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Meta-Analysis
. 2017 May 5;5(5):CD011719.
doi: 10.1002/14651858.CD011719.pub3.

Remote ischaemic preconditioning for coronary artery bypass grafting (with or without valve surgery)

Carina Benstoem  1 , Christian Stoppe  2 , Oliver J Liakopoulos  3 , Julia Ney  4 , Dirk Hasenclever  5 , Patrick Meybohm  6 , Andreas Goetzenich  1
Affiliations
Meta-Analysis

Remote ischaemic preconditioning for coronary artery bypass grafting (with or without valve surgery)

Carina Benstoem et al. Cochrane Database Syst Rev. .

Abstract

Background: Despite substantial improvements in myocardial preservation strategies, coronary artery bypass grafting (CABG) is still associated with severe complications. It has been reported that remote ischaemic preconditioning (RIPC) reduces reperfusion injury in people undergoing cardiac surgery and improves clinical outcome. However, there is a lack of synthesised information and a need to review the current evidence from randomised controlled trials (RCTs).

Objectives: To assess the benefits and harms of remote ischaemic preconditioning in people undergoing coronary artery bypass grafting, with or without valve surgery.

Search methods: In May 2016 we searched CENTRAL, MEDLINE, Embase and Web of Science. We also conducted a search of ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). We also checked reference lists of included studies. We did not apply any language restrictions.

Selection criteria: We included RCTs in which people scheduled for CABG (with or without valve surgery) were randomly assigned to receive RIPC or sham intervention before surgery.

Data collection and analysis: Two review authors independently assessed trials for inclusion, extracted data and checked them for accuracy. We calculated mean differences (MDs), standardised mean differences (SMDs) and risk ratios (RR) using a random-effects model. We assessed quality of the trial evidence for all primary outcomes using the GRADE methodology. We completed a 'Risk of bias' assessment for all studies and performed sensitivity analysis by excluding studies judged at high or unclear risk of bias for sequence generation, allocation concealment and incomplete outcome data. We contacted authors for missing data. Our primary endpoints were 1) composite endpoint (including all-cause mortality, non-fatal myocardial infarction or any new stroke, or both) assessed at 30 days after surgery, 2) cardiac troponin T (cTnT, ng/L) at 48 hours and 72 hours, and as area under the curve (AUC) 72 hours (µg/L) after surgery, and 3) cardiac troponin I (cTnI, ng/L) at 48 hours, 72 hours, and as area under the curve (AUC) 72 hours (µg/L) after surgery.

Main results: We included 29 studies involving 5392 participants (mean age = 64 years, age range 23 to 86 years, 82% male). However, few studies contributed data to meta-analyses due to inconsistency in outcome definition and reporting. In general, risk of bias varied from low to high risk of bias across included studies, and insufficient detail was provided to inform judgement in several cases. The quality of the evidence of key outcomes ranged from moderate to low quality due to the presence of moderate or high statistical heterogeneity, imprecision of results or due to limitations in the design of individual studies.Compared with no RIPC, we found that RIPC has no treatment effect on the rate of the composite endpoint with RR 0.99 (95% confidence interval (CI) 0.78 to 1.25); 2 studies; 2463 participants; moderate-quality evidence. Participants randomised to RIPC showed an equivalent or better effect regarding the amount of cTnT release measured at 72 hours after surgery with SMD -0.32 (95% CI -0.65 to 0.00); 3 studies; 1120 participants; moderate-quality evidence; and expressed as AUC 72 hours with SMD -0.49 (95% CI -0.96 to -0.02); 3 studies; 830 participants; moderate-quality evidence. We found the same result in favour of RIPC for the cTnI release measured at 48 hours with SMD -0.21 (95% CI -0.40 to -0.02); 5 studies; 745 participants; moderate-quality evidence; and measured at 72 hours after surgery with SMD -0.37 (95% CI -0.59 to -0.15); 2 studies; 459 participants; moderate-quality evidence. All other primary outcomes showed no differences between groups (cTnT release measured at 48 hours with SMD -0.14, 95% CI -0.33 to 0.06; 4 studies; 1792 participants; low-quality evidence and cTnI release measured as AUC 72 hours with SMD -0.17, 95% CI -0.48 to 0.14; 2 studies; 159 participants; moderate-quality evidence).We also found no differences between groups for all-cause mortality after 30 days, non-fatal myocardial infarction after 30 days, any new stroke after 30 days, acute renal failure after 30 days, length of stay on the intensive care unit (days), any complications and adverse effects related to ischaemic preconditioning. We did not assess many patient-centred/salutogenic-focused outcomes.

Authors' conclusions: We found no evidence that RIPC has a treatment effect on clinical outcomes (measured as a composite endpoint including all-cause mortality, non-fatal myocardial infarction or any new stroke, or both, assessed at 30 days after surgery). There is moderate-quality evidence that RIPC has no treatment effect on the rate of the composite endpoint including all-cause mortality, non-fatal myocardial infarction or any new stroke assessed at 30 days after surgery, or both. We found moderate-quality evidence that RIPC reduces the cTnT release measured at 72 hours after surgery and expressed as AUC (72 hours). There is moderate-quality evidence that RIPC reduces the amount of cTnI release measured at 48 hours, and measured 72 hours after surgery. Adequately-designed studies, especially focusing on influencing factors, e.g. with regard to anaesthetic management, are encouraged and should systematically analyse the commonly used medications of people with cardiovascular diseases.

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Conflict of interest statement

CS and PM are investigators of the RIPHeart Study, which investigates the effects of remote ischaemic preconditioning in cardiac surgery patients. The RIPHeart trial contributed published and unpublished data to this review. We independently judged eligibility and risk of bias (performed by CB, AG and JN). PM received research grants from the German Research Foundation, German Society of Anesthesiology and Intensive Care Medicine and International Anesthesia Research Society for his research focusing on remote ischaemic preconditioning. He also received grants from Fresenius Kabi, B. Braun Melsungen, Vifor Pharma, CSL Behring, Pfizer. CB no conflict of interest. AG no conflict of interest. JN no conflict of interest. DH no conflict of interest. OJL no conflict of interest.

Figures

1
1
Study flow diagram
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
1.1
1.1. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 1 Composite endpoint (including all‐cause mortality, non‐fatal myocardial infarction and/or any new stroke assessed at 30 days after surgery).
1.2
1.2. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 2 All‐cause mortality after 30 days.
1.3
1.3. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 3 Non‐fatal myocardial infarction after 30 days.
1.4
1.4. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 4 Any new stroke after 30 days.
1.5
1.5. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 5 Cardiac troponin T 6 hours after surgery (ng/L).
1.6
1.6. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 6 Cardiac troponin T 12 hours after surgery (ng/L).
1.7
1.7. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 7 Cardiac troponin T 24 hours after surgery (ng/L).
1.8
1.8. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 8 Cardiac troponin T 48 hours after surgery (ng/L).
1.9
1.9. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 9 Cardiac troponin T 72 hours after surgery (ng/L).
1.10
1.10. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 10 Cardiac troponin T AUC 72 hours (µg/L).
1.11
1.11. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 11 Cardiac troponin I 1 hour after surgery (µg/L).
1.12
1.12. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 12 Cardiac troponin I 6 hours after surgery (µg/L).
1.13
1.13. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 13 Cardiac troponin I 12 hours after surgery (µg/L).
1.14
1.14. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 14 Cardiac troponin I 24 hours after surgery (µg/L).
1.15
1.15. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 15 Cardiac troponin I 48 hours after surgery (µg/L).
1.16
1.16. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 16 Cardiac troponin I 72 hours after surgery (µg/L).
1.17
1.17. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 17 Cardiac troponin I AUC 72 hours (µg/L).
1.18
1.18. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 18 Acute renal failure after 30 days.
1.19
1.19. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 19 Length of stay on the intensive care unit (days).
1.20
1.20. Analysis
Comparison 1 RIPC versus no RIPC in people undergoing CABG (with or without valve surgery), Outcome 20 Any complications and adverse effects related to the intervention reported.
2.1
2.1. Analysis
Comparison 2 RIPC versus no RIPC (subgroup analysis: isolated CABG without additional surgery), Outcome 1 Composite endpoint (including all‐cause mortality, non‐fatal myocardial infarction and/or any new stroke assessed at 30 days after surgery).
2.2
2.2. Analysis
Comparison 2 RIPC versus no RIPC (subgroup analysis: isolated CABG without additional surgery), Outcome 2 Cardiac troponin T 48 hours after surgery (ng/L).
2.3
2.3. Analysis
Comparison 2 RIPC versus no RIPC (subgroup analysis: isolated CABG without additional surgery), Outcome 3 Cardiac troponin T 72 hours after surgery (ng/L).
2.4
2.4. Analysis
Comparison 2 RIPC versus no RIPC (subgroup analysis: isolated CABG without additional surgery), Outcome 4 Cardiac troponin T AUC 72 hours (µg/L).
2.5
2.5. Analysis
Comparison 2 RIPC versus no RIPC (subgroup analysis: isolated CABG without additional surgery), Outcome 5 Cardiac troponin I 48 hours after surgery (µg/L).
2.6
2.6. Analysis
Comparison 2 RIPC versus no RIPC (subgroup analysis: isolated CABG without additional surgery), Outcome 6 Cardiac troponin I 72 hours after surgery (µg/L).
2.7
2.7. Analysis
Comparison 2 RIPC versus no RIPC (subgroup analysis: isolated CABG without additional surgery), Outcome 7 Cardiac troponin I AUC 72 hours (µg/L).
3.1
3.1. Analysis
Comparison 3 RIPC versus no RIPC (subgroup analysis in people undergoing CABG, with or without valve surgery and a high preoperative risk status, EuroSCORE ≥ 6), Outcome 1 Composite endpoint (including all‐cause mortality, non‐fatal myocardial infarction and/or any new stroke assessed at 30 days after surgery).
3.2
3.2. Analysis
Comparison 3 RIPC versus no RIPC (subgroup analysis in people undergoing CABG, with or without valve surgery and a high preoperative risk status, EuroSCORE ≥ 6), Outcome 2 Cardiac troponin T 48 hours after surgery (ng/L).
3.3
3.3. Analysis
Comparison 3 RIPC versus no RIPC (subgroup analysis in people undergoing CABG, with or without valve surgery and a high preoperative risk status, EuroSCORE ≥ 6), Outcome 3 Cardiac troponin T 72 hours after surgery (ng/L).
3.4
3.4. Analysis
Comparison 3 RIPC versus no RIPC (subgroup analysis in people undergoing CABG, with or without valve surgery and a high preoperative risk status, EuroSCORE ≥ 6), Outcome 4 Cardiac troponin I 48 hours after surgery (µg/L).
4.1
4.1. Analysis
Comparison 4 RIPC versus no RIPC (subgroup analysis: isoflurane anaesthesia or similar volatile agents versus propofol anaesthesia in people undergoing CABG, with or without valve surgery), Outcome 1 Composite endpoint (including all‐cause mortality, non‐fatal myocardial infarction and/or any new stroke assessed at 30 days after surgery).
4.2
4.2. Analysis
Comparison 4 RIPC versus no RIPC (subgroup analysis: isoflurane anaesthesia or similar volatile agents versus propofol anaesthesia in people undergoing CABG, with or without valve surgery), Outcome 2 Cardiac troponin T 48 hours after surgery (ng/L).
4.3
4.3. Analysis
Comparison 4 RIPC versus no RIPC (subgroup analysis: isoflurane anaesthesia or similar volatile agents versus propofol anaesthesia in people undergoing CABG, with or without valve surgery), Outcome 3 Cardiac troponin T 72 hours after surgery (ng/L).
4.4
4.4. Analysis
Comparison 4 RIPC versus no RIPC (subgroup analysis: isoflurane anaesthesia or similar volatile agents versus propofol anaesthesia in people undergoing CABG, with or without valve surgery), Outcome 4 Cardiac troponin T AUC 72 hours (µg/L).
4.5
4.5. Analysis
Comparison 4 RIPC versus no RIPC (subgroup analysis: isoflurane anaesthesia or similar volatile agents versus propofol anaesthesia in people undergoing CABG, with or without valve surgery), Outcome 5 Cardiac troponin I 48 hours after surgery (µg/L).
4.6
4.6. Analysis
Comparison 4 RIPC versus no RIPC (subgroup analysis: isoflurane anaesthesia or similar volatile agents versus propofol anaesthesia in people undergoing CABG, with or without valve surgery), Outcome 6 Cardiac troponin I 72 hours after surgery (µg/L).
4.7
4.7. Analysis
Comparison 4 RIPC versus no RIPC (subgroup analysis: isoflurane anaesthesia or similar volatile agents versus propofol anaesthesia in people undergoing CABG, with or without valve surgery), Outcome 7 Cardiac troponin I AUC 72 hours (µg/L).
5.1
5.1. Analysis
Comparison 5 RIPC versus no RIPC (sensitivity analysis by sequence generation, allocation concealment and incomplete outcome data in people undergoing CABG, with or without valve surgery), Outcome 1 Composite endpoint (including all‐cause mortality, non‐fatal myocardial infarction and/or any new stroke assessed at 30 days after surgery).
5.2
5.2. Analysis
Comparison 5 RIPC versus no RIPC (sensitivity analysis by sequence generation, allocation concealment and incomplete outcome data in people undergoing CABG, with or without valve surgery), Outcome 2 Cardiac troponin T 48 hours after surgery (ng/L).
5.3
5.3. Analysis
Comparison 5 RIPC versus no RIPC (sensitivity analysis by sequence generation, allocation concealment and incomplete outcome data in people undergoing CABG, with or without valve surgery), Outcome 3 Cardiac troponin T 72 hours after surgery (ng/L).
5.4
5.4. Analysis
Comparison 5 RIPC versus no RIPC (sensitivity analysis by sequence generation, allocation concealment and incomplete outcome data in people undergoing CABG, with or without valve surgery), Outcome 4 Cardiac troponin I 48 hours after surgery (µg/L).
5.5
5.5. Analysis
Comparison 5 RIPC versus no RIPC (sensitivity analysis by sequence generation, allocation concealment and incomplete outcome data in people undergoing CABG, with or without valve surgery), Outcome 5 Cardiac troponin I 72 hours after surgery (µg/L).
5.6
5.6. Analysis
Comparison 5 RIPC versus no RIPC (sensitivity analysis by sequence generation, allocation concealment and incomplete outcome data in people undergoing CABG, with or without valve surgery), Outcome 6 Cardiac troponin I AUC 72 hours (µg/L).
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References

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    1. Brevoord D, Hollmann MW, Hert SG, Dongen EH, Heijnen BG, Bruin A, et al. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO‐trial). BMC Anesthesiology 2011;11(11):1‐6. - PMC - PubMed
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Contractor 2009a {published data only}
    1. Contractor H, Ashrafian H, Rahman I, Juul‐Dam K, Redington A, Mascaro CJ. Beta‐catenin pathway expression in human myocardium is increased by a remote ischaemic preconditioning stimulus. Research Gate 2009;54(5):1173–74.
Contractor 2009b {published data only}
    1. Contractor H, Ashrafian H, Rahman I, Redington A, Frenneaux M, Mascaro CJ, et al. Increased beta‐catenin pathway expression by a remote ischaemic preconditioning stimulus: first evidence in humans. Journal of the American College of Cardiology 2009;53(10):A309.
D'Ascenzo 2012 {published data only}
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Deng 2015 {published data only}
    1. Deng QW, Xia ZQ, Qiu YX, Wu Y, Liu JX, Li C, et al. Clinical benefits of aortic cross‐clamping versus limb remote ischemic preconditioning in coronary artery bypass grafting with cardiopulmonary bypass: a meta‐analysis of randomized controlled trials. Journal of Surgical Research 2015;193(1):52‐68. - PubMed
Healy 2014 {published data only}
    1. Healy DA, Khan WA, Wong CS, Moloney MC, Grace PA, Coffey JC, et al. Remote preconditioning and major clinical complications following adult cardiovascular surgery: systematic review and meta‐analysis. International Journal of Cardiology 2014;176(120‐31):20‐31. - PubMed
Hong 2014 {published data only}
    1. Hong DM, Lee EH, Kim HJ, Min JJ, Chin JH, Choi DK, et al. Does remote ischaemic preconditioning with postconditioning improve clinical outcomes of patients undergoing cardiac surgery? Remote Ischaemic Preconditioning with Postconditioning Outcome Trial. European Heart Journal 2014;35(3):176‐83. - PubMed
King 2016 {published data only}
    1. King N, Dieberg G, Smart NA. Remote ischaemic pre‐conditioning does not affect clinical outcomes following coronary artery bypass grafting. A systematic review and meta‐analysis. Clinical Trials and Regulatory Science in Cardiology 2016;17:1‐8.
Marczak 2012 {published data only}
    1. Marczak ED, Marzec J, Zeldin DC, Kleeberger SR, Brown NJ, Pretorius M, et al. Is remote ischaemic preconditioning of benefit to patients undergoing cardiac surgery?. Pharmacogenetics and Genomics 2012;22(8):620‐8. - PMC - PubMed
Pei 2014 {published data only}
    1. Pei H, Wu Y, Wei Y, Yang Y, Teng S, Zhang H. Remote ischemic preconditioning reduces perioperative cardiac and renal events in patients undergoing elective coronary intervention: a meta‐analysis of 11 randomized trials. PLOS One 2014;9(12):e115500. - PMC - PubMed
Pilcher 2012 {published data only}
    1. Pilcher JM, Young P, Weatherall M, Rahman I, Bonser RS, Beasley RW. A systematic review and meta‐analysis of the cardioprotective effects of remote ischaemic preconditioning in open cardiac surgery. Journal of the Royal Society of Medicine 2012;105(10):436‐45. - PMC - PubMed
Sabbagh 2013 {published data only}
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Sivaraman 2010 {published data only}
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Wagner 2010 {published data only}
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Walsh 2016 {published data only}
    1. Walsh M, Whitlock R, Garg AX, Légaré JF, Duncan AE, Zimmerman R, et al. Effects of remote ischemic preconditioning in high‐risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial. Canadian Medical Association Journal 2016;188(5):329‐36. - PMC - PubMed
Yang 2014 {published data only}
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Zarbock 2015 {published data only}
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Zhao 2014 {published data only}
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References to studies awaiting assessment

Gasparovic 2014a {published data only}
    1. Gasparovic H, Kopjar T, Rados M, Anticevic A, Rados M, Malojcic B, et al. Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial. Trials 2014;15(414):1‐8. - PMC - PubMed

References to ongoing studies

Akhyari 2012 {unpublished data only}
    1. NCT01608984. Effects of Remote Ischemic PreConditioning in Off‐pump Versus On‐pump Coronary Artery Bypass Grafting(RIPCON) (RIPCON) [Effects of Remote Ischemic PreConditioning in Off‐pump Versus On‐pump Coronary]. https://clinicaltrials.gov/ct2/show/NCT01608984 (first received 29 May 2012).
Choi 2009 {unpublished data only}
    1. NCT00953368. Effect of Remote Ischemic Preconditioning on Cognitive Function After Off‐Pump Coronary Artery Bypass Graft. https://clinicaltrials.gov/ct2/show/NCT00953368 (first received 5 August 2009). - PMC - PubMed
Dong 2009 {unpublished data only}
    1. NCT01231789. The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter. https://clinicaltrials.gov/ct2/show/NCT01231789 (first received 15 September 2010).
Gasparovic 2014b {unpublished data only}
    1. NCT02177981. Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting on Inducing nEuroprotection (RIPCAGE). https://clinicaltrials.gov/ct2/show/NCT02177981 (first received 7 April 2014).
Kamler 2013 {unpublished data only}
    1. NCT01956708. Transfer of Cardioprotection During RIPC. https://clinicaltrials.gov/ct2/show/NCT01956708 (first received 27 September 2013).
Lofti 2010 {unpublished data only}
    1. NCT01500369. Effect of Remote Ischemic Preconditioning on Incidence of Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Graft Surgery. https://clinicaltrials.gov/ct2/show/NCT01500369 (first received 22 December 2011).
Petrucci 2013 {unpublished data only}
    1. NCT01906918. Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries [Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury]. https://clinicaltrials.gov/ct2/show/NCT01906918 (first received 21 July 2013).
Preckel 2010 {unpublished data only}
    1. NCT01107184. Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG) (RICO) [A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting]. https://clinicaltrials.gov/ct2/show/NCT01107184 (first received 19 April 2010).
Yellon 2010 {unpublished data only}
    1. NCT00397163. Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery. https://clinicaltrials.gov/ct2/show/NCT00397163 (first received 6 November 2006).

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References to other published versions of this review

Benstoem 2015a
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