Abstract
SummaryBackgroundRemote 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.MethodsWe 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.FindingsBetween 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.InterpretationRemote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.FundingBritish Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.
Highlights
Despite timely reperfusion with primary percutaneous coronary intervention (PPCI), morbidity and mortality following acute ST-elevation myocardial infarction (STEMI) remain substantial, and improvements in mor tality and survival free of heart failure have plateaued.[1,2] New treatments are needed to reduce myocardial infarct size and preserve cardiac function to reduce risk of death and prevent onset of heart failure
Added value of this study In this large, sufficiently powered, multicentre, randomised controlled trial of 5401 patients with STEMI, we investigated whether remote ischaemic conditioning applied as an adjunct to PPCI could reduce the incidence of cardiac death or hospitalisation for heart failure within 12 months post-PPCI, when compared with PPCI alone
There was no evidence of difference between the con trol group (8·6% [n=220]) and the remote ischaemic conditioning group (9·4% [n=239]) with respect to the combined primary end point of cardiac death or hos pitalisation for heart failure at 12 months
Summary
Despite timely reperfusion with primary percutaneous coronary intervention (PPCI), morbidity and mortality following acute ST-elevation myocardial infarction (STEMI) remain substantial, and improvements in mor tality and survival free of heart failure have plateaued.[1,2] New treatments are needed to reduce myocardial infarct size and preserve cardiac function to reduce risk of death and prevent onset of heart failure In this regard, remote ischaemic conditioning, in which brief cycles of ischaemia and reperfusion are applied to an organ or tissue (including a limb) away from the heart, has been shown to reduce myocardial infarct size in animal models.[2,3].
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