Intensive vs Conventional Blood Pressure Lowering After Endovascular Thrombectomy in Acute Ischemic Stroke: The OPTIMAL-BP Randomized Clinical Trial

Hyo Suk Nam, Young Dae Kim, Joon Nyung Heo, Hyungwoo Lee, Jae Wook Jung, Jin Kyo Choi, Il Hyung Lee, In Hwan Lim, Soon Ho Hong, Minyoul Baik, Byung Moon Kim, Dong Joon Kim, Na Young Shin, Bang Hoon Cho, Seong Hwan Ahn, Hyungjong Park, Sung Il Sohn, Jeong Ho Hong, Tae Jin Song, Yoonkyung ChangGyu Sik Kim, Kwon Duk Seo, Kijeong Lee, Jun Young Chang, Jung Hwa Seo, Sukyoon Lee, Jang Hyun Baek, Han Jin Cho, Dong Hoon Shin, Jinkwon Kim, Joonsang Yoo, Kyung Yul Lee, Yo Han Jung, Yang Ha Hwang, Chi Kyung Kim, Jae Guk Kim, Chan Joo Lee, Sungha Park, Hye Sun Lee, Sun U. Kwon, Oh Young Bang, Craig S. Anderson, Ji Hoe Heo

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)832-842
Number of pages11
JournalJAMA - Journal of the American Medical Association
Volume330
Issue number9
DOIs
StatePublished - 5 Sep 2023

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