Safety and efficacy of active blood-pressure reduction to the recommended thresholds for intravenous thrombolysis in patients with acute ischaemic stroke in the Netherlands (TRUTH): a prospective, observational, cluster-based, parallel-group study

• Published in: Lancet neurology 2024-08, Vol.23 (8), p.807-815
• Main Authors: Zonneveld, Thomas P, Vermeer, Sarah E, van Zwet, Erik W, Groot, Adrien E D, Algra, Ale, Aerden, Leo A M, Alblas, Kees C L, de Beer, Frank, Brouwers, Paul J A M, de Gans, Koen, van Gemert, H Maarten A, van Ginneken, Bart C A M, Grooters, Gerke S, Halkes, Patricia H A, van der Heijden-Montfroy, Tonny A M H G, Jellema, Korné, de Jong, Sonja W, Lövenich-Ciccarello, Harry, van der Meulen, Willem D M, Peters, Edwin W, van der Ree, Taco C, Remmers, Michel J M, Richard, Edo, Rovers, Jörgen M P, Saxena, Ritu, van Schaik, Sander M, Schonewille, Wouter J, Schreuder, Tobien A H C M L, de Schryver, Els L L M, Schuiling, Wouter J, Spaander, Fianne H, van Tuijl, Julia H, Visser, Marieke C, Zinkstok, Sanne M, Zock, Elles, Dippel, Diederik W J, Kappelle, L Jaap, van Oostenbrugge, Robert J, Roos, Yvo B W E M, Vermeij, Frederique H, Wermer, Marieke J H, van der Worp, H Bart, Nederkoorn, Paul J, Kruyt, Nyika D
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antihypertensive Agents - administration & dosage; Antihypertensive Agents - therapeutic use; Antihypertensives; Blood pressure; Blood Pressure - drug effects; Blood Pressure - physiology; Cardiovascular system; Clinical outcomes; Clinical trials; Consent; Contraindications; Female; Fibrinolytic Agents - administration & dosage; Fibrinolytic Agents - therapeutic use; Hemorrhage; Humans; Hypertension - drug therapy; Intravenous administration; Ischemia; Ischemic Stroke - drug therapy; Ischemic Stroke - therapy; Male; Middle Aged; Netherlands; Patients; Pharmacists; Prospective Studies; Stroke; Thrombolysis; Thrombolytic Therapy - methods; Treatment Outcome
• ISSN: 1474-4422; 1474-4465; 1474-4465
• DOI: 10.1016/S1474-4422(24)00177-7

Intravenous 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. Thrombolysis 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. Recruitment 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-p