BACKGROUND: Intensive blood pressure (BP) lowering after successful reperfusion has resulted in short-term harm in acute ischemic stroke. However, it remains unclear whether these adverse effects persist over the long term.

METHODS: The OPTIMAL-BP (Outcome in Patients Treated With Intra-Arterial Thrombectomy-Optimal Blood Pressure Control) was a phase 3, multicenter, prospective, open-label, blinded end point, randomized controlled trial with 19 centers throughout South Korea. Patients who underwent endovascular thrombectomy for acute ischemic stroke caused by large vessel occlusion, achieved successful reperfusion of the occluded artery, and exhibited elevated BP (systolic BP =140 mm Hg) on 2 measurements obtained 2 minutes apart within 2 hours after recanalization were randomly assigned to receive intensive BP management (systolic BP target <140 mm Hg) or conventional management (systolic BP target, 140-180 mm Hg) for 24 hours after enrollment. This study was a 1-year follow-up extension of the OPTIMAL-BP. The primary outcomes were a modified Rankin Scale score of 0 to 2 at 1 year, indicating functional independence and all-cause mortality within 1 year. Adjusted odds ratios were estimated using multivariable logistic regression models adjusting for age, sex, onset-to-randomization time, and baseline National Institutes of Health Stroke Scale.

RESULTS: Among 306 randomized patients, 294 (96.1%) completed the 1-year follow-up. In the intention-to-treat analysis, functional independence at 1 year was numerically lower in the intensive BP management group than in the conventional group (40.5% versus 52.7%; adjusted odds ratios, 0.59 [95% CI, 0.34-1.00]; P=0.051). Consistent findings were observed in the per-protocol analysis (41.1% versus 54.7%; adjusted odds ratios, 0.56 [95% CI, 0.32-0.97]; P=0.040). One-year mortality and distribution of modified Rankin Scale changes from 3 months to 1 year did not differ between groups.

CONCLUSIONS: Intensive BP lowering targeting a systolic BP of <140 mm Hg resulted in worse functional outcomes at 1 year compared with conventional BP management. These randomized data suggest that early postthrombectomy BP management has durable effects on recovery and support current recommendations against intensive BP lowering.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04205305.

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