Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial

Hyo Suk Nam, Young Dae Kim, Jin Kyo Choi, Minyoul Baik, Byung Moon Kim, Dong Joon Kim, Joon Nyung Heo, Dong Hoon Shin, Kyung Yul Lee, Yo Han Jung, Jang Hyun Baek, Yang Ha Hwang, Sung Il Sohn, Jeong Ho Hong, Hyungjong Park, Chi Kyung Kim, Gyu Sik Kim, Kwon Duk Seo, Kijeong Lee, Jung Hwa SeoOh Young Bang, Woo Keun Seo, Jong Won Chung, Jun Young Chang, Sun U. Kwon, Jun Lee, Jinkwon Kim, Joonsang Yoo, Tae Jin Song, Seong Hwan Ahn, Bang Hoon Cho, Han Jin Cho, Jae Guk Kim, Yoonkyung Chang, Chan Joo Lee, Sungha Park, Goeun Park, Hye S. Lee

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
JournalInternational Journal of Stroke
DOIs
StateAccepted/In press - 2021

Keywords

  • Reperfusion therapy
  • blood pressure
  • cerebral infarction
  • outcome research

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