Randomized clinical trial of remote ischaemic preconditioning versus no preconditioning in the prevention of perioperative myocardial infarction during open surgery for ruptured abdominal aortic aneurysm

T F Pedersen, J Budtz-Lilly, C N Petersen, J Hyldgaard, J-O Schmidt, R Kroijer, M-L Grønholdt, N Eldrup, T F Pedersen, J Budtz-Lilly, C N Petersen, J Hyldgaard, J-O Schmidt, R Kroijer, M-L Grønholdt, N Eldrup

Abstract

Background: Remote ischaemic preconditioning (RIPC) has been suggested as a means of protecting vital organs from reperfusion injury during major vascular surgery. This study was designed to determine whether RIPC could reduce the incidence of perioperative myocardial infarction (MI) during open surgery for ruptured abdominal aortic aneurysm (AAA). Secondary aims were to see if RIPC could reduce 30-day mortality, multiple organ failure, acute intestinal ischaemia, acute kidney injury and ischaemic stroke.

Methods: This randomized, non-blinded clinical trial was undertaken at three vascular surgery centres in Denmark. Patients who had open surgery for ruptured AAA were randomized to intervention with RIPC or control in a 1 : 1 ratio. Postoperative complications and deaths were registered, and ECG and blood samples were obtained daily during the hospital stay.

Results: Of 200 patients randomized, 142 (72 RIPC, 70 controls) were included. There was no difference in rates of perioperative MI between the RIPC and control groups (36 versus 43 per cent respectively), or in rates of organ failure. However, in the per-protocol analysis 30-day mortality was significantly reduced in the RIPC group (odds ratio 0·46, 95 per cent c.i. 0·22 to 0·99; P = 0·048).

Conclusion: RIPC did not reduce the incidence of perioperative MI in patients undergoing open surgery for ruptured AAA. Registration number: NCT00883363 ( http://www.clinicaltrials.gov).

Figures

Figure 1
Figure 1
Flow chart for the study. *Mostly owing to problems with starting study protocol. AAA, abdominal aortic aneurysm; RIPC, remote ischaemic preconditioning
Figure 2
Figure 2
Forest plot showing effect of remote ischaemic preconditioning versus standard treatment on myocardial infarction and secondary endpoints. Odds ratios are shown with 95 per cent confidence intervals on a logarithmic scale for the per‐protocol analysis

References

    1. Bown MJ, Sutton AJ, Bell PR, Sayers RD. A meta‐analysis of 50 years of ruptured abdominal aortic aneurysm repair. Br J Surg 2002; 89: 714–730.
    1. Cho JS, Kim JY, Rhee RY, Gupta N, Marone LK, Dillavou ED et al Contemporary results of open repair of ruptured abdominal aortoiliac aneurysms: effect of surgeon volume on mortality. J Vasc Surg 2008; 48: 10–17.
    1. Hoornweg LL, Storm‐Versloot MN, Ubbink DT, Koelemay MJ, Legemate DA, Balm R. Meta analysis on mortality of ruptured abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2008; 35: 558–570.
    1. Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med 2007; 357: 1121–1135.
    1. Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res 2008; 79: 377–386.
    1. Healy DA, Clarke Moloney M, McHugh SM, Grace PA, Walsh SR. Remote ischaemic preconditioning as a method for perioperative cardioprotection: concepts, applications and future directions. Int J Surg 2014; 12: 1093–1099.
    1. Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E et al Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet 2007; 370: 575–579.
    1. Desai M, Gurusamy KS, Ghanbari H, Hamilton G, Seifalian AM. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev 2011; (12)CD008472.
    1. Twine CP, Ferguson S, Boyle JR. Benefits of remote ischaemic preconditioning in vascular surgery. Eur J Vasc Endovasc Surg 2014; 48: 215–219.
    1. Sukkar L, Hong D, Wong MG, Badve SV, Rogers K, Perkovic V et al Effects of ischaemic conditioning on major clinical outcomes in people undergoing invasive procedures: systematic review and meta‐analysis. BMJ 2016; 355: i5599.
    1. Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM et al Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation 2007; 116(Suppl): I98–I105.
    1. Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T et al Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev 2012; (11)MR000030.
    1. Brevoord D, Kranke P, Kuijpers M, Weber N, Hollmann M, Preckel B. Remote ischemic conditioning to protect against ischemia–reperfusion injury: a systematic review and meta‐analysis. PLoS One 2012; 7: e42179.
    1. Hausenloy DJ, Garcia‐Dorado D, Bøtker HE, Davidson SM, Downey J, Engel FB et al Novel targets and future strategies for acute cardioprotection: position paper of the European Society of Cardiology Working Group on Cellular Biology of the Heart. Cardiovasc Res 2017; 113: 564–585.
    1. Thygesen K, Alpert JS, White HD. Universal definition of myocardial infarction. J Am Coll Cardiol 2007; 50: 2173–2195.
    1. Li C, Li YS, Xu M, Wen SH, Yao X, Wu Y et al Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial. Anesthesiology 2013; 118: 842–852.
    1. Murphy N, Vijayan A, Frohlich S, O'Farrell F, Barry M, Sheehan S et al Remote ischemic preconditioning does not affect the incidence of acute kidney injury after elective abdominal aortic aneurysm repair. J Cardiothorac Vasc Anesth 2014; 28: 1285–1292.
    1. Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG et al Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg 2010; 44: 334–340.
    1. Mouton R, Pollock J, Soar J, Mitchell DC, Rogers CA. Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial. Trials 2015; 16: 377.
    1. Healy DA, Boyle E, McCartan D, Bourke M, Medani M, Ferguson J et al; Preconditioning Shields Against Vascular Events in Surgery (Preconditioning SAVES) Trial Group. A multicenter pilot randomized controlled trial of remote ischemic preconditioning in major vascular surgery. Vasc Endovascular Surg 2015; 49: 220–227.
    1. Min JJ, Bae JY, Kim TK, Kim JH, Hwang HY, Kim KH et al Pulmonary protective effects of remote ischaemic preconditioning with postconditioning in patients undergoing cardiac surgery involving cardiopulmonary bypass: a substudy of the Remote Ischaemic Preconditioning with Postconditioning Outcome trial. Heart Lung Circ 2016; 25: 484–492.
    1. Heusch G. Molecular basis of cardioprotection: signal transduction in ischemic pre‐, post‐, and remote conditioning. Circ Res 2015; 116: 674–699.
    1. Aimo A, Borrelli C, Giannoni A, Pastormerlo LE, Barison A, Mirizzi G et al Cardioprotection by remote ischemic conditioning: mechanisms and clinical evidences. World J Cardiol 2015; 7: 621–632.
    1. Basalay M, Barsukevich V, Mastitskaya S, Mrochek A, Pernow J, Sjöquist PO et al Remote ischaemic pre‐ and delayed postconditioning – similar degree of cardioprotection but distinct mechanisms. Exp Physiol 2012; 97: 908–917.
    1. Heusch G. Remote ischemic conditioning in cardiovascular surgery. J Cardiovasc Pharmacol Ther 2017; 22: 297–301.

Source: PubMed

3
订阅