No major differences in 30-day outcomes in high-risk patients randomized to off-pump versus on-pump coronary bypass surgery: The best bypass surgery trial

Circulation

Volumn 121, Issue 4, 2010, Pages 498-504

  Møller, Christian H ^a   Perko, Mario J ^a   Lund, Jens T ^a   Andersen, Lars W ^a   Kelbæk, Henning ^a   Madsen, Jan K ^b   Winkel, Per ^a   Gluud, Christian ^a   Steinbrüchel, Daniel A ^a  

^a Rigshospitalet   (Denmark)

^b GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Cardiopulmonary bypass; High risk patients; Off pump; OPCAB; Revascularization

Indexed keywords

ADULT; AGED; ARTICLE; CARDIOPULMONARY BYPASS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; FEMALE; HEART MUSCLE REVASCULARIZATION; HIGH RISK PATIENT; HUMAN; INTERMETHOD COMPARISON; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; OFF PUMP CORONARY SURGERY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SURGICAL RISK;

AGED; AGED, 80 AND OVER; CARDIAC OUTPUT, LOW; CORONARY ARTERY BYPASS; CORONARY ARTERY BYPASS, OFF-PUMP; CORONARY ARTERY DISEASE; FEMALE; FOLLOW-UP STUDIES; HEART ARREST; HUMANS; MALE; MYOCARDIAL INFARCTION; RISK FACTORS; STROKE; TREATMENT OUTCOME;

EID: 76349100701     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.109.880443     Document Type: Article

References (27)

1. Al-Ruzzeh S, George S, Bustami M, Wray J, Ilsley C, Athanasiou T, Amrani M. Effect of off-pump coronary artery bypass surgery on clinical, angiographic, neurocognitive, and quality of life outcomes: randomised controlled trial. BMJ. 2006;332:1365.
2. 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 randomised controlled trials. Lancet. 2002;359:1194-1199.
3. Nathoe HM, van Dijk D, Jansen EW, Suyker WJ, Diephuis JC, van Boven WJ, de la Riviere AB, Borst C, Kalkman CJ, Grobbee DE, Buskens E, de Jaegere PP. A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients. N Engl J Med. 2003;348:394-402. (Pubitemid 36159356)
4. 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;291:1841-1849.
5. Moller CH, Penninga L, Wetterslev J, Steinbruchel 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;29:2601-2616.
6. Society of Thoracic Surgeons National Adult Cardiac Database: Spring Report 2007. Durham, NC: Duke Clinical Research Institute; June 2007.
7. Filsoufi F, Rahmanian PB, Castillo JG, Chikwe J, Adams DH. Excellent results of contemporary coronary artery bypass grafting with systematic application of modern perioperative strategies. Heart Surg Forum. 2007; 10:E349-E356.
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;77:574-579.
9. Ohata T, Kaneko M, Kuratani T, Ueda H, Shimamura K. Using the EuroSCORE to assess changes in the risk profiles of the patients undergoing coronary artery bypass grafting before and after the introduction of less invasive coronary surgery. Ann Thorac Surg. 2005;80:131-135.
10. Tuman KJ, McCarthy RJ, Najafi H, Ivankovich AD. Differential effects of advanced age on neurologic and cardiac risks of coronary artery operations. J Thorac Cardiovasc Surg. 1992;104:1510-1517.
11. Nalysnyk L, Fahrbach K, Reynolds MW, Zhao SZ, Ross S. Adverse events in coronary artery bypass graft (CABG) trials: a systematic review and analysis. Heart. 2003;89:767-772.
12. Al Ruzzeh S, Nakamura K, Athanasiou T, Modine T, George S, Yacoub M, Ilsley C, Amrani M. Does off-pump coronary artery bypass (OPCAB) surgery improve the outcome in high-risk patients? A comparative study of 1398 high-risk patients. Eur J Cardiothorac Surg. 2003;23:50-55. (Pubitemid 35472097)
13. Mack MJ, Pfister A, Bachand D, Emery R, Magee MJ, Connolly M, Subramanian V. Comparison of coronary bypass surgery with and without cardiopulmonary bypass in patients with multivessel disease. J Thorac Cardiovasc Surg. 2004;127:167-173.
14. Stamou SC, Jablonski KA, Hill PC, Bafi AS, Boyce SW, Corso PJ. Coronary revascularization without cardiopulmonary bypass versus the conventional approach in high-risk patients. Ann Thorac Surg. 2005;79: 552-557.
15. Moller CH, Jensen BO, Gluud C, Perko MJ, Lund JT, Andersen LW, Madsen JK, Hughes P, Steinbruchel DA. The Best Bypass Surgery Trial: rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting. Contemp Clin Trials. 2007;28:540-547.
16. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325:652-654.
17. van Dijk D, Nierich AP, Jansen EW, Nathoe HM, Suyker WJ, Diephuis JC, van Boven WJ, Borst C, Buskens E, Grobbee DE, Robles De Medina EO, de Jaegere PP. Early outcome after off-pump versus on-pump coronary bypass surgery: results from a randomized study. Circulation. 2001;104:1761-1766.
18. 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 a prospective randomized study PRAGUE-4. Ann Thorac Surg. 2004;77:789-793.
19. Puskas JD, Williams WH, Duke PG, Staples JR, Glas KE, Marshall JJ, Leimbach M, Huber P, Garas S, Sammons BH, McCall SA, Petersen RJ, Bailey DE, Chu H, Mahoney EM, Weintraub WS, Guyton RA. Off-pump coronary artery bypass grafting provides complete revascularization with reduced myocardial injury, transfusion requirements, and length of stay: a prospective randomized comparison of two hundred unselected patients undergoing off-pump versus conventional coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003;125:797-808.
20. Calafiore AM, Di MM, Canosa C, Di GG, Iaco AL, Contini M. Early and late outcome of myocardial revascularization with and without cardiopulmonary bypass in high risk patients (EuroSCORE > or = 6). Eur J Cardiothorac Surg. 2003;23:360-367.
21. Jensen BO, Hughes P, Rasmussen LS, Pedersen PU, Steinbruchel DA. Cognitive outcomes in elderly high-risk patients after off-pump versus conventional coronary artery bypass grafting: a randomized trial. Circulation. 2006;113:2790-2795. (Pubitemid 44305290)
22. Amar D, Shi W, Hogue CW Jr, Zhang H, Passman RS, Thomas B, Bach PB, Damiano R, Thaler HT. Clinical prediction rule for atrial fibrillation after coronary artery bypass grafting. J Am Coll Cardiol. 2004;44:1248-1253.
23. Briffa N. Off pump coronary artery bypass: a passing fad or ready for prime time? Eur Heart J. 2008;29:1346-1349.
24. Kobayashi J, Tashiro T, Ochi M, Yaku H, Watanabe G, Satoh T, Tagusari O, Nakajima H, Kitamura S. Early outcome of a randomized comparison of off-pump and on-pump multiple arterial coronary revascularization. Circulation. 2005;112:I338-I343.
25. Gotzsche PC. Blinding during data analysis and writing of manuscripts. Control Clin Trials. 1996;17:285-290.
26. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analy-ses. Ann Intern Med. 2001;135:982-989.
27. Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336:601-605.