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

Abstract

Rationale: Very early stage blood pressure (BP) levels may affect outcome in stroke patients who have successfully undergone recanalization following intra-arterial treatment (IAT), 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-lowering after successful recanalization by IAT. 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 ≥ 2b), 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 (systolic BP, 140−180 mm Hg) group. Study outcomes: The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at 3 months (mRS scores: 0–2 vs. 3–6) and from a shift analysis. A shift in functioning measures according to the full range of mRS scores will be analyzed. The primary safety outcomes are symptomatic intracerebral hemorrhage and death within 3 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 IAT.

Intensive vs Conventional Blood Pressure Lowering After Endovascular Thrombectomy in Acute Ischemic Stroke

“…We performed a systematic review to estimate the necessary sample size . A total of 3436 articles were identified, of which 9 met the inclusion criteria.…”

“…This trial was performed at 19 centers throughout South Korea. The protocol is published 16 and provided in Supplement 1 along with the statistical analysis plan in Supplement 2. The trial protocol and consent forms were approved by the institutional review board of each participating hospital, and all patients or their legal representatives provided written informed consent.…”

“…We performed a systematic review to estimate the necessary sample size. 16 A total of 3436 articles were identified, of which 9 met the inclusion criteria. The data showed that a 10-mm Hg increase in mean SBP within 24 hours of successful reperfusion with EVT was associated with worse mRS outcomes at 3 months (odds ratio [OR], 1.45 [95% CI, 1.14-1.83]; P = .002).…”

Association between blood pressure variability and outcomes after endovascular thrombectomy for acute ischemic stroke: An individual patient data meta-analysis

“…[1][2][3][4][5] Conversely, intraprocedural BP reduction has been related to larger infarct volumes and adverse clinical outcomes, with even a 10% BP drop from baseline being associated with worse functional outcomes. 6,7 Recently completed randomized-controlled clinical trials (RCTs), [8][9][10][11] investigating the safety and efficacy of a stricter BP control among EVT-treated patients compared to standard of care have demonstrated that intensive BP lowering did not reduce the odds of sICH and was associated with adverse 3-month clinical outcomes.…”

The 10th Korea–Japan Joint Stroke Conference (KJJSC) at Osaka: The First-Ever and Hopefully, the Last Virtual Conference

“…For example, four complete or ongoing trials were introduced. The Korean investigators presented the “Outcome in Patients Treated with Intraarterial thrombectomy: optiMAL Blood Pressure control (OPTIMAL-BP)” trial [ 3 ] and the “Dual antiplatelet Use for extended period taRgeted to AcuTe Ischemic stroke with presumed atherosclerotic OrigiN (DURATION)” study, while the Japanese researchers discussed the “Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan - Large IscheMIc core Trial (RESCUE-Japan LIMIT)” trial [ 4 ] and the “STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation (STABLED)” study [ 5 ]. In addition, presentations on machine learning for stroke subtype classification [ 6 ] and digital stroke therapies [ 7 ] were delivered by Korean speakers, and ring finger protein 213 (RNF213)-related arteriopathy [ 8 ] and multi-lineage differentiating stress enduring (Muse) cell therapy [ 9 ] were presented by Japanese speakers.…”