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

被引：254

作者：

Hausenloy, Derek J. ^{[1
,4
,5
,6
,7
,8
]}

Kharbanda, Rajesh K. ^{[9
,10
]}

Moller, Ulla Kristine ^{[11
]}

Ramlall, Manish ^{[1
,13
]}

Aaroe, Jens ^{[14
]}

Butler, Robert ^{[15
]}

Bulluck, Heerajnarain ^{[16
]}

Clayton, Tim ^{[17
,18
]}

Dana, Ali ^{[19
]}

Dodd, Matthew ^{[17
,18
]}

Engstrom, Thomas ^{[20
]}

Evans, Richard ^{[17
,18
]}

Lassen, Jens Flensted ^{[11
]}

Christensen, Erika Frischknecht ^{[21
]}

Manuel Garcia-Ruiz, Jose ^{[22
,23
,24
]}

Gorog, Diana A. ^{[25
,26
]}

Hjort, Jakob ^{[27
]}

Houghton, Richard F. ^{[28
]}

Ibanez, Borja ^{[23
,29
,30
]}

Knight, Rosemary ^{[17
,18
]}

Lippert, Freddy K. ^{[31
]}

Lonborg, Jacob T. ^{[20
]}

Maeng, Michael ^{[11
]}

Milasinovic, Dejan ^{[32
]}

More, Ranjit ^{[37
]}

Nicholas, Jennifer M. ^{[17
,18
]}

Jensen, Lisette Okkels ^{[38
]}

Perkins, Alexander ^{[17
,18
]}

Radovanovic, Nebojsa ^{[33
,34
]}

Rakhit, Roby D. ^{[2
,3
]}

Ravkilde, Jan ^{[14
]}

Ryding, Alisdair D. ^{[16
]}

Schmidt, Michael R. ^{[11
]}

Riddervold, Ingunn Skogstad ^{[21
]}

Sorensen, Henrik Toft ^{[12
]}

Stankovic, Goran ^{[33
,35
,36
]}

Varma, Madhusudhan ^{[39
]}

Webb, Ian ^{[40
]}

Terkelsen, Christian Juhl ^{[11
]}

Greenwood, John P. ^{[41
,42
]}

Yellon, Derek M. ^{[1
]}

Botker, Hans Erik ^{[11
]}

机构：

[1] UCL, Hatter Cardiovasc Inst, London WC1E 6HX, England

[2] UCL, Royal Free Hosp London, London, England

[3] UCL, Inst Cardiovasc Sci, London, England

[4] Univ Coll London Hosp, Natl Inst Hlth Res Biomed Res Ctr, Res & Dev, London, England

[5] Duke Natl Univ Singapore Med Sch, Cardiovasc & Metab Disorders Program, Singapore, Singapore

[6] Natl Heart Ctr, Natl Heart Res Inst Singapore, Singapore, Singapore

[7] Natl Univ Singapore, Yong Loo Lin Sch Med, Singapore, Singapore

[8] Tecnol Monterrey, Ctr Biotecnol FEMSA, Monterrey, Mexico

[9] Oxford Univ Hosp Natl Hlth Serv Trust, Oxford Heart Ctr, Oxford, England

[10] Univ Oxford, Dept Cardiovasc Med, Oxford, England

[11] Aarhus Univ Hosp, Dept Cardiol, DK-8200 Aarhus N, Denmark

[12] Aarhus Univ Hosp, Dept Clin Epidemiol, Aarhus, Denmark

[13] Univ Hosp Southampton Natl Hlth Serv Fdn Trust, Southampton, Hants, England

[14] Aalborg Univ Hosp, Dept Cardiol, Aalborg, Denmark

[15] Royal Stoke Univ Hosp, Dept Cardiol, Univ Hosp North Midlands, Stoke On Trent, Staffs, England

[16] Norfolk & Norwich Univ Hosp, Dept Cardiol, Norwich, Norfolk, England

[17] London Sch Hyg & Trop Med, Clin Trials Unit, London, England

[18] London Sch Hyg & Trop Med, Dept Med Stat, London, England

[19] Portsmouth Hosp Natl Hlth Serv Trust, Portsmouth, Hants, England

[20] Univ Copenhagen, Dept Cardiol, Rigshosp, Copenhagen, Denmark

[21] Cent Denmark Reg, Prehosp Emergency Med Serv, Aarhus, Denmark

[22] Hosp Univ Cabuenes, Inst Invest Sanitaria Principado Asturias, Oviedo, Spain

[23] Ctr Nacl Invest Cardiovasc, Madrid, Spain

[24] Ctr Invest Biomed Red Enfermedades Cardiovasc, Madrid, Spain

[25] East & North Hertfordshire Natl Hlth Serv Trust, Dept Cardiol, Lister Hosp, Stevenage, Herts, England

[26] Imperial Coll London, Natl Heart & Lung Inst, London, England

[27] Aarhus Univ, Dept Clin Med, Aarhus, Denmark

[28] Serv Atenc Med Urgencia Asturias, Oviedo, Spain

[29] Ctr Invest Biomed Red Cardiovasc, Madrid, Spain

[30] IIS Fdn Jimenez Diaz Univ Hosp, Madrid, Spain

[31] Capital Reg Denmark, Prehosp Emergency Med Serv, Copenhagen, Denmark

[32] Univ Belgrade, Dept Cardiol, Clin Ctr Serbia, Fac Med, Belgrade, Serbia

[33] Univ Belgrade, Cardiol Clin, Clin Ctr Serbia, Fac Med, Belgrade, Serbia

[34] Univ Belgrade, Emergency Ctr, Clin Ctr Serbia, Fac Med, Belgrade, Serbia

[35] Univ Belgrade, Dept Diagnost, Clin Ctr Serbia, Fac Med, Belgrade, Serbia

[36] Univ Belgrade, Catheterizat Labs, Clin Ctr Serbia, Fac Med, Belgrade, Serbia

[37] Blackpool Teaching Hosp Natl Hlth Serv Fdn Trust, Lancashire Cardiac Ctr, Blackpool, England

[38] Odense Univ Hosp, Dept Cardiol, Odense, Denmark

[39] North Cumbria Univ Hosp Natl Hlth Serv Trust, Ctr Heart, Carlisle, PA USA

[40] Kings Coll Hosp London, Kings Hlth Partnership, London, England

[41] Univ Leeds, Leeds Inst Cardiovasc & Metab Med, Leeds, W Yorkshire, England

[42] Leeds Teaching Hosp Natl Hlth Serv Trust, Leeds, W Yorkshire, England

来源：

LANCET | 2019年 / 394卷 / 10207期

基金：

英国医学研究理事会;

关键词：

PERCUTANEOUS CORONARY INTERVENTION; ST-SEGMENT ELEVATION; ISCHEMIA/REPERFUSION INJURY; TASK-FORCE; SIZE; CARDIOPROTECTION; ADJUNCT; LIMB;

D O I：

10.1016/S0140-6736(19)32039-2

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. Copyright (C) 2019 The Author(s). Published by Elsevier Ltd.

引用

页码：1415 / 1424

页数：10

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