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61
Coronary artery bypass graing in patients
withventriculardysfunction
Indications, techniques, and outcomes
Andrea Garatti, Serenella Castelvecchio, Alessandro Parolari, and Lorenzo Menicanti
Introduction
Ischaemic chronic heart failure represents one of the cardiovascular diseases with the worst degree of morbidity and mortality
in the Western world, along with the highest healthcare costs.
Despite several retrospective studies demonstrating that surgical
revascularization (coronary artery bypass graing (CABG)), especially in the presence of viable myocardium, improves heart function and therefore survival in this subgroup of patients, the matter
remains unclear and controversial.
e reported prevalence of severe ischaemic le ventricular dysfunction (LVD) in patients undergoing CABG in large series and
registries ranged from 3.4% to 15%. e dierences may be partly explained by dierent denitions of severely depressed le ventricular
function, even if most studies choose an ejection fraction (EF) of less
than or equal to 35%. In a recent analysis of the Society of oracic
Surgeons National Adult Cardiac Surgery Database, among 774,881
isolated CABG procedures performed on adult patients between
2002 and 2006, the prevalence of LVD (EF <35%) was 10.6%, with
3.3% of patients presenting with very poor EF of less than 20%. In
the Society for Cardiothoracic Surgery in Great Britain and Ireland
National Database, among 23,740 cardiac procedures performed between 2010 and 2011, the incidence of EF less than 30% was 6%, with
0.5% of patients presenting with severe LVD (EF <20%). In our department, among 8555 patients undergoing isolated CABG between
2000 and 2016, nearly 10% presented with an EF less than 35%, and
this incidence appears to have slightly increased in recent years. As
a result of the steady increase in the incidence of congestive heart
failure in developed countries, it is expected that a growing number
of patients with ischaemic cardiomyopathy and LVD will require
myocardial revascularization.
is chapter discusses the available evidence in the literature,
from observational studies to randomized trials, including operative techniques and controversial issues, in order to clarify the role of
CABG in the current management of patients with ischaemic LVD.
Early and long- termoutcomes
Observationalstudies
Patients with reduced EF undergoing CABG have been consistently
shown to have higher operative mortality and reduced long- term
survival compared with patients with preserved EF. However, 30day mortality has signicantly improved over time— from 20% in
the late 1980s to 5% in patients operated on aer 2000. is improvement in operative outcome is certainly multifactorial and probably
related to improvements in myocardial protection strategies and
overall perioperative management. Ameta- analysis including 4119
patients from 26 observational studies with ischaemic LVD (mean
preoperative EF of 24%) undergoing CABG, reported a mean estimated 30- day mortality of 5.4%, with a limited postoperative use
of an intra- aortic balloon pump (IABP) (8%) and inotropic support (43%), and a signicant improvement in postoperative systolic
function, as mean EF improved from 24% to 35% with an estimated
5- year survival of 75%. ese results demonstrate that CABG can
be performed in this high- risk subgroup of patients with acceptable
perioperative mortality and long- term survival.
e comparison between medical therapy and CABG in the treatment of chronic stable angina has been addressed in several early
trials. Unfortunately, these results can hardly be applied to the contemporary management of patients with ischaemic cardiomyopathy
as patients with severe LVD were largely excluded and both surgical techniques and medical therapy have signicantly improved
since then.
ere are currently no dedicated randomized clinical trials comparing percutaneous coronary intervention (PCI) versus medical
therapy in patients with heart failure and LVD. In addition, CABG
versus PCI randomized trials have excluded patients with severe
heart failure. Even in modern trials comparing CABG and PCI,
such as the SYNTAX (Synergy between Percutaneous Coronary
Intervention with Taxus and Cardiac Surgery) and the FREEDOM
(Future Revascularization Evaluation in Patients with Diabetes
420
(a) Death from Any Cause (Primary Outcome)
37
42
011
No. at Risk
Medical therapy
CAB
(b) Death from Cardiovascular Causes
37
42
011
No. at Risk
Medical therapy
CAB
(c) Death from Any Cause or Cardiovascular Hospitalization
610
431
376
334
293
259
218
18498166571061943
910
No. at Risk
Medical therapy
CABG
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SECTION 8 Coronary artery bypass graft surgery inspecial situations
Mellitus:Optimal Management of Multivessel Disease) trials, patients with severe LVD represent only around 2% of the enrolled
patients.
Until the STICH (Surgical Treatment for Ischemic Heart Failure)
trial, data supporting the role of surgical revascularization for patients
with LVD were primarily observational. Studies comparing survival
in patients treated with surgery versus medical therapy uniformly
suggested that CABG enhances survival in patients with ischaemic
LVD. Reductions in mortality with surgery compared with medical
therapy ranged from 10% to greater than 50%. However, most of
these studies either date from the 1960s and 1970s, or fail to provide
sucient detail to determine if optimal medical management by current standards might have enhanced survival in the medical groups.
PCI should be considered in older patients without diabetes in whom
complete revascularization can be achieved, whereas CABG is preferred in younger patients with more extensive CAD or those with
diabetes. Indeed, in patients with diabetes and LVD, CABG is associated with better long- term survival and reduced incidence of major
adverse cardiac and cerebrovascular events.
The STICH and STICHEStrials
e STICH trial is the only prospective randomized controlled
trial to specically investigate the role of CABG in patients with
le ventricular EF less than 35% who are also receiving optimal
medical therapy (OMT). In the analysis of data from the surgical
revascularization hypothesis (enrolling 1212 patients), at a median follow- up period of 56months, no signicant dierence was
observed in the primary outcome of all- cause mortality between
patients randomized to CABG versus OMT. However, the CABG
group had improved rates of death from cardiovascular causes and
improved rates of a combined end point of death from any cause
and hospitalization for heart failure, as well as a greater improvement with regard to symptoms and quality of life. Furthermore, patients with more advanced forms of ischaemic cardiomyopathy (as
expressed by the presence of three- vessel disease and more severe
systolic LVD and remodelling) received the greatest benet from
surgical revascularization. is resulted in an overall statistically
signicant benet of CABG over the entire follow- up period despite the higher early mortality with surgery compared with OMT.
Interestingly, the results of the STICH Extension Study (STICHES)
demonstrated that at 10- year follow- up, all- cause mortality, cardiovascular mortality, and a composite end point of mortality and heart
failure readmission were indeed signicantly reduced in CABG patients compared to OMT (Fig. 61.1), and these results were more
evident in younger compared to older patients.
Operativetechniques
O- pump CABG has been advocated by some authors in patients
with LVD undergoing myocardial revascularization in order to
minimize ischaemic time and perioperative myocardial damage.
Ameta- analysis including 1512 patients with LVD undergoing either
o- pump CABG (498 patients) or on- pump CABG (1014 patients),
demonstrated a non- signicant hazard ratio of 0.71 (95% condence
interval 0.351– 1.426; P=0.334) for mortality with o- pump CABG
compared with the on- pump technique (in- hospital mortality was
5.4% vs 4.4% for on- pump and o- pump respectively). However,
100
Hazard ratio, 0.84 (95% CI, 0.73–0.97)
90
P = 0.02 by log-rank test
80
70
60
50
40
Event Rate (%)
30
20
10
0
01
602
G
G
610
100
90
80
70
60
50
40
Event Rate (%)
30
20
10
0
01
602
610
100
90
80
60
50
40
Event Rate (%)
30
20
10
0
01
602
234567891
Years since Randomization
532
487
435
404
357
219
392
357
392
185
315
356
315
356
532
487
460
432
Hazard ratio, 0.79 (95% CI, 0.66–0.93)
P = 0.006 by log-rank test
234567891
Years since Randomization
532
487
435
532
487
Hazard ratio, 0.72 (95% CI, 0.64–0.82)
P < 0.001 by log-rank test
385
404
460
432
2 345678
Years since Randomization
314
259
152
274
312
274
312
Medical therapy
248
164
286
20582103
Medical therapy
248
164
286
20582103
Medical therapy
123
CABG
CABG
CABG70
Fig.61.1 Kaplan– Meier estimates of the rates of death from any
cause, death from cardiovascular causes, and death from any cause or
hospitalization for cardiovascular causes.
Reproduced from Velazquez EJ, Lee KL, Jones RH, etal. Coronary- Artery Bypass Surgery
in Patients with Ischemic Cardiomyopathy. N Engl J Med. 2016;374(16):1511– 1520.
doi:10.1056/ NEJMoa1602001 with permission from Massachusetts Medical Society.
these ndings have to be interpreted with caution, given the small
proportion of patients in this subgroup analysis that underwent opump CABG and the fact that the studies included in this metaanalysis were non- randomized.
61 Coronary artery bypass grafting in patients withventriculardysfunction 421
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e use of bilateral internal thoracic arteries (ITAs) has been associated with improved outcomes following myocardial revascularization, especially in patients with a predicted survival greater than
10years. However, the impact of a strategy of bilateral ITA graing
on survival is less clear for high- risk subgroups such as those with
low EF. Some evidence in patients with LVD demonstrated no
long- term survival advantage of the bilateral ITA over the single
ITA strategy, suggesting that the use of a second ITA is not associated with improved survival following CABG among patients
with LVD. One possible explanation for these results is that systolic LVD constitutes a powerful predictor of late mortality among
CABG patients that may negate any potential advantage of bilateral
ITA graing.
Despite the enormous amount of data regarding myocardial protection reported in literature, very few studies (and no randomized
clinical trial) addressed the role of cardioplegia type (crystalloid vs
blood; cold vs warm; antegrade vs retrograde) in patients with LVD
undergoing myocardial revascularization. e CABG Patch Trial
represented a high- risk group of 900 patients with EFs less than 36%
who underwent CABG, who were randomly assigned to implantable cardioverter debrillator implantation. Although not designed
to address this issue, the trial collected limited data on cardioplegic
type and perioperative events in addition to survival. e study
demonstrated that blood, warm, and combined antegrade/ retrograde cardioplegia were associated with less postoperative myocardial damage (inotrope/ IABP use and conduction defects) compared
to antegrade crystalloid cardioplegia alone. Despite this, no signicant dierences in early or late survival, as well as postoperative lowoutput syndrome or acute myocardial infarction, were observed
between dierent types of myocardial protection.
reduction in mortality utilizing viability testing in patients with
known ischaemic cardiomyopathy, irrespective of imaging modality
chosen. ese initial studies, although favourable, shared several
limitations (small studies, wide temporal distribution, retrospective
analysis, dierent methods of viability assessment, incomplete adherence to OMT) and lacked sucient power and sample size to
provide conclusive statement on viability assessment in this subgroup of patients.
In recent years, the impact of preoperative myocardial viability
assessment on the outcomes of surgical revascularization in patients
with ischaemic LVD was investigated in multicentre randomized
trials,, suggesting that preoperative myocardial viability assessment could have a prognostic benet in centres with proved experience in cardiac imaging. In the revascularization hypothesis of the
STICH trial, half of the enrolled patients underwent assessment
of myocardial viability by means of either single- photon emission
computed tomography or low- dose dobutamine echocardiography.
Although patients with viable tissue experienced a signicantly
lower 5- year mortality compared to patients without myocardial
viability (37% vs 51%), the viability analysis did not identify patients who would preferentially benet from CABG over OMT.
Moreover, there was no signicant interaction with respect to mortality between viability status and assignment to CABG or OMT.
Despite some limitations (including the lack of more advanced
modalities of viability assessment such as positron emission tomography and cardiac magnetic resonance imaging), this study represents the largest analysis of the inuence of myocardial viability
on clinical end points in patients with ischaemic cardiomyopathy to
date, and was the rst to assess the dierential eect of viability on
revascularization versus medical management.
e perioperative use of an IABP in cardiac surgery is widespread.
One meta- analysis of eight randomized clinical trials, including
625 high- risk elective CABG patients, reported that preoperative
Indications and closingremarks
IABP insertion was associated with a signicant reduction in the
risk of perioperative mortality (3.5% vs 11% in IABP vs non- IABP
groups). e benet on mortality reduction was consistent aer
restricting the analysis to trials with low risk of bias, those reporting
30- day follow- up, and trials with patients undergoing CABG with
cardiopulmonary bypass. ese studies should guide surgeons towards considering elective preoperative insertion of IABP in highrisk patients with severe LVD.
e decision of whether to proceed with surgical revascularization
in a patient with ischaemic cardiomyopathy is an increasingly
common one, given the rising prevalence of this condition.
Unfortunately, it is also a dicult one because of the complexity and
variability of the clinical presentations and, until recently, because of
the paucity of data from randomized clinical trials. In summary, the
results of the available literature (including the STICHES data) seem
to support a signicant benet of CABG plus OMT over medical
Myocardial viabilityassessment
therapy alone across all clinically relevant long- term outcomes in
patients with LVD. Although more extensive CAD and worse LVD
and remodelling may be intuitively thought to be associated with inViability of the myocardium is the central principle that underpins reperfusion therapies. In the context of ischaemic chronic
LVD, identifying myocardial hibernation is of clinical relevance, as
it represents potentially salvageable myocardial tissue. Should ‘viable’ myocardial tissue be present, restoration of adequate coronary
blood ow should in theory improve myocardial performance and
le ventricular EF, with the expectation of translating into improved
long- term outcomes.
On these premises, numerous non- randomized retrospective
studies in the early 1990s evaluated the value of viability testing in the
decision- making process concerning myocardial revascularization
in patients with ischaemic LVD. Ameta- analysis of these trials revealed a signicant association between revascularization and
creased operative mortality, those characteristics are found among
patients who derive the greatest benet from revascularization
and, hence, are those in whom CABG should not be delayed. e
role of preoperative assessment of myocardial viability on determining the treatment choice remains partially unsolved. On the
basis of the STICH results, however, assessment of myocardial viability should not be the arbitrating factor for therapy choice. ese
considerations are reected in the current recommendations for
revascularization in the 2018 European Society of Cardiology/
European Association for Cardio- oracic Surgery Guidelines on
myocardial revascularization, which indicate that (1)in patients
with severe systolic LVD and coronary artery disease suitable for
intervention, myocardial revascularization is recommended; and
422
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SECTION 8 Coronary artery bypass graft surgery inspecial situations
(2)CABG is recommended as the rst revascularization strategy
choice in patients with multivessel disease and acceptable surgical
risk (classI, level of evidence B).
REFERENCES
1. Shahian DM, O’Brien SM, Filardo G, Ferraris VA, Haan CK, Rich
JB, etal. e Society of oracic Surgeons 2008 cardiac surgery
risk models:part1— coronary artery bypass graing surgery. Ann
orac Surg. 2009;88(1, Suppl):S2– 22.
2. Kunadian V, Zaman A, Qiu W. Revascularization among patients
with severe le ventricular dysfunction:a meta- analysis of
observational studies. Eur J Heart Fail. 2011;13(7):773– 84.
3. Nagendran J, Bozso SJ, Norris CM, McAlister FA, Appoo JJ, Moon
MC, etal. Coronary artery bypass surgery improves outcomes in
patients with diabetes and le ventricular dysfunction. J Am Coll
Cardiol. 2018;71(8):819– 27.
4. Velazquez EJ, Lee KL, Deja MA, Jain A, Sopko G, Marchenko
A, etal. Coronary- artery bypass surgery in patients with le
ventricular dysfunction. N Engl J Med. 2011;364(17):1607– 16.
5. Panza JA, Velazquez EJ, She L, Smith PK, Nicolau JC, Favaloro RR,
etal. Extent of coronary and myocardial disease and benet from
surgical revascularization in LV dysfunction. J Am Coll Cardiol.
2014;64(6):553– 61.
6. Velazquez EJ, Lee KL, Jones RH, Al- Khalidi HR, Hill JA, Panza
JA, etal. STICHES Investigators. Coronary- artery bypass
surgery in patients with ischemic cardiomyopathy. N Engl J Med.
2016;374(16):1511– 20.
7. Petrie MC, Jhund PS, She L, Adlbrecht C, Doenst T, Panza JA, etal.
Ten- year outcomes aer coronary artery bypass graing according
to age in patients with heart failure and le ventricular systolic
dysfunction:an analysis of the extended follow- up of the STICH
trial (surgical treatment for ischemic heart failure). Circulation.
2016;134(18):1314– 24.
8. Mohammadi S, Kalavrouziotis D, Cresce G, Dagenais F, Dumont
E, Charbonneau E, etal. Bilateral internal thoracic artery use in
patients with low ejection fraction:is there any additional longterm benet? Eur J Cardiothorac Surg. 2014;46(3):425– 31.
9. Flack JE 3rd, Cook JR, May SJ, Lemeshow S, Engelman RM,
Rousou JA, etal. Does cardioplegia type aect outcome and
survival in patients with advanced le ventricular dysfunction?
Results from the CABG Patch Trial. Circulation. 2000;102(19,
Suppl 3):III84– 9.
10. Zangrillo A, Pappalardo F, Dossi R, Di Prima AL, Sassone ME,
Greco T, etal. Preoperative intra- aortic balloon pump to reduce
mortality in coronary artery bypass gra:a meta- analysis of
randomized controlled trials. Crit Care. 2015;19(1):10.
11. Orlandini A, Castellana N, Pascual A, Botto F, Cecilia Bahit
M, Chacon C, etal. Myocardial viability for decision- making
concerning revascularization in patients with le ventricular
dysfunction and coronary artery disease:a meta- analysis of nonrandomized and randomized studies. Int J Cardiol. 2015;182:494– 9.
12. Beanlands RS, Nichol G, Huszti E, Humen D, Racine N, Freeman
M, etal. F- 18- uorodeoxyglucose positron emission tomography
imaging- assisted management of patients with severe le
ventricular dysfunction and suspected coronary disease:a
randomized, controlled trial (PARR- 2). J Am Coll Cardiol.
2007;50(20):2002– 12.
13. Abraham A, Nichol G, Williams KA, Guo A, deKemp RA,
Garrard L, etal. 18F- FDG PET imaging of myocardial viability
in an experienced center with access to 18F- FDG and integration
with clinical management teams:the Ottawa- ve substudy of the
PARR 2 trial. J Nucl Med. 2010;51(4):567– 74.
14. Bonow RO, Maurer G, Lee KL, Holly TA, Binkley PF, DesvigneNickens P, etal. Myocardial viability and survival in ischemic le
ventricular dysfunction. N Engl J Med. 2011;364(17):1617– 25.
15. Neumann FJ, Sousa- Uva M, Ahlsson A, Alfonso F, Banning AP,
Benedetto U, etal. 2018 ESC/ EACTS Guidelines on myocardial
revascularization. Eur Heart J. 2019;40(2):87– 165.
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62
Coronary artery bypassgraing
Diabetes and kidney disease
Michael E. Farkouh and Valentin Fuster
Coronary bypass surgery anddiabetes
e prevalence of diabetes is expected to rise considerably to aect
over 500million adults worldwide by 2030. ere are important
distinctions between type 1 and type 2 diabetes, as their pathophysiology is dierent, but for the sake of this discussion, the focus
will predominantly be on patients with type 2 diabetes, which accounts for more than 95% of the cases of diabetes globally. Patients
with diabetes have high risk of atherosclerotic plaques related to
the increased inammation, insulin resistance, dyslipidaemia, and
elevated glucose levels. is dysfunctional cardio- metabolic environment promotes accelerated atherosclerosis. Diabetic coronary
artery disease (CAD) is marked by its diuse and multivessel nature. Agreat deal of study has been committed to the optimal approaches to the revascularization of patients with diabetes and
multivessel CAD.
Theevidence
e comparison of multivessel stenting to coronary artery bypass
surgery began in the late 1980s with a series of trials. At that time,
the comparator to bypass surgery was balloon angioplasty (percutaneous transluminal coronary balloon angioplasty). Although
a number of trials were conducted, the landmark study was the
Bypass Angioplasty Revascularization Investigation (BARI) trial,
which recruited over 300 patients with diabetes among a total of
1829 subjects., In the BARI trial, the evaluation of a diabetic subgroup was prespecied by the data safety monitoring board because of the concern regarding the interaction between diabetes
and contrast- induced nephropathy. Overall, there was no dierence in overall survival at 5years. However, there was a marked
dierence in the diabetic subgroup at 5years with mortality in
the bypass group of 19.4% compared to 34.5% in the percutaneous transluminal coronary balloon angioplasty arm (P=0.003).
BARI was important with regard to the study of diabetes and heart
disease on two fronts:rst, the mortality dierence and second,
high usage of internal thoracic artery (ITA) graing in over 80%
in the surgical arm. is led to a hypothesis that ITA graing was
protective in diabetes when compared to surgical vein graing
alone leading to a National Heart, Lung, and Blood Institute alert
in the United States for diabetic patients with multivessel disease
with the recommendation that these patients be considered for
coronary artery bypass gra (CABG) surgery given the ndings
of BARI.
The bare metal stentingera
A number of important trials were conducted with bare- metal
stents (BMSs) with regard to a diabetic subpopulation. e Arterial
Revascularization Study (ARTS) trial demonstrated an improved
trend in survival of bypass patients when the ITA graing was used
more than 89% of the time. e mortality rate in the percutaneous
coronary intervention (PCI) arm was 6.3% compared to 3.1% in the
surgical arm (P=0.294 trend). Similarly, there was an important
nding in the diabetic subpopulation of the Stent or Surgery (SoS)
trial, which showed a hazard ratio (HR) of 3.53 (95% composite
1.14– 10.95) in favour of bypass surgery. Finally, there was no difference in mortality up to 5years in the Medicine, Angioplasty, or
Surgery Study (MASS II), but the patients treated medically only
had increased mortality. e major issue in the BMS era was the
high rates of restenosis and accelerated neointimal hyperplasia.
With the advent of drug- eluting stents (DESs) the issue of restenosis seemed to be addressed. However, the trends in mortality
between PCI and CABG in favour of CABG continued into the
DES era.
The drug- eluting stentera
A number of trials have been undertaken in the DES era, predominantly with rst- generation DES platforms to compare PCI
with CABG. e rst trial to report was the Synergy between
Percutaneous Coronary Interventions with Taxus versus Bypass
Surgery (SYNTAX) trial, which had a 12- month end point with 452
424
No. at risk
PCI
CABG
(a) Primary outcome
(b)
219
221
No. at risk
PCI
CABG
947
855
806
449
243
238
655
45
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SECTION 8 Coronary artery bypass graft surgery inspecial situations
of the 1800 patients having diabetes and complex CAD with either
three- vessel or le main disease. Although the 12- month primary
outcome was negative for non- inferiority of PCI versus bypass, the
investigators have recently released their 5- year major adverse cardiac and cerebrovascular events (MACCE) outcome data. At 5years,
MACCE rates were signicantly increased in the PCI– DES group,
46.5% versus 29% (P <0.001). Other smaller studies, the Veterans
Aairs Coronary Artery Revascularization in Diabetes Study (VA
CARDS) and the Coronary Artery Revascularization in Diabetes
(CARDia) trial, also reported similar trends in favour of bypass surger y., e CARDia trial and VA CARDS were both underpowered to show signicant dierences in MACCE.
e Future Revascularization Evaluation in Patients with
Diabetes Mellitus: Optimal Management of Multivessel Disease
60
50
P = 0.005 by log-rank test
5-yr event rate: 26.6% vs 18.7%
40
30
or stroke (%)
20
10
Death, myocardial infarction,
(FREEDOM) trial, sponsored by the National Heart, Lung, and
Blood Institute, was carried out from 2005 to 2012 at over 100 international centres. FREEDOM directly addressed the BARI- 1 hypothesis and enrolled exclusively diabetic patients. In FREEDOM,
1900 patients were randomized to bypass surgery or PCI– DES.
With a median follow- up of 3.8years, the 5- year Kaplan– Meier estimates in FREEDOM showed a signicant increase in the primary
composite of all- cause mortality, non- fatal myocardial infarction,
or non- fatal stroke, 26.6% in the PCI group versus 18.7% in the
bypass group (P=0.005) (Fig. 62.1). When the individual components of the primary outcome were reported, there was a signicant reduction in myocardial infarction in the CABG group, 6.0%
versus 13.9% (P <0.001) and a strong trend towards a reduction in
overall mortality (P=0.049). As has been noted in FREEDOM and
PCI
CABG
0
0 123
953
947
Death
Death from any cause (%)
60
50
P = 0.049 by log-rank test
5-yr event rate: 16.3% vs 10.9%
40
30
20
10
0
0123
953
Years since randomization
848
814
897
788
758
Years since randomization
845
625
613
685
416
422
PCI
CABG
466
Fig.62.1 Kaplan– Meier analyses of primary outcome (composite of all- cause mortality, non- fatal myocardial infarction, or non- fatal stroke) (a)and
mortality (b)in the FREEDOM trial.
62 Coronary artery bypassgrafting 425
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other bypass versus PCI trials, there was an increase in non- fatal
stroke with the rate almost doubling at 5.2% in the bypass group
ere was no signicant interaction in mortality whether BMS or
DES platforms were used (Fig. 62.2).
compared to 2.4% in the PCI group (P=0.03) at 5years. e results of FREEDOM in combination with the three other trials led to
a classIrecommendation by the American College of Cardiology
and American Heart Association that bypass surgery be the preferred mode of revascularization in individuals with diabetes and
multivessel disease using a Heart Team approach. e long- term
follow- up of FREEDOM, the FREEDOM Follow- On Study, followed 943 patients from the original cohort. At a median followup of 7.5years, the all- cause mortality rate was signicantly higher
in the PCI arm (24.3% vs 18.3%, HR 1.36, 95% condence interval
(CI) 1.07– 1.74; P= 0.01). is is the rst randomized controlled
trial since BARI to demonstrate a survival advantage of CABG over
PCI in the overall multivessel population.
Mechanisms ofbenefit forsurvival
ofbypass surgery overPCI
ere are a number of hypotheses as to why patients with bypass
surgery enjoyed greater survival and freedom from MACCE events
when compared to PCI across the dierent eras of PCI. ere are
a number of theories as to the mechanisms of this benet which
range from greater completeness of revascularization in the sur-
gical arm, longer patency of ITA gras, the greater use of multiple
arterial gras (MAGs), and better optimal medical therapy with
statin use and newer antidiabetic therapies. ese are plausible but
likely the most important dierence is the protection of bypass pa-
The modern era oflater- generationstents
tients from non- target lesion events. is is well established by the
landmark work of Cutlip and colleagues. What is now clear from
FREEDOM is that the SYNTAX score does not inform the choice of
A great deal of emphasis has been put on later- generation DESs as
well as other stent platforms. Recently, there has been a suggestion
that these platforms, by reducing stent thrombosis, may reduce the
rates of MACCE as well and make up some of the dierence between
PCI and CABG that has been demonstrated in the earlier trials.
e totality of the evidence suggests that for the MACCE event rates,
the dierence between PCI and CABG continues to be maintained
regardless of stent platforms. is may very well have to do with
non- target lesion events in the long term.
A meta- analysis by Verma and colleagues of the four main BMS
and the four main DES trials comparing PCI with CABG has demonstrated an improved survival for diabetics with multivessel disease and CABG with a relative risk of 0.67 (P=0.002) (Table 62.1).
revascularization strategy in patients with diabetes largely because
it is not an independent predictor of MACCE in the CABG cohort
with any tertile of score.
Chronic kidney disease incoronary bypasssurgery
Chronic kidney disease (CKD) stage 3 and stage 4 aects about
7% of the adult population in the United States. e optimal
revascularization strategy for patients with CKD and multivessel
CAD is not well established as these patients have been excluded
from most clinical trials. e overall sample of patients with CKD
registered in clinical trials comparing CABG and PCI is extremely
limited. erefore, the majority of our data comes from registrybased cohorts from which there is conicting evidence.,
Table62.1 Trials ofPCI withstents versus CABG
BMS DES
ERACI II ARTS SoS MASS II CARDia SYNTAX FREEDOM VA CARDS
No. patients with
diabetes/ total
patients
Trial characteristics
Funding Industry Industry Industry Public Public/ industry Industry Public/ industry Public
Number of centres 7 67 53 1 24 85 140 22
Enrolment period Oct 1996– Sep
Mean follow- up
duration (years)
Male (%) 79 76 79 61 74 71 71 99
Previous MI (%) 28 43 46 41 N/ R 32 26 41
Triple vessel
disease (%)
Intervention— PCI
% DES 0 0 0 0 69 100 100 100
Reproduced from Verma S, Farkouh ME, Yanagawa B, etal. Comparison of coronary artery bypass surgery and percutaneous coronary intervention in patients with diabetes:a metaanalysis of randomised controlled trials. The Lancet. Diabetes & Endocrinology. Dec 2013;1(4):317- 328 with permission from Elsevier.
78/ 450 208/ 1205 142/ 988 115/ 407* 510/ 510 452/ 1800 1900/ 1900 207/ 207
1998
5 5 6 (median) 4.6
56 32 43 61 62 83 83 N/ R
Apr 1997– Jun
1998
Nov 1996– Dec
1999
May 1995– May
2000
5.0 (median)
Jan 2002– Jul
2007
5.1 (median) 5 3.8 (median) 2
Mar 2005– Apr
2007
Apr 2005– Apr
2010
Aug 2006– Mar
2010
426
https://t.me/medicina_free
SECTION 8 Coronary artery bypass graft surgery inspecial situations
Fig.62.2 Forest plots for individual study and pooled risk ratios for all- cause mortality (a), non- fatal myocardial infarction (b), non- fatal stroke (c), and
need for repeat revascularization (d), in randomized controlled trials comparing patients with diabetes and multivessel CAD with CABG versus PCI after
5years or the longest follow- up.
Reproduced from Verma S, Farkouh ME, Yanagawa B, Fitchett DH, Ahsan MR, Ruel M, etal. Comparison of coronary artery bypass surgery and percutaneous coronary intervention
in patients with diabetes:a meta- analysis of randomised controlled trials. The Lancet. Diabetes & Endocrinology. Dec 2013;1(4):317- 328 with permission from Elsevier.
Overall, it is well documented that patients with CKD have a
higher mortality and MACCE rate. ere are two types of patients
with CKD, those with and without the need for dialysis. Because of
the association of revascularization procedures with exacerbation of
CABG was associated with lower risk of mortality (HR 2.0 for PCI
vs CABG, 95% CI 1.40– 2.93).
Data from the FREEDOM trial comparing PCI to CABG reported
similar ndings consistent with the guideline recommendations.
acute kidney injury on top of CKD, there are renal and cardiovascular end points that are important to consider.
Based on very limited data, the American College of Cardiology
and American Heart Association guidelines for CABG suggest that
decisions in patients with multivessel CAD be considered independently of the CKD if there is moderate to severe CKD. As a result,
for these patients and those with end- stage renal disease, the recommendation is for CABG over PCI.
Recently, Bangalore and colleagues performed propensity
matching on over 5000 patients from the NewYork State registries
and compared long- term mortality for PCI versus CABG. In patients with CKD, PCI was associated with a greater risk of repeat
revascularization and myocardial infarction, but at a lower risk
of stroke. Overall, there was no dierence in long- term mortality
when newer- generation stents were used compared to bypass (HR
1.07 for PCI vs CABG, 95% CI 0.92– 1.24). In a separate analysis of
approximately 500 matched patients, in patients on haemodialysis,
Table62.2 CKD versus no CKD inFREEDOM:rates ofadverse
events byrenal function and adjusted hazard ratios (95% CI)
CKD (N=451) No CKD (N=1392)
Death, n (%) 82 (18.2) 108 (7.8)
Myocardial infarction, n (%) 37 (8.2) 108 (7.8)
Stroke, n (%) 21 (4.7) 34 (2.4)
Major bleeding, n (%) 40 (8.9) 82 (5.9)
MACE, n (%) 117 (25.9) 221 (15.9)
Event rates expressed as Kaplan– Meier estimates at 5years.
CKD, chronic kidney disease; HR, hazard ratio; CI, confidence interval; MACE, major
adverse cardiovascular events.
Reproduced from Baber U, Farkouh ME, Arbel Y, Muntner P, Dangas G, Mack MJ,
Hamza TH, Mehran R, Fuster V.Comparative efficacy of coronary artery bypass surgery
versus percutaneous Ccoronary intervention in patients with diabetes and multivessel
coronary artery disease with or without chronic kidney disease. Eur Heart J.2016 Aug 29.
pii:ehw378 with permission from Oxford University Press
62 Coronary artery bypassgrafting 427
(a) (b)
(c)
Survival (%)Survival (%)
Freedom from MACCE (%)
577 528 462 399 317 240 126
577 525 459 395 307 225 113
01
https://t.me/medicina_free
Patients in FREEDOM were classied as having CKD based on estimated glomerular ltration rate using the Chronic Kidney Disease
Epidemiology Collaboration equation. CKD in the FREEDOM trial
FREEDOM trial. Overall, the mortality rate at 5years was 20.3%
for those with renal insuciency alone and 28.5% for those who had
both diabetes and renal insuciency.
was dened as an estimated glomerular ltration rate less than 60 mL/
min/ 1.73 m in accordance with the National Kidney Foundation
guidelines. When compared to those without CKD, those with CKD
undergoing CABG enjoyed a greater absolute reduction in the risk
Renal insufficiency asa complication ofcoronary
bypasssurgery
of the composite of death, myocardial infarction, and stroke (26.0%
vs 35.6%, HR 0.73, 95% CI 0.50– 1.05) (Table 62.2). e trend for a
higher risk of stroke in the bypass group did not reach statistical signicance. In the FREEDOM analysis, CABG had long- term benets
with regard to MACCE and these eects were consistent whether
patients had CKD or not. One caveat was that there were very few
patients in FREEDOM with an estimated glomerular ltration rate
less than 30 mL/ min/ 1.73 m.
It is well documented that acute kidney injury is an important
postoperative complication of CABG surgery and is a predictor of
long- term survival. Modine and others conducted a prospective
randomized trial of on- pump versus o- pump CABG surgery and
reported no signicant dierence in postoperative plasma creatinine
levels. However, when comparing day 0 to day 5 of surgery there
was a signicant dierence in the level of microalbuminuria, with a
reduced rate of albumin secretion in the o- pump group (P=0.003).
Combined diabetes and renalinsufficiency
An intention- to- treat analysis of 42,477 consecutive CABG patients
in the Society of oracic Surgeons National Cardiac Database re-
vealed that o- pump CABG was associated with an approximately
Recent analyses in diabetic patients with CKD have been consistent with the ndings of both the Bangalore etal. study and the
100
*
80
25% reduction in risk of new postoperative renal failure, dened
as an increase in the baseline creatinine above 2.0 mg/ dL or new
100
80
*
60
40
20
0
024681012
431 396 343 299 250 214 185
431 364 313 240 164 108 46
100
80
60
40
20
0
0246810
577 537 492 443 393 342 299
Single AG
Multiple AG
Single AG
Multiple AG
Years after surgery Years after surgery
60
40
20
Freedom from MACCE (%)
0
024681
431 384 338 293 224 207 166
431 359 303 230 156 103 45
(d)
100
*
12 0246810 12
80
60
40
20
0
577 533 486 431 377 317 269
Single AG
Multiple AG
Years after surgeryYears after surgery
*
Single AG
Multiple AG
2
Fig.62.3 Kaplan– Meier curves showing long- term survival of the propensity score- matched patients given a single arterial graft (AG) versus those
given multiple AGs. The numbers at risk at each time point are also shown. (a)Overall survival of diabetic patients. (b)Major adverse cardiovascular and
cerebrovascular event (MACCE)- free survival of diabetic patients. (c)Overall survival of non- diabetic patients. (d)MACCE- free survival of non- diabetic
patients. *P < 0.05 (by the log- rank test) versus single arterial graft group.
Reproduced from Yamaguchi A, Kimura N, Itoh S, Adachi K, Yuri K, Okamura H, Adachi H.Efficacy of multiple arterial coronary bypass grafting in patients with diabetes mellitus.
European Journal of Cardio- Thoracic Surgery. 2016;50:520– 527 with permission from Oxford University Press.
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