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BEST-II Trial: Blood Pressure Targets After Successful Endovascular Therapy

After successful EVT, does targeting a lower systolic blood pressure (SBP less than 140 or less than 160 mm Hg) improve utility-weighted functional outcomes at 90 days compared with permissive control (SBP at or below 180 mm Hg)?

Mistry et al. (JAMA 2023) · doi:10.1001/jama.2023.14330 · 120 patients

Population

Included

  • Age 18 or older
  • Anterior circulation LVO stroke
  • Successful EVT (mTICI 2c or better)
  • BP target initiated within 60 minutes of procedure end
  • Treatment maintained for 24 hours

Excluded

  • Unsuccessful EVT (mTICI below 2c)
  • Severe heart failure (EF below 30%)
  • LVAD or extracorporeal membrane oxygenation
  • Pre-stroke mRS greater than 2
  • Unable to maintain assigned BP target

Futility design: low predicted success for lower BP targets

BEST-II was a phase 2 futility trial. Neither lower target formally crossed the futility boundary (P=0.93), but predicted success in a future superiority trial was only 14-25% for lower targets. The highest-target arm (SBP <=180 mm Hg) produced the best utility-weighted mRS (0.58 vs 0.51). OPTIMAL-BP subsequently confirmed functional harm from SBP <140 mm Hg.

Primary Outcome — Utility-Weighted mRS at 90 days (x100)

120 patients; 3-arm futility trial: SBP <140, <160, or <=180 mm Hg after successful EVT

Target <140 mm Hg
51 / 100
Target <=180 mm Hg
58 / 100

Negligible absolute difference

Utility-Weighted mRS at 90 days (x100)

Risk ratio Delta -0.0795% CI N/A–N/Ap = Futility P=0.93

Study Arms

Agent
Intravenous nicardipine (first-line); intravenous labetalol and hydralazine recommended as second-line and third-line agents
Dose
Target systolic blood pressure less than 140 mm Hg
Route
Intravenous
Frequency
Titrated to target; agent reduced or stopped if SBP fell below the next lower target
Duration
Initiated within 60 minutes of recanalisation and maintained for 24 hours
Co-interventions
Standard post-EVT stroke-unit care. BP monitored noninvasively (recumbent cuff) every 5 min for the first 15 min after nicardipine initiation or dose adjustment, every 15 min for the first hour, then at least every 30 min for 24 hours; arterial-line monitoring allowed but not required.

n=40 randomised (1:1:1, block sizes 3, 6, 9). Lowest of three futility-design targets. Mistry JAMA 2023 p.822.

Trial Design

Type

  • Phase 2 randomized open-label blinded-endpoint futility trial
  • Three post-EVT systolic blood pressure targets: <140, <160, and <=180 mm Hg
  • Successful endovascular therapy required before randomization
  • Blood pressure strategy initiated within 60 minutes and maintained for 24 hours

Timeline

Three US comprehensive stroke centers, 2020-2022

N

120

Enrollment

120 patients at three US comprehensive stroke centers. Phase 2 open-label randomized futility trial with three arms. BP targeting initiated within 60 minutes of successful EVT and maintained for 24 hours. Published JAMA 2023.

ClinicalTrials.gov

NCT04116112

Bedside Pearl

BEST-II and OPTIMAL-BP together make a consistent case: permissive BP management (SBP up to 180 mm Hg) is safer than aggressive lowering after successful EVT. BEST-II showed low predicted benefit from lower targets; OPTIMAL-BP confirmed functional harm. Do not force SBP below 140 mm Hg in the first 24 hours after successful reperfusion.

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