Individualized vs Standard Blood Pressure Control During Thrombectomy for Ischemic Stroke: The DETERMINE Randomized Clinical Trial.

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.