University of Hertfordshire

Documents

  • Derek Hausenloy
  • Rajesh 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 Christensen
  • José Manuel Garcia-Ruiz
  • Jakob Hjort
  • Richard Houghton
  • Borja Ibanez
  • Rosemary Knight
  • Freddy K Lippert
  • Jacob Lønborg
  • Michael Maeng
  • Dejan Milasinovic
  • Ranjit More
  • Jennifer M Nicholas
  • Lisette O Jensen
  • Alexander Perkins
  • Nebojsa Radovanovic
  • Roby Rakhit
  • Jan Ravkilde
  • Alisdair D Ryding
  • Michael R Schmidt
  • Ingun S Riddervold
  • Henrik T Sørensen,
  • Goran Stankovic
  • Madhusudhan Varma
  • Ian Webb
  • Christian J Terkelsen
  • John Greenwood
  • Derek Yellon
  • Hans E Bøtker†
View graph of relations
Original languageEnglish
JournalThe Lancet
Journal publication date6 Sep 2019
DOIs
Publication statusPublished - 6 Sep 2019

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.

ID: 17365595