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

What research is your doctor and hospital initiating to remove the uncertainty of blood pressure management? Doing nothing  should be cause for firing up to and including the board of directors.

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

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Hyo Suk Nam, MD, PhD, Young Dae Kim, MD, PhD, Jin Kyo Choi, MD, ...

First Published August 29, 2021 Product Review Find in PubMed 

https://doi.org/10.1177/17474930211041213

Article information

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.

Keywords

Reperfusion therapy, blood pressure, cerebral infarction, outcome research

Introduction and rationale

Recent endovascular thrombectomy trials have proven the effectiveness of intra-arterial treatment (IAT) in patients with large cerebral artery occlusion. The recanalization rate of IAT is approximately 80%, but only 50% of patients achieve functional independence.¹ Therefore, new treatment strategies are needed to reduce the rate of poor outcomes. One potential strategy is to optimize management of blood pressure (BP) in patients with successful recanalization after IAT.

BP is associated with outcome of stroke patients with recanalization treatment. Spontaneous decline of BP over 12 to 24 h after IAT more often occurs in patients with successful recanalization than in those with persistent occlusion.^2–4 BP directly affects cerebral perfusion pressure. Low BP may decrease the cerebral perfusion pressure and exert harmful effects on ischemic brain areas. In contrast, sustained high BP may increase the risk of intracranial hemorrhage (ICH) and worse functional outcomes.^5–7

The American Heart Association guidelines recommend reducing BP below 180/105 mmHg in patients after successful recanalization (class of recommendation IIb, level of evidence B-NR). The European guidelines recommend keeping BP below 180/105 mmHg during and 24 h after IAT.⁸ In contrast, previous retrospective studies and meta-analysis have shown a possible association between BP within 24 h after IAT and clinical outcomes and suggested that lowering BP may be beneficial.^5,6,9 However, the optimal target of BP control in stroke patients with successful recanalization following IAT remains uncertain.

Aim

The aim of this trial is to determine whether the clinical outcome of aggressive BP-lowering is superior to that of conventional BP-lowering after successful recanalization by IAT.