Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial
Authors: Maïer Benjamin , Gory Benjamin , Chabanne Russell , Tavernier Benoît , Balanca Baptiste , Audibert Gérard , Thion Laurie-Anne , Le Guen Morgan , Geeraerts Thomas , Calviere Lionel , Degos Vincent , Lapergue Bertrand , Richard Sebastien , Djarallah Azeddine , Mophawe Ornellia , Boursin Perrine , Le Cossec Chloé , Blanc Raphael , Piotin Michel , Mazighi Mikael , Gayat Etienne ,   on behalf of the DETERMINE Investigators, Maïer Benjamin , Escalard Simon , Delvoye François , Hebert Solène , Redjem Hocine , Smajda Stanislas , Desilles Jean-Philippe , Blanc Raphael , Piotin Michel , Mazighi Mikael , Yavchitz Amélie , Le Cossec Chloé , Mophawe Ornellia , Djarallah Azedine , Boursin Perrine , Thion Laurie-Anne , Amarouche Abdenour , Shaffii Anoushee , Fogang Audrey , Marcou Aurore , Ferri Elisabeth , Le Garrec Fanny , Da Costa Ines , Moures Jean-Marie , Devys Jean-Michel , Omarjee Malika , Dubois Marie-Claude , Nghe-Mann Marie-Claire , Dorison Matthieu , Sénéchal Mélanie , Le Bigot Pascal , Belhadj-Tahar Nouria , Gras Severine , Clariot Simon , Merat Stéphane , Froucht-Hirsch Sylvie , Yahia Yasmine Ait , Seners Pierre , Sabben Candice , Lapergue Bertrand , Le Guen Morgan , Rousset Julien , Geeraerts Thomas , Cognard Christophe , Olivot Jean-Marc , Calviere Lionel , Pommier Maxime , Naboulsi Edouard , Begard Marc , Boissy Camille , Cammas Thibaud , Cosserant Bernard , Grobost Romain , Guyot Adrien , Levrier Katia , Pioche Pierre-Antoine , Moreno Ricardo , Zerroug Abderahim , Lteif Elie , Chabert Emmanuel , Ferrier Anna , Masgrau Aurélie , Balanca Baptiste , Bapteste Lionel , Bouchier Baptiste , Di Roio Claudio , Lak Charles-Antoine , Gemanar Anisoara , Carrillon Romain , Bodonian Carole , Gory Benjamin , Bracard Serge , Anxionnat René , Braun Marc , Derelle Anne-Laure , Liao Liang , Zhu François , Schmitt Emmanuelle , Planel Sophie , Richard Sébastien , Humbertjean Lisa , Mione Gioia , Lacour Jean-Christophe , Douarinou Marian , Audibert Gérard , Voicu Marcela , Alb Lionel , Reitter Marie , Brezeanu Madalina , Masson Agnès , Tabarna Adriana , Podar Iona , Bourst Pauline , Georges Valérie , Guy Sarah , Bechiri Fatiha , Tavernier Benoît , Julean Gabriela , Boussemart Pierre , Roudies Sidi Hamza , Envain Dominique , Appourchaux Pierre , Martin Julien , Lestrade Victor , Schiava Lucie Della , Bricout Nicolas , Prévost Erine , Bellet Julie , Gayat Etienne , Mazighi Mikael , Degos Vincent , Julie Dupont , Clarençon Frédéric 
Published: July 2022

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.