Biomedical papers, 2016 (vol. 160), issue 2

Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016, 160(2):263-270 | 10.5507/bp.2015.059

Off-pump versus on-pump coronary artery bypass grafting surgery in high-risk patients: PRAGUE-6 trial at 30 days and 1 year

Jan Hlavickaa, Zbynek Strakaa, Stepan Jelineka, Petr Buderaa, Tomas Vaneka, Marek Malyb, Petr Widimskya
a Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University in Prague, Czech Republic
b National Institute of Public Health, Prague, Czech Republic

Aims: Off-pump coronary artery bypass graft surgery (OPCAB) is an established alternative to on-pump surgical revascularization. Previous studies in patients with low or intermediate risk showed no significant differences between off-pump and on-pump surgical revascularization. The aim of this study was to compare the two techniques in patients with high operative risk.

Methods: PRAGUE-6 is a prospective randomized single-center study of 206 patients, with an additive EuroSCORE ≥ 6, scheduled for isolated coronary surgery: Group A - on-pump (n = 108) versus Group B - off-pump (n = 98). The primary outcome was a combined endpoint of all-cause deaths, stroke, myocardial infarction, or renal failure requiring new hemodialysis, within 30 days and 1 year after randomization. All data were analyzed using the "intention-to-treat" principle.

Results: Early postoperative myocardial infarction was detected in 12.1% (A) vs. 4.1% (B) of patients (P = 0.048, hazard ratio 0.32, 95% CI 0.11-0.99). There was a significantly higher incidence of primary combined end-point in group A (20.6% vs. 9.2%, P = 0.028, HR 0.41, 95% CI 0.19-0.91) in the first 30 days, but not after 1 year (30.8% vs. 21.4%, P = 0.117, HR 0.65, CI 0.37-1.12).

Conclusion: Off-pump surgical revascularization in patients with high operative risks can significantly reduce the incidence of major postoperative complications during the first 30 days. There was no statistically significant difference in the incidence of these complications after 1 year.

Keywords: revascularization, cardiopulmonary bypass, off-pump, high-risk patient

Received: June 14, 2015; Accepted: November 20, 2015; Prepublished online: January 5, 2016; Published: June 24, 2016


References

  1. Matata BM, Sosnowski AW, Galinanes M. Off-pump bypass graft operation significantly reduces stress and inflammation. Ann Thorac Surg 2000;69:785-91. Go to original source... Go to PubMed...
  2. Czerny M, Baumer H, Kilo J, Lassnigg A, Hamwi A, Vukovich T, Wolner E, Grimm M. Inflammatory response and myocardial injury following coronary artery bypass grafting with and without cardiopulmonary bypass. Eur J Cardiothorac Surg 2000;17:737-42. Go to original source... Go to PubMed...
  3. Calafiore AM, Di Mauro M, Canosa C, Di Giammarco G, Iaco AL, Contini M. Myocardial revascularization with and without cardiopulmonary bypass:advantages, disadvantages and similarities. Eur J Cardiothorac Surg 2003;24:953-60. Go to original source... Go to PubMed...
  4. Angelini GD, Taylor FC, Reeves BC, Ascione R. Early and midterm outcome after off-pump and on-pump surgery in Beating Heart Against Cardioplegic Arrest Studies (BHACAS 1 and 2): a pooled analysis of two randomized controlled trials. Lancet 2002;359:1194-9. Go to original source... Go to PubMed...
  5. Straka Z, Widimsky P, Jirasek K, Stros P, Votava J, Vanek T, Brucek P, Kolesar M, Spacek R. Off-pump versus on pump coronary surgery: final results from prospective randomized study Prague-4. Ann Thorac Surg 2004;77:789-93. Go to original source... Go to PubMed...
  6. Shroyer AL, Grover FL, Hattler B, Collins JF, McDonald GO, Kozora E, Lucke JC, Baltz JH, Novitzky D. On-Pump versus Off-Pump Coronary-Artery Bypass Surgery. N Engl J Med 2009;361:1827-37. Go to original source... Go to PubMed...
  7. Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy SK, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Pogue J, Chrolavicius S, Yusuf S. Off-Pump or On-Pump Coronary-Artery Bypass Grafting at 30 Days. N Engl J Med 2012;366:1489-97. Go to original source... Go to PubMed...
  8. Gaudino M, Glieca F, Alessandrini F, Nasso G, Pragliola C, Luciani N, Morelli M, Possati G. High risk coronary artery bypass patient: incidence, surgical strategies, and results. Ann Thorac Surg 2004;77:574-9. Go to original source... Go to PubMed...
  9. Puskas JD, Thourami VH, Kilgo P, Cooper W, Vassiliades T, Vega JD, Morris C, Chen E, Schmotzer BJ, Guyton RA, Lattouf OM. Off-Pump Coronary Artery Bypass Disproportionately Benefits High-Risk Patients. Ann Thorac Surg 2009;88:1142-7. Go to original source... Go to PubMed...
  10. Abu-Omar Y, Taggart DP. The present status of off-pump coronary artery bypass grafting. Eur J Cardiothorac Surg 2009;36:312-21. Go to original source... Go to PubMed...
  11. Vanek T, Brucek P, Straka Z. Fast track as a routine for open-heart surgery. Eur. J Cardiothorac Surg 2002;21(2):369-70. Go to original source... Go to PubMed...
  12. Al-Attar N. Postoperative myocardial infarction. e-journal of the ESC Council for Cardiology Practice 2011;10, available at: http://www.escardio.org/communities/councils/ccp/e-journal/volume10/Pages/Postoperative-myocardial-infarction-Nawwar-Al-Attar.aspx#.UZuJbJ1Iuzk
  13. Young-Nam Y, Young-Lan K, Kyung-Jong Y. Can the EuroSCORE Predict the Early and Mid-Term Mortality After Off-Pump Coronary Artery Bypass Grafting? Ann Thorac Surg 2007;83:2111-7. Go to original source... Go to PubMed...
  14. Nilsson J, Algotsson L, Höglund P, Lührs C, Brandt J. Early Mortality in Coronary Bypass Surgery: the EuroSCORE Versus The Society of Thoracic Surgeons Risk Algoritm, Ann Thorac Surg 2004;77:1235-9. Go to original source... Go to PubMed...
  15. Møller CH, Perko MJ, Lund JT, Andersen LW, Kelbæk H, Madsen JK, Winkel P, Gluud C, Steinbrüchel DA. No Major Differences in 30-Day Outcomes in High-Risk Patients Randomized to Off-Pump Versus On-Pump Corornary Bypass Surgery: The Best Bypass Surgery Trial. Circulation 2010;121:498-504. Go to original source... Go to PubMed...
  16. Lemma MG, Coscioni E, Tritto FP, Centofanti P, Fondacone C, Salica A, Rossi A, De Santo T, Di Benedetto G, Piazza L, Rinaldi M, Schinosa AL, De Paulis R, Contino M, Genoni M. On-pump versus off-pump coronary artery bypass surgery in high-risk patients: Operative results of a prospective randomized trial (on-off study). J Thorac Cardiovasc Surg 2012;143:625-31. Go to original source... Go to PubMed...
  17. Paparella D, Cappabianca G, Malvindi P, Paramythiotis A, Galeone A, Veneziani N, Fondacone C, de Luca Tupputi Schinosa L. Myocardial injury after off-pump coronary artery bypass grafting operation. Eur J Cardiothorac Surg 2007;32:481-7. Go to original source... Go to PubMed...
  18. Yau JM, Alexander JH, Hafley G, Mahaffey KW, Mack MJ, Kouchoukos N, Goyal A, Peterson ED, Gibson CM, Califf RM, Harrington RA, Ferguson TB, PREVENT IV Investigators. Impact of perioperative myocardial infarction on angiographic and clinical outcomes following coronary artery bypass grafting. Am J Cardiol 2008;102:546-51. Go to original source... Go to PubMed...
  19. Vasques F, Rainio A, Heikkinen J, Mikkola R, Lahtinen J, Kettunen U, Juvonen T, Biancari F. Off-pump versus on-pump coronary artery bypass surgery in patients aged 80 years and older: institutional results and meta-analysis. Heart Vessels 2013;28:46-56. Go to original source... Go to PubMed...
  20. Houlind K, Kjeldsen BJ, Madsen SN, Rasmussen BS, Holme SJ, Nielsen PH, Mortensen PE. On-pump versus off-pump coronary artery bypass surgery in elderly patients: results from the Danish On-Pump versus Off-Pump Randomization Study. Circulation 2012;125:2431-9. Go to original source... Go to PubMed...
  21. Møller CH, Penninga L, Wetterslev J, Steinbrüchel DA, Gluud C. Clinical outcomes in randomized trials of off- vs. on-pump coronary artery bypass surgery: systematic review with meta-analyses and trial sequential analyses. Eur Heart J 2008;29:2601-16. Go to original source... Go to PubMed...
  22. Ong ATL, Serruys PW. Complete Revascularisation. Circulation. 2006;114:249-55. Go to original source... Go to PubMed...
  23. Widimsky P, Straka Z, Stros P, Jirasek K, Dvorak J, Votava J, Lisa L, Budesinsky T, Kolesar M, Vanek T, Brucek P. One-year coronary bypass graft patency: a randomized comparison between off-pump and on-pump surgery angiographic results of the PRAGUE-4 trial. Circulation. 2004;110(22):3418. Go to original source... Go to PubMed...
  24. Puskas JD, Williams WH, Mahoney EM, Huber PR, Block PC, Duke PG, Staples JR, Glas KE, Marshall JJ, Leimbach ME, McCall SA, Petersen RJ, Bailey DE, Weintraub WS, Guyton RA. Off-pump vs conventional coronary artery bypass grafting: early and 1-year graft patency, cost, and quality-of-life outcomes: a randomized trial. JAMA. 2004;291:1841-9. Go to original source... Go to PubMed...
  25. Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy SK, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Pogue J, Chrolavicius S, Yusuf S. Effects of Off-Pump and On-Pump Coronary-Artery Bypass Grafting at 1 Year. N Engl J Med 2013;368:1179-88. Go to original source... Go to PubMed...