Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial

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Dokumenter

DOI

  • Derek J Hausenloy, University College London, National University of Singapore
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  • Rajesh K Kharbanda, Oxford Heart Centre, Oxford University Hospitals National Health Service Trust, Oxford, UK; Department of Cardiovascular Medicine, University of Oxford, Oxford, UK.
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  • Ulla Kristine Møller
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  • Manish Ramlall, The Hatter Cardiovascular Institute, University College London, London, UK; University Hospital Southampton National Health Service Foundation Trust, Southampton, UK.
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  • Jens Aarøe, Aalborg Universitet
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  • Robert Butler, Department of Cardiology, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, UK.
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  • Heerajnarain Bulluck, Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
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  • Tim Clayton, Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
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  • Ali Dana, Portsmouth Hospitals National Health Service Trust, Portsmouth, UK.
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  • Matthew Dodd, Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
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  • Thomas Engstrom, Københavns Universitet
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  • Richard Evans, Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
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  • Jens Flensted Lassen
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  • Erika Frischknecht Christensen
  • José Manuel Garcia-Ruiz, Instituto de Investigación Sanitaria del Principado de Asturias, Hospital Universitario de Cabueñes, Oviedo, Spain; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.
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  • Diana A Gorog, Department of Cardiology, Lister Hospital, East and North Hertfordshire National Health Service Trust, Stevenage, UK; National Heart and Lung Institute, Imperial College London, London, UK.
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  • Jakob Hjort
  • Richard F Houghton, Servicio de Atención Médica de Urgencia-Asturias, Oviedo, Spain.
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  • Borja Ibanez, Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Centro de Investigacion Biomedica En Red Cardiovascular, Madrid, Spain; IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain.
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  • Rosemary Knight, Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
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  • Freddy K Lippert, Prehospital Emergency Medical Services, The Capital Region of Denmark.
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  • Jacob T Lønborg, Københavns Universitet
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  • Michael Maeng
  • Dejan Milasinovic, Department of Cardiology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
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  • Ranjit More, Lancashire Cardiac Centre, Blackpool Teaching Hospitals National Health Service Foundation Trust, Blackpool, UK.
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  • Jennifer M Nicholas, Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
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  • Lisette Okkels Jensen, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
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  • Alexander Perkins, Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
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  • Nebojsa Radovanovic, Cardiology Clinic, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Emergency Centre, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
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  • Roby D Rakhit, Royal Free Hospital London and Institute of Cardiovascular Science, University College London, London, UK.
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  • Jan Ravkilde, Aalborg Universitet
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  • Alisdair D Ryding, Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.
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  • Michael R Schmidt
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  • Ingunn Skogstad Riddervold
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  • Henrik Toft Sørensen
  • Goran Stankovic, Cardiology Clinic, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Department for Diagnostic and Catheterization Laboratories, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
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  • Madhusudhan Varma, The Heart Centre, North Cumbria University Hospitals National Health Service Trust, Carlisle, UK.
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  • Ian Webb, King's College Hospital, King's Health Partnership, London, UK.
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  • Christian Juhl Terkelsen
  • John P Greenwood, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Teaching Hospitals National Health Service Trust, Leeds, UK.
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  • Derek M Yellon, The Hatter Cardiovascular Institute, University College London, London, United Kingdom.
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  • Hans Erik Bøtker
  • CONDI-2/ERIC-PPCI Investigators

BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months.

METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed.

FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed.

INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.

FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.

OriginalsprogEngelsk
TidsskriftLancet
Vol/bind394
Nummer10207
Sider (fra-til)1415-1424
Antal sider10
ISSN0140-6736
DOI
StatusUdgivet - okt. 2019

Bibliografisk note

Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

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