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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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Harvard

Hausenloy, DJ, Kharbanda, RK, Møller, UK, Ramlall, M, Aarøe, J, Butler, R, Bulluck, H, Clayton, T, Dana, A, Dodd, M, Engstrom, T, Evans, R, Lassen, JF, Christensen, EF, Garcia-Ruiz, JM, Gorog, DA, Hjort, J, Houghton, RF, Ibanez, B, Knight, R, Lippert, FK, Lønborg, JT, Maeng, M, Milasinovic, D, More, R, Nicholas, JM, Jensen, LO, Perkins, A, Radovanovic, N, Rakhit, RD, Ravkilde, J, Ryding, AD, Schmidt, MR, Riddervold, IS, Sørensen, HT, Stankovic, G, Varma, M, Webb, I, Terkelsen, CJ, Greenwood, JP, Yellon, DM, Bøtker, HE, CONDI-2/ERIC-PPCI Investigators & Holmvang, L 2019, 'Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial' Lancet, vol. 394, no. 10207, 10207, pp. 1415-1424. https://doi.org/10.1016/S0140-6736(19)32039-2

APA

CBE

Hausenloy DJ, Kharbanda RK, Møller UK, Ramlall M, Aarøe J, Butler R, Bulluck H, Clayton T, Dana A, Dodd M, Engstrom T, Evans R, Lassen JF, Christensen EF, Garcia-Ruiz JM, Gorog DA, Hjort J, Houghton RF, Ibanez B, Knight R, Lippert FK, Lønborg JT, Maeng M, Milasinovic D, More R, Nicholas JM, Jensen LO, Perkins A, Radovanovic N, Rakhit RD, Ravkilde J, Ryding AD, Schmidt MR, Riddervold IS, Sørensen HT, Stankovic G, Varma M, Webb I, Terkelsen CJ, Greenwood JP, Yellon DM, Bøtker HE, CONDI-2/ERIC-PPCI Investigators, Holmvang L. 2019. Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial. Lancet. 394(10207):1415-1424. https://doi.org/10.1016/S0140-6736(19)32039-2

MLA

Vancouver

Author

Hausenloy, Derek J ; Kharbanda, Rajesh K ; 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 Frischknecht ; Garcia-Ruiz, José Manuel ; Gorog, Diana A ; Hjort, Jakob ; Houghton, Richard F ; Ibanez, Borja ; Knight, Rosemary ; Lippert, Freddy K ; Lønborg, Jacob T ; Maeng, Michael ; Milasinovic, Dejan ; More, Ranjit ; Nicholas, Jennifer M ; Jensen, Lisette Okkels ; Perkins, Alexander ; Radovanovic, Nebojsa ; Rakhit, Roby D ; Ravkilde, Jan ; Ryding, Alisdair D ; Schmidt, Michael R ; Riddervold, Ingunn Skogstad ; Sørensen, Henrik Toft ; Stankovic, Goran ; Varma, Madhusudhan ; Webb, Ian ; Terkelsen, Christian Juhl ; Greenwood, John P ; Yellon, Derek M ; Bøtker, Hans Erik ; CONDI-2/ERIC-PPCI Investigators ; Holmvang, Lene. / Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI) : a single-blind randomised controlled trial. In: Lancet. 2019 ; Vol. 394, No. 10207. pp. 1415-1424.

Bibtex

@article{ef3c6e1212fa49719a9f14ce416e018d,
title = "Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial",
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.",
keywords = "Aged, Combined Modality Therapy, Death, Sudden, Cardiac/prevention & control, Female, Heart Failure/etiology, Hospitalization, Humans, Intention to Treat Analysis, Ischemic Preconditioning, Myocardial/methods, Male, Middle Aged, Myocardial Infarction/complications, Percutaneous Coronary Intervention, Prospective Studies, Single-Blind Method, Treatment Outcome, United Kingdom",
author = "Hausenloy, {Derek J} and Kharbanda, {Rajesh K} and M{\o}ller, {Ulla Kristine} and Manish Ramlall and Jens Aar{\o}e and Robert Butler and Heerajnarain Bulluck and Tim Clayton and Ali Dana and Matthew Dodd and Thomas Engstrom and Richard Evans and Lassen, {Jens Flensted} and Christensen, {Erika Frischknecht} and Garcia-Ruiz, {Jos{\'e} Manuel} and Gorog, {Diana A} and Jakob Hjort and Houghton, {Richard F} and Borja Ibanez and Rosemary Knight and Lippert, {Freddy K} and L{\o}nborg, {Jacob T} and Michael Maeng and Dejan Milasinovic and Ranjit More and Nicholas, {Jennifer M} and Jensen, {Lisette Okkels} and Alexander Perkins and Nebojsa Radovanovic and Rakhit, {Roby D} and Jan Ravkilde and Ryding, {Alisdair D} and Schmidt, {Michael R} and Riddervold, {Ingunn Skogstad} and S{\o}rensen, {Henrik Toft} and Goran Stankovic and Madhusudhan Varma and Ian Webb and Terkelsen, {Christian Juhl} and Greenwood, {John P} and Yellon, {Derek M} and B{\o}tker, {Hans Erik} and {CONDI-2/ERIC-PPCI Investigators} and Lene Holmvang",
note = "Copyright {\circledC} 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.",
year = "2019",
month = "10",
day = "19",
doi = "10.1016/S0140-6736(19)32039-2",
language = "English",
volume = "394",
pages = "1415--1424",
journal = "Lancet",
issn = "0140-6736",
publisher = "The/Lancet Publishing Group",
number = "10207",

}

RIS

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 - Holmvang, Lene

N1 - Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

PY - 2019/10/19

Y1 - 2019/10/19

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.

KW - Aged

KW - Combined Modality Therapy

KW - Death, Sudden, Cardiac/prevention & control

KW - Female

KW - Heart Failure/etiology

KW - Hospitalization

KW - Humans

KW - Intention to Treat Analysis

KW - Ischemic Preconditioning, Myocardial/methods

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/complications

KW - Percutaneous Coronary Intervention

KW - Prospective Studies

KW - Single-Blind Method

KW - Treatment Outcome

KW - United Kingdom

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

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

M3 - Journal article

VL - 394

SP - 1415

EP - 1424

JO - Lancet

JF - Lancet

SN - 0140-6736

IS - 10207

M1 - 10207

ER -

ID: 57929993