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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.
|Surgery - Vascular|
|Surgery - Neurosurgery|
The authors declared at the end of the paper many limitations of the study. For this reason, it is not clear how to manage these patients ant the study doesn't add any information that can be generalized to similar populations. The final message is caution in lowering blood pressure in this patient setting.
Practice-defining trial. Lowering BP after EVT was associated with worse functional outcomes at 3 months.
This RCT reveals that intensive BP management for 24 hours led to a lower likelihood of functional independence at 3 months compared with conventional BP management in a number of patients.
An interesting study on a topic that is very current and important. The study showed that 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. The use of random allocation, blinding assessment, and intention-to-treat analysis are the main strengths of the study. The sample size and number of sites are sufficiently large.
The results of this study suggest that intensive BP-lowering management may be harmful and should be avoided after successful EVT in acute ischemic stroke. There is still much to learn about tailoring the best BP target for patients according to their own physiological status and stroke characteristics.
A well-designed and well-conducted RCT providing direct, clear, and relevant recommendations in acute stroke treatment - a cornerstone in the field.