Randomized Controlled Trial

. 2021 Feb 1;39(2):280-285.

doi: 10.1097/HJH.0000000000002640.

Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial

Jatinder S Minhas¹, Xia Wang², Richard I Lindley^{2

3}, Candice Delcourt², Lili Song², Mark Woodward^{2

4

5}, Tsong-Hai Lee⁶, Joseph P Broderick⁷, Octavio M Pontes-Neto⁸, Jong S Kim⁹, Stefano Ricci¹⁰, Pablo M Lavados¹¹, Philip M Bath^{12

13}, Alice C Durham¹, Ji-Guang Wang¹⁴, Vijay K Sharma¹⁵, Andrew M Demchuk¹⁶, Sheila O Martins¹⁷, John Chalmers², Craig S Anderson^{2

18

19}, Thompson G Robinson¹; ENCHANTED Investigators

Affiliations

¹ Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
² Faculty of Medicine, The George Institute for Global Health, University of New South Wales.
³ Westmead Applied Research Centre, University of Sydney, Sydney, New South Wales, Australia.
⁴ The George Institute for Global Health, University of Oxford, Oxford, UK.
⁵ Department of Epidemiology, John Hopkins University, Baltimore, Maryland, USA.
⁶ Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
⁷ Department of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, Cincinnati, Ohio, USA.
⁸ Stroke Service, Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil.
⁹ Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
¹⁰ Uo Neurologia, Unità Sanitaria Locale Umbria 1, Sedi di Citta di Castello e Branca, Trento, Italy.
¹¹ Departamento de Desarrollo Académico e Investigación, Unidad de Investigación y Ensayos Clínicos, Clínica Alemana, Universidad del Desarrollo, Concepción, Chile.
¹² Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham.
¹³ Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK.
¹⁴ The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China.
¹⁵ Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
¹⁶ Calgary Stroke Program, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
¹⁷ Neurology Service Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul and Hospital Moinhos de Vento, Porto Alegre, Brazil.
¹⁸ The George Institute China at Peking University Health Science Center, Beijing, PR China.
¹⁹ Neurology Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.

PMID: 33031175
DOI: 10.1097/HJH.0000000000002640

Randomized Controlled Trial

Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial

Jatinder S Minhas et al. J Hypertens. 2021.

. 2021 Feb 1;39(2):280-285.

doi: 10.1097/HJH.0000000000002640.

Authors

Affiliations

¹ Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
² Faculty of Medicine, The George Institute for Global Health, University of New South Wales.
³ Westmead Applied Research Centre, University of Sydney, Sydney, New South Wales, Australia.
⁴ The George Institute for Global Health, University of Oxford, Oxford, UK.
⁵ Department of Epidemiology, John Hopkins University, Baltimore, Maryland, USA.
⁶ Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
⁷ Department of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, University of Cincinnati, Cincinnati, Ohio, USA.
⁸ Stroke Service, Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil.
⁹ Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
¹⁰ Uo Neurologia, Unità Sanitaria Locale Umbria 1, Sedi di Citta di Castello e Branca, Trento, Italy.
¹¹ Departamento de Desarrollo Académico e Investigación, Unidad de Investigación y Ensayos Clínicos, Clínica Alemana, Universidad del Desarrollo, Concepción, Chile.
¹² Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham.
¹³ Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK.
¹⁴ The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, PR China.
¹⁵ Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
¹⁶ Calgary Stroke Program, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
¹⁷ Neurology Service Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul and Hospital Moinhos de Vento, Porto Alegre, Brazil.
¹⁸ The George Institute China at Peking University Health Science Center, Beijing, PR China.
¹⁹ Neurology Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.

PMID: 33031175
DOI: 10.1097/HJH.0000000000002640

Abstract

Objective: Limited data exist on the optimum level of SBP in thrombolyzed patients with acute ischemic stroke (AIS). We aimed to determine the effects of intensive blood pressure (BP) lowering, specifically in patients with severe AIS who participated in the international, Enhanced Control of Hypertension and Thrombolysis Stroke Study.

Methods: Prespecificed subgroup analyzes of the BP arm of Enhanced Control of Hypertension and Thrombolysis Stroke Study, a multicenter, partial-factorial, open, blinded outcome assessed trial, in which 2227 thrombolysis-eligible and treated AIS patients with elevated SBP (>150 mmHg) were randomized to intensive (target 130-140 mmHg) or guideline-recommended (<180 mmHg) BP management. Severe stroke was defined by computed tomography or magnetic resonance angiogram confirmation of large-vessel occlusion, receipt of endovascular therapy, final diagnosis of large artery atheromatous disease, or high (>10) baseline neurological scores on the National Institutes of Health Stroke Scale. The primary efficacy outcome was death or any disability (modified Rankin scale scores 2-6). The key safety outcome was intracranial hemorrhage (ICH). Treatment effects estimated in logistic regression models are reported as odds ratios (ORs) with 95% confidence intervals (CIs).

Results: There were 1311 patients [mean age 67 years; 37% female; median baseline National Institutes of Health Stroke Scale of 11 (range 6.0-15.0)] with severe AIS. Overall, there was no significant difference in the primary outcome of death or disability. However, intensive BP lowering significantly increased mortality (OR 1.52, 95% CI 1.09-2.13; P = 0.014) compared with guideline BP lowering, despite significantly lowering clinician-reported ICH (OR 0.63, 95% CI 0.43-0.92; P = 0.016).

Conclusion: Intensive BP lowering is associated with increased mortality in patients with severe AIS despite lowering the risk of ICH. Further randomized trials are required to provide reliable evidence over the optimum SBP target in the most serious type of AIS.

Trial registration: ClinicalTrials.gov Identifier: NCT01422616.

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References

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Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial

Affiliations

Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical