Abstract
BACKGROUND
The optimal blood pressure management strategy in patients undergoing endovascular therapy for acute ischemic stroke is unknown. This pilot study aimed to assess the feasibility of a standard versus individualized blood pressure management strategy during endovascular therapy.
METHODS
This randomized controlled pilot trial included adult patients with acute ischemic stroke with large‐vessel occlusion in the anterior circulation undergoing endovascular therapy. Patients were randomized to either standard (mean arterial blood pressure [MABP] targeted between 70 and 90 mm Hg) or individualized (MABP targeted ±10% of a baseline value measured in the neurointerventional suite) blood pressure targets until reperfusion or removal of groin sheath. The main outcome was the modified Rankin Scale score at 90 days. Secondary outcomes included feasibility outcomes, 90‐day dichotomized modified Rankin Scale score (0–2 versus 3–6), and reperfusion rates.
RESULTS
Between April 2021 and February 2022, 60 patients (median [interquartile range] age, 76 [66–84] years) were randomly assigned to standard (n=30) or individualized (n=30) blood pressure targets. Median (interquartile range) National institutes of Health Stroke Scale score was 15 (10–18). Mean (SD) MABP, mean (SD) systolic blood pressure, and median (interquartile range) cardiac output were significantly higher in the individualized group compared with the standard group (MABP: 94 [9] versus 88 [9] mm Hg; P=0.012; systolic blood pressure: 149 [21] versus 139 [17] mm Hg; P=0.032; and cardiac output: 5.82 [4.22–7.23] versus 4.35 [3.73–5.1] L/min; P=0.02). The odds ratio for improved outcome in the individualized group was 1.37 (95% CI, 0.56–3.36). The relative risk for improved dichotomized outcome in the individualized group was 1.31 (95% CI, 0.87–1.98). Full reperfusion rates were comparable between the standard and individualized groups (90% versus 93%; P=0.64). The median percentage of time outside the MABP targets was 54.3% in the standard group versus 61.4% in the individual group (P=0.30) and did not meet the feasibility target. Recruitment rate, data completeness, and safety were within feasibility limits.
CONCLUSIONS
The feasibility criteria were not met in this study because of difficulties in achieving the desired blood pressure targets. These findings do not support continuing with a large trial using the current protocol.
The optimal blood pressure management strategy in patients undergoing endovascular therapy for acute ischemic stroke is unknown. This pilot study aimed to assess the feasibility of a standard versus individualized blood pressure management strategy during endovascular therapy.
METHODS
This randomized controlled pilot trial included adult patients with acute ischemic stroke with large‐vessel occlusion in the anterior circulation undergoing endovascular therapy. Patients were randomized to either standard (mean arterial blood pressure [MABP] targeted between 70 and 90 mm Hg) or individualized (MABP targeted ±10% of a baseline value measured in the neurointerventional suite) blood pressure targets until reperfusion or removal of groin sheath. The main outcome was the modified Rankin Scale score at 90 days. Secondary outcomes included feasibility outcomes, 90‐day dichotomized modified Rankin Scale score (0–2 versus 3–6), and reperfusion rates.
RESULTS
Between April 2021 and February 2022, 60 patients (median [interquartile range] age, 76 [66–84] years) were randomly assigned to standard (n=30) or individualized (n=30) blood pressure targets. Median (interquartile range) National institutes of Health Stroke Scale score was 15 (10–18). Mean (SD) MABP, mean (SD) systolic blood pressure, and median (interquartile range) cardiac output were significantly higher in the individualized group compared with the standard group (MABP: 94 [9] versus 88 [9] mm Hg; P=0.012; systolic blood pressure: 149 [21] versus 139 [17] mm Hg; P=0.032; and cardiac output: 5.82 [4.22–7.23] versus 4.35 [3.73–5.1] L/min; P=0.02). The odds ratio for improved outcome in the individualized group was 1.37 (95% CI, 0.56–3.36). The relative risk for improved dichotomized outcome in the individualized group was 1.31 (95% CI, 0.87–1.98). Full reperfusion rates were comparable between the standard and individualized groups (90% versus 93%; P=0.64). The median percentage of time outside the MABP targets was 54.3% in the standard group versus 61.4% in the individual group (P=0.30) and did not meet the feasibility target. Recruitment rate, data completeness, and safety were within feasibility limits.
CONCLUSIONS
The feasibility criteria were not met in this study because of difficulties in achieving the desired blood pressure targets. These findings do not support continuing with a large trial using the current protocol.
Original language | Danish |
---|---|
Article number | e001027 |
Journal | Stroke: Vascular and Interventional Neurology |
Volume | 3 |
Issue | 6 |
Number of pages | 8 |
DOIs | |
Publication status | Published - Nov 2023 |