European Heart Journal (2010) 31, 2470–2481 doi:10.1093/eurheartj/ehq318
ESC HOT LINE
Randomized trial to compare bilateral vs. single internal mammary coronary artery bypass grafting: 1-year results of the Arterial Revascularisation Trial (ART)
1 Nuffield Department of Surgery, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU, UK; 2Centre for Statistics in Medicine, University of Oxford, Wolfson College, Linton Road, Oxford OX2 6UD, UK; 3Department of Public Health, Health Economics Research Centre, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK; 4Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Trust, Sydney Street, London SW3 6NP, UK; and 5National Heart and Lung Institute, Imperial College London, London SW7 2AZ, UK
Received 2 August 2010; revised 6 August 2010; accepted 10 August 2010; online publish-ahead-of-print 30 August 2010
See page 2444 for the editorial comment on this article (doi:10.1093/eurheartj/ehq341)
Aims
Observational data suggest that the use of bilateral internal mammary arteries (BIMA) during coronary artery bypass graft surgery provides superior revascularization to a single internal mammary artery (SIMA), but concerns about safety have prevented the widespread use of BIMA. The Arterial Revascularisation Trial (ART) is a randomized trial of BIMA vs. SIMA, with a primary outcome of survival at 10 years. This paper reports mortality, morbidity, and resource use data at 1 year. ..................................................................................................................................................................................... Methods Coronary artery bypass graft patients were enrolled in 28 hospitals in seven countries. Three thousand one hundred and results and two patients were randomly assigned to SIMA (n ¼ 1554) or BIMA (n ¼ 1548). The mean number of grafts was 3 for both groups. Forty per cent of the SIMA procedures and 42% of the BIMA were performed off-pump. Mortality at 30 days was 18 of 1548 (1.2%) for SIMA and 19 of 1537 (1.2%) for BIMA, and at 1 year was 36 of 1540 (2.3%) and 38 of 1529 (2.5%), respectively. The rates of stroke, myocardial infarction, and repeat revascularization were all ≤2% at 1 year and similar between the two groups. Sternal wound reconstruction was required in 0.6 and 1.9% of the SIMA and BIMA groups, respectively. ..................................................................................................................................................................................... Conclusion Data from ART demonstrate similar clinical outcomes for SIMA and BIMA at 1 year but BIMA grafts are associated with a small absolute increase (1.3%) in the need for sternal wound reconstruction. The results suggest that the use of BIMA grafts is feasible on a routine basis. The 10-year results of the ART will confirm whether BIMA grafting results in lower mortality and the need for repeat intervention. Trial registration: Controlled-trials.com (ISRCTN46552265).
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Revascularization † Bypass
Introduction Despite advances in percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) surgery remains the best therapy, prognostically and symptomatically, for severe multivessel
ischaemic heart disease.1 – 3 Consequently, CABG remains one of the most commonly performed operations worldwide. Most CABG patients require three bypass grafts (one to each of the major coronary arteries), and from the inception of CABG in the 1960s, the most commonly used conduit was saphenous vein.
* Corresponding author. Tel: +44 1865 221121, Fax: +44 1865 220244, Email:
[email protected] Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2010. For permissions please email:
[email protected]
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David P. Taggart 1*, Douglas G. Altman 2, Alastair M. Gray 3, Belinda Lees 4,5, Fiona Nugara 4, Ly-Mee Yu 2, Helen Campbell 3, and Marcus Flather 4,5 on behalf of the ART Investigators
2471
Randomized trial to compare BIMA vs. SIMA
Methods Trial design The protocol for ART has been published.22 Briefly, ART is a two-arm, randomized multicentre trial, conducted in 28 hospitals in seven countries, with patients being randomized equally to SIMA or BIMA grafts. All eligible patients requiring CABG were considered for entry into the study. Eligible patients were those with multivessel coronary artery disease (including urgent patients but not evolving myocardial infarction) undergoing CABG, whereas those requiring single grafts or redo CABG were excluded. The ART study complied with the Declaration of Helsinki. The trial commenced after ethical approval was obtained in participating centres
and each patient was required to provide written informed consent. Central co-ordination for the study was provided by the Clinical Trials and Evaluation Unit (CTEU) at the Royal Brompton and Harefield NHS Foundation Trust in London and the study was sponsored by the University of Oxford. The randomization sequence was generated with randomly varying block sizes and stratified by centre,23 to provide equal numbers in each group. Patients were enrolled and randomized by telephone call to the co-ordinating centre. To reduce the possibility of outcome events occurring between randomization and revascularization, it was recommended that surgery be performed within 6 weeks of randomization.
Surgical procedure The SIMA group received a SIMA graft to the LAD plus supplemental vein or radial artery graft to other coronary arteries, whereas the BIMA group received BIMA grafts to the two most important left-sided coronary arteries with supplemental vein or radial artery to other coronary arteries. In the BIMA group, the internal mammary artery (IMA) grafts could be used as composite grafts to each other, as long as one remained in situ. Anastomosis of an IMA graft to the right coronary artery was not permitted because of concerns of inferior long-term patency. Only surgeons with experience of .50 BIMA operations were able to undertake BIMA procedures in the trial and standard methods for anaesthesia and myocardial protection were used according to local practice.
Outcome measures The primary outcome of ART is a comparison of all-cause mortality at 10 years of follow-up between patients randomized to the SIMA or BIMA procedure. The main outcomes in this analysis were clinical outcomes at 30 days and 1 year (all-cause mortality, myocardial infarction, stroke, and repeat revascularization) and safety outcomes including sternal wound reconstruction. Data were censored as of 1 July 2010. Serious adverse events were reported by the investigators on specific forms. Two members of the Clinical Event Review Committee (membership given in Appendix) then adjudicated each event (death, myocardial infarction, stroke, and re-intervention) in a blinded fashion to ensure that the events met the definitions given. If the two adjudicators did not concur, then the event was adjudicated by a third adjudicator. All other adverse events requiring or prolonging hospitalization were adjudicated by one member of the Committee. Patient’s QoL was assessed using the shortened WHO Rose angina questionnaire24 and the EuroQol EQ-5D questionnaire.25
Trial size To detect a true absolute 5% reduction in 10-year mortality (i.e. from 25 – 20%), with 90% power at 5% significance level required 2928 patients. The aim was to enrol at least 3000 patients (1500 in each arm) over a 2- to 3-year recruitment period.
Statistical analysis The trial data were analysed by intention-to-treat, irrespective of actual management and events. The Kaplan– Meier method was used to analyse time to death. The number and percentage of events at 30 days and 1 year were calculated by treatment groups. We calculated the relative risks and corresponding 95% CI to describe the direction and magnitude of the treatment effect. All analyses were performed using Stata software version 11 (StataCorp). Health resource use data were presented as medians and also as
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In 1986, however, when the Cleveland Clinic group reported4 that a single internal mammary artery (SIMA) rather than vein graft to the left anterior descending (LAD) coronary artery (anatomically, the most important coronary artery) improved 10-year survival and freedom from recurrent angina, myocardial infarction, and the need for repeat intervention, the use of a SIMA graft rapidly became the ‘gold standard’. Indeed, more than 95% of the CABG patients currently receive a SIMA graft and its benefits of excellent long-term patency in comparison with vein grafts are now known to extend into the second and third decade of follow-up.5,6 That superior clinical outcome is largely due to the excellent long-term patency of a SIMA graft, with rates in excess of 90% up to a decade after CABG, in contrast to vein grafts where, due to atherosclerosis, around half are occluded and half of the remainder are severely diseased.7 – 9 The superior clinical outcome associated with a SIMA graft encouraged several groups to investigate the use of bilateral internal mammary arteries (BIMA) with reports of even better clinical outcomes.10 – 14 Angiographic studies demonstrate markedly superior patency of BIMA grafts compared with vein grafts, with patency rates of BIMA grafts being as high as 98% at 7 days15 and 95% at 216 and 7 years.17 A systematic review of observational studies including 15 962 patients (comprising 11 269 SIMA and 4693 BIMA patients either matched or adjusted for age, sex, ventricular function, and diabetes) reported a survival advantage for BIMA grafts [hazard ratio for death ¼ 0.81, 95% confidence intervals (CI): 0.70–0.94].12 Although BIMA grafting appears to offer superior revascularization to SIMA, it is technically more challenging, and concerns that it leads to a longer operation and increases the risk of early mortality and major morbidity, in particular impaired wound healing,6,12,13 have prevented widespread use. Indeed, BIMA grafting is only used routinely in around 10% of the CABG patients in Europe18 and 4% of the CABG patients in the USA.19 The primary objective of the Arterial Revascularisation Trial (ART) is to assess whether the use of BIMA grafts during CABG improves 10-year survival and reduces the need for further interventions compared with a SIMA graft. The secondary outcome measures include clinical events and quality of life (QoL) and health economic assessments. However, because of concerns over the ‘safety’ of the routine use of BIMA grafts,6,12,13,20,21 the results presented in this paper describe the mortality and morbidity data up to 1-year post-randomization.
2472 mean values in accordance with the recent NICE guidance: ‘For continuous variables, mean values should be presented and used in the analyses. For all variables, measures of precision should be detailed’.26
Results We enrolled 3102 patients into ART between 30 June 2004 and 20 December 2007 in 28 cardiac surgery centres in seven countries (details of the participating centres and investigators are given in the Appendix). Figure 1 shows the flow of participants through the trial. Screening logs completed by each centre showed that 28% of the patients who met the eligibility criteria were actually randomized into the study.
D.P. Taggart et al.
One thousand five hundred and fifty-four patients were randomized to SIMA and 1548 to BIMA. The groups were well matched with respect to age, gender, ethnic origin, body mass index, systolic and diastolic blood pressure, and smoking status (Table 1). The groups were also well matched for co-morbidities including diabetes (6% insulin-dependent and 18% non-insulin-dependent), previous stroke or transient ischaemic attacks, and peripheral vascular disease. Both groups had similar severities of angina and breathlessness and a similar incidence of previous myocardial infarction and/or PCI with stenting. Approximately 8% of the patients had unstable angina. Table 2 shows the surgical details for each group. Approximately 97% of the patients in each group had their surgery within 6 weeks of randomization. The mean number of grafts in both groups was
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Figure 1 Participant flow chart. aPatient consent for data collection (SIMA ¼ 2, BIMA ¼ 7). bIncluding participants who died before 1-year follow-up (SIMA ¼ 36, BIMA ¼ 38).
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Randomized trial to compare BIMA vs. SIMA
Table 1
Baseline demographic and clinical characteristics by randomized group SIMA (n 5 1554)
BIMA (n 5 1548)
Overall (n 5 3102)
1338 (86.1)
1318 (85.1)
2656 (85.6)
63.5 (9.1)
63.7 (8.7)
63.6 (8.9)
Current smoker
214 (13.8)
237 (15.3)
451 (14.5)
Ex-smoker Never smoked
898 (57.8) 442 (28.4)
834 (53.9) 477 (30.8)
1732 (55.8) 919 (29.6)
1431 (92.1)
1418 (91.6)
2849 (91.8)
1 (0.1) 76 (4.9)
5 (0.3) 74 (4.8)
6 (0.2) 150 (4.8)
............................................................................................................................................................................... Male [n (%)] Mean (SD) age at randomization (years)
............................................................................................................................................................................... Smoking status [n (%)]
............................................................................................................................................................................... Ethnic origin [n (%)] Caucasian East Asian South Asian Afro-Caribbean
Missing
2 (0.1) 1 (0.1) 42 (2.7)
0 4 (0.3) 47 (3.0)
2 (0.1) 5 (0.2) 89 (2.9)
1
0
1
170.4 (8.4)
170.0 (8.5)
170.2 (8.5)
2
6
8
............................................................................................................................................................................... Mean (SD) height (cm) Missing
............................................................................................................................................................................... Mean (SD) weight (kg) Missing
81.9 (14.2) 0
82.0 (13.5) 2
81.9 (13.9) 2
Mean (SD) body mass index
28.1 (4.1)
28.3 (4.0)
28.2 (4.0)
............................................................................................................................................................................... Missing
2
6
8
............................................................................................................................................................................... Mean (SD) systolic blood pressure (mmHg) Missing
131.8 (18.5) 1
131.7 (18.0) 3
131.7 (18.2) 4
Mean (SD) diastolic blood pressure (mmHg)
74.8 (11.1)
75.0 (11.0)
74.9 (11.1)
............................................................................................................................................................................... Missing
1
3
4
............................................................................................................................................................................... Diabetes [n (%)] No history Insulin-dependent diabetes
1191 (76.6) 79 (5.1)
1177 (76.0) 95 (6.1)
2368 (76.3) 174 (5.6)
284 (18.3)
276 (17.8)
560 (18.1)
Hypertension treated with drugs [n (%)]
1217 (78.3)
1193 (77.1)
2410 (77.7)
Hyperlipidaemia treated with drugs [n (%)] Missing
1448 (93.2) 0
1457 (94.1) 1
2905 (93.7) 1
Documented peripheral arterial disease [n (%)]
118 (7.6)
103 (6.6)
221 (7.1)
Documented transient ischaemic attack [n (%)] Missing
57 (3.7) 1
53 (3.4) 0
110 (3.6) 1
Prior CVA [n (%)]
48 (3.1)
42 (2.7)
90 (2.9)
Non-insulin-dependent diabetes
...............................................................................................................................................................................
...............................................................................................................................................................................
............................................................................................................................................................................... Missing
1
0
1
............................................................................................................................................................................... Prior MI [n (%)]
681 (43.8)
619 (40.0)
1300 (41.9)
Missing Prior PCI + stent [n (%)]
1 248 (16.0)
1 242 (15.6)
2 490 (15.8)
Missing
1
1
2
............................................................................................................................................................................... NYHA class [n (%)] I II
481 (31.0) 747 (48.1)
481 (31.1) 722 (46.6)
962 (31.0) 1469 (47.4)
III
263 (16.9)
279 (18.0)
542 (17.5)
Continued
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African Other
2474
D.P. Taggart et al.
Table 1 Continued SIMA (n 5 1554)
BIMA (n 5 1548)
Overall (n 5 3102)
............................................................................................................................................................................... IV Missing
61 (3.9) 2
66 (4.3) 0
127 (4.1) 2
............................................................................................................................................................................... CCS class [n (%)] 0
128 (8.2)
132 (8.5)
260 (8.4)
I II
355 (22.8) 598 (38.5)
348 (22.5) 582 (37.6)
703 (22.7) 1180 (38.0)
III
351 (22.6)
368 (23.8)
719 (23.2)
IV
122 (7.9)
118 (7.6)
240 (7.7)
CVA, cerebrovascular accident; MI, myocardial infarction; PCI, percutaneous coronary intervention; NYHA, New York Heart Association; CCS, Canadian Cardiovascular Score.
little difference between the BIMA and SIMA groups in QoL at 12 months as measured using the shortened WHO Rose angina questionnaire or the EuroQol EQ-5D (Table 5).
Discussion The ART is unique in not only being the largest randomized trial of two surgical operations ever undertaken in cardiac surgery but also with a primary outcome at 10 years of follow-up. It is designed to specifically answer the question of whether BIMA grafts offer additional survival benefit and freedom from re-intervention at 10 years to that already provided by a SIMA graft. There are two key findings of the 1-year interim analyses of ART. The first is the overall very low mortality and major morbidity of contemporary CABG, irrespective of whether the procedure was BIMA or SIMA, with a 30-day mortality of around 1% and a 1-year mortality of around 2.5%. This is consistent with other contemporary reports of CABG outcome such as the SYNTAX Trial3 and the United Kingdom National Database for Cardiac Surgery,18 which reported an in-hospital mortality of around 1.1% in all 78 000 elective CABG patients in the UK for the 5-year period 2004–08. Likewise, the rates of stroke, myocardial infarction, and repeat revascularization were all ≤2% at 1 year and similar between the two groups. The use of BIMA grafts added, on average, 23 min to the duration of operation and 105 min to the duration of mechanical ventilation but did not significantly affect the duration of ITU stay or post-operative duration of hospital stay. The second key finding is a 1.3% increase in the incidence of sternal wound reconstruction associated with the BIMA. Diabetes is a well-recognized major risk factor for impaired sternal healing and it is notable that approximately half of all patients requiring sternal reconstruction had diabetes in comparison with around onequarter of all patients in the trial as a whole. This slight increase in the risk of need for sternal reconstruction in diabetic patients has to be balanced against the fact that diabetic patients tend to have the most severe coronary artery disease and may actually be the very patients with most to gain from BIMA grafts.27 The risk of impaired wound healing can be minimized with judicious patient selection (avoiding BIMA grafts in obese diabetic patients or those with respiratory impairment) and modification of the IMA dissection
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3. In the SIMA group, 96.6% received a SIMA graft, whereas 3.4% did not. In the BIMA group, 84.5% received BIMA grafts, whereas 15.5% did not. The reasons reported by the investigator for the patient not having the allocated procedure at surgery were: for patients allocated SIMA: vessel unsuitable due to size or condition (n ¼ 15, 29%), patient status (n ¼ 5, 10%), surgeon preference (n ¼ 16, 31%), unsuitable coronary anatomy (n ¼ 12, 23%), or other reason (n ¼ 4, 7%); and for patients allocated BIMA: vessel unsuitable due to size or condition (n ¼ 72, 30%), patient status (n ¼ 60, 25%), surgeon preference (n ¼ 54, 23%), unsuitable coronary anatomy (n ¼ 42, 18%), or other reason (n ¼ 9, 4%). Forty per cent of procedures in the SIMA group and 42% in the BIMA group were done off-pump. The mean (SD) operation time was 199 min (58) for SIMA and 222 min (61) for BIMA (mean difference 23 min, 95% CI: 19 – 27). In the immediate postoperative period, 4% of the patients were returned to the operating room predominantly because of bleeding. The use of blood products was similar in both groups. Approximately 4% of the patients required an intra-aortic balloon pump and the respective use of renal support was 4.4 and 5.9%. The mean duration of ventilation was 863 min in the SIMA group and an additional 105 min in the BIMA group. For patients admitted to ITU following surgery, the mean (SD) length of stay was 38 h (106) in the SIMA group and 41 h (94) in the BIMA group (mean difference 3 h, 95% CI: 25 to 10). The mean (SD) total post-operative hospital stay was 7.5 (7.6) and 8.0 (7.4) days in the SIMA and BIMA groups, respectively (mean difference 0.5 days, 95% CI: 20.03 to 1.03 days). Table 3 shows the adverse events for each group and Figure 2 shows the time from randomization to death by the randomized group (cut-off at 12 months). For SIMA and BIMA, 30-day mortalities were 1.2 and 1.2% in each group and respective 1-year mortalities were 2.3 and 2.5% (Table 4). The rates of stroke and myocardial infarction and repeat revascularization were similar at 30 days and 1 year. The incidence of sternal wound reconstruction was 0.6% for SIMA and 1.9% for BIMA, and in both groups, around half of these patients had a history of diabetes in comparison with around one-quarter of all patients in the whole trial. There was
2475
Randomized trial to compare BIMA vs. SIMA
Table 2
Details of surgical procedure by randomized group
Procedures
SIMA (n 5 1552)
BIMA (n 5 1542)
Details of operation
(n ¼ 1546)
(n ¼ 1532)
............................................................................................................................................................................... On-pump Off-pump Unknown
928 (60.0%) 618 (40.0%)
890 (58.1%) 641 (41.8%)
0
1
13/618 (2.1%) 199 (58)
15/641 (2.3%) 222 (61)
............................................................................................................................................................................... Intra-operative conversions to bypass Mean (SD) duration of operation (min) Median (IQR)
190 (160–250)
215 (185–250)
............................................................................................................................................................................... Number of vessels grafted
(n ¼ 1546)
(n ¼ 1530)
1 2
11 (0.7%) 273 (17.7%)
8 (0.5%) 272 (17.8%)
3
749 (48.54%)
771 (50.4%)
4+
513 (33.2%)
479 (31.3%)
372 (24.0%)
368 (23.9%)
...............................................................................................................................................................................
Aprotinin given after surgery Blood transfusion Median (IQR) blood (red cells) Platelets Fresh frozen plasma Cell saver
89 (5.7%) 184/1515 (12.2%) 500 (300–600)
98 (6.4%) 179/1492 (12.0%) 500 (300–600)
35/1512 (2.3%)
46/1494 (3.1%)
53/1513 (3.5%) 474/1500 (31.6%)
66/1493 (4.4%) 461/1479 (31.2%)
............................................................................................................................................................................... Immediate post-operative period Return to theatre and reason Bleeding Tamponade Other Unknown Intra-aortic balloon pump used Renal support therapy Mean (SD) duration of ventilation (minutes) Median (IQR)
54 (3.5%)
66 (4.3%)
44 2
51 6
8
9
3 57 (3.7%)
6 68 (4.4%)
68 (4.4%)
91 (5.9%)
(n ¼ 1539) 863 (3293)
(n ¼ 1524) 968 (3029)
580 (335–830)
598 (360–890)
............................................................................................................................................................................... Pre-discharge details ITU admissions 0 1
(n ¼ 1448) 8 (0.6%)
(n ¼ 1433) 8 (0.6%)
1390 (96.1%)
1362 (95.3%)
49 (3.4%) 1
59 (4.1%) 4
Mean (SD) ITU length of stay (h)
38 (106)
41 (94)
Median (IQR) Mean (SD) HDU length of stay (days)
22 (16–43) 2 (3.7)
22 (15– 45) 2 (3.8)
2 or more Missing
Median (IQR) Mean (SD) post-operative total hospital stay (days) Median (IQR)
1 (1– 2)
1 (1–2)
7.5 (7.6) 6 (5– 8)
8.0 (7.4) 6.5 (5–8)
ITU, intensive therapy unit; HDU, high dependency unit, IQR, inter-quartile range.
method whereby harvesting only the IMA (‘skeletonized’) rather than the IMA and its surrounding tissue (‘pedicled’) preserves collaterals and sternal blood supply28,29 and improves wound healing, particularly in diabetic patients.30
There was no evidence of QoL differences between the BIMA and SIMA groups at 12 months. One key issue is whether participating surgeons were appropriately experienced to conduct this trial? The trial
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Blood products used during surgery Aprotinin started during surgery
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Table 3
D.P. Taggart et al.
Adverse event data by randomized group
Safety
SIMA (n 5 1552)a
BIMA (n 5 1542)a
Relative risk (95% CI)b
3.24 (1.54–6.83)
............................................................................................................................................................................... Sternal wound reconstructionc
9 (0.6%)
29 (1.9%)
No history of diabetes Insulin-dependent diabetes
4 2
15 5
Non-insulin-dependent diabetes
3
9
............................................................................................................................................................................... MI event at 30 days CVA event at 30 days Revascularization at 30 daysd
23 (1.5%) 19 (1.2%)
22 (1.4%) 15 (1.0%)
0.96 (0.54–1.72) 0.79 (0.40–1.56)
6 (0.4%)
11 (0.7%)
1.85 (0.68–4.98)
MI event at 1 year
(n ¼ 1540) 31 (2.0%)
(n ¼ 1529) 30 (2.0%)
0.97 (0.59–1.60)
CVA event at 1 year
28 (1.8%)
23 (1.5%)
0.83 (0.48–1.43)
Revascularization at 1 yeard
20 (1.3%)
27 (1.8%)
1.36 (0.77–2.41)
a
Participants with in-hospital or 6-week follow-up details available. BIMA vs. SIMA. c To 6 weeks from randomization. d Including any repeat CABG or PCI. b
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Figure 2 Survival to 1 year.
protocol stipulated that surgeons should have performed at least 50 BIMA grafts to be eligible for participation. In the SIMA group, 3.4% did not receive their randomized treatment compared with 15.5% in the BIMA group. This higher figure for the BIMA group may in part reflect some degree of inexperience in doing BIMA operations, but about 40% of all CABG surgeries were performed ‘off-pump’, suggesting a high level of surgical expertise in the surgeons in this trial. This is also emphasized by the very low rate of intra-operative conversion from off-pump to on-pump CABG at 2%. One of the major strengths of ART is that it has been carried out in a broad range of centres in seven countries and includes more than a quarter of all patients
who received CABG in those centres during the enrolment period. This supports the generalizability of our results to routine clinical practice. The trial stipulated that for optimal patency, both IMA should be placed to the left-sided arteries as previous studies had suggested that patency of the right IMA was lower if placed to the right coronary artery due to size discrepancy and eventual disease development at the crux.12 More recently, the Cleveland Clinic group reported that the right IMA could be placed to either the circumflex or right coronary artery system (with at least a 70% stenosis) with similar early and late outcomes.31
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Randomized trial to compare BIMA vs. SIMA
Table 4
Mortality details by randomized group SIMA
Relative risk (95% CI)a
BIMA
............................................................................................................................................................................... (n ¼ 1548) All-cause mortality at 30 days [n (%)] Cardiac Other vascular Non-cardiovascular
(n ¼ 1537)
18 (1.2) 12
19 (1.2) 9
2
5
4 (n ¼ 1540)
5 (n ¼ 1529)
All-cause mortality at 1 year [n (%)]
36 (2.3)
38 (2.5)
Cardiac Other vascular
18 8
18 7
Non-cardiovascular
10
13
1.06 (0.56– 2.02)
1.06 (0.68– 1.67)
a
BIMA vs. SIMA.
Health-related quality of life assessed at 12
Measure
SIMA (n 5 1504)
BIMA (n 5 1491)
................................................................................ Shortened WHO Rose angina questionnaire: (1) Do you ever have any pain or discomfort in your chest? Yes (%)
430 (28.4)
460 (30.7)
No (%) Missing
994 (71.6) 80
939 (69.3) 92
(2) When you walk at an ordinary pace on the level does this produce the pain?a Yes (%) No (%) Unable (%) Missing
43 (10.2)
57 (12.7)
375 (89.3) 2 (0.5)
389 (86.6) 3 (0.7)
10
11
(3) When you walk uphill or hurry does this produce the pain?a Yes (%) 181 (43.5) 199 (44.7) No (%) Unable (%) Missing EQ-5D Mean (SD) tariff value (1 ¼ full health, 0 ¼ dead)
229 (55.0)
238 (53.5)
6 (1.5) 14
8 (1.8) 15
n ¼ 1399 0.858 (0.204)
n ¼ 1375 0.863 (0.195)
a Responses reported only for patients answering Yes to question 1 on the Shortened WHO Rose angina questionnaire (WHO, World Health Organization).
Conclusion Analysis of early data from this trial demonstrates similar surgical mortality and major morbidity for both the SIMA and the BIMA groups at 30 days and 1 year but with a small increase in the need for sternal wound reconstruction using BIMA. These results support the feasibility of CABG using BIMA grafts in patients undergoing CABG. Particular care should be used in patient selection especially in the case of diabetics. These are early data from a longterm trial, and results from 10-year follow-up will in time provide more definitive evidence on survival, morbidity, the need for repeat intervention, and the relative costs and cost-effectiveness of BIMA vs. SIMA grafting in coronary revascularization.
Acknowledgements We thank the following: Jill Mollison and Ed Juszczak for statistical support; Oliver Rivero-Arias and Andrew Briggs for health economic analysis; Eva Matesanz, Wajid Aslam, and Monica Yanez-Lopez for data co-ordination and management; Pauline Newlands for database design; Professor Jeremy Pearson from the British Heart Foundation and Dr Mark Pitman from the Medical Research Council for support throughout; and all of the patients who are participating in ART in the seven countries worldwide.
Funding ART was funded jointly by a grant from the British Heart Foundation (SP/03/001) and a grant from the Medical Research Council (G0200390). Conflict of interest: none declared.
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Table 5 months
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D.P. Taggart et al.
Appendix ART centres, number of patients enrolled, principal investigators (PIs), participating surgeons, and co-ordinators Centre
No. of patients enrolled
PIs (in bold) and participating surgeons
Co-ordinator(s)
............................................................................................................................................................................... 427
D. Taggart, C. Ratnatunga, S. Westaby
J. Cook, C. Wallis
Medical University of Silesia (2nd Department of Cardiac Surgery), Katowice, Poland
256
S. Wos, M. Jasinski, K. Widenka, A. Blach, R. Gocol, D. Hudziak, P. Zurek, M. Deja, R. Bachowski, R. Mrozek, T. Kargul, W. Domarardzki
J. Frackiewicz
Edinburgh Royal Infirmary, Edinburgh, UK
217
V. Zamvar
D. Ezakadan
Austin and Repatriation Medical Centre, Melbourne, Australia
192
B. Buxton, S. Seevanayagam, G. Matalanis, A. Rosalion, J. Negri, S. Moten, V. Atkinson, A. Newcomb
P. Polidano, R. Pana, S. Gerbo
University Hospital of Wales, Cardiff, UK
185
P. O’Keefe, U. von Oppell, D. Mehta, A. Azzu, A. Szafranek, E. Kulatilake
J. Evans, N. Martin, D. Banner
Royal Sussex County, Brighton, UK
180
U. Trivedi, A. Forsyth, J. Hyde, A. Cohen, M. Lewis
E. Gardner, A. MacKenzie, N. Cooter, E. Joyce
Freeman Hospital, Newcastle, UK
152
S. Clark, J. Dark, K. Tocewicz, T. Pillay
S. Rowling
Medical University of Silesia (1st Department of Cardiac Surgery), Katowice, Poland
145
A. Bochenek, M. Cisowski, M. Bolkowski, W. Morawski, M. Guc, M. Krejca, M. Wilczynski, A. Duralek, W. Gerber, J. Skarysz, R. Shrestha, W. Swiech, P. Szmagala
L. Krzych, A. Pawlak
Royal Infirmary, Manchester, UK
115
R. Hasan, D. Keenan, B. Prendergast, N. Odom, K. McLaughlin
G. Cummings-Fosong, C. Mathew, H. Iles-Smith
King’s College Hospital, London, UK
114
J. Desai, A. El-Gamel, L. John, O. Wendler
Papworth Hospital, Cambridge, UK
101
A. Ritchie, C. Choong, S. Nair, D. Jenkins, S. Large, C. Sudarshan, M. Barman, K. Dhital, T. Routledge, B. Rosengard
M. Andrews, K. Rance, R. Williams, V. Hogervorst, J. Gregory H. Munday, K. Rintoul, E. Jarrett, S. Lao-Sirieix, A. Wilkinson
Castle Hill Hospital, Hull, UK
97
A. Cale, S. Griffin
J. Dickson
Glenfield Hospital, Leicester, UK
95
T. Spyt, M. Hickey, A. Sosnowski, G. Peek, J. Szostek, L. Hadjinikalaou
E. Logtens, M. Oakley
Harefield Hospital, London, UK
94
J. Gaer, M. Amrani, G. Dreyfus, T. Bahrami, F. de Robertis, K. Baig, G. Asimakopoulos, H. Vohra, V. Pai, S. Tadjkarimi, B. Soleimani, G. Stavri
G. Bull, H. Collappen
John Paul II, Krakow, Poland
92
J. Sadowksi, B. Gaweda, P. Rudzinski, J. Stolinski
Heart Institute of Pernambuco, Recife, Brazil
82
F. Moraes, C. Moraes
J. Wanderley
Royal Brompton Hospital, London, UK
82
J. Pepper, A. De Souza, M. Petrou, R. Trimlett
T. Morgan, J. Gavino
St George’s Hospital, London, UK
78
V. Chandrasekaran, R. Kanagasaby, M. Sarsam
H. Ryan, L. Billings, L. Ruddick, A. Achampong
Medical University of Gdansk, Gdansk, Poland
74
R. Pawlaczyk, P. Siondalski, J. Rogowski, K. Roszak, K. Jarmoszewicz, D. Jagielak
S. Gafka
Care Hospital, Hyderabad, India
69
G. Mannam, G. Naguboyin, L. Rao Sajja, B. Dandu
Northern General Hospital, Sheffield, UK
67
N. Briffa, P. Braidley, G. Cooper,
A. Knighton, K. Allen
Ospedale Mauriziano, Turin, Italy
60
R. Casabona, G. Actis Dato, G. Bardi, S. Del Ponte, P. Forsennati, F. Parisi, G. Punta
R. Flocco, F. Sansone, E. Zingarelli
The Cardiothoracic Centre, Liverpool, UK
50
W. Dihmis, M. Kuduvali
C. Prince, H. Rogers
Szpital Uniwersytecki, Bydgoszcz, Poland
23
L. Anisimowicz, M. Bokszanski, W. Pawliszak, J. Kolakowski, G. Lau, W. Ogorzeja
I. Gumanska, P. Kulinski
Landesklinikum, St Polten, Austria
20
B. Podesser, K. Trescher, O. Bernecker, Ch. Holzinger, K. Binder, I. Schor, P. Bergmann, H. Kassal
B. Motovova
Continued
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John Radcliffe Hospital, Oxford, UK
2479
Randomized trial to compare BIMA vs. SIMA
(Continued) Centre
No. of patients enrolled
PIs (in bold) and participating surgeons
Co-ordinator(s)
............................................................................................................................................................................... Escorts Heart Institute, New Delhi, India
19
N. Trehan, Z. Meharwal, R. Malhotra, M. Goel, B. Kumer, S. Bazaz, N. Bake, A. Singh, Y. Mishka, R. Gupta
Silesian Centre for Heart Disease, Zabrze, Poland
10
M. Zembala, B. Szafron, J. Pacholewicz, M. Krason, Wojarski, Zych
6
K. Widenka, I. Szymanik, M. Kolwca, W. Mazur, A. Kurowicki, S. Zurek, T. Stacel
Szpital Wojewodzki 2, Rzeszow, Poland
S. Basumatary
I. Jaworska
Trial Steering Committee membership Trial role
Title
Location
Professor G. Vermes
Patient Lay Member
Emeritus Professor of Hebrew Studies
Oxford, UK
Professor D. Altman
Statistician
Professor of Statistics in Medicine
Oxford, UK
Professor J. Dark Ms B. Farrell
Lead Surgeon Trials Advisor
Professor of Cardiac Surgery Co-Director, Resource Centre for Randomised Trials
Newcastle, UK Oxford, UK
Dr M. Flather
Co-Principal Investigator
Director, CTEU, Royal Brompton Hospital
London, UK
Professor A. Gray Professor J. Pepper
Health Economist Lead Surgeon
Professor of Health Economics Professor of Cardiac Surgery
Oxford, UK London, UK
Professor P. Sleight
CHAIRMAN
Emeritus Professor Cardiology
Oxford, UK
Professor K. Channon Dr R. Stables
Cardiologist Cardiologist
Professor of Cardiovascular Medicine Consultant Cardiologist
Oxford, UK Liverpool, UK
Professor D. Taggart
Chief Investigator
Consultant Cardiac Surgeon
Oxford, UK
Professor J. Pearson Dr M. Pitman
Observer from British Heart Foundation Observer from Medical Research Council
Assistant Medical Director Research Manager
London, UK London, UK
...............................................................................................................................................................................
Data Monitoring Committee membership Name
Trial role
Title
Location
Professor S. Yusuf
Chairman
Professor of Medicine
Hamilton, Canada
Professor S. Pocock
Statistician
Professor of Medical Statistics
London, UK
Professor D. Julian Professor T. Treasure
Cardiology advisor Surgical advisor
Emeritus Professor of Cardiology Professor of Cardiothoracic Surgery
London, UK London, UK
...............................................................................................................................................................................
Clinical Events Review Committee membership Name
Hospital
City
Mr U. Trivedi
Royal Sussex County Hospital
Brighton, UK
Mr P. O’Keefe
University Hospital of Wales
Cardiff, UK
Professor U. Von Oppel Mr V. Zamvar
University Hospital of Wales Edinburgh Royal Infirmary
Cardiff, UK Edinburgh, UK
Mr A. Cale
Castle Hill Hospital
Hull, UK
Mr M. Hickey Mr T. Spyt
Glenfield Hospital Glenfield Hospital
Leicester, UK Leicester, UK
...............................................................................................................................................................................
Continued
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Name
2480
D.P. Taggart et al.
(Continued) Name
Hospital
City
Professor J. Pepper
Royal Brompton Hospital
London, UK
Mr R. Kanagasabay Mr T. Pillay
St George’s Hospital Freeman Hospital
London, UK Newcastle, UK
Mr P. Braidley
Northern General Hospital
Sheffield, UK
Mr G. Cooper Dr M. Flather
Northern General Hospital Royal Brompton Hospital
Sheffield, UK London, UK
Mr J. Collinson
Chelsea and Westminster Hospital
London, UK
Dr A. Bakhai Dr R. Pawlaczyk
Barnet General Hospital Medical University of Gdansk
Barnet, UK Gdansk, Poland
Dr R. O’Hanlon
Royal Brompton Hospital
London, UK
Dr D. Kotecha Dr K. Qureshi
Royal Brompton Hospital London Chest Hospital
London, UK London, UK
...............................................................................................................................................................................
Medical University of Silesia
Katowice, Poland
Dr T. Geisler Mr N. Briffa
London, UK Sheffield, UK
Dr L. Manzano-Espinosa
Royal Brompton Hospital Northern General Hospital Hospital Universitario Ramo´n y Cajal
Madrid, Spain
Dr M. Jasinski
Medical University of Silesia
Katowice, Poland
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CARDIOVASCULAR FLASHLIGHT
doi:10.1093/eurheartj/ehq196 Online publish-ahead-of-print 18 June 2010
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Traumatic left ventricular intramural dissection Danja S. Groves 1,2* and Christoph Schmidt 1 1 Department of Anesthesiology and Intensive Care Medicine, University of Muenster, Albert-Schweitzer-Str. 33, 48149 Muenster, Germany and 2Department of Anesthiology, University of Virginia, Charlottesville, PO Box 800710, VA 22903, USA
* Corresponding author. Tel: +1 434 227 0897, Fax: +1 434 982 0019, Email:
[email protected]
Supplementary material Supplementary material is available at European Heart Journal online. Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2010. For permissions please email:
[email protected].
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A 30-year-old man sustained a severe blunt chest injury from a hydraulic pipe thruster, and suffered multiple rip fractures with hemo- and pneumothorax, lung contusion and laceration, pericardial effusion, scapula fracture, liver laceration, and thoracic vertebral fracture. After initial volume resuscitation, he still required highdose vasopressors and inotropes to maintain adequate perfusion pressure. Transoesophageal echocardiography (TEE) was performed to reveal the cause of haemodynamic instability and demonstrated a small pericardial effusion and an extended intramural dissection of the left ventricle (LV) involving the anterolateral papillary muscle and the apical and mid-segments of the anterior and lateral ventricular walls (Supplementary material online, Videos A –D; Panel A). Entry and re-entry sites could be identified (Supplementary material online, Video E, Panel B). Global systolic LV function was depressed. Interestingly, re-evaluation of the admission computed tomography scan showed an intraventricular hypodensity corresponding to the dissection (Panel C ) that was not appreciated initially. Results of the TEE lead to an adjustment in medical therapy (inotropes discontinued). Since the dissection flap could not be re-attached, an epicardial patch was placed over a severely thinned part of the antero-lateral wall to prevent LV rupture. Echocardiographic evaluation of trauma patients is an important tool in identifying injuries. In most cases, it can even be performed in haemodynamically unstable patients at the bedside. It adds valuable and critical information and helps guiding critical care management.
