Intensive vs Conventional Blood Pressure Lowering After Endovascular Thrombectomy in Acute Ischemic Stroke: The OPTIMAL-BP Randomized Clinical Trial
- PMID: 37668619
- PMCID: PMC10481233
- DOI: 10.1001/jama.2023.14590
Intensive vs Conventional Blood Pressure Lowering After Endovascular Thrombectomy in Acute Ischemic Stroke: The OPTIMAL-BP Randomized Clinical Trial
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.
Conflict of interest statement
Figures
Comment in
-
Blood Pressure Management After Successful Thrombectomy.JAMA. 2023 Sep 5;330(9):811-812. doi: 10.1001/jama.2023.14588. JAMA. 2023. PMID: 37668632 No abstract available.
-
After EVT for ischemic stroke, intensive vs. conventional BP management reduced functional independence at 3 mo.Ann Intern Med. 2024 Jan;177(1):JC5. doi: 10.7326/J23-0106. Epub 2024 Jan 2. Ann Intern Med. 2024. PMID: 38163376 Clinical Trial.
Similar articles
-
Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial.JAMA. 2021 Jan 19;325(3):234-243. doi: 10.1001/jama.2020.23523. JAMA. 2021. PMID: 33464335 Free PMC article. Clinical Trial.
-
Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke: The SKIP Randomized Clinical Trial.JAMA. 2021 Jan 19;325(3):244-253. doi: 10.1001/jama.2020.23522. JAMA. 2021. PMID: 33464334 Free PMC article. Clinical Trial.
-
Admission Blood Pressure in Relation to Clinical Outcomes and Successful Reperfusion After Endovascular Stroke Treatment.Stroke. 2020 Nov;51(11):3205-3214. doi: 10.1161/STROKEAHA.120.029907. Epub 2020 Oct 12. Stroke. 2020. PMID: 33040702 Free PMC article.
-
Bridging therapy improves functional outcomes and reduces 90-day mortality compared with direct endovascular thrombectomy in patients with acute posterior ischemic stroke: a systematic review and meta-analysis.Neurol Sci. 2024 Feb;45(2):495-506. doi: 10.1007/s10072-023-07096-x. Epub 2023 Oct 4. Neurol Sci. 2024. PMID: 37792113 Review.
-
Standard Versus Intensive Blood Pressure Control in Acute Ischemic Stroke Patients Successfully Treated With Endovascular Thrombectomy: A Systemic Review and Meta-Analysis of Randomized Controlled Trials.J Stroke. 2024 Jan;26(1):54-63. doi: 10.5853/jos.2023.04119. Epub 2024 Jan 30. J Stroke. 2024. PMID: 38326706 Free PMC article. Review.
Cited by
-
Machine learning models reveal the critical role of nighttime systolic blood pressure in predicting functional outcome for acute ischemic stroke after endovascular thrombectomy.Front Neurol. 2024 May 9;15:1405668. doi: 10.3389/fneur.2024.1405668. eCollection 2024. Front Neurol. 2024. PMID: 38784914 Free PMC article.
-
Overview of systematic reviews comparing endovascular to best medical treatment for large-vessel occlusion acute ischaemic stroke: an umbrella review.Ther Adv Neurol Disord. 2024 Apr 29;17:17562864241246938. doi: 10.1177/17562864241246938. eCollection 2024. Ther Adv Neurol Disord. 2024. PMID: 38685935 Free PMC article. Review.
-
Functional Outcomes Associated With Blood Pressure Decrease After Endovascular Thrombectomy.JAMA Netw Open. 2024 Apr 1;7(4):e246878. doi: 10.1001/jamanetworkopen.2024.6878. JAMA Netw Open. 2024. PMID: 38630474 Free PMC article.
-
Blood Pressure Variability in Acute Stroke: A Narrative Review.J Clin Med. 2024 Mar 29;13(7):1981. doi: 10.3390/jcm13071981. J Clin Med. 2024. PMID: 38610746 Free PMC article. Review.
-
Blood pressure targets after successful reperfusion in mechanical thrombectomy for acute ischemic stroke: an updated systematic review and meta-analysis of randomized clinical trials.Neurol Sci. 2024 Aug;45(8):3879-3886. doi: 10.1007/s10072-024-07458-z. Epub 2024 Mar 18. Neurol Sci. 2024. PMID: 38494461
References
-
- Lapergue B, Blanc R, Costalat V, et al. ; ASTER2 Trial Investigators . Effect of thrombectomy with combined contact aspiration and stent retriever vs stent retriever alone on revascularization in patients with acute ischemic stroke and large vessel occlusion: the ASTER2 randomized clinical trial. JAMA. 2021;326(12):1158-1169. doi:10.1001/jama.2021.13827 - DOI - PMC - PubMed
Publication types
MeSH terms
Substances
Associated data
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical