EXPRESS: Outcome in patients treated with intra-arterial thrombectomy: the optiMAL Blood-Pressure Control (OPTIMAL-BP) Trial
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, deï¬ned 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, 140â180 mm Hg) group. Study outcomes: The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at 3 months (mRS scores: 0â2 vs. 3â6) 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.