOPPED FOR SAFETY: Intensive BP management (SBP <140 mm Hg) led to significantly lower functional independence (39.4% vs 54.4%, adjusted OR 0.56, P=0.03) and nearly 8-fold higher malignant cerebral edema (adjusted OR 7.88, P=0.01) after successful EVT. The DSMB terminated the trial at 306 of 450 planned patients.
Negligible absolute difference
Functional Independence (mRS 0-2) at 3 Months
Study Arms
- Agent
- Intravenous nicardipine (preferred BP-lowering drug); other drugs used at physician discretion
- Dose
- Target systolic blood pressure less than 140 mm Hg
- Route
- Intravenous
- Frequency
- Continuous noninvasive BP monitoring; titrated to target with goal SBP reached within 1 h of randomisation
- Duration
- Maintained for 24 hours after enrolment
- Co-interventions
- Care in a stroke unit with continuous BP monitoring and best-practice management; intravenous fluids and inotropes could be administered for clinically significant hypotension. All patients underwent EVT under conscious sedation.
Intensive arm, n=155. Randomised 1:1 within 2 h of reperfusion, stratified by site and NIHSS (<15 vs ≥15). Nam JAMA 2023 p.833.
- Agent
- Vasopressor drugs not used to achieve the target unless SBP decreased below 140 mm Hg; nicardipine and other agents available if needed
- Dose
- Target systolic blood pressure 140 to 180 mm Hg
- Route
- Intravenous
- Frequency
- At physician discretion, intravenous fluids or inotropes given for clinically significant hypotension; goal SBP reached within 1 h of randomisation
- Duration
- Maintained for 24 hours after enrolment
- Co-interventions
- Care in a stroke unit with continuous BP monitoring and best-practice management. All patients underwent EVT under conscious sedation.
Conventional arm, n=151. Nam JAMA 2023 p.833.
Trial Design
Type
- Multicenter randomized open-label trial with blinded endpoint evaluation
- Patients had successful reperfusion after EVT (mTICI 2b or greater)
- Intensive SBP target <140 mm Hg vs conventional target 140-180 mm Hg
- Blood pressure strategy maintained for 24 hours
Timeline
19 South Korean stroke centers, 2020-2022
N
306
Enrollment
306 patients at 19 South Korean stroke centers. Open-label randomized trial with blinded endpoint assessment. Stopped early by DSMB for safety at 68% of planned enrollment. Intensive BP strategy (SBP <140 mm Hg) maintained for 24 hours. Published JAMA 2023.
ClinicalTrials.gov
NCT04205305Bedside Pearl
OPTIMAL-BP stopped early for harm: SBP <140 mm Hg after successful EVT reduced functional independence by 15 percentage points and increased malignant cerebral edema 8-fold. After successful reperfusion, allow SBP up to 180 mm Hg. Do not target SBP below 140 mm Hg.