[en] [en] BACKGROUND AND OBJECTIVES: Current recommended blood pressure (BP) targets during mechanical thrombectomy (MT) rely on a one-size-fits-all approach aiming at preventing hypertension. The efficacy and safety of an individualized BP control during thrombectomy for ischemic stroke has not been well studied. We aimed to evaluate whether an individualized BP control during MT could improve functional outcome at 90 days.
METHODS: We conducted a multicenter, open-label, blinded-endpoint, randomized clinical trial at 8 academic comprehensive stroke centers in France. Adult patients with an acute ischemic stroke due to an anterior large vessel occlusion and an indication for MT were eligible. Recruitment was performed between March 10, 2021, and September 18, 2023. Patients were randomly assigned (1:1) to an individualized BP group during MT (where the mean arterial pressure [MAP] was maintained within 10% of the first MAP measured before MT) or a control BP group (systolic BP maintained within 140 and 180 mm Hg). The primary outcome was favorable functional outcome, defined as a modified Rankin Scale score between 0 and 2 at 90 days. Safety outcomes included symptomatic intracranial hemorrhages at 24 hours and mortality at 90 days.
RESULTS: Overall, 433 patients (median age, 69.3 years, 228 females [52.8%]) were assigned to an individualized BP group (n = 215) or the control BP group (n = 218); one was excluded because of consent withdrawal. No significant differences in mean BP levels or BP variability were observed between groups during the procedure. Favorable functional outcome at 90 days was observed in 94 patients (44.2%) in the individualized BP group and 106 patients (48.8%) in the control group (adjusted odds ratio, 0.82; 95% CI 0.54-1.24; p = 0.34). Mortality from any cause at 90 days was not significantly different between groups (18.8% in the individualized BP group vs 16.4% in the control BP group: adjusted odds ratio, 1.19; 95% CI 0.70-2.03). Rates of symptomatic intracranial hemorrhages were not different between the 2 groups.
DISCUSSION: In patients with acute ischemic stroke due to an anterior large vessel occlusion, an individualized BP management during MT did not increase rates of favorable functional outcome at 90 days compared with a standard BP management.
TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov, DETERMINE, number NCT04352296.
CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in patients undergoing mechanical thrombectomy for stroke due to anterior large vessel occlusion, functional outcomes at 90 days were similar with individualized BP management and standard BP management.
Disciplines :
Neurology
Author, co-author :
Maïer, Benjamin ; Neurology Department, Hôpital Paris Saint-Joseph, France ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France ; INSERM, U1144, Paris, France ; Université Paris Cité, France ; FHU Neurovasc 2030, Paris, France
Gory, Benjamin ; Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, CHRU-Nancy, France ; Université de Lorraine, INSERM 1254, IADI, Nancy, France
Chabanne, Russell; Department of Anesthesia, Critical Care and Peri-Operative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, France
Tavernier, Benoit ; Department of Anesthesia and Critical Care, University Hospital, Lille, France ; Université Lille, ULR 2694 - METRICS, France
Jacquens, Alice ; Department of Anesthesia, Critical Care and Peri-Operative Medicine, APHP, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France ; INSERM UMR 1141, Paris, France
Balanca, Baptiste ; Department of Neurological Anesthesiology and Intensive Care, Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Groupement Hospitalier Est, Bron, France ; Lyon's Neuroscience Research Center, INSERM U1028/CNRS UMR 5292, Lyon 1 University, France
Pommier, Maxime; Anesthesiology and Critical Care Department, University Hospital of Toulouse, University Toulouse 3-Paul Sabatier, France
Le Guen, Morgan ; Anesthesiology Department, Foch Hospital, Suresnes, France
Thion, Laurie-Anne; Anesthesiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Clariot, Simon; Anesthesiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Lapergue, Bertrand ; Neurology Department, Stroke Unit, Foch Hospital, Suresnes, France
Guyot, Adrien; Department of Anesthesia, Critical Care and Peri-Operative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, France
Eker, Omer F ; Interventional Neuroradiology Department, Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Groupement Hospitalier Est, Bron, France
Bapteste, Lionel; Department of Neurological Anesthesiology and Intensive Care, Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Groupement Hospitalier Est, Bron, France ; Lyon's Neuroscience Research Center, INSERM U1028/CNRS UMR 5292, Lyon 1 University, France
Olivot, Jean Marc ; Neurology Department, University Hospital of Toulouse, France
Calviere, Lionel ; Neurology Department, University Hospital of Toulouse, France
Julean, Gabriela ; Department of Anesthesia and Critical Care, University Hospital, Lille, France ; Université Lille, ULR 2694 - METRICS, France
Bourst, Pauline; Anesthesiology Department, CHRU Nancy, France
Audibert, Gérard ; Anesthesiology Department, CHRU Nancy, France
Degos, Vincent; Department of Anesthesia, Critical Care and Peri-Operative Medicine, APHP, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France ; INSERM UMR 1141, Paris, France
Dupont, Julie; Department of Anesthesia, Critical Care and Peri-Operative Medicine, APHP, Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France ; INSERM UMR 1141, Paris, France
Robichon, Erwan; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Escalard, Simon ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Desilles, Jean-Philippe ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France ; INSERM, U1144, Paris, France ; Université Paris Cité, France ; FHU Neurovasc 2030, Paris, France
Smajda, Stanislas; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Redjem, Hocine; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Boisseau, William ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Al Raaisi, Amira; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Blanc, Raphael ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Piotin, Michel ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Seners, Pierre ; Neurology Department, Hôpital Fondation A. de Rothschild, Paris, France
Delvoye, François ; Université de Liège - ULiège > Département des sciences cliniques ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Comby, Pierre-Olivier ; Department of Neuroradiology and Emergency Radiology, François-Mitterand University Hospital, Dijon, France
Boursin, Perrine ; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France
Yavchitz, Amélie; Clinical Research Unit, Hôpital Fondation A. de Rothschild, Paris, France
Nekrouf, Célia; Clinical Research Unit, Hôpital Fondation A. de Rothschild, Paris, France
Le Cossec, Chloé; Clinical Research Unit, Hôpital Fondation A. de Rothschild, Paris, France
Mazighi, Mikael; Interventional Neuroradiology Department, Hôpital Fondation A. de Rothschild, Paris, France ; INSERM, U1144, Paris, France ; Université Paris Cité, France ; FHU Neurovasc 2030, Paris, France ; Neurology Department, Hôpital Lariboisière, Paris, Institut Universitaire de France
Gayat, Etienne; Université Paris Cité, AP-HP, Hôpital Lariboisière, DMU PARABOL, Service d'Anesthésie-Réanimation-CTB, France, and ; Inserm U942 MASCOT, Paris, France
The authors thank Pr C\u00E9dric Laouenan, Pr Mathieu Zuber, and Pr Audrey De Jong for their participation in the Data and Safety Monitoring Board, Sid Ahmed Bellahdid, Elise Vadurel, and H\u00E9l\u00E8ne Villain for study monitoring, Julien Fournier, Ornellia Mophawe, and Malek Ben Maacha for study supervision. This trial was funded by the French Health Ministry (PHRC AOR 19-019). There was no commercial involvement in the design, planning, analysis, or reporting of the results.
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