Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial
- Affiliated Author(s)
- 손성일; 홍정호; 박형종
- Alternative Author(s)
- Sohn, Sung Il; Hong, Jeong Ho; Park, Hyung Jong
- Journal Title
- Int J Stroke
- ISSN
- 1747-4949
- Issued Date
- 2021
- Keyword
- Reperfusion therapy; blood pressure; cerebral infarction; outcome research
- 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.
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