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J Thorac Cardiovasc Surg 2009;137:295-303
© 2009 The American Association for Thoracic Surgery
Acquired Cardiovascular Disease |
a Bristol Heart Institute, University of Bristol, Bristol Royal Infirmary, Bristol, United Kingdom
b United Bristol Healthcare NHS Trust, Bristol Royal Infirmary, Bristol, United Kingdom
Received for publication March 26, 2008; revisions received August 19, 2008; accepted for publication September 19, 2008. * Address for correspondence: Gianni D. Angelini, MCh, MD, FRCS, FETCS, Bristol Heart Institute, University of Bristol, Level 7, Bristol Royal Infirmary, Bristol BS2 8HW, United Kingdom. (Email: g.d.angelini{at}bristol.ac.uk).
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Abstract |
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 Top Abstract IntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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Methods: Participants in 2 randomized trials comparing off-pump coronary artery bypass and coronary artery bypass grafting with cardiopulmonary bypass were followed up for 6 to 8 years after surgical intervention to assess graft patency, major adverse cardiac-related events, and health-related quality of life. Patency was assessed by using multidetector computed tomographic coronary angiographic analysis with a 16-slice scanner. Two blinded observers classified proximal, body, and distal segments of each graft as occluded or not. Major adverse cardiac-related events and health-related quality of life were obtained from questionnaires given to participants and family practitioners.
Results: Patency was studied in 199 and health-related quality of life was studied in 299 of 349 survivors. There was no evidence of attrition bias. The likelihood of graft occlusion was no different between off-pump coronary artery bypass (10.6%) and coronary artery bypass grafting with cardiopulmonary bypass (11.0%) groups (odds ratio, 1.00; 95% confidence interval, 0.55–1.81; P > .99). Graft occlusion was more likely at the distal than the proximal anastomosis (odds ratio, 1.11; 95% confidence interval, 1.02–1.20). There were also no differences between the off-pump coronary artery bypass and coronary artery bypass grafting with cardiopulmonary bypass groups in the hazard of death (hazard ratio, 1.24; 95% confidence interval, 0.72–2.15) or major adverse cardiac-related events or death (hazard ratio, 0.84; 95% confidence interval, 0.58–1.24), or mean health-related quality of life across a range of domains and instruments.
Conclusions: Long-term health outcomes with off-pump coronary artery bypass are similar to those with coronary artery bypass grafting with cardiopulmonary bypass when both operations are performed by experienced surgeons.
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Introduction |
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intensive care unit and hospital stays1 and uses fewer resources3-5 than conventional surgery with cardiopulmonary bypass (CPB). However, only a minority of coronary artery bypass grafting (CABG) operations worldwide, about 15% to 20%, are carried out with the OPCAB technique.6,7
Surgeons might be reluctant to take up OPCAB because of concerns that the technique requires distal anastomoses to be performed on the beating heart, potentially compromising long-term patency. The literature on graft patency from randomized controlled trials (RCTs) of OPCAB versus CABG–CPB is inconsistent, and authors have reported findings for only relatively short durations of follow-up.1,8
We performed 2 of the earliest RCTs of OPCAB versus CABG–CPB: the Beating Heart Against Cardioplegic Arrest Study (BHACAS) 1 and 2. We have previously reported clinical and health-related quality of life (HRQoL) findings at 2 to 3 years.9,10 Here our objective is to report long-term follow-up (6–8 years) in survivors for clinical outcomes, HRQoL, and graft patency by using multidetector computed tomographic coronary angiographic (MDCTA) analysis.11
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Materials and Methods |
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Patients were recruited from March 1997 to August 1998 (BHACAS 1) and from September 1998 to November 1999 (BHACAS 2). Participants were randomly assigned to the OPCAB or CABG–CPB groups. Ethical approval to carry out the studies was obtained from the local research ethics committee (reference E3791).
MDCTA Protocol
MDCTA is a noninvasive method of imaging with high sensitivity and specificity compared with conventional coronary angiography.11 Exclusion criteria for MDCTA were as follows: inability to lie flat, heart rate greater than 100 beats/min, allergy to contrast medium, impaired renal function (serum creatinine, >130 µmol/L), pregnancy, or inability to provide informed consent. Patients with a heart rate of greater than 65 beats/min and no contraindication to β-blockade were given 50 to 100 mg of metoprolol 60 to 90 minutes before MDCTA.
A 16-slice scanner (Somatom Sensation 16; Siemens, Berlin, Germany) was used. The scanning protocol consisted of 3 steps. First, an initial short tomogram (50 mA; 80 kV; collimation, 1 mm) was performed to set upper and lower scan levels and reconstruction margins for the heart. Second, a test bolus scan was administered to determine the circulation time of the contrast medium. The start of the contrast-enhanced coronary scan was adapted by adding 3 seconds to the calculated circulation time to allow for homogeneous mixing of the contrast medium throughout the coronary arterial tree. Third, a contrast MDCTA spiral scan (550 mAs, 120 kV, 16 x 0.75–mm slice width collimation, 0.42-second rotation time, and 2.8 mm feed per rotation) was performed with contrast medium (125 mL of Iomeron 400 at 4 mL/s, Braceo Group, San Donato Milanese, Italy) infused at the start time, as described above. The scan was in a caudocranial direction, with the upper margin at the level of the clavicles to include internal thoracic artery (ITA) grafts and the lower margin just below the base of the heart.
Dedicated spiral algorithms provided 105- to 250-ms temporal resolution from retrospective electrocardiogram-triggered phase reconstruction, depending on heart rate and the vessel segment under consideration. The coronary scan has serial phase image reconstruction performed with retrospective gating between –60% and –40% absolute reverse (1-mm slice width, B30f medium smooth kernel).
Assessment of MDCTA Images
Images were interpreted on computer workstations (Wizard/Leonardo, Siemens) by 2 independent observers blinded to randomized allocation. Analysis of grafts was carried out from thin maximum-intensity projection slices and 3-dimensional volume images. Scans were reported by using an established system.13
Each graft was classified by conduit type (pedicle ITA or gastroepiploic artery [1 graft only], free ITA, radial artery, and saphenous vein [SV]) and assessed in 3 segments: the proximal anastomosis, the body of the graft, and the distal anastomosis. Each segment was classified as patent (flow visible), occluded, or not analyzable (eg, because the segment was obscured by a metal ligature clip or because the image quality was poor).
Follow-up to Assess Outcomes
Participants were followed up through the National Health Service Strategic Tracing Service and by annual questionnaire for major adverse cardiac-related events (MACEs); we also sent annual questionnaires to family practitioners.14 MACEs were defined as follows: (1) recurrent angina (hospital visit for angina reported by patient or hospital admission for angina reported by general practitioner); (2) myocardial infarction (hospital visit for myocardial infarction reported by patient or hospital admission for myocardial infarction reported by general practitioner); and (3) repeat revascularization (repeat operation or angioplasty since the index operation reported by patient or general practitioner). Reported admissions to the Bristol Heart Institute were all verified.
Survivors were sent 4 HRQoL questionnaires10 (ie, the Seattle Angina Questionnaire,15 the Coronary Revascularisation Outcome Questionnaire,16 the Short-Form Health Survey 36 version 2,17,18 and the EuroQol19) with their annual surveillance questionnaire. If there was no response to the first mailing, after a month, a second questionnaire was sent. If neither elicited a response, the patient was telephoned to find out whether there was a particular reason, such as ill health, preventing completion of forms. Patients who indicated that they would like to undergo MDCTA but did not return their questionnaires were asked to complete them when attending for MDCTA. Patients who were not able to complete the questionnaires themselves (eg, because of poor sight) were invited to complete them by telephone or face-to-face.
Statistical Analyses
Patency
Agreement between initial assessments of graft patency by the 2 observers was described by using the 
statistic. When grafts were assessed by observer 1 but classified as not analyzable by observer 2, the assessment of observer 1 was used and vice versa. Disagreements between observers were reconciled, if necessary, by a third observer.
Patency was analyzed by means of multivariable logistic regression (occluded or not), with segments as individual observations. Robust standard errors were estimated to take account of nesting of grafts within patients. Segments that could not be analyzed by either observer were excluded. Randomized allocation, trial (BHACAS 1 or 2), segment, conduit, and graft territory were included as covariates. Two interactions with operation type were also investigated: (1) allocation by trial to check the validity of pooling data across trials and (2) allocation by segment to test the prior hypothesis that distal anastomoses are more likely to occlude with OPCAB than with CABG–CPB.
All-cause mortality and MACEs
Cox regression analyses were carried out for 3 outcomes: (1) all-cause mortality; (2) all-cause mortality or MACEs; and (3) MACEs only. All participants were included in the analysis of all-cause mortality, censoring surviving participants at the last known date of follow-up. For survival free from MACEs or death, participants were censored at the last known date of follow-up if alive and free from MACEs. For the analysis of MACEs only, participants were censored at death if free from a MACE at this time. Models included type of operation and trial (ie, BHACAS 1 or 2). The interaction of allocation by trial was tested. Validity of the proportional hazards assumption was checked in all models.
HRQoL
HRQoL questionnaires were scored as previously reported.10 For all dimensions, higher scores represent better HRQoL. Linear regression models fitted type of operation and trial. The interaction of operation allocation by trial was tested. Confidence intervals (CIs) for differences between the CABG–CPB and OPCAB groups were estimated by means of bootstrapping because some distributions of scores were skewed. Analyses of all outcomes were by intention to treat.
Sample size justification
Original sample sizes were based on length of stay.9 In the protocol for this follow-up, we stated that patency would be analyzed for grafts and not patients, gaining additional power from multiple grafts per patient (approximately 2.5 grafts per patient). We expected to analyze data for 320 patients, providing 800 grafts for study. Assuming a design effect of 1.3 (intraclass correlation, 0.2), the study would have an effective sample size of about 610 "independent" observations.
The graft occlusion rate was expected to vary by conduit: in patients undergoing CABG–CPB, we expected approximately 10% of arterial and approximately 40% of SV grafts to be occluded. (Although the occlusion rate was expected to vary by conduit type, no interaction of conduit type and operation type was hypothesized.) Among participants who contributed to the previous follow-up,10 47% (388/834) of grafts were arterial conduits. Therefore the overall graft "failure" rate in the CABG–CPB group was estimated to be approximately 26%: (10%x47%)+(40%x53%).
Based on the above assumptions, we calculated that the study would have 80% power to detect an absolute difference of 11% (ie, 26% vs 37% or a relative risk of 1.4) in the risk of graft occlusion (
= .05, 2-tailed) or to exclude the possibility of differences smaller than 8% ( = .05, 2-tailed). The pooled data had 90% power to detect a small-to-moderate standardized difference (0.43) in HRQoL ( = .01, 2-tailed), assuming about 90% of survivors (350 x 0.90 
320) responded.
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Results |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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; only the proportions with unstable angina and Parsonnet scores of greater than 10 appeared to be lower among survivors, equally for both the CABG–CPB and OPCAB groups. Compared with all survivors, those who had MDCTA scans tended to be slightly younger and were more likely to be male but otherwise had similar characteristics. Baseline characteristics of participants who completed HRQoL questionnaires were similar to those for all survivors and similar for the CABG–CPB and OPCAB groups.
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= 0.62 for 505 grafts, analyzing grafts classified as not analyzable in a separate category; = 0.71 for 468 grafts classified by both observers as occluded or not). Overall, 53 (10.8%) of 492 grafts were classified as occluded after disagreements were reconciled. Percentages of grafts classified as occluded were similar in the CABG–CPB and OPCAB groups, both overall (27/255 [10.6%] and 26/237 [11.0%], respectively; Table 3
) and for arterial and SV grafts separately (arterial grafts, 13/126 [10.3%] vs 8/116 [6.9%]; SV grafts, 14/129 [10.9%] vs 18/121 [14.9%], respectively). SV grafts were more likely to be occluded (32/250 [12.8%]) than arterial grafts (21/242 [8.7%]) but not to the extent expected at the outset.
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Survival and MACEs
Mean durations of follow-up for survival were 75.5 (SD, 20.6) and 76.7 (SD, 19.3) months for OPCAB and CABG–CPB participants; there were 23 and 29 deaths in each group, respectively. Cox regression showed no difference in survival between the 2 groups (hazard ratio, 1.24; 95% CI, 0.72–2.15; P = .44). There was no effect of trial (P = .51) or the interaction of operation allocation by trial (P = .36).
MACEs that occurred in the 2 groups are shown in Table 4
. There were 49 and 39 MACEs in the CABG–CPB and OPCAB groups and a further 7 and 10 deaths as first events in each group, respectively (105 participants with 
1 event). There are no apparent differences in the number or nature of first-reported MACEs between the CABG–CPB and OPCAB groups.
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Discussion |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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Strengths and Limitations
Randomized allocation, which minimizes selection bias, is an important strength of the BHACAS trials which are reported here in compliance with the CONSORT statement (www.consort-statement.org). A further strength is the high proportion of screened patients who were recruited (almost 50%),9 enhancing the applicability of the findings in our center.
Attrition during the 6 to 8 years of follow-up is the main limitation, but this does not appear to have introduced bias (ie, there was no selective attrition by group). Attrition varied by outcome. Despite its relative noninvasiveness compared with conventional angiographic analysis, only 57% of survivors underwent MDCTA. The main reason for not undergoing MDCTA was because some participants declined to be reinvestigated. However, there was no difference in the percentages of participants undergoing MDCTA or differences in their baseline characteristics by surgical group. There was less attrition with HRQoL. In survival analyses all participants contributed up to the last known follow-up. The fact that attrition bias was not observed for other outcomes suggests that informative censoring is unlikely to have affected these analyses.
Because patency data were obtained for only 492 grafts (effective sample size, 378), analyses of graft patency had 80% power to detect a relative risk of occlusion of about 2.0 (ie, 11% for the CABG–CPB group vs 22% for the OPCAB group) compared with 1.4 as proposed at the outset (ie, 26% for the CABG–CPB group vs 37% for the OPCAB group). Note that this post-hoc calculation is based on the observed lower frequency of graft occlusion (11%), as well as the smaller sample size available.
Finally, it is important to remember that the BHACAS trials were carried out in a single center by a single academic surgical team. This surgical team has documented innovations in OPCAB technique, their performance and that of residents learning OPCAB, and other aspects of their experience with OPCAB over more than a decade. Therefore caution should be exercised in generalizing these findings to other surgeons and centers.
Findings in the Context of Other Literature
We did not synthesize our findings with those of other RCTs that have reported graft patency because the follow-up reported here was much longer and patency was assessed by means of MDCTA and not conventional angiographic analysis. Angiographic findings up to 1 year from previous RCTs have been pooled in a meta-analysis without statistical evidence of heterogeneity.8 However, this analysis took no account of varying duration of follow-up (from discharge to 1 year), varying attrition, or the lack of independence of grafts within patients. If occluded grafts tend to be in the same patients, as suggested by our data and by other studies, this latter failing could seriously undermine statistical inferences.
Three trials have reported 1-year patency findings that were subject to attrition, ranging from 22% to 36%, and none found a significant difference.4,5,20 Two trials compared the proportion of grafts that were patent but took no account of nesting of grafts within patients; both found a difference in patency of 2% favoring the CABG–CPB group.4,5 The third trial correctly compared the proportion of patients with none, 1, or at least 2 occluded grafts, observing differences of 2% to 6% favoring the OPCAB group.20 However, only about 50% of patients had all grafts patent at 1 year compared with 75% after 6 to 8 years in this study. One additional small trial reported that grafts performed during OPCAB were more likely to be occluded at 3 months (88% vs 98%).21 This trial was not powered to find a difference in graft patency and took no account of nesting of grafts within patients.
Given the time since surgical intervention, we observed few occluded grafts. The low rate of occlusion of SV grafts was particularly surprising. This might, in part, be due to early routine administration of aspirin (300 mg per rectum) during the first 6 hours and lifetime use of statins after surgical intervention. Our patency findings cannot be directly compared with previous findings, not least because of potential differences between conventional angiographic analysis and MDCTA. Although MDCTA has high sensitivity and specificity in detecting graft patency,11 we cannot rule out the presence of stenoses in patent SV grafts.
Metal ligature clips prevented assessment of some ITA and radial grafts. Some arterial grafts had a thread-like appearance because of new stenosis in the native vessel or poor runoff; these were identified with difficulty, and some might have been classed as occluded. Despite these difficulties, MDCTA assessment was not biased because the radiologic assessors were blinded to randomized allocation.
Two other RCTs have assessed HRQoL, reporting that improvements in HRQoL up to 1 year were similar with CABG–CPB and OPCAB.4,22 Three-year follow-up of the BHACASs also found no difference.10 The findings reported here are consistent with these reports. We assessed patency to address particular mechanistic hypotheses about OPCAB but maintain that HRQoL provides the most important evidence about the relative effectiveness of CABG–CPB and OPCAB (ie, the patient's view).10 Symptoms of ischemia after surgical intervention must be presumed to arise from stenoses that have developed since the operation and are likely to precede events attributable to coronary disease. Although new stenoses can arise either in grafts or native vessels, any difference in "average" symptoms between groups can be confidently attributed to operation type when patients have been randomized and there is little attrition. Also, HRQoL instruments are completely noninvasive and yield continuous scores rather than binary outcomes, resulting in greater power for a given sample size.
In addition to concern about graft patency, surgeons who use CABG–CPB might be worried by evidence that surgeons perform fewer grafts with OPCAB compared with CABG–CPB. However, the absolute difference reported by a systematic review of 22 RCTs was only 0.2 grafts fewer with OPCAB.1 This magnitude of difference was also observed in the BHACAS trials and clearly had no effect on any outcome.
We observed a significant reduction in the odds of graft occlusion in BHACAS 2 compared with BHACAS 1, despite broader eligibility criteria. Although the interaction of trial by operation type was not statistically significant, we attribute this at least in part to the learning curve and evolution of OPCAB in our center during the trials, in particular the attention given to careful surgical technique with better stabilization and hemodynamic control.23 Aspects of techniques developed for OPCAB might also have led to improved CABG–CPB technique.
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Conclusions |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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Figure E1 |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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Figure E2 |
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Table E1 |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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Logistic regression
Number of observations = 1364
Wald 
2 (8) = 18.41
Probability > 2 = 0.0184
Log pseudolikelihood = –459.49033
Pseudo R2 = 0.0362
(Standard error adjusted for 199 clusters in id)
CABG–CPB, Coronary artery bypass grafting with cardiopulmonary bypass; OPCAB, off-pump coronary artery bypass; BHACAS, Beating Heart Against Cardioplegic Arrest Studies; ITA, internal thoracic artery.
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Table E2 |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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Logistic regression
Number of observations = 1364
Wald 2 (9) = 18.87
Probability > 2 = .0263
Log pseudolikelihood = –459.07974
Pseudo R2 = 0.0370
(Standard error adjusted for 199 clusters in id)
CABG–CPB, Coronary artery bypass grafting with cardiopulmonary bypass; OPCAB, off-pump coronary artery bypass; BHACAS, Beating Heart Against Cardioplegic Arrest Studies; ITA, internal thoracic artery.
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Table E3 |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionConclusionsFigure E1Figure E2Table E1Table E2Table E3References |
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Logistic regression
Number of observations = 1364
Wald 2 (10) = 21.19
Probability > 2 = 0.0198
Log pseudolikelihood = –459.35623
Pseudo R2 = 0.0364
(Standard error adjusted for 199 clusters in id)
CABG–CPB, Coronary artery bypass grafting with cardiopulmonary bypass; OPCAB, off-pump coronary artery bypass; BHACAS, Beating Heart Against Cardioplegic Arrest Studies; ITA, internal thoracic artery.
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Acknowledgments |
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Footnotes |
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Read at the Eighty-eighth Annual Meeting of The American Association for Thoracic Surgery, San Diego, Calif, May 10–14, 2008.
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