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, 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

Get full access to this article

View all access options for this article.

References

Goyal

Menon

van Zwam

, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet 2016; 387: 1723–1731.

Mattle

Kappeler

Arnold

, et al. Blood pressure and vessel recanalization in the first hours after ischemic stroke. Stroke 2005; 36: 264–268.

Delgado-Mederos

Ribo

Rovira

, et al. Prognostic significance of blood pressure variability after thrombolysis in acute stroke. Neurology 2008; 71: 552–558.

Berge

Cohen

Lindley

, et al. Effects of blood pressure and blood pressure-lowering treatment during the first 24 hours among patients in the third international stroke trial of thrombolytic treatment for acute ischemic stroke. Stroke 2015; 46: 3362–3369.

Maier

Tsogkas

Behme

, et al. High systolic blood pressure after successful endovascular treatment affects early functional outcome in acute ischemic stroke. Cerebrovasc Dis 2018; 45: 18–25.

Goyal

Tsivgoulis

Pandhi

, et al. Blood pressure levels post mechanical thrombectomy and outcomes in large vessel occlusion strokes. Neurology 2017; 89: 540–547.

Martins

Sargento-Freitas

Silva

, et al. Recanalization modulates association between blood pressure and functional outcome in acute ischemic stroke. Stroke 2016; 47: 1571–1576.

Turc

Bhogal

Fischer

, et al. European Stroke Organisation (ESO) – European Society for Minimally Invasive Neurological Therapy (ESMINT) guidelines on mechanical thrombectomy in acute ischemic stroke. J Neurointerv Surg 2019, pp. 1–30.

Malhotra

Goyal

Katsanos

, et al. Association of blood pressure with outcomes in acute stroke thrombectomy. Hypertension 2020; 75: 730–739.

10.

Powers

Rabinstein

Ackerson

, et al. Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2019; 50: e344–e418.

11.

Hacke

Kaste

Bluhmki

, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008; 359: 1317–1329.

12.

Mazighi

Richard

Lapergue

, et al. Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial. Lancet Neurol 2021; 20: 265–274.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.61 MB