Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trial
Background: Novel cardioprotective strategies are required to improve clinical outcomes in higher-risk patients undergoing coronary artery bypass graft (CABG) with or without valve surgery. Remote ischaemic preconditioning (RIPC) in which brief episodes of non-lethal ischaemia and reperfusion are ap...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2016-06-01
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| Series: | Efficacy and Mechanism Evaluation |
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| Online Access: | https://doi.org/10.3310/eme03040 |
| _version_ | 1818141944437538816 |
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| author | Derek J Hausenloy Luciano Candilio Richard Evans Cono Ariti David P Jenkins Shyamsunder Kolvekar Rosemary Knight Gudrun Kunst Christopher Laing Jennifer M Nicholas John Pepper Steven Robertson Maria Xenou Timothy Clayton Derek M Yellon |
| author_facet | Derek J Hausenloy Luciano Candilio Richard Evans Cono Ariti David P Jenkins Shyamsunder Kolvekar Rosemary Knight Gudrun Kunst Christopher Laing Jennifer M Nicholas John Pepper Steven Robertson Maria Xenou Timothy Clayton Derek M Yellon |
| author_sort | Derek J Hausenloy |
| collection | DOAJ |
| description | Background: Novel cardioprotective strategies are required to improve clinical outcomes in higher-risk patients undergoing coronary artery bypass graft (CABG) with or without valve surgery. Remote ischaemic preconditioning (RIPC) in which brief episodes of non-lethal ischaemia and reperfusion are applied to the arm or leg has been demonstrated to reduce perioperative myocardial injury (PMI) following CABG with or without valve surgery. Objective: To investigate whether or not RIPC can improve clinical outcomes in this setting in the Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA) study in patients undergoing CABG surgery. Design: Multicentre, double-blind, randomised sham controlled trial. Setting: The study was conducted across 30 cardiothoracic centres in the UK between March 2010 and March 2015. Participants: Eligible patients were higher-risk adult patients (aged > 18 years of age; additive European System for Cardiac Operative Risk of ≥ 5) undergoing on-pump CABG with or without valve surgery with blood cardioplegia. Interventions: Patients were randomised to receive either RIPC (four 5-minute inflations/deflations of a standard blood pressure cuff placed on the upper arm) or the sham control procedure (simulated RIPC protocol) following anaesthetic induction and prior to surgical incision. Anaesthetic management and perioperative care were not standardised. Main outcome measures: The combined primary end point was the rate of major adverse cardiac and cerebral events comprising cardiovascular death, myocardial infarction, coronary revascularisation and stroke within 12 months of randomisation. Secondary end points included perioperative myocardial and acute kidney injury (AKI), intensive care unit and hospital stay, inotrope score, left ventricular ejection fraction, changes in quality of life and exercise tolerance. Results: In total, 1612 patients (sham control group, n = 811; RIPC group, n = 801) were randomised in 30 cardiac surgery centres in the UK. There was no difference in the primary end point at 12 months between the RIPC group and the sham control group (26.5% vs. 27.7%; hazard ratio 0.95, 95% confidence interval 0.79 to 1.15; p = 0.58). Furthermore, there was no evidence for any differences in either adverse events or the secondary end points of PMI (72-hour area under the curve for serum high-sensitivity troponin T), inotrope score, AKI, intensive therapy unit and hospital stay, 6-minute walk test and quality of life. Conclusions: In patients undergoing elective on-pump CABG with or without valve surgery, without standardisation of the anaesthetic regimen, RIPC using transient arm ischaemia–reperfusion did not improve clinical outcomes. It is important that studies continue to investigate the potential mechanisms underlying RIPC, as this may facilitate the translation of this simple, non-invasive, low-cost intervention into patient benefit. The limitations of the study include the lack of standardised pre-/perioperative anaesthesia and medication, the level of missing and incomplete data for some of the secondary end points and the incompleteness of the data for the echocardiography substudy. Trial registration: ClinicalTrials.gov NCT01247545. Funding: This project was funded by the Efficacy and Mechanism Evaluation programme, a MRC and NIHR partnership, and the British Heart Foundation. |
| first_indexed | 2024-12-11T11:07:55Z |
| format | Article |
| id | doaj.art-915c5151938d4bc497b25e8c80f09794 |
| institution | Directory Open Access Journal |
| issn | 2050-4365 2050-4373 |
| language | English |
| last_indexed | 2024-12-11T11:07:55Z |
| publishDate | 2016-06-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Efficacy and Mechanism Evaluation |
| spelling | doaj.art-915c5151938d4bc497b25e8c80f097942022-12-22T01:09:38ZengNIHR Journals LibraryEfficacy and Mechanism Evaluation2050-43652050-43732016-06-013410.3310/eme0304009/100/05Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trialDerek J Hausenloy0Luciano Candilio1Richard Evans2Cono Ariti3David P Jenkins4Shyamsunder Kolvekar5Rosemary Knight6Gudrun Kunst7Christopher Laing8Jennifer M Nicholas9John Pepper10Steven Robertson11Maria Xenou12Timothy Clayton13Derek M Yellon14Hatter Cardiovascular Institute, Institute of Cardiovascular Science, University College London, London, UKHatter Cardiovascular Institute, Institute of Cardiovascular Science, University College London, London, UKClinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UKClinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UKDepartment of Cardiothoracic Surgery, Papworth Hospital, Cambridge, UKThe Heart Hospital, University College London Hospitals NHS Foundation Trust, London, UKClinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UKDepartment of Anaesthetics and Pain Therapy, King’s College London and King’s College Hospital, London, UKUniversity College London Centre for Nephrology, Royal Free Hospital, London, UKClinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UKNational Institute for Health Research Cardiovascular Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust, London, UKClinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UKHatter Cardiovascular Institute, Institute of Cardiovascular Science, University College London, London, UKClinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UKHatter Cardiovascular Institute, Institute of Cardiovascular Science, University College London, London, UKBackground: Novel cardioprotective strategies are required to improve clinical outcomes in higher-risk patients undergoing coronary artery bypass graft (CABG) with or without valve surgery. Remote ischaemic preconditioning (RIPC) in which brief episodes of non-lethal ischaemia and reperfusion are applied to the arm or leg has been demonstrated to reduce perioperative myocardial injury (PMI) following CABG with or without valve surgery. Objective: To investigate whether or not RIPC can improve clinical outcomes in this setting in the Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA) study in patients undergoing CABG surgery. Design: Multicentre, double-blind, randomised sham controlled trial. Setting: The study was conducted across 30 cardiothoracic centres in the UK between March 2010 and March 2015. Participants: Eligible patients were higher-risk adult patients (aged > 18 years of age; additive European System for Cardiac Operative Risk of ≥ 5) undergoing on-pump CABG with or without valve surgery with blood cardioplegia. Interventions: Patients were randomised to receive either RIPC (four 5-minute inflations/deflations of a standard blood pressure cuff placed on the upper arm) or the sham control procedure (simulated RIPC protocol) following anaesthetic induction and prior to surgical incision. Anaesthetic management and perioperative care were not standardised. Main outcome measures: The combined primary end point was the rate of major adverse cardiac and cerebral events comprising cardiovascular death, myocardial infarction, coronary revascularisation and stroke within 12 months of randomisation. Secondary end points included perioperative myocardial and acute kidney injury (AKI), intensive care unit and hospital stay, inotrope score, left ventricular ejection fraction, changes in quality of life and exercise tolerance. Results: In total, 1612 patients (sham control group, n = 811; RIPC group, n = 801) were randomised in 30 cardiac surgery centres in the UK. There was no difference in the primary end point at 12 months between the RIPC group and the sham control group (26.5% vs. 27.7%; hazard ratio 0.95, 95% confidence interval 0.79 to 1.15; p = 0.58). Furthermore, there was no evidence for any differences in either adverse events or the secondary end points of PMI (72-hour area under the curve for serum high-sensitivity troponin T), inotrope score, AKI, intensive therapy unit and hospital stay, 6-minute walk test and quality of life. Conclusions: In patients undergoing elective on-pump CABG with or without valve surgery, without standardisation of the anaesthetic regimen, RIPC using transient arm ischaemia–reperfusion did not improve clinical outcomes. It is important that studies continue to investigate the potential mechanisms underlying RIPC, as this may facilitate the translation of this simple, non-invasive, low-cost intervention into patient benefit. The limitations of the study include the lack of standardised pre-/perioperative anaesthesia and medication, the level of missing and incomplete data for some of the secondary end points and the incompleteness of the data for the echocardiography substudy. Trial registration: ClinicalTrials.gov NCT01247545. Funding: This project was funded by the Efficacy and Mechanism Evaluation programme, a MRC and NIHR partnership, and the British Heart Foundation.https://doi.org/10.3310/eme03040randomised controlled trialcardiac surgeryremote ischaemic preconditioningperioperative myocardial injurycoronary artery bypass graftischaemia–reperfusion |
| spellingShingle | Derek J Hausenloy Luciano Candilio Richard Evans Cono Ariti David P Jenkins Shyamsunder Kolvekar Rosemary Knight Gudrun Kunst Christopher Laing Jennifer M Nicholas John Pepper Steven Robertson Maria Xenou Timothy Clayton Derek M Yellon Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trial Efficacy and Mechanism Evaluation randomised controlled trial cardiac surgery remote ischaemic preconditioning perioperative myocardial injury coronary artery bypass graft ischaemia–reperfusion |
| title | Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trial |
| title_full | Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trial |
| title_fullStr | Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trial |
| title_full_unstemmed | Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trial |
| title_short | Effect of Remote Ischaemic preconditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): a multicentre double-blind randomised controlled clinical trial |
| title_sort | effect of remote ischaemic preconditioning on clinical outcomes in patients undergoing coronary artery bypass graft surgery ericca study a multicentre double blind randomised controlled clinical trial |
| topic | randomised controlled trial cardiac surgery remote ischaemic preconditioning perioperative myocardial injury coronary artery bypass graft ischaemia–reperfusion |
| url | https://doi.org/10.3310/eme03040 |
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