traumatic left ventricular intramural dissection

12
..................................................................................................................................................................................... ..................................................................................................................................................................................... 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) 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 1 Nuffield Department of Surgery, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU, UK; 2 Centre for Statistics in Medicine, University of Oxford, Wolfson College, Linton Road, Oxford OX2 6UD, UK; 3 Department of Public Health, Health Economics Research Centre, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK; 4 Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Trust, Sydney Street, London SW3 6NP, UK; and 5 National 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 and results Coronary artery bypass graft patients were enrolled in 28 hospitals in seven countries. Three thousand one hundred 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. Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2010. For permissions please email: [email protected] * Corresponding author. Tel: +44 1865 221121, Fax: +44 1865 220244, Email: [email protected] European Heart Journal (2010) 31, 2470–2481 doi:10.1093/eurheartj/ehq318 by guest on April 6, 2012 http://eurheartj.oxfordjournals.org/ Downloaded from

Upload: virginia

Post on 28-Nov-2023

0 views

Category:

Documents


0 download

TRANSCRIPT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ESC HOT LINE

Randomized trial to compare bilateral vs. singleinternal mammary coronary artery bypassgrafting: 1-year results of the ArterialRevascularisation Trial (ART)

David P. Taggart1*, Douglas G. Altman2, Alastair M. Gray3, Belinda Lees4,5,Fiona Nugara4, Ly-Mee Yu2, Helen Campbell 3, and Marcus Flather4,5 on behalf of theART Investigators1Nuffield 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 CollegeLondon, 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 bypassgraft surgery provides superior revascularization to a single internal mammary artery (SIMA), but concerns aboutsafety have prevented the widespread use of BIMA. The Arterial Revascularisation Trial (ART) is a randomizedtrial 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.

Methodsand results

Coronary artery bypass graft patients were enrolled in 28 hospitals in seven countries. Three thousand one hundredand two patients were randomly assigned to SIMA (n ¼ 1554) or BIMA (n ¼ 1548). The mean number of grafts was 3for both groups. Forty per cent of the SIMA procedures and 42% of the BIMA were performed off-pump. Mortality at30 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 38of 1529 (2.5%), respectively. The rates of stroke, myocardial infarction, and repeat revascularization were all ≤2% at 1year and similar between the two groups. Sternal wound reconstruction was required in 0.6 and 1.9% of the SIMAand BIMA groups, respectively.

Conclusion Data from ART demonstrate similar clinical outcomes for SIMA and BIMA at 1 year but BIMA grafts are associatedwith a small absolute increase (1.3%) in the need for sternal wound reconstruction. The results suggest that the use ofBIMA grafts is feasible on a routine basis. The 10-year results of the ART will confirm whether BIMA grafting results inlower mortality and the need for repeat intervention.Trial registration: Controlled-trials.com (ISRCTN46552265).

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywords Revascularization † Bypass

IntroductionDespite advances in percutaneous coronary intervention (PCI),coronary artery bypass graft (CABG) surgery remains the besttherapy, prognostically and symptomatically, for severe multivessel

ischaemic heart disease.1 –3 Consequently, CABG remains one ofthe most commonly performed operations worldwide.

Most CABG patients require three bypass grafts (one to each ofthe major coronary arteries), and from the inception of CABG inthe 1960s, the most commonly used conduit was saphenous vein.

Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2010. For permissions please email: [email protected]

* Corresponding author. Tel: +44 1865 221121, Fax: +44 1865 220244, Email: [email protected]

European Heart Journal (2010) 31, 2470–2481doi:10.1093/eurheartj/ehq318

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

In 1986, however, when the Cleveland Clinic group reported4 thata single internal mammary artery (SIMA) rather than vein graft tothe left anterior descending (LAD) coronary artery (anatomically,the most important coronary artery) improved 10-year survivaland freedom from recurrent angina, myocardial infarction, andthe need for repeat intervention, the use of a SIMA graft rapidlybecame the ‘gold standard’. Indeed, more than 95% of theCABG patients currently receive a SIMA graft and its benefits ofexcellent long-term patency in comparison with vein grafts arenow known to extend into the second and third decade offollow-up.5,6 That superior clinical outcome is largely due to theexcellent long-term patency of a SIMA graft, with rates in excessof 90% up to a decade after CABG, in contrast to vein graftswhere, due to atherosclerosis, around half are occluded and halfof the remainder are severely diseased.7– 9

The superior clinical outcome associated with a SIMA graftencouraged several groups to investigate the use of bilateralinternal mammary arteries (BIMA) with reports of even betterclinical outcomes.10– 14 Angiographic studies demonstrate mark-edly superior patency of BIMA grafts compared with vein grafts,with patency rates of BIMA grafts being as high as 98% at 7days15 and 95% at 216 and 7 years.17 A systematic review of obser-vational studies including 15 962 patients (comprising 11 269 SIMAand 4693 BIMA patients either matched or adjusted for age, sex,ventricular function, and diabetes) reported a survival advantagefor BIMA grafts [hazard ratio for death ¼ 0.81, 95% confidenceintervals (CI): 0.70–0.94].12

Although BIMA grafting appears to offer superior revasculariza-tion to SIMA, it is technically more challenging, and concerns that itleads to a longer operation and increases the risk of early mortalityand major morbidity, in particular impaired wound healing,6,12,13

have prevented widespread use. Indeed, BIMA grafting is onlyused 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 CABGimproves 10-year survival and reduces the need for further inter-ventions compared with a SIMA graft. The secondary outcomemeasures include clinical events and quality of life (QoL) andhealth economic assessments. However, because of concernsover the ‘safety’ of the routine use of BIMA grafts,6,12,13,20,21 theresults presented in this paper describe the mortality and morbid-ity data up to 1-year post-randomization.

Methods

Trial designThe protocol for ART has been published.22 Briefly, ART is a two-arm,randomized multicentre trial, conducted in 28 hospitals in sevencountries, with patients being randomized equally to SIMA or BIMAgrafts. All eligible patients requiring CABG were considered forentry into the study. Eligible patients were those with multivessel cor-onary artery disease (including urgent patients but not evolving myo-cardial infarction) undergoing CABG, whereas those requiring singlegrafts or redo CABG were excluded.

The ART study complied with the Declaration of Helsinki. The trialcommenced 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 ClinicalTrials and Evaluation Unit (CTEU) at the Royal Brompton and Hare-field NHS Foundation Trust in London and the study was sponsoredby the University of Oxford.

The randomization sequence was generated with randomly varyingblock sizes and stratified by centre,23 to provide equal numbers ineach group. Patients were enrolled and randomized by telephonecall to the co-ordinating centre. To reduce the possibility ofoutcome events occurring between randomization and revasculariza-tion, it was recommended that surgery be performed within 6weeks of randomization.

Surgical procedureThe SIMA group received a SIMA graft to the LAD plus supplementalvein or radial artery graft to other coronary arteries, whereas theBIMA group received BIMA grafts to the two most important left-sidedcoronary arteries with supplemental vein or radial artery to other cor-onary arteries. In the BIMA group, the internal mammary artery (IMA)grafts could be used as composite grafts to each other, as long as oneremained in situ. Anastomosis of an IMA graft to the right coronaryartery was not permitted because of concerns of inferior long-termpatency. Only surgeons with experience of .50 BIMA operationswere able to undertake BIMA procedures in the trial and standardmethods for anaesthesia and myocardial protection were used accord-ing to local practice.

Outcome measuresThe primary outcome of ART is a comparison of all-cause mortality at10 years of follow-up between patients randomized to the SIMA orBIMA procedure. The main outcomes in this analysis were clinicaloutcomes at 30 days and 1 year (all-cause mortality, myocardial infarc-tion, stroke, and repeat revascularization) and safety outcomes includ-ing sternal wound reconstruction. Data were censored as of 1 July2010. Serious adverse events were reported by the investigators onspecific forms. Two members of the Clinical Event Review Commit-tee (membership given in Appendix) then adjudicated each event(death, myocardial infarction, stroke, and re-intervention) in ablinded fashion to ensure that the events met the definitions given.If the two adjudicators did not concur, then the event was adjudicatedby a third adjudicator. All other adverse events requiring or prolong-ing hospitalization were adjudicated by one member of theCommittee.

Patient’s QoL was assessed using the shortened WHO Rose anginaquestionnaire24 and the EuroQol EQ-5D questionnaire.25

Trial sizeTo detect a true absolute 5% reduction in 10-year mortality (i.e. from25–20%), with 90% power at 5% significance level required 2928patients. The aim was to enrol at least 3000 patients (1500 in eacharm) over a 2- to 3-year recruitment period.

Statistical analysisThe trial data were analysed by intention-to-treat, irrespective ofactual management and events. The Kaplan–Meier method wasused to analyse time to death. The number and percentage ofevents at 30 days and 1 year were calculated by treatment groups.We calculated the relative risks and corresponding 95% CI todescribe the direction and magnitude of the treatment effect. All ana-lyses were performed using Stata software version 11 (StataCorp).Health resource use data were presented as medians and also as

Randomized trial to compare BIMA vs. SIMA 2471

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

mean values in accordance with the recent NICE guidance: ‘For con-tinuous variables, mean values should be presented and used in theanalyses. For all variables, measures of precision should be detailed’.26

ResultsWe enrolled 3102 patients into ART between 30 June 2004 and 20December 2007 in 28 cardiac surgery centres in seven countries(details of the participating centres and investigators are given inthe Appendix). Figure 1 shows the flow of participants throughthe trial. Screening logs completed by each centre showed that�28% of the patients who met the eligibility criteria were actuallyrandomized into the study.

One thousand five hundred and fifty-four patients were ran-domized to SIMA and 1548 to BIMA. The groups were wellmatched with respect to age, gender, ethnic origin, body massindex, systolic and diastolic blood pressure, and smoking status(Table 1). The groups were also well matched for co-morbiditiesincluding diabetes (�6% insulin-dependent and 18%non-insulin-dependent), previous stroke or transient ischaemicattacks, and peripheral vascular disease. Both groups had similarseverities of angina and breathlessness and a similar incidence ofprevious myocardial infarction and/or PCI with stenting. Approxi-mately 8% of the patients had unstable angina.

Table 2 shows the surgical details for each group. Approximately97% of the patients in each group had their surgery within 6 weeksof randomization. The mean number of grafts in both groups was

Figure 1 Participant flow chart. aPatient consent for data collection (SIMA ¼ 2, BIMA ¼ 7). bIncluding participants who died before 1-yearfollow-up (SIMA ¼ 36, BIMA ¼ 38).

D.P. Taggart et al.2472

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table 1 Baseline demographic and clinical characteristics by randomized group

SIMA (n 5 1554) BIMA (n 5 1548) Overall (n 5 3102)

Male [n (%)] 1338 (86.1) 1318 (85.1) 2656 (85.6)

Mean (SD) age at randomization (years) 63.5 (9.1) 63.7 (8.7) 63.6 (8.9)

Smoking status [n (%)]

Current smoker 214 (13.8) 237 (15.3) 451 (14.5)

Ex-smoker 898 (57.8) 834 (53.9) 1732 (55.8)

Never smoked 442 (28.4) 477 (30.8) 919 (29.6)

Ethnic origin [n (%)]

Caucasian 1431 (92.1) 1418 (91.6) 2849 (91.8)

East Asian 1 (0.1) 5 (0.3) 6 (0.2)

South Asian 76 (4.9) 74 (4.8) 150 (4.8)

Afro-Caribbean 2 (0.1) 0 2 (0.1)

African 1 (0.1) 4 (0.3) 5 (0.2)

Other 42 (2.7) 47 (3.0) 89 (2.9)

Missing 1 0 1

Mean (SD) height (cm) 170.4 (8.4) 170.0 (8.5) 170.2 (8.5)

Missing 2 6 8

Mean (SD) weight (kg) 81.9 (14.2) 82.0 (13.5) 81.9 (13.9)

Missing 0 2 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) 131.8 (18.5) 131.7 (18.0) 131.7 (18.2)

Missing 1 3 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 1191 (76.6) 1177 (76.0) 2368 (76.3)

Insulin-dependent diabetes 79 (5.1) 95 (6.1) 174 (5.6)

Non-insulin-dependent diabetes 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 (%)] 1448 (93.2) 1457 (94.1) 2905 (93.7)

Missing 0 1 1

Documented peripheral arterial disease [n (%)] 118 (7.6) 103 (6.6) 221 (7.1)

Documented transient ischaemic attack [n (%)] 57 (3.7) 53 (3.4) 110 (3.6)

Missing 1 0 1

Prior CVA [n (%)] 48 (3.1) 42 (2.7) 90 (2.9)

Missing 1 0 1

Prior MI [n (%)] 681 (43.8) 619 (40.0) 1300 (41.9)

Missing 1 1 2

Prior PCI+ stent [n (%)] 248 (16.0) 242 (15.6) 490 (15.8)

Missing 1 1 2

NYHA class [n (%)]

I 481 (31.0) 481 (31.1) 962 (31.0)

II 747 (48.1) 722 (46.6) 1469 (47.4)

III 263 (16.9) 279 (18.0) 542 (17.5)

Continued

Randomized trial to compare BIMA vs. SIMA 2473

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

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, whereas15.5% did not.

The reasons reported by the investigator for the patient nothaving the allocated procedure at surgery were: for patients allo-cated 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 otherreason (n ¼ 4, 7%); and for patients allocated BIMA: vessel unsui-table due to size or condition (n ¼ 72, 30%), patient status (n ¼ 60,25%), surgeon preference (n ¼ 54, 23%), unsuitable coronaryanatomy (n ¼ 42, 18%), or other reason (n ¼ 9, 4%).

Forty per cent of procedures in the SIMA group and 42% in theBIMA group were done off-pump. The mean (SD) operation timewas 199 min (58) for SIMA and 222 min (61) for BIMA (meandifference 23 min, 95% CI: 19–27). In the immediate post-operative period, �4% of the patients were returned to theoperating room predominantly because of bleeding. The use ofblood products was similar in both groups. Approximately 4%of the patients required an intra-aortic balloon pump and therespective use of renal support was 4.4 and 5.9%. The mean dur-ation of ventilation was 863 min in the SIMA group and anadditional 105 min in the BIMA group. For patients admitted toITU 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) totalpost-operative hospital stay was 7.5 (7.6) and 8.0 (7.4) days inthe SIMA and BIMA groups, respectively (mean difference 0.5days, 95% CI: 20.03 to 1.03 days).

Table 3 shows the adverse events for each group and Figure 2shows the time from randomization to death by the randomizedgroup (cut-off at 12 months). For SIMA and BIMA, 30-day mortal-ities were 1.2 and 1.2% in each group and respective 1-year mor-talities were 2.3 and 2.5% (Table 4). The rates of stroke andmyocardial infarction and repeat revascularization were similar at30 days and 1 year.

The incidence of sternal wound reconstruction was 0.6% forSIMA and 1.9% for BIMA, and in both groups, around half ofthese patients had a history of diabetes in comparison witharound one-quarter of all patients in the whole trial. There was

little difference between the BIMA and SIMA groups in QoL at12 months as measured using the shortened WHO Rose anginaquestionnaire or the EuroQol EQ-5D (Table 5).

DiscussionThe ART is unique in not only being the largest randomized trial oftwo surgical operations ever undertaken in cardiac surgery but alsowith a primary outcome at 10 years of follow-up. It is designed tospecifically answer the question of whether BIMA grafts offeradditional survival benefit and freedom from re-intervention at10 years to that already provided by a SIMA graft.

There are two key findings of the 1-year interim analyses ofART. The first is the overall very low mortality and major morbid-ity of contemporary CABG, irrespective of whether the procedurewas BIMA or SIMA, with a 30-day mortality of around 1% and a1-year mortality of around 2.5%. This is consistent with other con-temporary 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 all78 000 elective CABG patients in the UK for the 5-year period2004–08. Likewise, the rates of stroke, myocardial infarction,and repeat revascularization were all ≤2% at 1 year and similarbetween the two groups. The use of BIMA grafts added, onaverage, 23 min to the duration of operation and 105 min to theduration of mechanical ventilation but did not significantly affectthe duration of ITU stay or post-operative duration of hospital stay.

The second key finding is a 1.3% increase in the incidence ofsternal wound reconstruction associated with the BIMA. Diabetesis a well-recognized major risk factor for impaired sternal healingand it is notable that approximately half of all patients requiringsternal reconstruction had diabetes in comparison with around one-quarter of all patients in the trial as a whole. This slight increase inthe risk of need for sternal reconstruction in diabetic patients hasto be balanced against the fact that diabetic patients tend to havethe most severe coronary artery disease and may actually be thevery patients with most to gain from BIMA grafts.27 The risk ofimpaired wound healing can be minimized with judicious patientselection (avoiding BIMA grafts in obese diabetic patients or thosewith respiratory impairment) and modification of the IMA dissection

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table 1 Continued

SIMA (n 5 1554) BIMA (n 5 1548) Overall (n 5 3102)

IV 61 (3.9) 66 (4.3) 127 (4.1)

Missing 2 0 2

CCS class [n (%)]

0 128 (8.2) 132 (8.5) 260 (8.4)

I 355 (22.8) 348 (22.5) 703 (22.7)

II 598 (38.5) 582 (37.6) 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.

D.P. Taggart et al.2474

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

method whereby harvesting only the IMA (‘skeletonized’) ratherthan the IMA and its surrounding tissue (‘pedicled’) preservescollaterals and sternal blood supply28,29 and improves woundhealing, particularly in diabetic patients.30

There was no evidence of QoL differences between the BIMAand SIMA groups at 12 months.

One key issue is whether participating surgeons wereappropriately experienced to conduct this trial? The trial

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 928 (60.0%) 890 (58.1%)

Off-pump 618 (40.0%) 641 (41.8%)

Unknown 0 1

Intra-operative conversions to bypass 13/618 (2.1%) 15/641 (2.3%)

Mean (SD) duration of operation (min) 199 (58) 222 (61)

Median (IQR) 190 (160–250) 215 (185–250)

Number of vessels grafted (n ¼ 1546) (n ¼ 1530)

1 11 (0.7%) 8 (0.5%)

2 273 (17.7%) 272 (17.8%)

3 749 (48.54%) 771 (50.4%)

4+ 513 (33.2%) 479 (31.3%)

Blood products used during surgery

Aprotinin started during surgery 372 (24.0%) 368 (23.9%)

Aprotinin given after surgery 89 (5.7%) 98 (6.4%)

Blood transfusion 184/1515 (12.2%) 179/1492 (12.0%)

Median (IQR) blood (red cells) 500 (300–600) 500 (300–600)

Platelets 35/1512 (2.3%) 46/1494 (3.1%)

Fresh frozen plasma 53/1513 (3.5%) 66/1493 (4.4%)

Cell saver 474/1500 (31.6%) 461/1479 (31.2%)

Immediate post-operative period

Return to theatre and reason 54 (3.5%) 66 (4.3%)

Bleeding 44 51

Tamponade 2 6

Other 8 9

Unknown 3 6

Intra-aortic balloon pump used 57 (3.7%) 68 (4.4%)

Renal support therapy 68 (4.4%) 91 (5.9%)

(n ¼ 1539) (n ¼ 1524)

Mean (SD) duration of ventilation (minutes) 863 (3293) 968 (3029)

Median (IQR) 580 (335–830) 598 (360–890)

Pre-discharge details (n ¼ 1448) (n ¼ 1433)

ITU admissions

0 8 (0.6%) 8 (0.6%)

1 1390 (96.1%) 1362 (95.3%)

2 or more 49 (3.4%) 59 (4.1%)

Missing 1 4

Mean (SD) ITU length of stay (h) 38 (106) 41 (94)

Median (IQR) 22 (16–43) 22 (15–45)

Mean (SD) HDU length of stay (days) 2 (3.7) 2 (3.8)

Median (IQR) 1 (1–2) 1 (1–2)

Mean (SD) post-operative total hospital stay (days) 7.5 (7.6) 8.0 (7.4)

Median (IQR) 6 (5–8) 6.5 (5–8)

ITU, intensive therapy unit; HDU, high dependency unit, IQR, inter-quartile range.

Randomized trial to compare BIMA vs. SIMA 2475

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

protocol stipulated that surgeons should have performed at least50 BIMA grafts to be eligible for participation. In the SIMA group,3.4% did not receive their randomized treatment compared with15.5% in the BIMA group. This higher figure for the BIMA groupmay in part reflect some degree of inexperience in doing BIMAoperations, but about 40% of all CABG surgeries were per-formed ‘off-pump’, suggesting a high level of surgical expertisein the surgeons in this trial. This is also emphasized by the verylow rate of intra-operative conversion from off-pump toon-pump CABG at 2%. One of the major strengths of ART isthat it has been carried out in a broad range of centres inseven countries and includes more than a quarter of all patients

who received CABG in those centres during the enrolmentperiod. This supports the generalizability of our results toroutine clinical practice.

The trial stipulated that for optimal patency, both IMA shouldbe placed to the left-sided arteries as previous studies hadsuggested that patency of the right IMA was lower if placedto the right coronary artery due to size discrepancy andeventual disease development at the crux.12 More recently,the Cleveland Clinic group reported that the right IMA couldbe placed to either the circumflex or right coronary arterysystem (with at least a 70% stenosis) with similar early andlate outcomes.31

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table 3 Adverse event data by randomized group

Safety SIMA (n 5 1552)a BIMA (n 5 1542)a Relative risk (95% CI)b

Sternal wound reconstructionc 9 (0.6%) 29 (1.9%) 3.24 (1.54–6.83)

No history of diabetes 4 15

Insulin-dependent diabetes 2 5

Non-insulin-dependent diabetes 3 9

MI event at 30 days 23 (1.5%) 22 (1.4%) 0.96 (0.54–1.72)

CVA event at 30 days 19 (1.2%) 15 (1.0%) 0.79 (0.40–1.56)

Revascularization at 30 daysd 6 (0.4%) 11 (0.7%) 1.85 (0.68–4.98)

(n ¼ 1540) (n ¼ 1529)

MI event at 1 year 31 (2.0%) 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)

aParticipants with in-hospital or 6-week follow-up details available.bBIMA vs. SIMA.cTo 6 weeks from randomization.dIncluding any repeat CABG or PCI.

Figure 2 Survival to 1 year.

D.P. Taggart et al.2476

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

ConclusionAnalysis of early data from this trial demonstrates similar surgicalmortality and major morbidity for both the SIMA and the BIMAgroups at 30 days and 1 year but with a small increase in the needfor sternal wound reconstruction using BIMA. These resultssupport the feasibility of CABG using BIMA grafts in patients under-going CABG. Particular care should be used in patient selectionespecially in the case of diabetics. These are early data from a long-term trial, and results from 10-year follow-up will in time providemore definitive evidence on survival, morbidity, the need forrepeat intervention, and the relative costs and cost-effectiveness ofBIMA vs. SIMA grafting in coronary revascularization.

AcknowledgementsWe thank the following: Jill Mollison and Ed Juszczak for statisticalsupport; Oliver Rivero-Arias and Andrew Briggs for health economicanalysis; Eva Matesanz, Wajid Aslam, and Monica Yanez-Lopez fordata co-ordination and management; Pauline Newlands for databasedesign; Professor Jeremy Pearson from the British Heart Foundationand Dr Mark Pitman from the Medical Research Council for supportthroughout; and all of the patients who are participating in ART in theseven countries worldwide.

FundingART 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.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table 4 Mortality details by randomized group

SIMA BIMA Relative risk (95% CI)a

(n ¼ 1548) (n ¼ 1537)

All-cause mortality at 30 days [n (%)] 18 (1.2) 19 (1.2) 1.06 (0.56–2.02)

Cardiac 12 9

Other vascular 2 5

Non-cardiovascular 4 5

(n ¼ 1540) (n ¼ 1529)

All-cause mortality at 1 year [n (%)] 36 (2.3) 38 (2.5) 1.06 (0.68–1.67)

Cardiac 18 18

Other vascular 8 7

Non-cardiovascular 10 13

aBIMA vs. SIMA.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table 5 Health-related quality of life assessed at 12months

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 (%) 994 (71.6) 939 (69.3)

Missing 80 92

(2) When you walk at an ordinary pace on the level does this producethe pain?a

Yes (%) 43 (10.2) 57 (12.7)

No (%) 375 (89.3) 389 (86.6)

Unable (%) 2 (0.5) 3 (0.7)

Missing 10 11

(3) When you walk uphill or hurry does this produce the pain?a

Yes (%) 181 (43.5) 199 (44.7)

No (%) 229 (55.0) 238 (53.5)

Unable (%) 6 (1.5) 8 (1.8)

Missing 14 15

EQ-5D n ¼ 1399 n ¼ 1375

Mean (SD) tariff value(1 ¼ full health,0 ¼ dead)

0.858 (0.204) 0.863 (0.195)

aResponses reported only for patients answering Yes to question 1 on theShortened WHO Rose angina questionnaire (WHO, World Health Organization).

Randomized trial to compare BIMA vs. SIMA 2477

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Appendix

ART centres, number of patients enrolled, principal investigators (PIs), participating surgeons, and co-ordinators

Centre No. ofpatientsenrolled

PIs (in bold) and participating surgeons Co-ordinator(s)

John Radcliffe Hospital, Oxford, UK 427 D. Taggart, C. Ratnatunga, S. Westaby J. Cook, C. Wallis

Medical University of Silesia (2ndDepartment 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 MedicalCentre, 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 (1stDepartment 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 M. Andrews, K. Rance, R.Williams, V. Hogervorst, J.Gregory

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

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

D.P. Taggart et al.2478

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(Continued)

Centre No. ofpatientsenrolled

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

S. Basumatary

Silesian Centre for Heart Disease,Zabrze, Poland

10 M. Zembala, B. Szafron, J. Pacholewicz, M. Krason,Wojarski, Zych

Szpital Wojewodzki 2, Rzeszow,Poland

6 K. Widenka, I. Szymanik, M. Kolwca, W. Mazur, A.Kurowicki, S. Zurek, T. Stacel

I. Jaworska

Trial Steering Committee membership

Name 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 Lead Surgeon Professor of Cardiac Surgery Newcastle, UK

Ms B. Farrell Trials Advisor Co-Director, Resource Centre for Randomised Trials Oxford, UK

Dr M. Flather Co-Principal Investigator Director, CTEU, Royal Brompton Hospital London, UK

Professor A. Gray Health Economist Professor of Health Economics Oxford, UK

Professor J. Pepper Lead Surgeon Professor of Cardiac Surgery London, UK

Professor P. Sleight CHAIRMAN Emeritus Professor Cardiology Oxford, UK

Professor K. Channon Cardiologist Professor of Cardiovascular Medicine Oxford, UK

Dr R. Stables Cardiologist Consultant Cardiologist Liverpool, UK

Professor D. Taggart Chief Investigator Consultant Cardiac Surgeon Oxford, UK

Professor J. Pearson Observer from British Heart Foundation Assistant Medical Director London, UK

Dr M. Pitman Observer from Medical Research Council Research Manager 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 Cardiology advisor Emeritus Professor of Cardiology London, UK

Professor T. Treasure Surgical advisor Professor of Cardiothoracic Surgery 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 University Hospital of Wales Cardiff, UK

Mr V. Zamvar Edinburgh Royal Infirmary Edinburgh, UK

Mr A. Cale Castle Hill Hospital Hull, UK

Mr M. Hickey Glenfield Hospital Leicester, UK

Mr T. Spyt Glenfield Hospital Leicester, UK

Continued

Randomized trial to compare BIMA vs. SIMA 2479

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(Continued)

Name Hospital City

Professor J. Pepper Royal Brompton Hospital London, UK

Mr R. Kanagasabay St George’s Hospital London, UK

Mr T. Pillay Freeman Hospital Newcastle, UK

Mr P. Braidley Northern General Hospital Sheffield, UK

Mr G. Cooper Northern General Hospital Sheffield, UK

Dr M. Flather Royal Brompton Hospital London, UK

Mr J. Collinson Chelsea and Westminster Hospital London, UK

Dr A. Bakhai Barnet General Hospital Barnet, UK

Dr R. Pawlaczyk Medical University of Gdansk Gdansk, Poland

Dr R. O’Hanlon Royal Brompton Hospital London, UK

Dr D. Kotecha Royal Brompton Hospital London, UK

Dr K. Qureshi London Chest Hospital London, UK

Dr L. Krzych Medical University of Silesia Katowice, Poland

Dr T. Geisler Royal Brompton Hospital London, UK

Mr N. Briffa Northern General Hospital Sheffield, UK

Dr L. Manzano-Espinosa Hospital Universitario Ramon y Cajal Madrid, Spain

Dr M. Jasinski Medical University of Silesia Katowice, Poland

References1. Yusuf S, Zucker D, Peduzzi P, Fisher LD, Takaro T, Kennedy JW, Davis K, Killip T,

Passamani E, Norris R. Effect of CABG surgery on survival: overview of 10-yearresults from randomised trials by the CABG Trialists Collaboration. Lancet1994;344:563–570.

2. Taggart DP. Thomas B. Ferguson Lecture. Coronary artery bypass grafting is stillthe best treatment for multivessel and left main disease, but patients need toknow. Ann Thorac Surg 2006;82:1966–1975.

3. Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ,Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K,Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary interven-tion versus coronary-artery bypass grafting for severe coronary artery disease. NEngl J Med 2009;360:961–972.

4. Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW,Golding LA, Gill CC, Taylor PC, Sheldon WC. Influence of the internalmammary artery graft on 10-year survival and other cardiac events. N Engl JMed 1986;314:1–6.

5. Cameron A, Davis KB, Green G, Schaff HV. Coronary bypass surgery withinternal-thoracic-artery grafts: effects on survival over a 15-year period. N EnglJ Med 1996;334:216–219.

6. Kurlansky P. Thirty-year experience with bilateral internal thoracic artery grafting:where have we been and where are we going? World J Surg 2010;34:646–651.

7. Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronarybypass graft fate and patient outcome: angiographic follow-up of 5,065 graftsrelated to survival in reoperation in 1,388 patients during 25 years. J Am CollCardiol 1996;28:616–626.

8. Weintraub WS, Jones EL, Craver JM, Guyton RA. Frequency of repeat coronarybypass or coronary angioplasty after CABG using saphenous vein grafts. Am JCardiol 1994;73:103–112.

9. Gansera B, Schmidtler F, Angelis I, Kiask T, Kemkes BM, Botzenhardt F. Patency ofinternal thoracic artery compared to vein grafts—postoperative angiographicfindings in 1189 symptomatic patients in 12 years. Thorac Cardiovasc Surg 2007;55:412–417.

10. Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R,McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are betterthan one. J Thorac Cardiovasc Surg 1999;117:855–872.

11. Buxton BF, Ruengsakulrach P, Fuller J, Rosalion A, Reid CM, Tatoulis J. The rightITA graft—benefits of grafting the left coronary system and native vessels with ahigh grade stenosis. Eur J Cardiothorac Surg 2001;18:255–261.

12. Taggart DP, D’Amico R, Altman DG. The effect of arterial revascularization onsurvival: a systematic review of studies comparing bilateral and single internalmammary arteries. Lancet 2001;358:870–875.

13. Ioannidis JP, Galanos O, Katritsis D, Connery CP, Drossos GE, Swistel DG,Anagnostopoulos CE. Early mortality and morbidity of bilateral versus singleinternal thoracic artery revascularization: propensity and risk modeling. J AmColl Cardiol 2001;37:521–528.

14. Rizzoli G, Schiavon L, Bellini P. Does the use of bilateral internal mammary artery(IMA) grafts provide incremental benefit relative to the use of a single IMA graft?A meta-analysis approach. Eur J Cardiothorac Surg 2002;22:781–786.

15. Endo M, Nishida H, Tomizawa Y, Kasanuki H. Benefit of bilateral over singleinternal mammary artery grafts for multiple coronary artery bypass grafting. Circu-lation 2001;104:2164–2170.

16. Calafiore AM, Contini M, Vitolla G, Di Mauro M, Mazzei V, Teodori G, DiGiammarco G. Bilateral internal thoracic artery grafting: long-term clinical andangiographic results of in situ versus Y grafts. J Thorac Cardiovasc Surg 2000;120:990–996.

17. Dion R, Glineur D, Derouck D, Verhelst R, Noirhomme P, El Khoury G,Degrave E, Hanet C. Long-term clinical and angiographic follow-up of sequentialinternal thoracic artery grafting. Eur J Cardiothorac Surg 2000;17:407–414.

18. Sixth National Adult Cardiac Surgical Database Report 2008. Bridgewater B,Keogh B, on behalf of the Society for Cardiothoracic Surgery in Great Britainand Ireland.

19. Tabata M, Grab JD, Khalpey Z, Edwards FH, O’Brien SM, Cohn LH, Bolman RM3rd. Prevalence and variability of internal mammary artery graft use in contem-porary multivessel coronary artery bypass graft surgery: analysis of theSociety of Thoracic Surgeons National Cardiac Database. Circulation 2009;120:935–940.

20. Lytle BW, Loop FD. Superiority of bilateral internal thoracic artery grafting: it’sbeen a long time comin’. Circulation 2001;104:2152–2154.

21. Catarino PA, Black E, Taggart DP. Why do UK cardiac surgeons not perform theirfirst choice operation for coronary artery bypass graft? Heart 2002;88:643–644.

22. Taggart DP, Lees B, Gray A, Altman DG, Flather M, Channon K, on behalf of theART Investigators. Protocol for the Arterial Revascularisation Trial (ART). A ran-domised trial to compare survival following bilateral versus single internalmammary grafting in coronary revascularisation [ISRCTN46552265]. Trials2006;7:7.

23. Schulz KF, Grimes DA. Unequal group sizes in randomised trials: guarding againstguessing. Lancet 2002;359:966–970.

24. Performance of the WHO Rose angina questionnaire in post-menopausalwomen: Are all of the questions necessary? J Epidemiol Commun Health 2003;57:538–541.

25. Brooks R, The EuroQol Group. EuroQol: the current state of play. Health Policy1996;37:53–72.

D.P. Taggart et al.2480

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from

26. National Institute for Health and Clinical Excellence (NICE). Guide to the Methodsof Technology Appraisals 2008, NICE: London.

27. Lawlor DA, Adamson J, Ebrahim S. Seven-year outcome in the Bypass AngioplastyRevascularization Investigation (BARI) by treatment and diabetic status. J Am CollCardiol 2000;35:1122–1129.

28. Boodhwani M, Lam BK, Nathan HJ, Mesana TG, Ruel M, Zeng W, Sellke FW,Rubens FD. Skeletonized internal thoracic artery harvest reduces pain anddysesthesia and improves sternal perfusion after coronary artery bypass surgery:a randomised, double-blind, within-patient comparison. Circulation 2006;114:766–773.

29. Kamiya H, Akhyari P, Martens A, Karck M, Haverich A, Lichtenberg A. Sternalmicrocirculation after skeletonized versus pedicled harvesting of theinternal thoracic artery: a randomised study. J Thorac Cardiovasc Surg 2008;135:32–37.

30. Matsa M, Paz Y, Gurevitch J, Shapira I, Kramer A, Pevny D, Mohr R. Bilateral ske-letonized internal thoracic artery grafts in patients with diabetes mellitus. J ThoracCardiovasc Surg 2001;121:668–674.

31. Sabik JF 3rd, Stockins A, Nowicki ER, Blackstone EH, Houghtaling PL, Lytle BW,Loop FD. Does location of the second internal thoracic artery graftinfluence outcome of coronary artery bypass grafting? Circulation 2008;118:S210–S215.

CARDIOVASCULAR FLASHLIGHT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

doi:10.1093/eurheartj/ehq196Online publish-ahead-of-print 18 June 2010

Traumatic left ventricular intramural dissection

Danja S. Groves1,2* and Christoph Schmidt1

1Department of Anesthesiology and Intensive Care Medicine, University of Muenster, Albert-Schweitzer-Str. 33, 48149 Muenster, Germany and 2Department ofAnesthiology, 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]

A 30-year-old man sustained a severeblunt chest injury from a hydraulicpipe thruster, and suffered multiple ripfractures with hemo- and pneu-mothorax, lung contusion and lacera-tion, pericardial effusion, scapulafracture, liver laceration, and thoracicvertebral fracture. After initial volumeresuscitation, he still required high-dose vasopressors and inotropes tomaintain adequate perfusion pressure.Transoesophageal echocardiography(TEE) was performed to reveal thecause of haemodynamic instability anddemonstrated a small pericardial effu-sion and an extended intramural dissec-tion of the left ventricle (LV) involvingthe anterolateral papillary muscle andthe apical and mid-segments of theanterior and lateral ventricular walls(Supplementary material online,Videos A–D; Panel A). Entry andre-entry sites could be identified (Sup-plementary material online, Video E,Panel B). Global systolic LV functionwas depressed. Interestingly,re-evaluation of the admission com-puted tomography scan showed anintraventricular 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 bere-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 inhaemodynamically unstable patients at the bedside. It adds valuable and critical information and helps guiding critical care management.

Supplementary materialSupplementary 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].

Randomized trial to compare BIMA vs. SIMA 2481

by guest on April 6, 2012

http://eurheartj.oxfordjournals.org/D

ownloaded from