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 - Sørensen, Henrik Toft

AU - Bøtker, Hans Erik

AU - Madsen, Morten

AU - Jakobsen, Lars

AU - Iversen, Allan

AU - Jørgensen, Erik

AU - Holmvang, Lene

AU - Sørensen, Rikke

AU - Helqvist, Steffen

AU - Hansen, Henrik Steen

AU - Ahlehoff, Ole

AU - Hansen, Poul Anders

AU - Hansen, Troels Martin Hansen

AU - Rai, Amrit

AU - Hall, Charlotte

AU - Kelbæk, Henning

AU - Andersen, Grethe

AU - CONDI-2/ERIC-PPCI Investigators

PY - 2019

Y1 - 2019

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.

U2 - 10.1016/S0140-6736(19)32039-2

DO - 10.1016/S0140-6736(19)32039-2

M3 - Journal article

C2 - 31500849

AN - SCOPUS:85073227920

VL - 394

SP - 1415

EP - 1424

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10207

ER -