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, JoonNyung 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 Seo, Oh 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 Sun Lee
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.