Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) - An explorative randomized controlled trial

Min Chen, Dorothea Kronsteiner, Markus A Möhlenbruch, Meinhard Kieser, Martin Bendszus, Wolfgang Wick, Simon Nagel, Peter A Ringleb, Silvia Schönenberger, Min Chen, Dorothea Kronsteiner, Markus A Möhlenbruch, Meinhard Kieser, Martin Bendszus, Wolfgang Wick, Simon Nagel, Peter A Ringleb, Silvia Schönenberger

Abstract

Background: Optimal blood pressure is not well established during endovascular therapy of acute ischemic stroke. Applying standardized blood pressure target values for every stroke patient might be a suboptimal approach.

Aim: To assess whether an individualized intraprocedural blood pressure management with individualized blood pressure target ranges might pose a better strategy for the outcome of the patients than standardized blood pressure targets.Sample size: Randomization of 250 patients 1:1 to receive either standard or individualized blood pressure management approach.

Methods and design: We conduct an explorative single-center randomized controlled trial with a PROBE (parallel-group, open-label randomized controlled trial with blinded endpoint evaluation) design. In the control group, intraprocedural systolic blood pressure target range is 140-180 mmHg. The intervention group is the individualized approach, which is maintaining the intraprocedural systolic blood pressure at the level on presentation (±10 mmHg).Study outcomes: The primary endpoint is the modified Rankin scale assessed 90 days +/- 2 weeks after stroke onset, dichotomized by 0-2 (favorable outcome) to 3-6 (unfavorable outcome). Secondary endpoints include early neurological improvement, infarction size, and systemic physiology monitor parameters.

Discussion: An individualized approach for blood pressure management during thrombectomy could lead to a better outcome for stroke patients. The trial is registered at clinicaltrials.gov as 'Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)' under NCT04578288.

Keywords: Ischemic stroke; blood pressure; endovascular therapy.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Peter Ringleb received honoraria for advisory boards and lecture fees from Boehringer Ingelheim, Bayer, Pfizer and Daichii Sankyo, not related to the topic of the manuscript. Markus A Möhlenbruch received honoraria for lectures including service on speakers bureaus from Medtronic, MicroVention, Stryker (money paid to the institution) and has grants/grants pending from Balt, Medtronic and MicroVention, not related to the topic of the manuscript. Simon Nagel consults Brainomix, has a grant from Cerenovus and received payment for lectures including service on Speakers Bureaus from Pfizer and Boehringer Ingelheim, not related to the topic of the manuscript.

© European Stroke Organisation 2021.

Figures

Figure 1.
Figure 1.
Schema of standard vs. individualized blood pressure management. BP: baseline blood pressure; SBP: systolic blood pressure; bSBP: baseline systolic blood pressure; rtPA: recombinant tissue plasminogen activator.

References

    1. Fiehler J, Cognard C, Gallitelli M, et al.. European Recommendations on Organisation of Interventional Care in Acute Stroke (EROICAS). Int J Stroke 2016; 11: 701–716.
    1. Powers WJ, Rabinstein AA, Ackerson T, et al..; American Heart Association Stroke Council. 2018 Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2018; 49: e46–e110.
    1. Talke PO, Sharma D, Heyer EJ, et al.. Society for neuroscience in anesthesiology and critical care expert consensus statement: anesthetic management of endovascular treatment for acute ischemic stroke*: endorsed by the Society of NeuroInterventional Surgery and the Neurocritical Care Society. J Neurosurg Anesthesiol 2014; 26: 95–108.
    1. Turc G, Bhogal P, Fischer U, 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. Epub ahead of print 2019.
    1. Fischer U, Cooney MT, Bull LM, et al.. Acute post-stroke blood pressure relative to premorbid levels in intracerebral haemorrhage versus major ischaemic stroke: a population-based study. Lancet Neurol 2014; 13: 374–384.
    1. Maïer B, Gory B, Taylor G, et al.. Mortality and disability according to baseline blood pressure in acute ischemic stroke patients treated by thrombectomy: a collaborative pooled analysis. J Am Heart Assoc 2017; 6: e006484.
    1. Leonardi-Bee J, Bath PMW, Phillips SJ, et al.. Blood pressure and clinical outcomes in the International Stroke Trial. Stroke 2002; 33: 1315–1320.
    1. Goyal N, Tsivgoulis G, Iftikhar S, et al.. Admission systolic blood pressure and outcomes in large vessel occlusion strokes treated with endovascular treatment. J Neurointerv Surg 2017; 9: 451–454.
    1. Mulder MJHL, Ergezen S, Lingsma HF, et al. Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN) Investigators. Baseline blood pressure effect on the benefit and safety of intra-arterial treatment in MR CLEAN (multicenter randomized clinical trial of endovascular treatment of acute ischemic stroke in The Netherlands). Stroke 2017; 48: 1869–1876.
    1. Malhotra K, Goyal N, Katsanos AH, et al.. Association of blood pressure with outcomes in acute stroke thrombectomy. Hypertension 2020; 75: 730–739.
    1. Matusevicius M, Cooray C, Bottai M, et al.. Blood pressure after endovascular thrombectomy: modeling for outcomes based on recanalization status. Stroke 2020; 51: 519–525.
    1. Lima FO, Furie KL, Silva GS, et al.. The pattern of leptomeningeal collaterals on CT angiography is a strong predictor of long-term functional outcome in stroke patients with large vessel intracranial occlusion. Stroke 2010; 41: 2316–2322.
    1. Liebeskind DS, Jahan R, Nogueira RG, et al.. Impact of collaterals on successful revascularization in solitaire FR with the intention for thrombectomy. Stroke 2014; 45: 2036–2040.
    1. Rasmussen M, Schönenberger S, Hendèn PL, for the SAGA orators et al.. Blood pressure thresholds and neurologic outcomes after endovascular therapy for acute ischemic stroke. JAMA Neurol 2020; 77: 622.
    1. Treurniet KM, Berkhemer OA, Immink RV, et al.. A decrease in blood pressure is associated with unfavorable outcome in patients undergoing thrombectomy under general anesthesia. J Neurointerv Surg 2018; 10: 107–111.
    1. Löwhagen Hendén P, Rentzos A, Karlsson JE, et al.. Hypotension during endovascular treatment of ischemic stroke is a risk factor for poor neurological outcome. Stroke 2015; 46: 2678–2680.
    1. Petersen NH, Ortega-Gutierrez S, Wang A, et al.. Decreases in blood pressure during thrombectomy are associated with larger infarct volumes and worse functional outcome. Stroke 2019; 50: 1797–1804.
    1. Whalin MK, Halenda KM, Haussen DC, et al.. Even small decreases in blood pressure during conscious sedation affect clinical outcome after stroke thrombectomy: an analysis of hemodynamic thresholds. AJNR Am J Neuroradiol 2017; 38: 294–298.
    1. Athiraman U, Sultan-Qurraie A, Nair B, et al.. Endovascular treatment of acute ischemic stroke under general anesthesia: predictors of good outcome. J Neurosurg Anesthesiol 2018; 30: 223–230.
    1. 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.
    1. John S, Hazaa W, Uchino K, et al.. Lower intraprocedural systolic blood pressure predicts good outcome in patients undergoing endovascular therapy for acute ischemic stroke. Interv Neurol 2016; 4: 151–157.
    1. Sel 2019. Create a blocked randomisation list, (accessed 23 April 2020).
    1. Schenker N, Taylor JMG. Partially parametric techniques for multiple imputation. Comput Stat Data Anal 1996; 22: 425–446.
    1. Higgins JP, White IR, Wood AM. Imputation methods for missing outcome data in meta-analysis of clinical trials. Clin Trials 2008; 5: 225–239.

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