Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial
- Authors
- Nam, H.S.; Kim, Y.D.; Choi, J.K.; Baik, M.; Kim, B.M.; Kim, D.J.; Heo, J.; Shin, D.H.; Lee, K.-Y.; Jung, Y.H.; Baek, J.-H.; Hwang, Y.-H.; Sohn, S.-I.; Hong, J.-H.; Park, H.; Kim, C.K.; Kim, G.S.; Seo, K.-D.; Lee, K.; Seo, J.H.; Bang, O.Y.; Seo, W.-K.; Chung, J.-W.; Chang, J.Y.; Kwon, S.U.; Lee, J.; Kim, J.; Yoo, J.; Song, T.-J.; Ahn, S.H.; Cho, B.-H.; Cho, H.-J.; Kim, J.G.; Chang, Y.; Lee, C.J.; Park, S.; Park, G.; Lee, H.S.
- Issue Date
- Oct-2022
- Publisher
- SAGE Publications Inc.
- Keywords
- blood pressure; cerebral infarction; outcome research; Reperfusion therapy
- Citation
- International Journal of Stroke, v.17, no.8, pp.931 - 937
- Journal Title
- International Journal of Stroke
- Volume
- 17
- Number
- 8
- Start Page
- 931
- End Page
- 937
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/85495
- DOI
- 10.1177/17474930211041213
- ISSN
- 1747-4930
- Abstract
- Rationale: Very early stage blood pressure (BP) levels may affect outcome in stroke patients who have successfully undergone recanalization following intra-arterial treatment, but the optimal target of BP management remains uncertain. Aim: We hypothesized that the clinical outcome after intensive BP-lowering is superior to conventional BP control after successful recanalization by intra-arterial treatment. Sample-size estimates: We aim to randomize 668 patients (334 per arm), 1:1. Methods and design: We initiated a multicenter, prospective, randomized, open-label trial with a blinded end-point assessment (PROBE) design. After successful recanalization (thrombolysis in cerebral infarction score ≥ 2 b), patients with elevated systolic BP level, defined as the mean of two readings ≥ 140 mmHg, will be randomly assigned to the intensive BP-lowering (systolic BP < 140 mm Hg) group or the conventional BP-lowering (systolic BP, 140−180 mm Hg) group. Study outcomes: The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at three months (mRS scores: 0–2 vs. 3–6). The primary safety outcomes are symptomatic intracerebral hemorrhage and death within three months. Discussion: The OPTIMAL-BP trial will provide evidence for the effectiveness of active BP control to achieve systolic BP < 140 mmHg during 24 h in patients with successful recanalization after intra-arterial treatment. Clinical trial registration: ClinicalTrials.gov Identifier: NCT04205305. © 2021 World Stroke Organization.
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