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      Blood Pressure Target in Acute Stroke to Reduce HemorrhaGe After Endovascular Therapy: The Randomized BP TARGET Study Protocol

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          Abstract

          Background: High systolic blood pressure (BP) is associated with an increased risk of intracranial hemorrhage (ICH) in patients undergoing reperfusion therapy. However, there are no data from randomized trials to guide BP management after reperfusion following endovascular therapy (EVT) for patients with acute ischemic stroke (AIS) with large vessel occlusion (LVO). The objective is to evaluate if BP control with a target of 100–129 mmHg systolic BP (“tight” SBP control) can reduce ICH as compared to 130–185 mmHg (“usual” SBP control) in AIS participants after reperfusion by EVT.

          Methods: The BP TARGET trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial. AIS participants with LVO experiencing successful reperfusion are randomly assigned, in a 1:1 ratio, to have a “tight” SBP control (100–129 mmHg) or a conservative SBP control (130–185 mmHg) during the following 24–36 h. The primary outcome is the rate of ICH (either symptomatic or asymptomatic) on follow-up CT scan at 24–36 h. Secondary outcomes include the rate of the symptomatic ICH, the overall distribution of the modified Rankin Scale (mRS) at 90 days, favorable outcome (90–day mRs 0–2), infarct volume at follow-up CT scan at 24–36 h, change in National Institute of Health Stroke Scale at 24 h, and all-cause mortality at 90 days.

          Conclusion: This is the first randomized trial directly comparing the efficacy of different SBP targets after EVT reperfusion. This prospective trial aims to determine whether a “tight” SBP control after EVT reperfusion can reduce the risk of ICH.

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          Most cited references 12

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          Blood pressure and clinical outcomes in the International Stroke Trial.

          Among patients with acute stroke, high blood pressure is often associated with poor outcome, although the reason is unclear. We analyzed data from the International Stroke Trial (IST) to explore the relationship between systolic blood pressure (SBP), subsequent clinical events over the next 2 weeks, and functional outcome at 6 months in patients with acute stroke. We included in the analysis 17 398 patients from IST with confirmed ischemic stroke. A single measurement of SBP was made immediately before randomization. Clinical events within 14 days of randomization were recorded: recurrent ischemic stroke, symptomatic intracranial hemorrhage, death resulting from presumed cerebral edema, fatal coronary heart disease, and death. Survival and dependency were assessed at 6 months. Outcomes were adjusted for age, sex, clinical stroke syndrome, time to randomization, consciousness level, atrial fibrillation, and treatment allocation (aspirin, unfractionated heparin, both, or neither). A U-shaped relationship was found between baseline SBP and both early death and late death or dependency: early death increased by 17.9% for every 10 mm Hg below 150 mm Hg (P<0.0001) and by 3.8% for every 10 mm Hg above 150 mm Hg (P=0.016). The rate of recurrent ischemic stroke within 14 days increased by 4.2% for every 10-mm Hg increase in SBP (P=0.023); this association was present in both fatal and nonfatal recurrence. Death resulting from presumed cerebral edema was independently associated with high SBP (P=0.004). No relationship between symptomatic intracranial hemorrhage and SBP was seen. Low SBP was associated with a severe clinical stroke (total anterior circulation syndrome) and an excess of deaths from coronary heart disease (P=0.002). Both high blood pressure and low blood pressure were independent prognostic factors for poor outcome, relationships that appear to be mediated in part by increased rates of early recurrence and death resulting from presumed cerebral edema in patients with high blood pressure and increased coronary heart disease events in those with low blood pressure. The occurrence of symptomatic intracranial hemorrhage within 14 days was independent of SBP.
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            The Heidelberg Bleeding Classification: Classification of Bleeding Events After Ischemic Stroke and Reperfusion Therapy.

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              Absolute risk reductions, relative risks, relative risk reductions, and numbers needed to treat can be obtained from a logistic regression model.

               P. Austin (2009)
              Logistic regression models are frequently used in cohort studies to determine the association between treatment and dichotomous outcomes in the presence of confounding variables. In a logistic regression model, the association between exposure and outcome is measured using the odds ratio (OR). The OR can be difficult to interpret and only approximates the relative risk (RR) in certain restrictive settings. Several authors have suggested that for dichotomous outcomes, RRs, RR reductions, absolute risk reductions, and the number needed to treat (NNT) are more clinically meaningful measures of treatment effect. We describe a method for deriving clinically meaningful measures of treatment effect from a logistic regression model. This method involves determining the probability of the outcome if each subject in the cohort was treated and if each subject was untreated. These probabilities are then averaged across the study cohort to determine the average probability of the outcome in the population if all subjects were treated and if they were untreated. Risk differences, RRs, and NNTs were derived using a logistic regression model. Clinically meaningful measures of effect can be derived from a logistic regression model in a cohort study. These methods can also be used in randomized controlled trials when logistic regression is used to adjust for possible imbalance in prognostically important baseline covariates.
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                Author and article information

                Contributors
                Journal
                Front Neurol
                Front Neurol
                Front. Neurol.
                Frontiers in Neurology
                Frontiers Media S.A.
                1664-2295
                19 June 2020
                2020
                : 11
                Affiliations
                1Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild Hospital , Paris, France
                2Laboratory of Vascular Translational Science, U1148 Institut National de la Santé et de la Recherche Médicale (INSERM) , Paris, France
                3Paris University , Paris, France
                4DHU NeuroVasc , Paris, France
                5University of Lille, CHU Lille, EA 2694, Santé Publique: Épidémiologie et Qualité des Soins , Lille, France
                6Department of Neurology, Stroke Unit, University Hospital of Nancy , Nancy, France
                7INSERM U1116 , Nancy, France
                8Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nancy , Nancy, France
                9INSERM U1254 , Nancy, France
                10Division of Neurology, Department of Neurology, Stroke Center, Foch Hospital, University Versailles Saint-Quentin en Yvelines , Suresnes, France
                11Pôle des Neurosciences Cliniques, CHU Bordeaux , Bordeaux, France
                12Interventional and Diagnostic Neuroradiology Department, Bordeaux University Hospital , Bordeaux, France
                13Stroke Unit, Toulouse University Hospital , Toulouse, France
                14Department of Neurology, Lariboisière Hospital , Paris, France
                15Department of Neuroradiology, Lariboisière Hospital , Paris, France
                16Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine , Cincinnati, OH, United States
                17Department of Clinical Research, Fondation Ophtalmologique Adolphe de Rothschild Hospital , Paris, France
                18Stroke Unit, Fondation Ophtalmologique Adolphe de Rothschild Hospital , Paris, France
                19Department of Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild Hospital , Paris, France
                Author notes

                Edited by: Santiago Ortega-Gutierrez, University of Iowa, United States

                Reviewed by: Karl Albert Kasischke, University of South Florida, United States; Nitin Goyal, University of Tennessee Health Science Center (UTHSC), United States

                *Correspondence: Mikael Mazighi mmazighi@ 123456for.paris

                This article was submitted to Endovascular and Interventional Neurology, a section of the journal Frontiers in Neurology

                Article
                10.3389/fneur.2020.00480
                7316985
                Copyright © 2020 Mazighi, Labreuche, Richard, Gory, Lapergue, Sibon, Berge, Olivot, Reiner, Houdart, Broderick, Duhammel, Maier, Yavchitz, Salomon, Obadia, Blanc, Savatovsky and Piotin.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                Page count
                Figures: 1, Tables: 2, Equations: 0, References: 26, Pages: 7, Words: 5005
                Categories
                Neurology
                Protocols

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