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Original article
Characteristics, management and response to alteplase in China versus non-China participants of the ENCHANTED trial
  1. Lily Song1,2,
  2. Xia Wang3,
  3. Thompson Robinson4,
  4. Richard I Lindley3,
  5. Hisatomi Arima3,5,
  6. Pablo M Lavados6,7,
  7. Xiaoying Chen3,
  8. John Chalmers3,
  9. Craig S Anderson1,3,8
  10. for the ENCHANTED Investigators and Coordinators
  1. 1 The George Institute for Global Health at Peking University Health Science Center, Beijing, China
  2. 2 Department of Neurology, 85 Hospital of People’s Liberation Army, Shanghai, China
  3. 3 The George Institute for Global Health, The University of New South Wales, Sydney, Australia
  4. 4 Department of Cardiovascular Sciences and NIHR Biomedical Research Unit for Cardiovascular Sciences, University of Leicester, Leicester, UK
  5. 5 Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
  6. 6 Clínica Alemana de Santiago, Universidad del Desarrollo, Concepción, Chile
  7. 7 Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Concepción, Chile
  8. 8 Neurology Department, Royal Prince Alfred Hospital, Sydney, Australia
  1. Correspondence to Professor Craig S Anderson; canderson{at}georgeinstitute.org.cn

Abstract

Background The characteristics of patients with acute ischaemic stroke (AIS) and their management vary across regions, which may influence outcomes. We examined for differential patterns of outcome between China and non-China participants of the ENhanced Control of Hypertension And Thrombolysis strokE stuDy (ENCHANTED), which tested different alteplase doses in AIS.

Methods ENCHANTED was an international, multicentre, open, blinded-endpoint trial of the effects of low-dose (0.6 mg/kg) versus standard-dose (0.9 mg/kg) intravenous alteplase on 90-day disability outcomes and symptomatic intracerebral haemorrhage (sICH) in 3310 patients with AIS.

Results Participants (n=1419, 48%) in China were younger, and more often male, hypertensive and with prior stroke and coronary artery disease, but less likely to have atrial fibrillation and use antihypertensive, antithrombotic and lipid-lowering agents, compared with non-China patients with AIS. Although China participants had more AIS due to large artery occlusion, were treated later and had differing ancillary management, there was no significant difference in 90-day modified Rankin scale scores 2–6 (55.6% vs 47.8%; OR, adjusted for baseline and management factors 0.87 (95% CI 0.71 to 1.07; p=0.20)) and risk of sICH (Safe Implementation of Thrombolysis in Stroke-Monitoring Study criteria: 1.4% vs 1.8%; p=0.12) compared with non-China participants. There was no heterogeneity in the treatment effects of low-dose versus standard-dose alteplase between China and non-China participants.

Conclusion Patients with AIS recruited to the ENCHANTED trial in China had similar outcomes in response to thrombolysis treatment despite significantly differing demographic, clinical and management factors to patients with AIS in other regions.

  • acute ischemic stroke
  • intravenous thrombolysis
  • clinical trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/svn-2017-000085

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    Footnotes

    • Contributors CSA contributed to study design, organisation, execution, statistical review, and review and critique of the report. LS contributed to study execution and writing of the report. XW contributed to data analysis and review and critique of the report. TR and RIL contributed to study design, organisation, execution and review and critique of the report. HA and JC contributed to study design and review and critique of the report. PML and XC contributed to study organisation, execution and review and critique of the report.

    • Funding Funding was principally received from the National Health and Medical Research Council (NHMRC) of Australia. Additional funding was from the Stroke Association of the United Kingdom, the National Council for Scientific and Technological Development of Brazil, and the Ministry for Health, Welfare and Family Affairs of the Republic of Korea (HI14C1985).

    • Competing interests T Robinson is a National Institute of Health Research Senior Investigator, and reports receiving speaking fees from Bayer and Boehringer Ingelheim, and fees for Advisory Panels from Bayer and Daiichi Sankyo. PM Lavados reports receiving research funding from Astra Zeneca, Bayer and Boehringer Ingelheim and speaking fees from Bayer. RI Lindley reports receiving speaking fees from Boehringer Ingelheim, Covidien, and Pfizer. CS Anderson reports receiving fees for Advisory Panels of Astra Zeneca and Medtronic, speaking at seminars for Takeda China and Boehringer Ingelheim, and a research grant from Takeda China. J Chalmers reports research grants and lecture fees from Servier for the ADVANCE trial and post-trial follow-up.

    • Patient consent Obtained.

    • Ethics approval Every ethics committee at the participating centers.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No data sharing.