Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial
Benjamin Maïer, Benjamin Gory, Russell Chabanne, B. Tavernier, Baptiste Balança, Gérard Audibert, Laurie-Anne Thion, Morgan Le Guen, Thomas Geeraerts, Lionel Calviere, Vincent Degos, Bertrand Lapergue, Sébastien Richard, Azeddine Djarallah, Ornellia Mophawe, Perrine Boursin, Chloé Le Cossec, Raphaël Blanc, Michel Piotin, Mikael Mazighi, Étienne Gayat, on behalf of the DETERMINE Investigators, Benjamin Maïer, Simon Escalard, François Delvoye, Solène Hébert, Hocine Redjem, Stanislas Smajda, Jean‐Philippe Desilles, Raphaël Blanc, Michel Piotin, Mikaël Mazighi, Amélie Yavchitz, Chloé Le Cossec, Ornellia Mophawe, Azedine Djarallah, Perrine Boursin, Laurie-Anne Thion, Abdenour Amarouche, Anoushée Shaffii, Audrey Fogang, Aurore Marcou, Elisabeth Ferri, Fanny Le Garrec, Ines Da Costa, Jean-Marie Moures, Jean‐Michel Devys, Malika Omarjee, Marie‐Claude Dubois, Marie-Claire Nghe-Mann, Matthieu Dorison, Mélanie Sénéchal, Pascal Le Bigot, Nouria Belhadj-Tahar, Séverine Gras, Simon Clariot, S. Mérat, Sylvie Froucht-Hirsch, Yasmine Ait Yahia, Pierre Seners, Candice Sabben, Bertrand Lapergue, Morgan Le Guen, Julien Rousset, Thomas Geeraerts, Christophe Cognard, Jean‐Marc Olivot, Lionel Calviere, Maxime Pommier, Edouard Naboulsi, Marc Bégard, Camille Boissy, Thibaud Cammas, Bernard Cosserant, Romain Grobost, Adrien Guyot, Katia Levrier, Pierre-Antoine Pioche, Ricardo Moreno, Abderahim Zerroug, Elie Lteif, Emmanuel Chabert, Anna Ferrier, Aurélie Masgrau, Baptiste Balança, Lionel Bapteste, Baptiste Bouchier, C. Di Roio, Charles-Antoine Lak, Anisoara Gemanar, Romain Carrillon, Carole Bodonian, Benjamin Gory, Serge Bracard, René Anxionnat, Marc Braun, Anne‐Laure Derelle, Liang Liao, François Zhu, Emmanuelle Schmitt
Abstract
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.