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Central and cerebral haemodynamic changes after antihypertensive therapy in ischaemic stroke patients: A double-blind randomised trial.

ABSTRACT: Central and cerebral haemodynamic parameters can vary under similar brachial blood pressure (BP). We aimed to investigate the effects of antihypertensive agents on central and cerebral haemodynamic parameters in hypertensive patients with ischaemic stroke. The Fimasartan, Atenolol, and Valsartan On haemodynamic paRameters (FAVOR) study was conducted in a prospective, double-blinded manner. One hundred five patients were randomly administered atenolol, valsartan, or fimasartan during 12 weeks. We measured brachial, central, cerebral haemodynamic parameters and plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) levels at baseline and after 12-week. Baseline haemodynamic parameters were balanced among the three groups. Even with similar brachial BP reduction, significantly lower central systolic BP (atenolol; 146.5?±?18.8 vs. valsartan; 133.5?±?20.7 vs. fimasartan; 133.6?±?19.8?mmHg, p?=?0.017) and augmentation index values (89.8?±?13.2 vs. 80.6?±?9.2 vs. 79.2?±?11.6%; p?=?0.001) were seen in the angiotensin receptor blockers (ARBs) groups. The pulsatility index on transcranial Doppler was significantly reduced in valsartan (p?=?0.002) and fimasartan group (p?=?0.008). Plasma NT-proBNP level was also significantly decreased in ARB groups, especially for the fimasartan group (37.8?±?50.6 vs. 29.2?±?36.9 vs.19.2?±?27.8?pg/mL; p?=?0.006). These findings suggest that short-term ARB administration would be favourable for ischaemic stroke patients with hypertension, permitting effective reduction of central pressure and dampening of cerebral pulsatility.

SUBMITTER: Choi MH

PROVIDER: S-EPMC5784025 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Central and cerebral haemodynamic changes after antihypertensive therapy in ischaemic stroke patients: A double-blind randomised trial.

Choi Mun Hee MH Lee Jin Soo JS Lee Sung Eun SE Lee Seong-Joon SJ Yoon Dukyong D Park Rae Woong RW Hong Ji Man JM

Scientific reports 20180124 1

Central and cerebral haemodynamic parameters can vary under similar brachial blood pressure (BP). We aimed to investigate the effects of antihypertensive agents on central and cerebral haemodynamic parameters in hypertensive patients with ischaemic stroke. The Fimasartan, Atenolol, and Valsartan On haemodynamic paRameters (FAVOR) study was conducted in a prospective, double-blinded manner. One hundred five patients were randomly administered atenolol, valsartan, or fimasartan during 12 weeks. We ...[more]

PMID: 29367614

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Project description:BackgroundIn animal models of ischaemic stroke, 25% albumin reduced brain infarction and improved neurobehavioural outcome. In a pilot clinical trial, albumin doses as high as 2 g/kg were safely tolerated. We aimed to assess whether albumin given within 5 h of the onset of acute ischaemic stroke increased the proportion of patients with a favourable outcome.MethodsWe did a randomised, double-blind, parallel-group, phase 3, placebo-controlled trial between Feb 27, 2009, and Sept 10, 2012, at 69 sites in the USA, 13 sites in Canada, two sites in Finland, and five sites in Israel. Patients aged 18-83 years with ischaemic (ie, non-haemorrhagic) stroke with a baseline National Institutes of Health stroke scale (NIHSS) score of 6 or more who could be treated within 5 h of onset were randomly assigned (1:1), via a central web-based randomisation process with a biased coin minimisation approach, to receive 25% albumin (2 g [8 mL] per kg; maximum dose 750 mL) or the equivalent volume of isotonic saline. All study personnel and participants were masked to the identity of the study drug. The primary endpoint was favourable outcome, defined as either a modified Rankin scale score of 0 or 1, or an NIHSS score of 0 or 1, or both, at 90 days. Analysis was by intention to treat. Thrombolytic therapies were permitted. This trial is registered with ClinicalTrials.gov, number NCT00235495.Findings422 participants were randomly assigned to receive albumin and 419 to receive saline. On Sept 12, 2012, the trial was stopped early for futility (n=841). The primary outcome did not differ between patients in the albumin group and those in the saline group (186 [44%] vs 185 [44%]; risk ratio 0·96, 95% CI 0·84-1·10, adjusted for baseline NIHSS score and thrombolysis stratum). Mild-to-moderate pulmonary oedema was more common in patients given albumin than in those given saline (54 [13%] of 412 vs 5 [1%] of 412 patients); symptomatic intracranial haemorrhage within 24 h was also more common in patients in the albumin group than in the placebo group (17 [4%] of 415 vs 7 [2%] of 414 patients). Although the rate of favourable outcome in patients given albumin remained consistent at 44-45% over the course of the trial, the cumulative rate of favourable outcome in patients given saline rose steadily from 31% to 44%.InterpretationOur findings show no clinical benefit of 25% albumin in patients with ischaemic stroke; however, they should not discourage further efforts to identify effective strategies to protect the ischaemic brain, especially because of preclinical literature showing convincing proof-of-principle for the possibility of this outcome.FundingNational Institute of Neurological Disorders and Stroke, US National Institutes of Health; and Baxter Healthcare Corporation.

Project description:OBJECTIVE:The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). DESIGN:Eligible patients had IVT started within 4.5?hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90?min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0-2 at day 90. RESULTS:Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13-21). Median stroke onset to IVT start was 120?min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0-1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0-2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). CONCLUSIONS:The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival. TRIAL REGISTRATION NUMBER:NCT01745692; Results.

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Dataset Information

Central and cerebral haemodynamic changes after antihypertensive therapy in ischaemic stroke patients: A double-blind randomised trial.

Publications

Central and cerebral haemodynamic changes after antihypertensive therapy in ischaemic stroke patients: A double-blind randomised trial.

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