2024-03-28T20:45:04Zhttp://repisalud.isciii.es/oai/requestoai:repisalud.isciii.es:20.500.12105/85242022-10-25T12:27:55Zcom_20.500.12105_2145com_20.500.12105_2051com_20.500.12105_2144col_20.500.12105_2146
00925njm 22002777a 4500
dc
Hausenloy, Derek J
author
Kharbanda, Rajesh K
author
Møller, Ulla Kristine
author
Ramlall, Manish
author
Aarøe, Jens
author
Butler, Robert
author
Bulluck, Heerajnarain
author
Clayton, Tim
author
Dana, Ali
author
Dodd, Matthew
author
Engstrom, Thomas
author
Evans, Richard
author
Lassen, Jens Flensted
author
Christensen, Erika Frischknecht
author
Garcia-Ruiz, Jose M
author
Gorog, Diana A
author
Hjort, Jakob
author
Houghton, Richard F
author
Ibáñez, Borja
author
Knight, Rosemary
author
Lippert, Freddy K
author
Lønborg, Jacob T
author
Maeng, Michael
author
Milasinovic, Dejan
author
More, Ranjit
author
Nicholas, Jennifer M
author
Jensen, Lisette Okkels
author
Perkins, Alexander
author
Radovanovic, Nebojsa
author
Rakhit, Roby D
author
Ravkilde, Jan
author
Ryding, Alisdair D
author
Schmidt, Michael R
author
Riddervold, Ingunn Skogstad
author
Sørensen, Henrik Toft
author
Stankovic, Goran
author
Varma, Madhusudhan
author
Webb, Ian
author
Terkelsen, Christian Juhl
author
Greenwood, John P
author
Yellon, Derek M
author
Bøtker, Hans Erik
author
2019-10
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.
Lancet. 2019; 394(10207):1415-1424
0140-6736
http://hdl.handle.net/20.500.12105/8524
31500849
10.1016/S0140-6736(19)32039-2
1474-547X
Lancet (London, England)
Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial