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-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]). Insufficient 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. Fonds NutsOhra.

中文翻译：

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荷兰急性缺血性卒中患者主动将血压降至静脉溶栓推荐阈值的安全性和有效性 （TRUTH）：一项前瞻性、观察性、基于整群的平行组研究


血压高于 185/110 mm Hg 的缺血性卒中患者禁用静脉溶栓。现行指南建议积极使用静脉注射降压药降低血压，以便进行溶栓;然而，没有强有力的证据支持这种策略。由于血压的快速下降也会对临床结果产生不利影响，因此一些荷兰中风中心使用不涉及降低血压的保守策略。我们旨在比较两种策略的临床结局。溶栓和不受控制的高血压 （TRUTH） 是一项前瞻性、观察性、基于整群的平行组研究，在荷兰的 37 个卒中中心进行。参与中心的血压降低策略必须严格遵守主动降压策略或不降低血压策略。符合条件的受试者是患有缺血性卒中的成年人（≥18 岁），他们的血压高于 185/110 毫米汞柱，但其他方面符合静脉溶栓的条件。主要结局是 90 天时的功能状态，使用改良的 Rankin 量表测量，并由训练有素的研究护士通过电话访谈进行评估。次要结局是症状性颅内出血、接受静脉溶栓治疗的患者比例和门到针时间。所有顺序 logistic 回归分析均针对年龄、性别、卒中严重程度、血管内血栓切除术和基线不平衡作为固定效应变量进行调整，并将中心作为随机效应变量进行调整，以解释聚类设计。根据意向治疗原则进行分析，即根据接受治疗的参与中心的治疗策略对所有患者进行分析。 招募于 2015 年 1 月 1 日开始，并于 2022 年 1 月 5 日因纳入率下降和资金不足而提前停止。在此期间，我们从 27 个遵循主动降血压策略的中心招募了 853 名患者，并从 10 个遵循非降血压策略的中心招募了 199 名患者。两组参与者的基线特征相似。15 例患者的 90 天 mRS 评分缺失。与无主动降血压相比，主动降压向更差的 90 天功能结局转变的校正比值比 （aOR） 为 1·27 （95% CI 0·96–1·68）。主动降压组 853 名患者中有 798 名 （94%） 接受了静脉溶栓治疗，中位门到穿刺时间为 35 分钟 （IQR 25-52），而非降血压组的 199 名患者中有 104 名 （52%） 接受了静脉溶栓治疗，中位时间为 47 分钟 （29-78）。主动降压组 852 名患者中有 42 名 （5%） 有症状性颅内出血，而非降血压组 199 名患者中有 6 名 （3%） （aOR 1·28 [95% CI 0·62–2·62]）。没有足够的证据来确定主动降压策略（使用抗高血压药物将血压降低到 185/110 毫米汞柱以下）和非降低策略对缺血性卒中患者功能结局的差异，尽管主动降压组患者的静脉溶栓率较高且门到针时间较短。需要随机对照试验来告知使用主动降压策略。Fonds NutsOhra.