Journal
LANCET
Volume 394, Issue 10207, Pages 1415-1424Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/S0140-6736(19)32039-2
Keywords
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Categories
Funding
- British Heart Foundation [CS/14/3/31002, FS/10/039/28270]
- University College London Hospitals/University College London Biomedical Research Centre clinical research grant
- Danish Innovation Foundation [11-108354, 11-115818]
- Novo Nordisk Foundation [NNF13OC0007447, NNF14OC0013337, NNF15OC0016674]
- TrygFonden [109624]
- National Institute for Health Research (NIHR) Biomedical Research Centre at University College London Hospitals
- Duke-National University Singapore Medical School
- Singapore Ministry of Health's National Medical Research Council under its Clinician Scientist-Senior Investigator scheme [NMRC/CSA-SI/0011/2017]
- Singapore Ministry of Health's National Medical Research Council under its Collaborative Centre Grant scheme [NMRC/CGAug16C006]
- Singapore Ministry of Education Academic Research Fund Tier 2 [MOE2016-T2-2-021]
- Oxford NIHR Biomedical Centre
- NIHR infrastructure at Leeds
- COST Action EU-CARDIOPROTECTION [CA16225]
- COST (European Cooperation in Science and Technology)
- MRC [MC_G1002673] Funding Source: UKRI
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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. Copyright (C) 2019 The Author(s). Published by Elsevier Ltd.
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