Revisão Acesso aberto Revisado por pares

Off-pump coronary artery bypass sacrifices graft patency: Meta-analysis of randomized trials

2006; Elsevier BV; Volume: 133; Issue: 1 Linguagem: Inglês

10.1016/j.jtcvs.2006.08.062

ISSN

1097-685X

Autores

Hisato Takagi, Toshiyuki Tanabashi, Norikazu Kawai, Takayoshi Kato, Takuya Umemoto,

Tópico(s)

Cardiac, Anesthesia and Surgical Outcomes

Resumo

The most recent meta-analysis1Cheng D.C. Bainbridge D. Martin J.E. Novick R.J. Evidence-Based Perioperative Clinical Outcomes Research GroupDoes off-pump coronary artery bypass reduce mortality, morbidity, and resource utilization when compared with conventional coronary artery bypass? A meta-analysis of randomized trials.Anesthesiology. 2005; 102: 188-203Crossref PubMed Scopus (372) Google Scholar of 37 randomized trials of off-pump coronary artery bypass (OPCAB) versus conventional coronary artery bypass grafting (CABG) demonstrated that mortality, stroke, myocardial infarction, and renal failure were not reduced in OPCAB; however, selected short-term and midterm clinical and resource outcomes were improved compared with CABG. The previous cumulative analysis (by Parolari and associates2Parolari A. Alamanni F. Polvani G. Agrifoglio M. Chen Y.B. Kassem S. et al.Meta-analysis of randomized trials comparing off-pump with on-pump coronary artery bypass graft patency.Ann Thorac Surg. 2005; 80: 2121-2125Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar) of 5 prospective randomized studies (by Nathoe,3Nathoe H.M. van Dijk D. Jansen E.W. Suyker W.J. Diephuis J.C. van Boven W.J. et al.A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients.N Engl J Med. 2003; 348: 394-402Crossref PubMed Scopus (375) Google Scholar Khan,4Khan N.E. De Souza A. Mister R. Flather M. Clague J. Davies S. et al.A randomized comparison of off-pump and on-pump multivessel coronary-artery bypass surgery.N Engl J Med. 2004; 350: 21-28Crossref PubMed Scopus (475) Google Scholar Puskas,5Puskas J.D. Williams W.H. Mahoney E.M. Huber P.R. Block P.C. Duke P.G. et al.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: 1841-1849Crossref PubMed Scopus (464) Google Scholar Widimsky,6Widimsky P. Straka Z. Stros P. Jirasek K. Dvorak J. Votava J. et al.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: 3418-3423Crossref PubMed Scopus (198) Google Scholar Lingaas,7Lingaas P.S. Hol P.K. Lundblad R. Rein K.A. Tonnesen T.I. Svennevig J.L. et al.Clinical and angiographic outcome of coronary surgery with and without cardiopulmonary bypass: a prospective randomized trial.Heart Surg Forum. 2004; 7: 37-41PubMed Google Scholar and their associates) then available in the literature, however, documented a reduction in postoperative patency of bypass grafts performed during OPCAB procedures. Since the meta-analysis by Parolari and associates2Parolari A. Alamanni F. Polvani G. Agrifoglio M. Chen Y.B. Kassem S. et al.Meta-analysis of randomized trials comparing off-pump with on-pump coronary artery bypass graft patency.Ann Thorac Surg. 2005; 80: 2121-2125Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar was conducted, Lingaas and colleagues8Lingaas P.S. Hol P.K. Lundblad R. Rein K.A. Mathisen L. Smith H.-J. et al.Clinical and radiologic outcome of off-pump coronary surgery at 12 months follow-up: a prospective randomized trial.Ann Thorac Surg. 2006; 81: 2089-2096Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar have updated the 3-month patency,7Lingaas P.S. Hol P.K. Lundblad R. Rein K.A. Tonnesen T.I. Svennevig J.L. et al.Clinical and angiographic outcome of coronary surgery with and without cardiopulmonary bypass: a prospective randomized trial.Heart Surg Forum. 2004; 7: 37-41PubMed Google Scholar and Kobayashi and coworkers9Kobayashi J. Tashiro T. Ochi M. Yaku H. Watanabe G. Satoh T. et al.Early outcome of a randomized comparison of off-pump and on-pump multiple arterial coronary revascularization.Circulation. 2005; 112: I338-I343PubMed Google Scholar and Al-Ruzzeh and associates10Al-Ruzzeh S. George S. Bustami M. Wray J. Ilsley C. Athanasiou T. et al.Effect of off-pump coronary artery bypass surgery on clinical, angiographic, neurocognitive, and quality of life outcomes: randomised controlled trial.BMJ. 2006; 332: 1365Crossref PubMed Scopus (145) Google Scholar have reported results of other randomized controlled trials. In these trials,8Lingaas P.S. Hol P.K. Lundblad R. Rein K.A. Mathisen L. Smith H.-J. et al.Clinical and radiologic outcome of off-pump coronary surgery at 12 months follow-up: a prospective randomized trial.Ann Thorac Surg. 2006; 81: 2089-2096Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar, 9Kobayashi J. Tashiro T. Ochi M. Yaku H. Watanabe G. Satoh T. et al.Early outcome of a randomized comparison of off-pump and on-pump multiple arterial coronary revascularization.Circulation. 2005; 112: I338-I343PubMed Google Scholar, 10Al-Ruzzeh S. George S. Bustami M. Wray J. Ilsley C. Athanasiou T. et al.Effect of off-pump coronary artery bypass surgery on clinical, angiographic, neurocognitive, and quality of life outcomes: randomised controlled trial.BMJ. 2006; 332: 1365Crossref PubMed Scopus (145) Google Scholar OPCAB provided the same angiographic graft patency as CABG, despite the conclusion of the meta-analysis by Parolari and colleagues.2Parolari A. Alamanni F. Polvani G. Agrifoglio M. Chen Y.B. Kassem S. et al.Meta-analysis of randomized trials comparing off-pump with on-pump coronary artery bypass graft patency.Ann Thorac Surg. 2005; 80: 2121-2125Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar To reassess differences in graft patency between OPCAB and CABG, we performed a meta-analysis of currently available randomized controlled trials of OPCAB versus CABG.See related editorial on page 1. See related editorial on page 1. All prospective randomized controlled trials that compared patency at least 3 months after OPCAB and CABG were identified using a 2-level search strategy. First, a public domain database (MEDLINE) was searched with a Web-based search engine (PubMed). Second, relevant studies were identified through a manual search of secondary sources including references of initially identified articles. The MEDLINE database was searched from January 1966 to June 2006. Keywords included "off-pump," "off pump," "opcab," "patency," and "randomized controlled trial." Studies considered for inclusion met the following criteria: The design was a prospective randomized controlled clinical trial; patients were randomly assigned to OPCAB versus CABG; and main outcomes included at least 3-month graft patency evaluated by angiography. All qualifying studies were assessed for adequate blinding of randomization, completeness of follow-up, and objectivity of the outcome assessment. Data regarding arterial graft and venous graft (excluding radial artery graft as available) patency were abstracted from each individual study. For each study, data regarding patency in both the OPCAB and CABG groups were used to generate risk ratios (RRs) ( 1, favors CABG) and risk differences (RDs) ( 0, favors CABG) for graft "occlusion" and 95% confidence intervals (CIs). Study-specific estimates were combined with a random-effect model. Between-study heterogeneity was analyzed by standard χ2 tests. Sensitivity analyses were performed to assess the contribution of each study to the pooled estimate by excluding individual trials one at a time and recalculating the pooled RR and RD estimates for the remaining studies. Publication bias was assessed graphically with a funnel plot and mathematically with an adjusted rank-correlation test. Our search identified 6 prospective randomized controlled clinical trials3Nathoe H.M. van Dijk D. Jansen E.W. Suyker W.J. Diephuis J.C. van Boven W.J. et al.A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients.N Engl J Med. 2003; 348: 394-402Crossref PubMed Scopus (375) Google Scholar, 4Khan N.E. De Souza A. Mister R. Flather M. Clague J. Davies S. et al.A randomized comparison of off-pump and on-pump multivessel coronary-artery bypass surgery.N Engl J Med. 2004; 350: 21-28Crossref PubMed Scopus (475) Google Scholar, 5Puskas J.D. Williams W.H. Mahoney E.M. Huber P.R. Block P.C. Duke P.G. et al.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: 1841-1849Crossref PubMed Scopus (464) Google Scholar, 6Widimsky P. Straka Z. Stros P. Jirasek K. Dvorak J. Votava J. et al.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: 3418-3423Crossref PubMed Scopus (198) Google Scholar, 8Lingaas P.S. Hol P.K. Lundblad R. Rein K.A. Mathisen L. Smith H.-J. et al.Clinical and radiologic outcome of off-pump coronary surgery at 12 months follow-up: a prospective randomized trial.Ann Thorac Surg. 2006; 81: 2089-2096Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar, 10Al-Ruzzeh S. George S. Bustami M. Wray J. Ilsley C. Athanasiou T. et al.Effect of off-pump coronary artery bypass surgery on clinical, angiographic, neurocognitive, and quality of life outcomes: randomised controlled trial.BMJ. 2006; 332: 1365Crossref PubMed Scopus (145) Google Scholar (Table 1). We excluded the trial by Kobayashi and associates9Kobayashi J. Tashiro T. Ochi M. Yaku H. Watanabe G. Satoh T. et al.Early outcome of a randomized comparison of off-pump and on-pump multiple arterial coronary revascularization.Circulation. 2005; 112: I338-I343PubMed Google Scholar because these workers merely examined early (within 3 weeks after the operation) graft patency. Allocation concealment and blinding were not possible in these trials given that the intervention was surgical; however, all trials used a blinded committee for adjudication of events. Careful accounting for dropouts and crossovers was provided in all cases, and all but one analysis5Puskas J.D. Williams W.H. Mahoney E.M. Huber P.R. Block P.C. Duke P.G. et al.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: 1841-1849Crossref PubMed Scopus (464) Google Scholar were conducted by intention-to-treat. All of the 6 individual trials demonstrated a statistically nonsignificant benefit of CABG over OPCAB for overall graft patency. Pooled analysis demonstrated a statistically significant 27% increase in overall graft "occlusion" with OPCAB relative to CABG (RR, 1.27; 95% CI, 1.03-1.56; P = .0234) (RD, 3.0%; 95% CI, 0.6%-5.4%; P = .0129). There was neither trial heterogeneity of results nor evidence of significant publication bias. Exclusion of any single trial from the analysis did not substantively alter the overall result of our analysis. Subanalyses demonstrated a statistically nonsignificant benefit of CABG over OPCAB for arterial graft patency (RR, 1.17; 95% CI, 0.62-2.24; P = .6259) (RD, 2.0%; 95% CI, −1.2%-5.2%; P = .2195) and a statistically significant 28% increase in venous graft "occlusion" with OPCAB relative to CABG (RR, 1.28; 95% CI, 1.06-1.54; P = .0094) (RD, 4.0%; 95% CI, 0.2%-7.8%; P = .0396).TABLE 1Characteristics of trials and meta-analysis of graft patencyAl-Ruzzeh10Al-Ruzzeh S. George S. Bustami M. Wray J. Ilsley C. Athanasiou T. et al.Effect of off-pump coronary artery bypass surgery on clinical, angiographic, neurocognitive, and quality of life outcomes: randomised controlled trial.BMJ. 2006; 332: 1365Crossref PubMed Scopus (145) Google ScholarLingaas8Lingaas P.S. Hol P.K. Lundblad R. Rein K.A. Mathisen L. Smith H.-J. et al.Clinical and radiologic outcome of off-pump coronary surgery at 12 months follow-up: a prospective randomized trial.Ann Thorac Surg. 2006; 81: 2089-2096Abstract Full Text Full Text PDF PubMed Scopus (57) Google ScholarWidimsky6Widimsky P. Straka Z. Stros P. Jirasek K. Dvorak J. Votava J. et al.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: 3418-3423Crossref PubMed Scopus (198) Google ScholarPuskas5Puskas J.D. Williams W.H. Mahoney E.M. Huber P.R. Block P.C. Duke P.G. et al.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: 1841-1849Crossref PubMed Scopus (464) Google ScholarKhan4Khan N.E. De Souza A. Mister R. Flather M. Clague J. Davies S. et al.A randomized comparison of off-pump and on-pump multivessel coronary-artery bypass surgery.N Engl J Med. 2004; 350: 21-28Crossref PubMed Scopus (475) Google ScholarNathoe3Nathoe H.M. van Dijk D. Jansen E.W. Suyker W.J. Diephuis J.C. van Boven W.J. et al.A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients.N Engl J Med. 2003; 348: 394-402Crossref PubMed Scopus (375) Google ScholarCombinedNo. of patients1681204001971031101098Timing of CAG, mo31212123129Patients undergoing CAG, %90916478806475Patients featuresIsolated, elective CASElective CASIsolated, elective CASIsolated, primary, elective CASIsolated, primary, CASIsolated, primary, elective CASIntention-to-treatNo crossoversYesNoYesYesYesEvents committeeBlindedNRNRBlindedBlindedBlindedArterial graft patency OPCAB, n/N⁎No. of patent grafts/Total No. of grafts. (%)111/113 (98)†Patency of internal thoracic artery grafts.(50/55 [91])§Patency of radial artery grafts.48/51 (94)†Patency of internal thoracic artery grafts.98/107 (91)†Patency of internal thoracic artery grafts.95/101 (94)‡Patency including radial artery grafts.46/50 (92)†Patency of internal thoracic artery grafts.(26/34 [76])§Patency of radial artery grafts.NR398/422 (94) CABG, n/N⁎No. of patent grafts/Total No. of grafts. (%)111/114 (97)†Patency of internal thoracic artery grafts.(44/50 [88])§Patency of radial artery grafts.54/56 (96)†Patency of internal thoracic artery grafts.100/110 (91)†Patency of internal thoracic artery grafts.102/104 (98)‡Patency including radial artery grafts.47/47 (100)†Patency of internal thoracic artery grafts.(22/22 [100])§Patency of radial artery grafts.NR414/431 (96) RR∥Risk ratio for graft "occlusion" ( 1, favors CABG). (95% CI)0.67 (0.11-3.95)1.65 (0.29-9.46)0.93 (0.39-2.19)3.09 (0.64-14.95)——1.17 (0.62-2.24) RD¶Risk difference for graft "occlusion" ( 0, favors CABG). (95% CI), %−0.9 (−4.7-3.0)2.3 (−5.8-10.4)−0.7 (−8.2-6.8)4.0 (−1.3-9.3)8.0 (0.5-15.5)—2.0 (−1.2-5.2)Venous graft patency OPCAB, n/N⁎No. of patent grafts/Total No. of grafts. (%)50/61 (82)67/84 (80)86/176 (49)140/150 (93)40/44 (91)NR383/515 (74) CABG, n/N⁎No. of patent grafts/Total No. of grafts. (%)60/68 (88)84/97 (87)145/246 (59)147/156 (94)56/59 (95)NR492/626 (79) RR∥Risk ratio for graft "occlusion" ( 1, favors CABG). (95% CI)1.53 (0.66-3.56)1.51 (0.78-2.92)1.25 (1.01-1.53)1.16 (0.48-2.76)1.79 (0.42-7.58)—1.28 (1.06-1.54) RD¶Risk difference for graft "occlusion" ( 0, favors CABG). (95% CI), %6.3 (−6.0-18.6)6.8 (−4.1-17.8)10.1 (0.5-19.7)0.9 (−4.5-6.3)4.0 (−6.2-14.2)—4.0 (0.2-7.8)Overall graft patency OPCAB, n/N⁎No. of patent grafts/Total No. of grafts. (%)161/174 (93)#Patency excluding radial artery grafts.115/135 (85)197/283 (70)235/251 (94)‡Patency including radial artery grafts.86/94 (91)#Patency excluding radial artery grafts.63/69 (91)857/1006 (85) CABG, n/N⁎No. of patent grafts/Total No. of grafts. (%)171/182 (94)#Patency excluding radial artery grafts.138/153 (90)264/356 (74)249/260 (96)‡Patency including radial artery grafts.103/106 (97)#Patency excluding radial artery grafts.83/89 (93)1008/1146 (88) RR∥Risk ratio for graft "occlusion" ( 1, favors CABG). (95% CI)1.24 (0.57-2.68)1.51 (0.81-2.83)1.18 (0.92-1.51)1.51 (0.71-3.18)3.01 (0.82-11.01)1.29 (0.43-3.83)1.27 (1.03-1.56) RD¶Risk difference for graft "occlusion" ( 0, favors CABG). (95% CI), %1.4 (−3.8-6.6)5.0 (−2.6-12.6)4.6 (−2.5-11.6)2.1 (−1.7-6.0)5.7 (−0.8-12.1)2.0 (−6.5-10.4)3.0 (0.6-5.4)CABG, Conventional coronary artery bypass grafting; CAG, coronary angiography; CAS, coronary artery surgery; CI, confidence interval; NR, not reported; OPCAB, off-pump coronary artery bypass; RD, risk difference; RR, risk ratio. No. of patent grafts/Total No. of grafts.† Patency of internal thoracic artery grafts.‡ Patency including radial artery grafts.§ Patency of radial artery grafts.∥ Risk ratio for graft "occlusion" ( 1, favors CABG).¶ Risk difference for graft "occlusion" ( 0, favors CABG).# Patency excluding radial artery grafts. Open table in a new tab CABG, Conventional coronary artery bypass grafting; CAG, coronary angiography; CAS, coronary artery surgery; CI, confidence interval; NR, not reported; OPCAB, off-pump coronary artery bypass; RD, risk difference; RR, risk ratio. The present meta-analysis demonstrated a significant increase in overall graft "occlusion," especially in venous graft "occlusion," with OPCAB relative to CABG. On the one hand, OPCAB decreases arterial fibrillation, transfusion, inotrope requirements, respiratory infections, ventilation time, intensive care unit stay, and hospital stay.1Cheng D.C. Bainbridge D. Martin J.E. Novick R.J. Evidence-Based Perioperative Clinical Outcomes Research GroupDoes off-pump coronary artery bypass reduce mortality, morbidity, and resource utilization when compared with conventional coronary artery bypass? A meta-analysis of randomized trials.Anesthesiology. 2005; 102: 188-203Crossref PubMed Scopus (372) Google Scholar At the expense of graft patency, dare we perform OPCAB rather than CABG to merely improve these selected clinical and resource outcomes? On-pump versus off-pump coronary artery bypass graftingThe Journal of Thoracic and Cardiovascular SurgeryVol. 133Issue 1PreviewOn the basis of a meta-analysis of five published reports that compare results of off-pump (OPCAB) versus on-pump coronary bypass graft (CABG) procedures, Takagi and his coauthors1 claim that OPCAB resulted in a significant increase in overall graft occlusion. Their conclusion is based on follow-up angiographic studies done between 3 and 12 months in these randomized patients. Their analyses of the data from these five studies seem to establish that vein graft patency at 3 to 12 months after surgery is reduced with OPCAB. Full-Text PDF

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