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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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  • Derek J Hausenloy
  • Rajesh K Kharbanda
  • Ulla Kristine Møller
  • Manish Ramlall
  • Jens Aarøe
  • Robert Butler
  • Heerajnarain Bulluck
  • Tim Clayton
  • Ali Dana
  • Matthew Dodd
  • Thomas Engstrom
  • Richard Evans
  • Jens Flensted Lassen
  • Erika Frischknecht Christensen
  • José Manuel Garcia-Ruiz
  • Diana A Gorog
  • Jakob Hjort
  • Richard F Houghton
  • Borja Ibanez
  • Rosemary Knight
  • Freddy K Lippert
  • Jacob T Lønborg
  • Michael Maeng
  • Dejan Milasinovic
  • Ranjit More
  • Jennifer M Nicholas
  • Lisette Okkels Jensen
  • Alexander Perkins
  • Nebojsa Radovanovic
  • Roby D Rakhit
  • Jan Ravkilde
  • Alisdair D Ryding
  • Michael R Schmidt
  • Ingunn Skogstad Riddervold
  • Henrik Toft Sørensen
  • Goran Stankovic
  • Madhusudhan Varma
  • Ian Webb
  • Christian Juhl Terkelsen
  • John P Greenwood
  • Derek M Yellon
  • Hans Erik Bøtker
  • CONDI-2/ERIC-PPCI Investigators
  • Lene Holmvang (Member of study group)
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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.

Original languageEnglish
Article number10207
JournalLancet
Volume394
Issue number10207
Pages (from-to)1415-1424
Number of pages10
ISSN0140-6736
DOIs
Publication statusPublished - 19 Oct 2019

    Research areas

  • 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

ID: 57929993