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MOUSSA ET AL.
lesion location (ostial or body vs. bifurcation), and the concomitant need for multivessel
intervention. The exceptionally high rate of repeat intervention (38%) at one year in the
study by Price et al. (11) was due to the systematic angiographic follow-up that revealed a
high rate of focal restenosis, particularly at the ostium of the left circumflex artery, which
was oftenasymptomatic.The extensiveuse ofkissing stenttechnique andlow rateof kissing
balloon inflation may have played a role as well. Similar trends were noted in the study by
Valgimigli et al. (15), where serial surveillance angiography in a cohort of LM PCI patients
with primarily bifurcation stenting revealed a 38% incidence of restenosis. In this study,
however, clinically driven TLR at 600 days was noted in
15% of patients with distal LM
intervention versus 3% of patients with ostialor body left main intervention. The favorable
outcome of patients with ostial or body left main intervention was also confirmed by
Chieffo and colleagues (12), where only 5.4%
of patients needed reintervention at 2.5 years
of follow-up.
Whether
one DES performs better than others in patients with ULMCAD awaits the results
of theappropriate trials. Asof this writing,the only randomizedstudy available is the ISAR-LM
trial, which compared SES to PES in patients with ULMCAD (16). In this trial, there was no
difference in cardiac death, nonfatal MI, or repeat intervention at two-year follow-up. Since
stent platforms, polymers, anddrugs are steadily evolving, itis unlikely that studies comparing
one product with another will ever be meaningful.
Although the above studiesprovided reassuring data similar to therole of DES in patients
with ULMCAD, the absence of a comparative CABG arm and the inclusion of high proportion
of high-risksurgical patients limit theirvalue with respectto informing clinicaldecision making
for the choice between CABG and DES in good-risk surgical patients.
Registries Comparing DES to CABG Surgery for ULMCAD
Although this category ofstudies provided new data regarding the comparativeefficacy of DES
to CABG surgery in patients with ULMCAD (Table 3), the majority of these studies (17–20)
included a large proportion of high-risk surgical patients, except for the study by Seung and
colleagues (21).
Tab le 3 Studies of DES Vs. CABG in Patients with ULMCAD
Patient
no.,
DES/
Registry
Chieffo
et al. (17)
Bolognab(18) 157/154 64/61 80/ NR 1.2 7.4/9.7 5.3/4.5 NR 22.3/2.6%
Lee et al. (19) 50/123 64/46 60/ NR 1 4/15 0/2 0/8 13/5
SanMartin
et al. (20)
Seung
et al. (21)
RCT
LE MANS
(22)
SYNTAX (23) 357/348 0/0 NR 1 4.2/4.4 4.3/4.1 0.3/2.7a12/6.7
High surgical risk defined by a Euroscore >6 or a parsonnet score >13–15.
a
p
< 0.05.
b
DES was used in 94 out of 157 patients (long-term events are for DES patients).
Abbreviation
CABG
107/142 32/29 81/NR 1 2.8/6.4 0.9/1.4 0.9/2.1 19.6/5.7%
96/245 27/25 62/ NR 1.3 5.2/8.4 0/1.3 0/0.8 5.2/0.8
396/396 3 61/61 3 9/7 NR NR 9/2
52/53 0/0 56/60 1 1.9/7.5 1.9/5.6 0/3.7 27/9.4
: NR, not reported (MI and stroke not reported separately in the study by Seung KB).
High
surgical
risk (%),
DES/
CABG
Distal
location (%),
DES/
CABG FU (yr)
Cardiac
death
(%),
DES/
CABG
Cumulative long-term events
MI (%),
DES/
CABG
Stroke
(%),
DES/
CABG
TVR (%),
DES/
CABG
a
a
a
a
a
CORONARY REVASCULARIZATION FOR PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE
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121
Compared to CABG surgery, DES use in patients with ULMCAD was associated with
1. Similar incidence of cardiac death and myocardial infarction.
2. Lower incidence of procedural strokes.
3. Higher incidence of repeat revascularization for PCI with significant variability among
studies reflecting previously discussed factors.
One of the largest and well-conducted registries comparing stenting in good surgical
candidates to CABG surgery in patients with ULMCAD is the MAIN-COMPARE registry (21).
In this registry, 1102 patients with ULMCAD who underwent stent implantation and 1138
patients who underwent CABG in Korea between January 2000 and June 2006 were evaluated.
The majority of patients (97%) inthis study were considered good surgical candidates. Atthreeyear follow-up, in the matched cohort, there was no significant difference between the stenting
and CABG groups in the risk of death [hazard ratio for the stenting group, 1.18;95% confidence
interval (CI), 0.77–1.80) or the risk of the composite outcome of death, Q-wave myocardial
infarction, stroke, and target-vessel revascularization (hazard ratio for the stenting group, 1.10;
95% CI, 0.75–1.62). The rates of target-vessel revascularization were significantly higher in the
group that received stents than in the group that underwent CABG (hazard ratio, 4.76; 95% CI,
2.80–8.11).
These studies demonstrate that PCI with DES is safe and results in acceptable shortand intermediate-term survival results compared with those seen with CABG surgery, even in
patients with complex disease.
Randomized Clinical Trials Comparing PCI and CABG for ULMCAD
To date there have been only two RCTs comparing CABG surgery to DES in patients with
ULMCAD who qualify for both procedures. In the
LE MANS study (22), 105 patients with
ULMCAD were randomly assignedto PCI (52 patients) or CABG(53 patients). The primary end
point wasthe changein left ventricularejection fraction(LVEF) 12 months after theintervention.
A significant increase in LVEF at the 12-month follow-up was noted only in the PCI group (3.3
± 6.7% after PCI vs. 0.5 ± 0.8% after CABG; p = 0.047). Patients performed equally well on
stress tests, and angina status improved similarly in the two groups. PCI was associated with
a lower 30-day risk of major adverse events (MAE) (p = 0.006) and major adverse cardiac and
cerebrovascular events (MACCE) (p = 0.03) and shorter hospitalizations (p = 0.0007). Total
and MACCE-free one-year survival was comparable. Left main target vessel failure (TVF) was
similar in the two groups. During the 28.0 ± 9.9 months follow-up, there were three deaths in
the PCI group and seven deaths in the CABG group (p =0.08).
The largest randomized clinical trial to address the efficacy of DES versus CABG surgery
in patients with ULMCAD who qualify for both is the SYNTAX (TAXUS Drug-Eluting Stent
Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries) study (23). In
this study, 1800 patients were randomized to CABG surgery versus PES. Patients were stratified
by the presence of diabetes mellitus or ULMCAD. The primary clinical endpoint of the trial
was the 12-month major cardiovascular or cerebrovascular event rate (MACCE). Among trial
participants, 705 patients withULMCAD were randomized to PES(n =357) and CABG surgery
(n = 348) (24). In patients with ULMCAD, the use of PES, compared to CABG surgery, resulted
in similar MACCE rates at one-year follow-up (Fig. 1) and similar combined safety endpoints
(death, MI, and stroke) (Fig. 2). For patients treated with PES compared to those undergoing
CABG, there was similar mortality and myocardial infarction, lower stroke rate, and higher
need for repeat revascularization at one-year follow-up (Fig. 3). The higher need for repeat
revascularization in the PES group was significant only in patients with LM plus two- or threevessel disease (Fig. 4). In this trial, the SYNTAX score was used to stratify patients according
to the angiographic complexity of coronary disease. Patients with low (Fig. 5) and intermediate
complexity scores (Fig. 6) had similar MACCE rate at one-year irrespective of revascularization
modality whilepatientswith highcomplexity scores(Fig. 7)had higher MACCE eventrate when
treated with PES as opposed to CABG primarily due to higher rate of repeat revascularization.
Interestingly, the rate of symptomatic stent thrombosis at one-year in the PES cohort was the
same as the rate of symptomatic graft occlusion in the CABG cohort (Fig. 8).
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MOUSSA ET AL.
CABG PCI
(n = 705)
LM, all
LM only
LM + 1VD
LM + 2VD
LM + 3VD
(n = 91)
(n = 138)
(n = 218)
(n = 258)
13.7 15.8
8.5 7.1
13.2 7.5
14.4 19.8
15.4 19.3
MACCE (%)
p = 0.44
p = 1.00
p = 0.27
p = 0.29
p = 0.42
Figure 1 Overall MACCE at 12 months in the left main subset of the SYNTAX trial. (ITT population.)
One criticism of the SYNTAX data is that the one-year safety data may look different after
several years, with the potential for CABG to show a survival benefit as time passes. However,
two recentmeta-analyses ofprior CABGversus PCItrials showno mortalitydifferencesbetween
the two techniques between 5 and 10 years. One of these used pooled patient level data for the
analysis (25,26). The subgroupdata from SYNTAX are not definitive because thistrial was powered for MACCE events in the total study population. Nonetheless, the value of the SYNTAX
trial ininforming clinical decision making cannotbe underestimated.The trial includedpatients
from 85 sites in the United States and Europe, and over
70% of the screened study population, and represents real world practice. This is in sharp contrast to prior randomized trials
comparing PCI with either medical therapy or CABG, where fewer than 10% of screened
patients were studied. The SYNTAX data should be considered as part of an increasing body
of knowledge that consistently points to the safety and efficacy of DES in treatment of patients
with ULMCAD.
HOW SHOULD WE MAKE CLINICAL DECISIONS REGARDING REVASCULARIZATION
OF PATIENTS WITH ULMCAD?
Although the existing data regarding the utility of PCI (stents) versus CABG for revascularization of patients with ULMCAD who are good surgicalcandidates stilllack important milestones,
such as long-term follow-up, it is certainly of higher quality than the “evidence” that was used
to categorize CABG as a class I and PCI as a class III recommendation in this important CAD
subgroup in the current clinical practice guidelines. The most contemporary data regarding
PCI CABG
(n = 705)
LM, all
LM only
LM + 1VD
LM + 2VD
LM + 3VD
(n = 91)
(n = 138)
(n = 218)
(n = 258)
9.2 7.0
2.0 0.0
7.4 4.5
7.7 9.9
14.5 8.1
Death/CVA/MI (%)
Figure 2 Safety (death/CVA/MI) at 12 months in the left main subset of the SYNTAX trial. (ITT population.)
p = 0.29
p = 1.00
p = 0.72
p = 0.57
p = 0.11
CORONARY REVASCULARIZATION FOR PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE
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123
100
80
60
Freedom from death (%)
Months since allocation
100
95.8%
95.6%
p = 0.88*
2106
95.9%
100
80
(B)(A)
60
Freedom from CVA (%)
100
Months since allocation
99.7%
97.3%
p
= 0.009*
93.3%
2106
95.7%
80
60
Freedom from MI (%)
Months since allocation
p
= 0.97*
2106
PCI (n = 357)
80
(D)(C)
60
Freedom from revasc. (%)
06
Months since allocation
88.0%
p
= 0.02*
21
CABG (n = 348)
Figure 3 (A) Freedom from death at 12 months in the left main subset of the SYNTAX trial. (B) Freedom from
CVA at 12 months in the left main subset of the SYNTAX trial. (C) Freedom from MI at 12 months in the left
main subset of the SYNTAX trial. (D) Freedom from revascularization (any revascularization PCI or CABG) at
12 months in the left main subset of the SYNTAX trial. Event rates are expressed as event rate ± 1.5 SE.
exact test; calculated by core laboratory per ITT population.
∗
Fisher
the role of PCI (DES) versus CABG in patients with ULMCAD were not included in either the
guidelines or the recent appropriateness document, and point to the following:
1. There is no difference in death or MI up to three-years follow-up.
2. CABG surgery is associated with higher perioperative stroke rate.
3. PCI is associated with higher frequency of repeat revascularization primarily driven by
patients with combined ULMCAD and multivessel disease.
Critics of this data point to two issues: first, the lack of long-term (beyond three years)
follow-up afterPCI; and second,the concerns aboutlate stent thrombosis.Recent meta-analyses
suggest no mortality differences between PCI and CABG up to five years (26). If anything,
historical evidence points tothe fact that revascularization efficacy isattenuated with long-term
CABG
(n = 705)
LM, all
LM only
LM + 1VD
LM + 2VD
LM + 3VD
(n = 91)
(n = 138)
(n = 218)
(n = 258)
6.5 11.8
6.4 7.1
5.9 3.0
7.7
6.0
Revascularization (%)
Figure 4 Revascularization at 12 months in the left main subset of the SYNTAX trial.
PCI
15.3
14.8
p = 0.02
p = 1.00
p = 0.68
p = 0.08
p = 0.02
124
100
MOUSSA ET AL.
(n = 118)
CABG (n = 103)
80
PCI
92.3%
87.0%
Freedom from MACCE (%)
60
Months since allocation
Figure 5 MACCE at 12 months in the left main subset of the SYNTAX trial by SYNTAX score tercile (low scores
0–22). Event rates are expressed as event rate ± 1.5 SE.
p = 0.19*
2160
∗
Fisher exact test; calculated by core laboratory per
ITT population.
CABG (n = 92)
100
80
Freedom from MACCE (%)
60
Months since allocation
Figure 6 MACCE at 12 monthsin the left mainsubset of the SYNTAX trial by SYNTAX score tercile (intermediate
scores 23–32). Event rates are expressed as event rate ±1.5 SE.
PCI (n = 103)
p = 0.54*
2160
87.4%
84.5%
∗
Fisher exact test; calculated by core laboratory
per ITT population.
(n = 150)
CABG
100
PCI
(n = 135)
87.1%
80
74.7%
Figure 7 MACCE at 12 months in the left
main subset of the SYNTAX trial by SYNTAX
Freedom from MACCE (%)
60
Months since allocation
p = 0.008*
2160
score tercile (high scores ≥33). Event rates
are expressed as event rate ± 1.5 SE.
∗
Fisher
exact test; calculated by core laboratory per ITT
population.
follow-up due to progression of the disease.The benefit of CABG surgery over medical therapy
in patients with ULMCAD in the CASS registry started to narrow down after seven years (6).
This is not surprising given the failure rate of saphenous vein grafts, disease progression distal
to the bypass conduits, and the acceleration of disease proximal to the bypass graft insertions.
Although concern regarding the impact of delayed stent thrombosis after DES implan-
tation on outcome of patients with ULMCAD is
legitimate, the existing data are reassuring.
Chieffo and colleagues (27) reported the rate of stent thrombosis in a multicenter registry that
included 731 consecutive patients who had sirolimus- or paclitaxel-eluting stent implantation
in patients with ULMCAD. At 29.5 + 13.7 months follow-up, 4 (0.5%) patients had a definite
ST—three early (twoacute and onesubacute) and one late ST—andno cases ofvery late definite
ST were recorded. All patients survived the event. Three patients had a probable ST. Therefore,
CORONARY REVASCULARIZATION FOR PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE
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125
CABG (n = 348)
n = 9
n=9
n = 11
Patients with GO or ST (%)
01234
PCI (n = 357)
2.7
2.7
3.7
3.7
Figure 8 Symptomatic graft occlusion and stent thrombosis at 12 months in the left main subset of the SYNTAX
trial.
7/731 (0.95%) patients had a definite or a probable ST and all were on dual antiplatelet therapy
at the time of the event.
Recently, critics assertedthat the ethics of a randomized controlled trialcomparing CABG
with DESfor ULMCADare questionable because there is a lackof equipoisebetween the proven
“standard of care” and DES (4).In light ofthe current state of knowledge,this statement appears
to be unjustified.
The Neglected Surgical Endpoints
The ongoing debate has thus far ignored the impact of many CABG surgery specific complications. These complications and their associated morbidity, patient suffering, and need for both
prolonged hospital stay and readmissions have not been included as endpoints in any clinical
trial. Our surgical colleagues suggest that these complications are self-limiting and of little consequence to the patient over the long term” (28). Let us review these problems and explore how
relevant they are to our discussion.
In-Hospital Postoperative Complications
Despite the significant improvements in perioperative care after CABG surgery, major complications remain common. Brown and colleagues (29) reported on the incidence of post-CABG
complications in 114,233 Medicare beneficiaries who survived isolated CABG during a hospitalization for fiscal year 2005. The frequencies of seven complications were determined: hemorrhage or postoperative shock, reoperation, postoperative adult respiratory distress syndrome,
new-onset hemodialysis, postoperative stroke, postoperative infection, and septicemia.
After
adjusting for patient demographics and comorbid conditions, 13.64% of Medicare beneficiaries
experienced one or more of the study complications. These patients consumed significantly
more hospital resources (incremental cost, $15,468) and had a longer length of stay (incremental
stay, 5.3 days). This study did not address the issue of postoperative atrial fibrillation, which
develops in
dysfunction, infection, and greater resource utilization (30).
CABG occurs in almost 17% of Medicare patients,
after
and heart failur
∼30% of patients, and its association with subsequent cognitive changes, renal
Rehospitalization in the first month
mostly due to arrhythmias, infections,
e (31). Furthermore, what has not been studied well is the impact of these
complications on patient’s perception and quality of life.
Postoperative Cognitive Decline
Apart from stroke, which occurs in 1% to 3% of CABG procedures, patients undergoing CABG
surgery can suffer from two distinct neurological disorders, delirium and delayed cognitive
decline. Delirium is a well-recognized complication of any major surgery including CABG. It
occurs in around 3% of patients and is associated with a fivefold increase in hospital mortality
and length of hospital stay
(32). Cognitive decline is not usually apparent on regular clinical
examination and accurate diagnosis requires formal assessment on a battery of neuropsychological tests.Some patientsrecognize intellectualdeterioration (classically with memory, proprioceptive skills, or intellectual tasks such as crosswords), while in others relatives may observe
that things are “not quite the same.” The incidence of cognitive impairment varies widely. In a
systematic review, van Dijk and colleagues (33) reported a 22% incidence of cognitive decline
126
MOUSSA ET AL.
two months after CABG. Newman and colleagues (34) reported the incidence of cognitive
decline to be
53% at discharge, 36% at six weeks, 24% at six months, and 42% at five years in
261 patients.
Durability of CABG
When apatient is referredto undergo CABG surgery, one ofthe main attractions isits publicized
durability to the extent that many patients believe it is a permanent cure! Although it is true
that the internal mammary artery is a durable conduit, the same cannot be said for saphenous
vein grafts. About 8% of LIMA grafts and one-fourth of vein grafts fail within one year of
implantation (35), and this number approaches 50% at 10 years (36). Although there have been
reports of good results with bilateral ITA grafting, this is not frequently performed. Data from
the Society of Thoracic Surgery suggest that considerably fewer than 20% of patients receive
this procedure at a first isolated CABG (37).
Furthermore, itis not uncommonthat when CABG surgery is performed, bypass conduits
are attached at or proximal to severely diseased coronary segments or that some coronary segments is not bypassed at all. Moreover, surgical therapy significantly accelerates atherosclerotic
progression in the grafted vessels, especially in the proximal portions (38). Proximal disease
progression has been shown to result in adverse clinical events at follow-up (39).
In brief, it is difficult to understand why these well-documented CABG-related complications have been excluded from the ongoing debatesimilar to the pros and cons of CABG versus
PCI in patients with ULMCAD.Our surgical colleagues assertthat “patients are influenced into
making a preordained choice” and that cardiologists “instigate” patients in making the choice
between
PCI and CABG” (4). Although thismay occur in aminority of cases, it is more concerning thatsurgeons rarely, if ever, review the fullrange of thewell-documented complications and
shortcomings of CABG surgery. Instead of declaring that “these complication are self-limiting
with no long-term sequelae” (28), we all need to provide this information to patients and let
them weigh the impact on their well-being.
HOW SHOULD GOOD-RISK SURGICAL PATIENTS WITH ULMCAD BE COUNSELED ON
REVASCULARIZATION OPTIONS IN THE YEAR 2009?
Some physicians may choose to continue relying on the current guidelines and simply refer
all patients with ULMCAD who are good surgical candidates to CABG surgery. We think that
the existing data can inform clinical decision making beyond what the current guidelines offer.
A few actual clinical scenarios illustrate the discussion with patients with ULMCAD who are
good surgical candidates:
Patient #1
A 45-year-old male with progressive exertional angina on medical therapy. Patient underwent
ECG exercisestress testwhere he exercisedfor 11minutes, developedangina, andischemic
ECG changes with concomitant drop in BP. CTA demonstrated obstructive disease in the
LAD and RCA. Coronary angiography showed ULMCAD and three-vessel disease and
normal left ventricular systolic function [Fig. 9(A)]. Subsequent management and follow-
up are illustrated in Figure 9(B).
Patient #2
A 58-year-old male with multiple cardiovascular risk factors and CAD status post-PCI on the
LAD presents with recurrent progressive exertional angina while on medical therapy.
Coronary angiography demonstrated ostial ULMCAD with no significant involvement of
other territories. He had normal left ventricular systolic function and no comorbidities.
Coronary angiography and subsequent management are shown in Figure 10.
Patient #3
A 78-year-oldmale with end-stage renal disease underwent cardiac work-up priorto hemodial-
ysis fistula construction. Pharmacological stress test showed anterior ischemia and an
echocardiogram demonstrated a left ventricular ejection fraction of 35%. The patient
did not have other comorbidities. Coronary angiography demonstrated ULMCAD with
involvement of the ostial LAD and LCx. The coronary anatomy and subsequent manage-
ment are shown in Figure 11.
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127
Counseling eachone of these patients regarding options of coronary revascularization can
take one of the following directions:
Counseling option #1
You have a severe blockage in the left main coronary artery as well as in some of its branches.
This is a serious condition and we need to restore blood flow to your heart as soon as
possible. When you return to your roomyou will be seen by a cardiac surgeon to evaluate
(a) (b)
(c)
(d)
(A)
Figure 9 (A) Coronary angiography at baseline: (a) note the distal ULMCAD (
LAD disease, severe distal LAD disease, and severe proximal LCx disease; (b) note the severe disease in the
distal LAD as well as the collaterals from the septal branches to the right poster lateral branch; (c) note the distal
LM and OM lesions; (d) note the proximally occluded RCA. The patient was counseled to undergo CABG surgery.
The patient could not return to work before two months. The patient had recurrent angina six-month post-CABG
with evidence of anterior ischemia, which was managed medically. Patient returned a year later with recurrent
progressive angina while on medical therapy. (B) Coronary angiography after one year: (a) note occlusion of
the mid-LAD; (b) note that the insertion site of the left internal mammary artery graft is proximal to a severely
diseased segment; (c) note that the insertion of the SVG to OM1 is proximal to a severely diseased segment;
(d) note patent SVG to OM2; (e) note the stenosed SVG to a small PDA. The large posterolateral branch was not
bypassed. In retrospect, was it appropriate to perform CABG surgery considering the extent of distal coronary
disease particularly in the LAD? Did CABG surgery provide complete revascularization in this patient? Did CABG
accelerate progression of disease in the proximal LAD?
white arrow
), moderate proximal
(
Continued on page 128
)
128
MOUSSA ET AL.
(a)
(c)
(b)
(d)
Figure 9 (
Continued
(e)
(B)
)
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129
(A)
(B)
(C) (D)
Figure 10 (A) Note the ostial disease in the ULMCA; (B) note mild disease in the LAD and LCx artery; (C) note
the moderate disease in the PDA. The patient was counseled by both the cardiac surgeon who offered him CABG
surgery and the interventionalist who offered him PCI with DES placement. (D) The patient declined CABG and
subsequently underwent ULMCAD PCI with DES. At one-year follow-up patient remains free of symptoms.
you for coronary bypass surgery because it is the standard of care for treatment of this
condition.
Counseling option #2
You have a severe blockage in the left main coronary artery as well as in some of its branches.
This is a serious condition and we need to restore blood flow to your heart as soon as
possible. When you return to your room I will visit you and explain to you how we can
restore blood flow using a minimally invasive approach with a stent.
Counseling option #3
You have a severe blockage in the left main coronary artery as well as in some of its branches.
This is a serious condition and we need to restore blood flow to your heart as soon as
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