• Thomas P Zonneveld, Sarah E Vermeer, Erik W van Zwet, Adrien E D Groot, Ale Algra, AerdenLeo A MLAMDepartment of Neurology, Reinier de Graaf Gasthuis, Delft, Netherlands., Kees C L Alblas, Frank de Beer, BrouwersPaul J A MPJAMDepartment of Neurology, Medisch Spectrum Twente, Enschede, Netherlands., Koen de Gans, van GemertH Maarten AHMADepartment of Neurology, Meander MC, Amersfoort, Netherlands., Bart C A M van Ginneken, Gerke S Grooters, Patricia H A Halkes, Tonny A M H G van der Heijden-Montfroy, Korné Jellema, Sonja W de Jong, Harry Lövenich-Ciccarello, Willem D M van der Meulen, Edwin W Peters, Taco C van der Ree, RemmersMichel J MMJMDepartment of Neurology, Amphia Hospital, Breda, Netherlands., Edo Richard, RoversJörgen M PJMPDepartment of Neurology, Gelderse Vallei Hospital, Ede, Netherlands., Ritu Saxena, Sander M van Schaik, Wouter J Schonewille, Tobien A H C M L Schreuder, Els L L M de Schryver, Wouter J Schuiling, Fianne H Spaander, Julia H van Tuijl, Marieke C Visser, Sanne M Zinkstok, Elles Zock, DippelDiederik W JDWJDepartment of Neurology, Erasmus MC, Rotterdam, Netherlands., L Jaap Kappelle, Robert J van Oostenbrugge, RoosYvo B W E MYBWEMDepartment of Neurology, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands., Frederique H Vermeij, WermerMarieke J HMJHDepartment of Neurology, UMC Groningen, Groningen, Netherlands., H Bart van der Worp, Paul J Nederkoorn, and Nyika D Kruyt.
• Department of Neurology, Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands.
• Lancet Neurol. 2024 Aug 1; 23 (8): 807815807-815.

BackgroundIntravenous thrombolysis is contraindicated in patients with ischaemic stroke with blood pressure higher than 185/110 mm Hg. Prevailing guidelines recommend to actively lower blood pressure with intravenous antihypertensive agents to allow for thrombolysis; however, there is no robust evidence for this strategy. Because rapid declines in blood pressure can also adversely affect clinical outcomes, several Dutch stroke centres use a conservative strategy that does not involve the reduction of blood pressure. We aimed to compare the clinical outcomes of both strategies.MethodsThrombolysis and Uncontrolled Hypertension (TRUTH) was a prospective, observational, cluster-based, parallel-group study conducted across 37 stroke centres in the Netherlands. Participating centres had to strictly adhere to an active blood-pressure-lowering strategy or to a non-lowering strategy. Eligible participants were adults (≥18 years) with ischaemic stroke who had blood pressure higher than 185/110 mm Hg but were otherwise eligible for intravenous thrombolysis. The primary outcome was functional status at 90 days, measured using the modified Rankin Scale and assessed through telephone interviews by trained research nurses. Secondary outcomes were symptomatic intracranial haemorrhage, the proportion of patients treated with intravenous thrombolysis, and door-to-needle time. All ordinal logistic regression analyses were adjusted for age, sex, stroke severity, endovascular thrombectomy, and baseline imbalances as fixed-effect variables and centre as a random-effect variable to account for the clustered design. Analyses were done according to the intention-to-treat principle, whereby all patients were analysed according to the treatment strategy of the participating centre at which they were treated.FindingsRecruitment began on Jan 1, 2015, and was prematurely halted because of a declining inclusion rate and insufficient funding on Jan 5, 2022. Between these dates, we recruited 853 patients from 27 centres that followed an active blood-pressure-lowering strategy and 199 patients from ten centres that followed a non-lowering strategy. Baseline characteristics of participants from the two groups were similar. The 90-day mRS score was missing for 15 patients. The adjusted odds ratio (aOR) for a shift towards a worse 90-day functional outcome was 1·27 (95% CI 0·96-1·68) for active blood-pressure reduction compared with no active blood-pressure reduction. 798 (94%) of 853 patients in the active blood-pressure-lowering group were treated with intravenous thrombolysis, with a median door-to-needle time of 35 min (IQR 25-52), compared with 104 (52%) of 199 patients treated in the non-lowering group with a median time of 47 min (29-78). 42 (5%) of 852 patients in the active blood-pressure-lowering group had a symptomatic intracranial haemorrhage compared with six (3%) of 199 of those in the non-lowering group (aOR 1·28 [95% CI 0·62-2·62]).InterpretationInsufficient evidence was available to establish a difference between an active blood-pressure-lowering strategy-in which antihypertensive agents were administered to reduce blood pressure below 185/110 mm Hg-and a non-lowering strategy for the functional outcomes of patients with ischaemic stroke, despite higher intravenous thrombolysis rates and shorter door-to-needle times among those in the active blood-pressure-lowering group. Randomised controlled trials are needed to inform the use of an active blood-pressure-lowering strategy.FundingFonds NutsOhra.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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