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

Autor:	Hausenloy DJ; The Hatter Cardiovascular Institute, University College London, London, UK; National Institute of Health Research Biomedical Research Centre at University College London Hospitals, Research & Development, London, UK; Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, Singapore; National Heart Research Institute Singapore, National Heart Centre, Singapore; Yong Loo Lin School of Medicine, National University Singapore, Singapore; Centro de Biotecnologia-FEMSA, Tecnologico de Monterrey, Monterrey, Mexico. Electronic address: d.hausenloy@ucl.ac.uk., Kharbanda RK; Oxford Heart Centre, Oxford University Hospitals National Health Service Trust, Oxford, UK; Department of Cardiovascular Medicine, University of Oxford, Oxford, UK., Møller UK; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Ramlall M; The Hatter Cardiovascular Institute, University College London, London, UK; University Hospital Southampton National Health Service Foundation Trust, Southampton, UK., Aarøe J; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark., Butler R; Department of Cardiology, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, UK., Bulluck H; Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK., Clayton T; Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK., Dana A; Portsmouth Hospitals National Health Service Trust, Portsmouth, UK., Dodd M; Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK., Engstrom T; Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Evans R; Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK., Lassen JF; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Christensen EF; Prehospital Emergency Medical Services, Central Denmark Region, Aarhus, Denmark., Garcia-Ruiz JM; 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., Gorog DA; 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., Hjort J; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Houghton RF; Servicio de Atención Médica de Urgencia-Asturias, Oviedo, Spain., Ibanez B; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Centro de Investigacion Biomedica En Red Cardiovascular, Madrid, Spain; IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain., Knight R; Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK., Lippert FK; Prehospital Emergency Medical Services, Capital Region of Denmark, Denmark., Lønborg JT; Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Maeng M; The Hatter Cardiovascular Institute, University College London, London, UK., Milasinovic D; Department of Cardiology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia., More R; Lancashire Cardiac Centre, Blackpool Teaching Hospitals National Health Service Foundation Trust, Blackpool, UK., Nicholas JM; Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK., Jensen LO; Department of Cardiology, Odense University Hospital, Odense, Denmark., Perkins A; Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK., Radovanovic N; 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., Rakhit RD; Royal Free Hospital London and Institute of Cardiovascular Science, University College London, London, UK., Ravkilde J; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark., Ryding AD; Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK., Schmidt MR; The Hatter Cardiovascular Institute, University College London, London, UK., Riddervold IS; Prehospital Emergency Medical Services, Central Denmark Region, Aarhus, Denmark., Sørensen HT; Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark., Stankovic G; 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., Varma M; The Heart Centre, North Cumbria University Hospitals National Health Service Trust, Carlisle, UK., Webb I; King's College Hospital, King's Health Partnership, London, UK., Terkelsen CJ; The Hatter Cardiovascular Institute, University College London, London, UK., Greenwood JP; Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Teaching Hospitals National Health Service Trust, Leeds, UK., Yellon DM; The Hatter Cardiovascular Institute, University College London, London, UK., Bøtker HE; The Hatter Cardiovascular Institute, University College London, London, UK. Electronic address: haboet@rm.dk.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2019 Oct 19; Vol. 394 (10207), pp. 1415-1424. Date of Electronic Publication: 2019 Sep 06.
DOI:	10.1016/S0140-6736(19)32039-2
Abstrakt:	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. (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.)
Databáze:	MEDLINE
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