Key PointsQuestion
Does early intensive blood pressure management improve
outcomes after successful reperfusion with endovascular thrombectomy in
acute ischemic stroke?
Findings
In this randomized clinical trial that included 306 patients,
39.4% of patients with intensive blood pressure management (systolic
blood pressure target <140 mm Hg) and 54.4% of those with
conventional blood pressure management (systolic blood pressure target
140-180 mm Hg) achieved functional independence (modified Rankin Scale
score ≤2) at 3 months; this represented a significant difference.
Meaning
Intensive blood pressure lowering during the first 24 hours
after successful reperfusion may be harmful in patients with acute
ischemic stroke who have undergone endovascular thrombectomy.
Importance
Optimal blood pressure (BP) control after successful
reperfusion with endovascular thrombectomy (EVT) for patients with acute
ischemic stroke is unclear.
Objective
To determine whether intensive BP management during the first
24 hours after successful reperfusion leads to better clinical outcomes
than conventional BP management in patients who underwent EVT.
Design, Setting, and Participants
Multicenter, randomized, open-label trial with a blinded
end-point evaluation, conducted across 19 stroke centers in South Korea
from June 2020 to November 2022 (final follow-up, March 8, 2023). It
included 306 patients with large vessel occlusion acute ischemic stroke
treated with EVT and with a modified Thrombolysis in Cerebral Infarction
score of 2b or greater (partial or complete reperfusion).
Interventions
Participants were randomly assigned to receive intensive BP
management (systolic BP target <140 mm Hg; n = 155) or conventional
management (systolic BP target 140-180 mm Hg; n = 150) for 24 hours
after enrollment.
Main Outcomes and Measures
The primary outcome was functional independence at 3 months
(modified Rankin Scale score of 0-2). The primary safety outcomes were
symptomatic intracerebral hemorrhage within 36 hours and death related
to the index stroke within 3 months.
Results
The trial was terminated early based on the recommendation of
the data and safety monitoring board, which noted safety concerns. Among
306 randomized patients, 305 were confirmed eligible and 302 (99.0%)
completed the trial (mean age, 73.0 years; 122 women [40.4%]). The
intensive management group had a lower proportion achieving functional
independence (39.4%) than the conventional management group (54.4%),
with a significant risk difference (−15.1% [95% CI, −26.2% to −3.9%])
and adjusted odds ratio (0.56 [95% CI, 0.33-0.96]; P = .03).
Rates of symptomatic intracerebral hemorrhage were 9.0% in the intensive
group and 8.1% in the conventional group (risk difference, 1.0% [95%
CI, −5.3% to 7.3%]; adjusted odds ratio, 1.10 [95% CI, 0.48-2.53]; P = .82).
Death related to the index stroke within 3 months occurred in 7.7% of
the intensive group and 5.4% of the conventional group (risk difference,
2.3% [95% CI, −3.3% to 7.9%]; adjusted odds ratio, 1.73 [95% CI,
0.61-4.92]; P = .31).
Conclusions and Relevance
Among patients who achieved successful reperfusion with EVT
for acute ischemic stroke with large vessel occlusion, intensive BP
management for 24 hours led to a lower likelihood of functional
independence at 3 months compared with conventional BP management. These
results suggest that intensive BP management should be avoided after
successful EVT in acute ischemic stroke.
Trial Registration
ClinicalTrials.gov Identifier: NCT04205305
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