TY - JOUR
T1 - Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI)
T2 - a single-blind randomised controlled trial
AU - Hausenloy, Derek J
AU - Kharbanda, Rajesh K
AU - Møller, Ulla Kristine
AU - Ramlall, Manish
AU - Aarøe, Jens
AU - Butler, Robert
AU - Bulluck, Heerajnarain
AU - Clayton, Tim
AU - Dana, Ali
AU - Dodd, Matthew
AU - Engstrom, Thomas
AU - Evans, Richard
AU - Lassen, Jens Flensted
AU - Christensen, Erika Frischknecht
AU - Garcia-Ruiz, José Manuel
AU - Gorog, Diana A
AU - Hjort, Jakob
AU - Houghton, Richard F
AU - Ibanez, Borja
AU - Knight, Rosemary
AU - Lippert, Freddy K
AU - Lønborg, Jacob T
AU - Maeng, Michael
AU - Milasinovic, Dejan
AU - More, Ranjit
AU - Nicholas, Jennifer M
AU - Jensen, Lisette Okkels
AU - Perkins, Alexander
AU - Radovanovic, Nebojsa
AU - Rakhit, Roby D
AU - Ravkilde, Jan
AU - Ryding, Alisdair D
AU - Schmidt, Michael R
AU - Riddervold, Ingunn Skogstad
AU - Sørensen, Henrik Toft
AU - Stankovic, Goran
AU - Varma, Madhusudhan
AU - Webb, Ian
AU - Terkelsen, Christian Juhl
AU - Greenwood, John P
AU - Yellon, Derek M
AU - Bøtker, Hans Erik
AU - CONDI-2/ERIC-PPCI Investigators
A2 - Villadsen, Anton Boel
A2 - Raungaard, Bent
A2 - Thuesen, Leif
A2 - Christiansen, Martin Kirk
A2 - Freeman, Phillip
A2 - Jensen, Svend Eggert
A2 - Skov, Charlotte Schmidt
PY - 2019/10
Y1 - 2019/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85073227920&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(19)32039-2
DO - 10.1016/S0140-6736(19)32039-2
M3 - Journal article
C2 - 31500849
SN - 0140-6736
VL - 394
SP - 1415
EP - 1424
JO - Lancet
JF - Lancet
IS - 10207
ER -