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        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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        1_s2.0_S0140673619320392_main.pdf (PDF, 1Mb)
        Author
        Hausenloy, Derek
        Kharbanda, Rajesh
        Møller, Ulla Kristine
        Ramlall, Manish
        Aarøe, Jens
        Butler, Robert
        Bulluck, Heerajnarain
        Clayton, Tim
        Dana, Ali
        Dodd, Matthew
        Engstrom, Thomas
        Evans, Richard
        Lassen, Jens Flensted
        Christensen, Erika
        Garcia-Ruiz, José Manuel
        Gorog, Diana
        Hjort, Jakob
        Houghton , Richard
        Ibanez, Borja
        Knight, Rosemary
        Lippert, Freddy K
        Lønborg, Jacob
        Maeng, Michael
        Milasinovic, Dejan
        More, Ranjit
        Nicholas, Jennifer M
        Jensen, Lisette O
        Perkins, Alexander
        Radovanovic, Nebojsa
        Rakhit, Roby
        Ravkilde, Jan
        Ryding, Alisdair D
        Schmidt, Michael R
        Riddervold, Ingun S
        Sørensen,, Henrik T
        Stankovic, Goran
        Varma, Madhusudhan
        Webb, Ian
        Terkelsen, Christian J
        Greenwood, John
        Yellon, Derek
        Bøtker†, Hans E
        Attention
        2299/21675
        Abstract
        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.
        Publication date
        2019-10-01
        Published in
        The Lancet
        Published version
        https://doi.org/10.1016/S0140-6736(19)32039-2
        Other links
        http://hdl.handle.net/2299/21675
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