Circulation. 2005;112:I-338-I-343
doi: 10.1161/CIRCULATIONAHA.104.524504
(Circulation. 2005;112:I-338 – I-343.)
© 2005 American Heart Association, Inc.
Surgery for Coronary Artery Disease |
Early Outcome of a Randomized Comparison of Off-Pump and On-Pump Multiple Arterial Coronary Revascularization
Junjiro Kobayashi, MD;
Tadashi Tashiro, MD;
Masami Ochi, MD;
Hitoshi Yaku, MD;
Go Watanabe, MD;
Toshihiko Satoh, MD;
Osamu Tagusari, MD;
Hiroyuki Nakajima, MD;
Soichiro Kitamura, MD, for the Japanese Off-Pump Coronary Revascularization Investigation (JOCRI) Study Group
From the Department of Cardiovascular Surgery (J.K., O.T., H.N., S.K.), National Cardiovascular Center, Osaka; the Department of Cardiovascular Surgery (T.T.), University of Fukuoka School of Medicine, Fukuoka; the Division of Cardiovascular Surgery, Department of Surgery (M.O.), Nippon Medical School, Tokyo; the Department of Cardiovascular Surgery (H.Y.), Kyoto Prefectural University of Medicine, Kyoto; the Department of General and Cardiothoracic Surgery (G.W.), Kanazawa University School of Medicine, Kanazawa; and the Department of Preventive Medicine and Public Health (T.S.), Kitasato University School of Medicine, Tokyo, Japan.
Correspondence to Junjiro Kobayashi, MD, Department of Cardiovascular Surgery, National Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565 Japan. E-mail jkobayas{at}hsp.ncvc.go.jp
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Abstract
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Background— Previous randomized comparisons of off-pump
and on-pump coronary artery bypass grafting (CABG) have yielded
controversial results about the cardiac and neurological events
and graft patency. In addition, these randomized studies were
composed of CABG with a few arterial grafts. We performed a
prospective randomized controlled study to compare off-pump
and on-pump CABG with multiple arterial grafts.
Methods and Results— Between July, 2002, and September, 2004, 167 consecutive unselected patients referred for elective primary CABG were randomly assigned to undergo multiple arterial off-pump CABG (n=81) or on-pump CABG (n=86). The clinical outcomes and S-100 protein, neuron-specific enolase, and maximum creatine kinase-MB levels were compared. Early graft patency was examined within 3 weeks after the operation by angiography. The number of grafts performed per patient (3.5±1.0 for off-pump CABG and 3.6±0.9 for on-pump CABG) and the number of arterial grafts performed per patient (3.3±1.0 for off-pump CABG and 3.4±0.9 for on-pump CABG) were similar. Completeness of revascularization (completed grafts/planned grafts) was 98% in both procedures. There were no hospital deaths in either group. The operation time was significantly (P<0.001) shorter in the off-pump group than in the on-pump group (267±60 minutes versus 307±59 minutes). The incidence of perioperative complications was similar. The frequency of no need for transfusion was higher in the off-pump group than in the on-pump group (80% versus 55%, P<0.001). The S-100 protein levels at the admission into the intensive care unit were significantly (P<0.001) lower in the off-pump group than in the on-pump group (0.20±0.11 ng/mL versus 0.34±0.22 ng/mL). The neuron-specific enolase levels at the intensive care unit admission were significantly (P<0.001) lower in the off-pump group than in the on-pump group (10.4±9.0 ng/mL versus 16.9±6.9 ng/mL). Maximum creatine kinase-MB levels were significantly (P=0.046) lower in the off-pump group than in the on-pump group (17.1±16.7 IU/L versus 21.5±10.6 IU/L). The overall early graft patency rate with or without stenosis was the same (98%) in both groups, but the rate without stenosis was slightly worse in the off-pump group (93%) than in the on-pump group (96%) (P=0.093). The stenosis-free patency rate in the right coronary area was significantly (P=0.028) worse in the off-pump CABG group (90%) than in the on-pump group (99%).
Conclusions— Off-pump CABG with multiple arterial grafts was as safe as the conventional on-pump CABG, with similar completeness of revascularization and early graft patency.
Key Words: coronary disease • revascularization • angiography
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Introduction
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Off-pump coronary artery bypass grafting (OPCAB) has become
an established method of coronary artery bypass grafting (CABG),
and the advantage of OPCAB over the standard CABG with cardiopulmonary
bypass (CPB) has been reported
1–3 in many retrospective
studies. Previous randomized controlled studies also showed
OPCAB resulted in a shorter postoperative stay in the intensive
care unit (ICU) and hospital, a reduced postoperative bleeding,
a reduced use of blood products, and reduced morbidity.
4–9 There are still controversies, however, regarding atrial fibrillation,
cardiac and neurological protection, incidence of recurrent
angina, and re-intervention. In addition, these randomized comparative
studies were composed of CABG mainly with left internal thoracic
artery (LITA) to left anterior descending artery (LAD) and small
number of other arterial grafts. Recent analyses have shown
significantly better outcomes when both ITAs were used as compared
with a single ITA.
10,11 The radial artery (RA) as a second arterial
conduit in LITA to LAD as opposed to vein graft has also achieved
improved long-term outcomes, probably because of better graft
patency.
12,13 The quality and completeness of revascularization
have been major concerns in OPCAB. Suboptimal anastomosis and
incomplete revascularization may cause poor graft patency and
poor long-tem results after OPCAB. In the present study, we
compared the early outcome of both off-pump and on-pump CABG
with multiple arterial grafts in a prospective randomized controlled
trial.
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Methods
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Study Design and Patients
The Japanese Off-pump Coronary Revascularization Investigation
(JOCRI) was designed to compare the early outcome of off-pump
and on-pump coronary revascularization in patients with a low
risk for CPB over a 3-year period. The primary end points were
3-year cardiac events after CABG, including acute myocardial
infarction, admission for angina pectoris or congestive heart
failure, cardiac death, and re-intervention. The secondary end
points were completeness of revascularization, early clinical
outcomes, and neurocognitive function. This was a prospective,
randomized, controlled multicenter trial performed in 5 centers.
Collectively, the surgeons had performed more than 200 OPCABs
before this study, and more than 90% of CABG was performed in
2001 before the study period. In an effort to minimize bias
by the operator, all procedures were performed by a single surgeon
in each hospital. Patients who were referred for isolated, first-time
CABG because of at least 2 vessel diseases were eligible for
enrollment in the study. The exclusion criteria were age >70
years, an indication for additional surgical procedures, documented
history of stroke, severe ascending aortic calcification shown
by computed tomography scanning, carotid arterial stenosis >75%
shown by Duplex scanning, acute Q-wave myocardial infarction
that necessitates emergency operation; left ventricular ejection
fraction <30%, serum creatinine level >2.0 mg/dL, liver
cirrhosis, chronic obstructive pulmonary disease that needs
a bronchodilator or steroid, pulmonary hypertension with a mean
pulmonary artery pressure >25mm Hg, or another comorbidity
that is not appropriate for CPB, such as anomalous coagulation,
cancer, or an inability to provide written informed consent.
The institutional review board and the ethical committee in each hospital approved the study. Written informed consent was obtained from each patient and family. The patients were randomly assigned by means of a computer access to internet assignment in equal proportions to undergo off-pump or on-pump CABG. The surgical plan was decided by coronary angiography before randomization. Randomization was performed according to the method of minimization. Randomization was stratified according to age (< 60 years, 60 to 65 years, 65 to 70 years), sex, coronary artery diseases (2-vessel disease, 3-vessel disease, and left main trunk lesion), and institution to ensure roughly equal numbers of patients within strata defined by these characteristics.
Study Protocols
The patients participating in this JOCRI study had the same anesthetic protocols, CPB, and postoperative care protocols as nonrandomized patients in each hospital. The heart was exposed through a median sternotomy incision. A stabilizer and an apical suction device were used for OPCAB. The surgical technique and strategy of OPCAB were previously reported.14 On-pump CABG was done in a standardized fashion with ascending aortic cannulation and single venous cannulation of the right atrium. The body temperature was kept between 32° and 34°C. Intermittent tepid blood cardioplegia was delivered antegradely and retrogradely. A standardized protocol of antiplatelet therapy (daily dose of aspirin 81 to 200 mg) was used. Creatine kinase-MB (CK-MB) was measured every 8 hours after admission into ICU until 24 hours as a marker of cardiac damage. The upper limit of the normal range was 23 IU/L. A maximum CK-MB higher than 100 IU/L with ECG change (new Q-wave or T inversion by Minnesota criteria code) was assessed as perioperative myocardial infarction. The levels of S-100 protein and neuron-specific enolase were measured as markers of neurological damage when the patient was admitted into ICU. The upper limits of the normal range were 0.06 ng/mL for S-100 protein and 10 ng/mL for neuron-specific enolase, respectively. The criteria for transfusion of red blood cells were blood hemoglobin level <8.0 g/dL and/or mixed venous blood oxygen saturation less than 55%. However, the decision was up to the physicians in ICU of each hospital.
All patients underwent postoperative angiography to evaluate the graft patency within 3 weeks after CABG. The interventional cardiologists were blinded to group assignment for angiographic evaluation. The graft patency was defined when the anastomosed site and graft were opacified by contrast medium either via the conduit or native coronary artery. Flow competition or string sign was not defined as occlusion. The quality of the grafts was assessed using the criteria of FitzGibbon et al.15
Follow-Up
The preoperative and postoperative data were obtained in each hospital to fulfill case report forms. All data were transferred to the data center and analyzed independently. Follow-up was completed in the outpatient clinic or via telephone interview every 3 months. Incidence of adverse events, admission because of angina, myocardial infarction, and re-intervention were recorded for all patients.
Testing Statistical Hypothesis and Statistical Analysis
The sample size calculation was based on the assumptions that the actuarial freedom from cardiac event rate at 3 years after the standard CABG was 95% and that OPCAB did not decrease the rate by more than 10%. The 
error was set at 0.05 and the ß error was set at 0.20. The required sample size was 141 in each group, for a total of 282. All values are expressed as mean±standard deviation or percentage. The continuous variables were compared by the Wilcoxon rank sum test, whereas the discrete variables were analyzed with Fisher’s exact test. The differences were considered statistically significant when the probability value was less than 0.05. All data analysis was done according to intent to treat. Interim analyses were carried out annually to evaluate the safety.
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Results
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This is the second interim analysis of the early outcomes. Between
July of 2002 and September of 2004, a total of 1538 patients
underwent isolated CABG, and 302 patients were eligible for
this study. Of those, 167 patients (55%) underwent randomization
after informed consent was obtained. They were assigned to undergo
either off-pump CABG (n=81) or on-pump CABG (n=86). One patient
in the on-pump group was found to have severe ascending aortic
calcification after randomization and decided to undergo OPCAB.
No patients were converted from off-pump CABG to CPB. All patients
were completely followed-up for more than 30 days after the
operation.
Most of the baseline demographic data were similar in the 2 groups (Table 1). The operative data are shown in Table 2. The operation time was significantly shorter (P<0.001) in the off-pump group than in the on-pump group (267±60 minutes versus 307±59 minutes). The number of grafts performed per patient (3.5±1.0 for off-pump CABG and 3.6±0.9 for on-pump CABG) and the number of arterial grafts performed per patient (3.3±1.0 for off-pump CABG and 3.4±0.9 for on-pump CABG) were similar between groups. Arterial grafts were used in 94% of the total grafts in the off-pump group and 97% in the on-pump group. Completeness of revascularization (completed grafts/planned grafts) was 98% in both groups. Aorta no-touch technique was applied in 84% of patients in the off-pump group. There were no hospital deaths in either group (Table 3). There was no difference in the incidence of intraoperative complications such as arrhythmia and bleeding between the 2 groups. The incidences of postoperative complications such as atrial fibrillation, infection, stroke, bleeding, and perioperative myocardial infarction were also similar. The frequency of no need for transfusion was higher in the off-pump group than in the on-pump group (80% versus 55%, P<0.001) (Table 4). The S-100 protein levels at ICU admission were significantly lower (P<0.001) in the off-pump group than in the on-pump group (0.20±0.11 ng/mL versus 0.33±0.24 ng/mL). The neuron-specific enolase levels at the ICU admission were significantly lower (P<0.001) in the off-pump group than in the on-pump group (10.4±9.0 ng/mL versus 16.9±6.9 ng/mL). The maximum CK-MB levels were significantly lower (P=0.046) in the off-pump group than in the on-pump group (17.1±16.7 IU/L versus 21.5±10.6 IU/L).
The early graft patency rate was the same (98%) in both groups. The early graft patency without stenosis according to the graft material and bypass sites is shown in Table 5. The early graft patency without stenosis was slightly worse in the off-pump group (93%) than in the on-pump group (96%) (P=0.093). The graft patency rates of the RA and gastroepiploic artery were slightly worse in the off-pump group (95% and 86%) than in the on-pump group (99% and 96%), though the differences were not statistically significant (P=0.055 and P=0.34). The stenosis-free graft patency rate in the right coronary area was significantly worse (P=0.028) in the off-pump group (90%) than in the on-pump group (99%). The stenosis-free graft patency of the gastroepiploic artery in the right coronary area was slightly worse in the off-pump group (86%) than in the on-pump group (100%) (P=0.23).
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Discussion
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OPCAB has become an established method of CABG, and the advantage
of OPCAB over the standard CABG in high-risk patients has been
reported.
1–3 On the other hand, the LITA is widely recognized
as the ideal graft to the LAD, and the bilateral use of ITA
further improved the long-term results compared with the single
use of ITA.
10,11 The bilateral use of ITA may not be enough
for complete revascularization because of the length of the
conduit, even if a skeletonized technique were applied for harvesting.
RA has been also used as a free graft with increasing frequency
instead of the saphenous vein because of easy harvesting and
handling
16 and superior late outcomes as compared with the saphenous
vein.
13 Composite RA grafts make more efficient use of the conduit
by placing the inflow close to coronary arteries. Complete arterial
revascularization with LITA and RA composite grafts has been
reported.
14,17 The advantage of LITA as the inflow of RA over
the ascending aorta was also speculated. As partial aortic cross
clamp may cause atheromatous emboli,
18 OPCAB without aortic
manipulation is feasible to reduce the incidence of stroke.
Thus, coronary revascularization with in situ and composite
arterial graft is optimal to reduce the neurological complications
in OPCAB. In this randomized controlled study, arterial grafts
were used in 94% of the total grafts in the off-pump group and
97% in the on-pump group. In the previous randomized studies,
the frequency of arterial graft use ranged from 41% to 66%.
4–9 Therefore, our multiple arterial revascularization strategy,
which should be the most frequently used in randomized comparative
studies, must ultimately be an ideal option in OPCAB and should
be compared with on-pump CABG.
The quality and completeness of revascularization have been major concerns in OPCAB. As OPCAB with arterial grafts is thought to be technically demanding, suboptimal anastomoses and incomplete revascularization with poor long-tem results after OPCAB are anticipated. This study was undertaken after the operating surgeons in each hospital had performed more than 200 OPCAB cases with multiple arterial grafts. Thus, complete multiple arterial coronary revascularization without CPB was possible in almost all cases. The graft patency was the same irrespective of CPB use. The stenosis-free graft patency rate, however, was slightly worse in the off-pump group, though the difference was not statistically significant. OPCAB might be still technically demanding in some situations. The stenosis-free graft patency of the gastroepiploic artery to the right coronary area was slightly lower in the off-pump group than in the on-pump group. There may be 2 reasons. One is that the target right coronary artery is sometimes very thick and calcified as compared with the other territories of the coronary branches, which are not suitable for OPCAB. The graft patency of RITA as in situ graft to the right coronary artery is reportedly worse than that of LITA to LAD in the standard CABG.19 The other possibility is the characteristics of the gastroepiploic artery. According to our experience, it has many size variations, and its handling is difficult for sequential bypass grafting in OPCAB.
Although previous nonrandomized studies showed excellent early graft patency in patients undergoing OPCAB,14,20,21 Khan and colleagues7 reported that the graft patency of the off-pump surgery (88%) was worse than that of the on-pump surgery (98%). The difference was mainly attributed to the poor RA patency in the OPCAB group. This poor result with OPCAB may be explained by the fact that only 13% of their total CABG cases were performed without CPB. This may indicate that their trial was performed within the learning curve phase, although they had started OPCAB 2 years before their randomized study. We believe that OPCAB should be performed consistently in at least 50% of cases as a standardized technique in any randomized comparative trial. The other possibility is the different vasospastic environment in OPCAB if the intraoperative or postoperative medical treatment was inappropriate. The stenosis-free graft patency of the RA was slightly worse in our present study. In our previous series, the graft patency of the RA was as good as others.16,22 One of the problems with RA use was spasm that occurred early after the operation. Possati et al23 reported that the partial irregularity of the RA seen at early angiography usually disappeared with time because of the marked reduction in the contractile response. A randomized comparison of the midterm graft patency between the RA and the saphenous vein showed disappointing graft patency of the RA as compared with the saphenous vein graft.24 Stricter antivasospastic treatment might be necessary for RA use in OPCAB.
Various previous studies revealed unanimous benefits of OPCAB in reduction of the transfusion requirement due to avoidance of CPB and postoperative coagulopathy.4,5,7,8 The amount of bleeding and blood transfusion did not differ significantly between the 2 groups in this study. The frequency of no need for transfusion, however, was higher in the off-pump group than in the on-pump group. Only Légaré et al9 demonstrated very low transfusion rates in both of the off-pump and on-pump surgeries (9.3% and 8.7%) in a randomized comparative study. The difference may be due to transfusion guidelines.
The incidence of perioperative myocardial infarction was similar in both groups. The maximum CK-MB as a marker of myocardial damage was lower in the off-pump group, though the difference was small. This finding is consistent with findings in a previous randomized study using CK-MB, troponin T, and troponin I to evaluate the myocardial damage in CABG.4,8,25 CK-MB was also released from the right atrium, which was incised for cannulation in the on-pump group. In addition, there was clinically no significant difference in the cardiac function between the groups. However, a lower level of release of CK-MB after CABG26 and percutaneous coronary intervention27 was associated with a better prognosis.
Neurological damage is one of the most ominous complications after CABG. Stroke is thought to result from embolism of an atheromatous plaque during manipulation of the diseased aorta or jet flow to the atheroma, whereas the neurocognitive dysfunction is probably caused by cerebral microembolism during CPB. Previous investigators have found a lower release of S-100 protein and lower incidence of high-intensity transient signals of microemboli using transcranial Doppler in off-pump surgery than in on-pump surgery.28,29 Diegeler and colleagues28 have reported that the S-100 protein level was higher in on-pump surgery and correlated with the postoperative impairment of the neurocognitive function. As the patients in our study had little comorbidity, the incidence of the neurological complication was as low as 1% in both groups. Elderly patients with cerebrovascular disease may have a higher incidence of type 2 neurological complication in on-pump surgery. There were differences in the levels of S-100 protein and neuron-specific enolase as markers of brain injury between the 2 groups. This may be also related to the fact that 84% of patients in the off-pump group experienced aorta no-touch technique in addition to the avoidance of CPB. The values of neuron-specific enolase and S-100 protein as markers for neurological damage have been recently considered doubtful because of their association with hemolysis.30 As the sampling point was set at the admission into the ICU, however, the effect of blood suction during CPB and cell-saver is thought to be minimal.30 Because neuron-specific enolase and S-100 protein were not higher with OPCAB than with the standard CABG, hypotension and other maneuvers in OPCAB were believed to be at least not worse than CPB.
Our study demonstrated that off-pump CABG with multiple arterial grafts was as safe as the conventional on-pump CABG, with similar completeness of revascularization and early graft patency. A drawback of this study is that the study groups were composed of highly selected low-risk patients and not the general population at large. In addition, OPCAB was performed by experienced surgeons and the results may not be the same with surgeons in their learning curve period. These results might be true only for cardiac surgeons and anesthesiologists who are fully accustomed to OPCAB. A further expansion of the randomized comparative studies on patients with high morbidity in the general hospitals is thought to be ethically impossible, however. The effects of graft quality by OPCAB need to be examined by evaluation of long-term cardiac events in the future.
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Acknowledgments
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This work was supported by Health and Labor Science Research
Grant 14-013 from the Japanese Ministry of Health, Labor, and
Welfare.
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Abstract
Introduction