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Lancet. 2019 Oct 19;394(10207):1415-1424. doi: 10.1016/S0140-6736(19)32039-2. Epub 2019 Sep 6.

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

Collaborators (545)

Junker A, Kaltoft A, Madsen M, Christiansen EH, Jakobsen L, Carstensen S, Kristensen SD, Thim T, Pedersen KM, Korsgaard MT, Iversen A, Jørgensen E, Joshi F, Pedersen F, Tilsted HH, Alzuhairi K, Saunamäki K, Holmvang L, Ahlehof O, Sørensen R, Helqvist S, Mark BL, Villadsen AB, Raungaard B, Thuesen L, Christiansen MK, Freeman P, Jensen SE, Skov CS, Aziz A, Hansen HS, Ellert J, Veien K, Pedersen KE, Hansen KN, Ahlehoff O, Cappelen H, Wittrock D, Hansen PA, Ankersen JP, Hedegaard KW, Kempel J, Kaus H, Erntgaard D, Pedersen DM, Giebner M, Hansen TMH, Radosavljevic-Radovanovic M, Prodanovic M, Savic L, Pejic M, Matic D, Uscumlic A, Subotic I, Lasica R, Vukcevic V, Suárez A, Samaniego B, Morís C, Segovia E, Hernández E, Lozano I, Pascual I, Vegas-Valle JM, Rozado J, Rondán J, Avanzas P, Del Valle R, Padrón R, García-Castro A, Arango A, Medina-Cameán AB, Fente AI, Muriel-Velasco A, Pomar-Amillo Á, Roza CL, Martínez-Fernández CM, Buelga-Díaz C, Fernández-Gonzalo D, Fernández E, Díaz-González E, Martinez-González E, Iglesias-Llaca F, Viribay FM, Fernández-Mallo FJ, Hermosa FJ, Martínez-Bastida G, Goitia-Martín J, Vega-Fernández JL, Tresguerres JM, Rodil-Díaz JA, Villar-Fernández L, Alberdi L, Abella-Ovalle L, de la Roz M, Fernández-Carral MF, Naves MC, Peláez MC, Fuentes MD, García-Alonso M, Villanueva MJ, Vinagrero MS, Vázquez-Suárez M, Martínez-Valle M, Nonide M, Pozo-López M, Bernardo-Alba P, Galván-Núñez P, Martínez-Pérez PJ, Castro R, Suárez-Coto R, Suárez-Noriega R, Guinea R, Quintana RB, de Cima S, Hedrera SA, Laca SI, Llorente-Álvarez S, Pascual S, Cimas T, Mathur A, McFarlane-Henry E, Leonard G, Veerapen J, Westwood M, Colicchia M, Prossora M, Andiapen M, Mohiddin S, Lenzi V, Chong J, Francis R, Pine A, Jamieson-Leadbitter C, Neal D, Din J, McLeod J, Roberts J, Polokova K, Longman K, Penney L, Lakeman N, Wells N, Hopper O, Coward P, O'Kane P, Harkins R, Guyatt S, Kennard S, Orr S, Horler S, Morris S, Walvin T, Snow T, Cunnington M, Burd A, Gowing A, Krishnamurthy A, Harland C, Norfolk D, Johnstone D, Newman H, Reed H, O'Neill J, Greenwood J, Cuxton J, Corrigan J, Somers K, Anderson M, Burtonwood N, Bijsterveld P, Brogan R, Ryan T, Kodoth V, Khan A, Sebastian D, Gorog D, Boyle G, Shepherd L, Hamid M, Farag M, Spinthakis N, Waitrak P, De Sousa P, Bhatti R, Oliver V, Walshe S, Odedra T, Gue Y, Kanji R, Ryding A, Ratcliffe A, Merrick A, Horwood C, Sarti C, Maart C, Moore D, Dockerty F, Baucutt K, Pitcher L, Ilsley M, Clarke M, Germon R, Gomes S, Clare T, Nair S, Staines J, Nicholson S, Watkinson O, Gallagher I, Nelthorpe F, Musselwhite J, Grosser K, Stimson L, Eaton M, Heppell R, Turney S, Horner V, Schumacher N, Moon A, Mota P, O'Donnell J, Panicker AS, Musa A, Tapp L, Krishnamoorthy S, Ansell V, Ali D, Hyndman S, Banerjee P, Been M, Mackenzie A, McGregor A, Hildick-Smith D, Champney F, Ingoldby F, Keate K, Bennett L, Skipper N, Gregory S, Harfield S, Mudd A, Wragg C, Barmby D, Grech E, Hall I, Middle J, Barker J, Fofie J, Gunn J, Housley K, Cockayne L, Weatherlley L, Theodorou N, Wheeldon N, Fati P, Storey RF, Richardson J, Iqbal J, Adam Z, Brett S, Agyemang M, Tawiah C, Hogrefe K, Raju P, Braybrook C, Gracey J, Waldron M, Holloway R, Burunsuzoglu S, Sidgwick S, Hetherington S, Beirnes C, Fernandez O, Lazar N, Knighton A, Rai A, Hoare A, Webb I, Breeze J, Martin K, Andrews M, Patale S, Bennett A, Smallwood A, Radford E, Cotton J, Martins J, Wallace L, Milgate S, Munir S, Metherell S, Cottam V, Massey I, Copestick J, Delaney J, Wain J, Sandhu K, Emery L, Butler R, Hall C, Bucciarelli-Ducci C, Besana R, Hussein J, Bell S, Gill A, Bales E, Polwarth G, East C, Smith I, Oliveira J, Victor S, Woods S, Hoole S, Ramos A, Sevillano A, Nicholson A, Solieri A, Redman E, Byrne J, Joyce J, Riches J, Davies J, Allen K, Saclot L, Ocampo M, Vertue M, Christmas N, Koothoor R, Gamma R, Alvares W, Pepper S, Kobson B, Reeve C, Malik I, Chester E, Saunders H, Mojela I, Smee J, Davies J, Davies N, Clifford P, Dias P, Kaur R, Moreira S, Ahmad Y, Tomlinson L, Pengelley C, Bidle A, Spence S, Al-Lamee R, Phuyal U, Abbass H, Bose T, Elliott R, Foundun A, Chung A, Freestone B, Lee DK, Elshiekh DM, Pulikal G, Bhatre G, Douglas J, Kaeng L, Pitt M, Watkins R, Gill S, Hartley A, Lucking A, Moreby B, Darby D, Corps E, Parsons G, De Mance G, Fahrai G, Turner J, Langrish J, Gaughran L, Wolyrum M, Azkhalil M, Bates R, Given R, Kharbanda R, Douthwaite R, Lloyd S, Neubauer S, Barker D, Dana A, Suttling A, Turner C, Smith C, Longbottom C, Ross D, Cunliffe D, Cox E, Whitehead H, Hudson K, Jones L, Drew M, Chant N, Haworth P, Capel R, Austin R, Howe S, Smith T, Hobson A, Strike P, Griffiths H, Anantharam B, Jack P, Thornton E, Hodgson A, Jennison A, McSkeane A, Smith B, Shaw C, Leathers C, Armstrong E, Carruthers G, Simpson H, Smith J, Hodierne J, Kelly J, Barclay J, Scott K, Gregson L, Buchanan L, McCormick L, Varma M, Kelsall N, Mcarthy R, Taylor R, Thompson R, Shelton R, Moore R, Tomlinson S, Thambi S, Cooper T, Oakes T, Deen Z, Relph C, Prentice S, Hall L, Dillon A, Meadows D, Frank E, Markham-Jones H, Thomas I, Gale J, Denman J, Gale J, O'Connor J, Hindle J, Jackson-Lawrence K, Warner K, Lee K, Upton R, Elston R, Lee S, Venugopal V, Finch A, Fleming C, Whiteside C, Pemberton C, Wilkinson C, Sebastian D, Riedel E, Giuffrida G, Burnett G, Spickett H, Glen J, Brown J, Thornborough L, Pedley L, Morgan M, Waddington N, Brennan O, More R, Brady R, Preston S, Loder C, Vlad I, Laurence J, Smit A, Dimond K, Hayes M, Paddy L, Crause J, Amed N, Kaur-Babooa P, Rakhit R, Kotecha T, Fayed H, Francis R, Pavlidis A, Prendergast B, Clapp B, Perara D, Atkinson E, Ellis H, Wilson K, Gibson K, Smith M, Khawaja MZ, Sanchez-Vidal R, Redwood S, Jones S, Tipping A, Oommen A, Hendry C, Fath-Orboubadi DF, Phillips H, Kolakaluri L, Sherwood M, Mackie S, Aleti S, Charles T, Roy L, Henderson R, Stables R, Redwood S, Marber M, Berry A, Redington A, Thygesen K, Andersen HR, Berry C, Copas A, Meade T, Kelbæk H, Bueno H, von Weitzel-Mudersbach P, Andersen G, Ludman A, Cruden N, Topic D, Mehmedbegovic Z, de la Hera Galarza JM, Robertson S, Van Dyck L, Chu R, Astarci J, Jamal Z, Hetherington D, Collier L.

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.

PMID:
31500849
DOI:
10.1016/S0140-6736(19)32039-2
[Indexed for MEDLINE]
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