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Ann Thorac Surg 2003;76:37-40
© 2003 The Society of Thoracic Surgeons

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Original article: cardiovascular

Off-pump versus on-pump coronary artery bypass: meta-analysis of currently available randomized trials

^a Department of Cardiac Surgery, Centro Cardiologico Monzino IRCCS, University of Milan, Milan Italy
^b Institute of General Surgery and Organ Transplantation, University of Parma, Parma, Italy
^c Biostatistics Unit, Centro Cardiologico Monzino IRCCS, University of Milan, Milan, Italy

Accepted for publication January 17, 2003.

^* Address reprint requests to Dr Parolari, Department of Cardiac Surgery, University of Milan, Centro Cardiologico Monzino IRCCS, Via Parea, 4, 20138, Milan, Italy
e-mail: aparolari{at}cardiologicomonzino.it

	Abstract

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BACKGROUND: Off-pump coronary artery bypass (OPCAB) challenges the conventional on-pump coronary artery bypass grafting (CABG) as the standard of surgical therapy for coronary disease. The aim of this study is to assess the differences in clinical outcomes between CABG and OPCAB by meta-analysis of data published in randomized trials.

METHODS: A literature search (Medline, Pubmed, Cochrane Controlled Trials Register, and the Cochrane Medical Editors Trial Amnesty of unpublished clinical trials) was done for the period starting from January 1990 until May 2002 and was supplemented with a manual bibliographic review for all peer-reviewed English language publications. A systematic overview (meta-analysis) of the randomized trials was done to define the risk of the composite end point (death, stroke, or myocardial infarction) in CABG versus OPCAB.

RESULTS: A literature search yielded nine comparable randomized studies, for a total of 1090 patients, of whom 558 and 532 were randomly assigned to CABG and OPCAB, respectively. Meta-analysis of these studies showed a trend, albeit not statistically significant, toward reduction in the risk of the composite end point for patients who had OPCAB (odds ratio 0.48; 95% confidence interval 0.21 to 1.09; p = 0.08).

CONCLUSIONS: Cumulative analysis of the few prospective randomized studies currently available found a potential clinical benefit of OPCAB, indicating that the avoidance of extracorporeal circulation might result in improved clinical outcomes. Further evidence, however, from large randomized trials is needed to assess potential advantages of OPCAB in terms of early outcomes.

	Introduction

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For decades the use of cardiopulmonary bypass has been recognized as the main cause of a complex systemic inflammatory response, which significantly contributes to several adverse postoperative outcomes, including renal, pulmonary, or neurologic complications, bleeding, and even multiple organ dysfunction.

Beating heart operations were reintroduced to routine clinical practice 17 years ago by Benetti and Buffolo [1] as a last-resort technique limited to patients at high-risk of cardiopulmonary bypass–induced complications. The pioneering off-pump procedures, in which anastomoses were performed on moving and bloody coronary vessels, were technically demanding, and the revascularization of the lateral wall of the left ventricle was often not feasible. After the recent development of effective devices for target vessel exposure and stabilization, off-pump coronary artery bypass grafting (OPCAB) has gained widespread use as an alternative technique and is now challenging conventional on-pump coronary artery bypass grafting (CABG) as the standard for surgical therapy in multivessel disease. It has been proposed that OPCAB improves clinical outcomes in patients who need coronary artery bypass operations. The aim of this study was to assess the potential clinical benefits of off-pump procedures by meta-analysis of published randomized trials comparing OPCAB and CABG.

	Material and methods

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We performed a computerized literature search of Medline and Pubmed databases from January 1990 to May 2002, to which manual bibliography review was added. The following free text search string was used (coronary AND [off-pump OR off pump OR midcab OR midcabg OR opcab OR opcabg OR without extracorporeal circulation OR without extra-corporeal circulation OR without cardiopulmonary bypass] AND [mortality OR death OR morbidity OR myocardial infarction OR myocardial infarct OR mi OR stroke OR neurologic deficit OR cva OR cerebrovascular accident]). Also, the Cochrane Controlled Trials Register and the Cochrane Medical Editors Trial Amnesty of unpublished clinical trials were searched using the same strategy.

Approximately 1,300 publications were identified with this literature search. All titles and abstracts of the identified articles were reviewed by two investigators (AP and AC) to determine the potential eligibility for subsequent analysis; if insufficient detail was provided in the title or in the abstract to determine eligibility, the article was retrieved for further review. All peer-reviewed prospective randomized studies comparing CABG and OPCAB published in the English language were identified and retrieved for further examination. Among them, studies that reported the incidence of perioperative major outcomes (death, myocardial infarction, and stroke occurring within 30 days postoperatively) in CABG versus OPCAB were identified and reviewed. To assess the quality of the search strategy, four studies that were already collected and considered relevant, were sampled; the search strategy identified them.

To test whether there are differences between CABG and OPCAB in terms of early outcomes for the patients needing multivessel myocardial revascularization, all trials satisfying the following criteria were selected:

1. prospective randomized studies comparing CABG and OPCAB;
   
2. data about three major perioperative complications (death, myocardial infarction, and stroke) occurring during the first 30 days postoperatively reported in the study;
   
3. low-to-average risk patients included in the study (studies performed only on high or very high risk patients were excluded);
   
4. average number of grafts per patient at least two;
   
5. myocardial protection with cardioplegia in the CABG group.
   

Cardioplegia was selected as an inclusion criterion because it is the most widely experimentally and clinically tested and adopted method for myocardial protection. Probable double publications were excluded from the analysis.

Data from each study were independently abstracted onto study data forms by two authors (AP and AC), and disagreements were resolved by consensus. When necessary, authors were contacted to provide missing data or to clarify results.

The clinical outcomes that were abstracted included the incidence of perioperative death, myocardial infarction, and stroke occurring within 30 days postoperatively, and the sum of the three complications, which was chosen as the primary end point (composite end point) of the meta-analysis. The proportion of patients with each composite end point in CABG and OPCAB was then analyzed by means of RevMan 4.1 (RevMan 4.1, The Cochrane Review Manager, 2000) using the fixed effects model.

Results are reported as odds ratios with 95% confidence intervals. An odds ratio of 1.0 suggests that there were no differences in the primary outcome between CABG and OPCAB, whereas an odds ratio less than 1.0 indicates that there was a lower incidence of the composite end point in patients who had OPCAB; conversely, an odds ratio greater than 1.0 indicates higher rates of the composite end-point in patients who had OPCAB.

	Results

Top Abstract Introduction Material and methods Results Comment References

 
The selection criteria described in the Methods section were applied to the approximately 1,300 studies identified by the literature search, the publications were examined, and 16 candidate trials were identified for further assessment [2–17].

Of these, 9 matched selection criteria [2–10], for a total of 558 patients randomized to CABG and 532 to OPCAB. The remaining seven studies were excluded for one or more of the following reasons: because the average number of distal anastomoses was less than 2 in at least one group of patients [11–13], because of different selection of patients in the study (only chronic obstructive pulmonary disease patients) [13], because myocardial protection in CABG patients was not defined or was different from the use of cardioplegia [11, 14], or because of probable double publication of at least some of the patients [15–17]. All of the included trials had been published. The mean number of patients randomized per included trial was 121 ± 29 (standard error of the mean).

Meta-analysis (Fig 1) showed a trend toward a reduction in the risk of the composite end point (death, stroke, and myocardial infarction) for patients who had OPCAB (odds ratio 0.48; 95% confidence interval 0.21 to 1.09; p = 0.08). There was no statistically significant heterogeneity with respect to the primary end point among all trials (² = 2.70, p = 0.75).

View larger version (21K): [in this window] [in a new window]   Fig 1. Meta-analysis of the combined end point (death, myocardial infarction, and stroke occurring during the first 30 days postoperatively) in nine controlled trials of off-pump (OPCAB) versus on-pump (CABG) coronary artery bypass grafting. Squares indicating individual trial differences are scaled according to weighting in the meta-analysis. The width of the diamond for pooled data denotes the lower and upper 95% confidence intervals (CI). Note that the x-axis is logarithmic. (BHACAS = Beating Heart Against Cardioplegic Arrest Studies; OR = operating room.)

	Comment

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In conclusion, the analysis of current available randomized trials failed to show the clinical superiority of OPCAB versus CABG or vice-versa, leaving this question still open. These findings underscore the compelling need for prospective, multicenter, randomized clincal trials to determine the clinical benefits (or drawbacks) of OPCAB procedures.

Confounding variables can add bias to the analysis of data. Among these, the possibility should be considered that in some trials perioperative complications were underrepresented [18]. In addition, there could have been differences in inclusion or exclusion criteria, experience of the surgical teams, as well as selection bias due to the inclusion of low-risk patients.

	References

Top Abstract Introduction Material and methods Results Comment References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Alessandro Parolari Francesco Alamanni Paolo Biglioli Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Parolari, A. Articles by Biglioli, P. Search for Related Content PubMed PubMed Citation Articles by Parolari, A. Articles by Biglioli, P. Related Collections Minimally invasive surgery