Journal Article

Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial

Fanny Le Garrec, Chloé Le Cossec, Nouria Belhadj-Tahar, Thibaud Cammas, Gérard Audibert, Marian Douarinou, Sebastien Richard, Jean-Michel Devys, Bertrand Lapergue, Gioia Mione, Fatiha Bechiri, Anisoara Gemanar, Ricardo Moreno, Charles-Antoine Lak, Madalina Brezeanu, Dominique Envain, Sarah Guy, Carole Bodonian, Vincent Degos, Baptiste Bouchier, Michel Piotin, Perrine Boursin, Lisa Humbertjean, Adriana Tabarna, Azeddine Djarallah, Camille Boissy, Bernard Cosserant, Katia Levrier, Simon Escalard, Simon Clariot, Maxime Pommier, René Anxionnat, Romain Carrillon, Erine Prévost, François Zhu, Frédéric Clarençon, Pierre Seners, Pierre-Antoine Pioche, Benoît Tavernier, Sidi Hamza Roudies, Marie-Claude Dubois, Pierre Appourchaux, Jean-Marc Olivot, Solène Hebert, Severine Gras, Marc Begard, Abdenour Amarouche, Benjamin Gory, Lionel Calviere, Thomas Geeraerts, Pascal Le Bigot, Christophe Cognard, Adrien Guyot, Liang Liao, Gabriela Julean, Yasmine Ait Yahia, Etienne Gayat, Marcela Voicu, Julien Rousset, Valérie Georges, Lionel Alb, Jean-Philippe Desilles, Anna Ferrier, Iona Podar, Russell Chabanne, Victor Lestrade, Elie Lteif, M

2022

Overview

Background Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management. Methods The DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140–180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included. Discussion DETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines. Trial registration ClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.

• Publisher: Springer Science and Business Media LLC,BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: [SDV]Life Sciences [q-bio] / Anesthesia / Biomedicine / Blood Pressure / Brain Ischemia / Brain Ischemia/diagnosis / Brain Ischemia/etiology / Brain Ischemia/therapy / Care and treatment / Carotid arteries / Circulation / Contraindications / Disability / Drugs / Endovascular Procedures / Endovascular Procedures/adverse effects / Endovascular stents / Health Sciences / Hemodynamics / Human health sciences / Humans / Hypertension / Hypotension / Ischemic Stroke / Life Sciences / Mean arterial pressure / Medicine / Medicine & Public Health / Medicine (General) / Medicine (miscellaneous) / Neurologie / Neurology / Patients / Pharmacology (medical) / Prospective Studies / R5-920 / Randomized controlled trial / Regulation / Sciences de la santé humaine / Statistics for Life Sciences / Stroke / Stroke (Disease) / Stroke/diagnosis / Stroke/etiology / Stroke/therapy / Study Protocol / Surgery / Thrombectomy / Thrombectomy/adverse effects / Treatment Outcome / Veins & arteries