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,
Benoît Tavernier,
Baptiste Balanca,
Gérard Audibert,
Laurie-Anne Thion,
Morgan Le Guen,
Thomas Geeraerts,
Lionel Calviere,
Vincent Degos,
Bertrand Lapergue,
Sebastien Richard,
Azeddine Djarallah,
Ornellia Mophawe,
Perrine Boursin,
Chloé Le Cossec,
Raphael Blanc,
Michel Piotin,
Mikael Mazighi,
Etienne Gayat,
on behalf of the DETERMINE Investigators
Affiliations
Benjamin Maïer
Interventional Neuroradiology Department
Benjamin Gory
Diagnostic and Therapeutic Neuroradiology Department, CHRU-Nancy, Université de Lorraine, INSERM U124
Russell Chabanne
Department of Anesthesia, Critical Care and Peri-Operative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand
Benoît Tavernier
Department of Anesthesia and Critical Care, University Hospital
Baptiste Balanca
Department of Neurological Anesthesiology and Intensive Care, Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Groupement Hospitalier Est
Gérard Audibert
Anesthesiology Department, CHRU Nancy
Laurie-Anne Thion
Anesthesiology Department, Hôpital fondation A. de Rothschild
Morgan Le Guen
Anesthesiology Department, Foch Hospital
Thomas Geeraerts
Anesthesiology and Critical Care department, University Hospital of Toulouse, University Toulouse 3-Paul Sabatier
Lionel Calviere
Neurology Department, University Hospital of Toulouse
Vincent Degos
Department of Anesthesia, Critical Care and Peri-Operative Medicine, APHP, Sorbonne Université, Hôpital Pitié-Salpêtrière
Bertrand Lapergue
Neurology Department, Stroke Unit, Foch Hospital
Sebastien Richard
Neurology Department, CHRU-Nancy, Université de Lorraine
Azeddine Djarallah
Clinical Research Unit, Hôpital fondation A. de Rothschild
Ornellia Mophawe
Clinical Research Unit, Hôpital fondation A. de Rothschild
Perrine Boursin
Interventional Neuroradiology Department
Chloé Le Cossec
Clinical Research Unit, Hôpital fondation A. de Rothschild
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.
