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Transcript
Online Materials
1
2
Full title: Coronary Artery Bypass Graft Surgery and Percutaneous Coronary
3
Interventions in Patients with Unprotected Left Main Coronary Artery Disease
4
Contents
5
Ⅰ Online Methods
6
Data source and management
7
Revascularization procedures
8
Definitions
9
Ⅱ Online Tables
10
Table 1. Indicators for either CABG or PCI procedure
11
Table 2. Candidate patient-level covariates for adjustment
12
Table 3. Discrimination and calibration results for multivariable logistic regression
13
models
14
Table 4. Proportional hazards assumption of the Cox regressions
15
Table 5. Baseline characteristics of patients after adjustment with inverse
16
probability-of-treatment weighting
17
Table 6. 30-day outcomes for patients treated with CABG and PCI
18
Table 7. Baseline characteristics of patients with baseline SYNTAX scores
19
Table 8. Baseline characteristics of patients without contraindications to CABG
20
Table 9. Procedural characteristics of patients with baseline SYNTAX scores
21
Table 10. Procedural characteristics of patients without contraindications to CABG
22
Table 11. 30-day and 3-year outcomes for patients with baseline SYNTAX scores
23
Table 12. 30-day and 3-year for patients without contraindications to CABG
24
Ⅲ Online Figures
1
1
Figure 1. Patient Flowchart.
2
ULMD = unprotected left main disease; CABG = coronary artery bypass graft; PCI
3
= percutaneous coronary intervention; STEMI = ST-segment elevation myocardial
4
infarction.
5
6
7
8
9
10
11
12
13
14
15
16
Figure 2. Revascularization Strategy Selection for Patients with ULMD at Our
Institution During 2004 and 2010.
ULMD = unprotected left main disease; CABG = coronary artery bypass graft; PCI
= percutaneous coronary intervention.
Figure 3. Unadjusted Kaplan-Meier Curves of 3-Year Outcomes According to
Revascularization Strategy and SYNTAX Score.
(A) patients with low to intermediate-risk SYNTAX score (≤32); (B) patients with
high-risk SYNTAX score (>32).
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention;
MI = myocardial infarction.
Figure 4. Adjusted Survival Curves of 3-Year Outcomes According to
Revascularization Strategy and SYNTAX Score.
17
(A) patients with low to intermediate-risk SYNTAX score (≤32); (B) patients with
18
high-risk SYNTAX score (>32). The HRs were reported for patients undergoing PCI
19
with those undergoing CABG as reference.
20
21
22
23
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention;
MI = myocardial infarction.
Figure 5. Unadjusted Kaplan-Meier Curves of 3-Year Outcomes According to
Revascularization Strategy and Diabetes Mellitus.
24
(A) patients without diabetes mellitus; (B) patients with diabetes mellitus.
25
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention;
2
1
2
3
MI = myocardial infarction.
Figure 6. Adjusted Survival Curves of 3-Year Outcomes According to
Revascularization Strategy and Diabetes Mellitus.
4
(A) patients without diabetes mellitus; (B) patients with diabetes mellitus. The HRs
5
were reported for patients undergoing PCI with those undergoing CABG as reference.
6
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention;
7
8
9
10
11
12
13
14
15
16
MI = myocardial infarction.
Figure 7. Unadjusted Hazard Ratios of Clinical Outcomes According to
Selected Major Subgroups.
a
Data are Kaplan-Meier estimates of cumulative event rate at 3 years, expressed as
percent of patients.
b
ULM bifurcation and SYNTAX Score subsets analyses were conducted in 2,752
patients whose baseline angiogram was available.
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention;
MI = myocardial infarction; LVEF = left ventricular ejection fraction.
Figure 8. Patients Distribution and 3-Year All-cause Mortality According to
17
Revascularization Strategy and SYNTAX Score.
18
Patients were divided into low or intermediate risk (≤32) and high risk (>32) groups
19
according to the SYNTAX score in the PCI and the CABG group. Data are expressed
20
as percent of patients.
21
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention.
22
3
1
Online Methods
2
Data source and management
3
The two primary databases used in the study were our institutional CABG registry and
4
PCI registry. These registries were developed in 1999 and 1997, respectively, after the
5
approval of the institutional review board, for the purpose of collecting information on
6
all consecutive patients who had undergone CABG or PCI in our institution. The two
7
registries contain information on demographics, comorbidities, hemodynamic state,
8
left ventricular function, diseased vessels and vessels for which bypass or angioplasty
9
was attempted, operator identifiers, and in-hospital adverse outcomes. The PCI
10
registry also contains information on the types of device used for each patient,
11
including bare-metal stents and drug-eluting stents. Uniform definitions for these
12
elements are used in our study. These clinical, angiographic, procedural or operative,
13
and outcome data were collected with the use of a dedicated computer-based reporting
14
system. We performed routine data auditing to ensure timeliness, completeness and
15
accuracy of the data.
16
For in-hospital data collection, we established 11 modules with 392 items, among
17
which 184 items composed the core dataset and 208 composed the extended dataset.
18
The core dataset is a mandatory set of variables believed to be necessary for the
19
accurate representation of a clinical practice, risk model development, and analysis.
20
The extended dataset includes less critical but still important fields that are strongly
21
encouraged to be collected but are not mandatory for submission. The creation of
22
custom fields is permissible such that the sites can collect specific data that are
23
desirable. The complete in-hospital data is requested to be submitted within 30 days
24
after CABG or PCI.
25
Data variables have been added for internal quality and integrity checks. If any
4
1
component of the required mandatory data elements is missing or any of the
2
validation roles of logic are not meet, then the data will be automatically rejected. The
3
Medical Research & Biometrics Center (MRBC) of National Center for
4
Cardiovascular Diseases (NCCD) back-end checks data for completeness and integrity.
5
To further audit the accuracy of the data, we randomly select 5-10% of in-hospital
6
data annually. Two qualified physicians from the MRBC abstract all of the medical
7
record data independently. After discussion between the two physicians, the final
8
standard data are established. Next, we compare the data between MRBC data
9
abstraction and the database. We defined the accuracy of the data elements as present
10
when the standard data and the submitted data are exactly the same or both are
11
missing for categorical variables. For continuous variables, we defined the accuracy
12
of the data as it was within ±10% of the value recorded in the standard data. The
13
accuracy report is fed back to each data collection staff, and we also request that staffs
14
review and correct the data in error.
15
5
1
Revascularization procedures
2
1. CABG
3
Anesthesia was managed by inhalation of isoflurane with the addition of fentanyl or
4
sufentanil, and propofol was administered continuously until the end of the procedure
5
if necessary. Surgical revascularization was performed using standard bypass
6
techniques. CABG procedures were performed under cardiopulmonary bypass or
7
off-pump, at the surgeon’s discretion. For on-pump CABG, a standard
8
cardiopulmonary bypass was established, and moderate systemic hypothermia (28°C
9
to 32°C) and perfusion with antegrade intermittent cold crystalloid cardioplegia were
10
used. Heparin was given to achieve activated clotting times of 480 seconds or above
11
before institution of cardiopulmonary bypass. For off-pump CABG, stabilization
12
devices were used to provide a motionless anastomosis site, and heparin was
13
administered before the start of the first distal anastomosis to achieve an activated
14
clotting time of 300 to 350 seconds. On-pump CABG involved aortic cross-clamping
15
and cardioplegic arrest, while off-pump CABG was performed with a partial
16
occlusion clamp. Whenever feasible, Y or T grafts were used to avoid partial aortic
17
clamping when performing proximal anastomoses. Whenever possible, complete
18
revascularization was attempted, and the internal thoracic artery was used
19
preferentially for revascularization of the left anterior descending artery. The
20
remaining vessels were to be bypassed either using another arterial conduit or the
21
saphenous vein in the configuration decided by the surgeon. During reperfusion, the
22
bypass grafting was completed with proximal anastomoses to the ascending aorta. The
23
decision to switch to cardiopulmonary bypass during the procedure was based on
24
significant hemodynamic instability or ventricular arrhythmia. After separation from
25
cardiopulmonary bypass or on completion of all anastomoses, protamine was given to
6
1
reverse the effects of heparin. Postoperatively, starting within the first 24 hours,
2
aspirin therapy (100 mg/d) was recommended and should be continued indefinitely.
3
2. PCI
4
All patients undergoing PCI received aspirin plus clopidogrel (loading dose, 300 or
5
600 mg) before the coronary intervention. Vascular access method and the choice of
6
the specific type of drug-eluting stents (ie, sirolimus- or paclitaxel- or everolimus- or
7
zotarolimus-eluting stents) was left to the interventionalist’s discretion. Lesions at the
8
ostium or shaft without involvement of ULM bifurcation were usually treated with
9
single stents. ULM bifurcation lesions were treated using different stenting strategies
10
including provisional stenting or 2-stent technique in the vast majority of cases. Stent
11
strategies to treat distal bifurcation lesions included: crossover stenting with side
12
branch balloon angioplasty, provisional or dedicated T stenting, simultaneous kissing
13
or V stenting (TF approach only), Culotte or crush technique (including “step crush”
14
technique involving sequential balloon crushing of side branch stent followed by main
15
vessel stenting). Final kissing balloon post-dilation was performed in cases with
16
suboptimal results after crossover stenting at the side branch ostium and, in most
17
cases, with 2-stent implantation. During the procedure, unfractionated heparin (100
18
U/kg) was administered to all patients. Proximal optimization technique (POT) with
19
additional bigger balloons was performed to optimize stent apposition. Intravascular
20
ultrasound was recommended to assess the baseline characteristics and the final
21
results. Adjunctive devices including cutting balloon angioplasty or rotablator were
22
used in selected patients with severe calcified or fibrous plaque. Glycoprotein IIb/IIIa
23
antagonists and an intra-aortic balloon pump were used if clinically indicated. After
24
the procedure, aspirin plus clopidogrel therapy was continued indefinitely. After the
25
procedure, aspirin was prescribed at a dose of 300 mg daily for 3 months, followed by
7
1
100 mg daily indefinitely; clopidogrel 75 mg daily was prescribed for at least 1 year.
2
For patients with stents requiring anticoagulation (chronic atrial fibrillation for
3
example), it was recommended to follow the American College of
4
Cardiology/American Heart Association ST elevation myocardial infarction
5
guidelines for triple therapy after stenting.
6
8
1
Definitions
2
Death was defined as death from any cause.
3
Myocardial infarction occurred when there were clinical signs and symptoms of
4
ischemia that were distinct from the presenting ischemic event and meeting at least 1
5
of the following criteria:
6
1. Spontaneous (>48 h after PCI, and/or after CABG)
7
A. New, significant Q waves in at least 2 contiguous leads of an ECG that were not
8
present with the presenting ischemic event;
9
B. Patients whose most recent cardiac markers measured before reinfarction, which
10
were normal, require an increase in CK-MB or troponin above the 99th percentile
11
limit of normal and at least ≥20% above the most recent value.
12
2. Within 48 h after PCI:
13
A. Patients with normal biomarker values (preprocedure) who then develop an
14
increase in biomarker values >5 times the 99th percentile ULN or if the baseline
15
values are elevated and are stable or falling, a rise of cTn values ≥20%. In addition,
16
symptoms suggestive of myocardial ischemia or new ischemic electrocardiographic
17
changes or angiographic findings consistent with a procedural complication or
18
imaging demonstration of new loss of viable myocardium are required.
19
B. Stent thrombosis associated with MI when detected by coronary angiography or
20
autopsy in the setting of myocardial ischemia and with a rise and/or fall of cardiac
21
biomarker values with at least 1 value above the 99th percentile ULN.
22
C. For patients with elevated baseline (preprocedure) cardiac biomarkers, there are 2
23
possible scenarios. In these scenarios, electrocardiographic changes or symptoms are
24
not required to qualify.
25
i. Patients with cardiac markers above the ULN (preprocedure) assumed to be in
9
1
the midst of an acute MI.
2
ii. Patients with elevated biomarkers with a characteristic rise and fall in
3
biomarker levels preprocedure most likely have completed their presenting infarct.
4
Further rises in cardiac markers must be ≥20% above the most recent value to be
5
coded as reinfarction.
6
D. Patients with new, significant Q waves in at least 2 contiguous leads of an ECG
7
that were not present with the presenting ischemic event.
8
9
3. Within 48 h after CABG:
A CABG-related MI was defined by elevation of cardiac biomarker values >5 times
10
the 99th percentile upper reference limit in patients with normal baseline cardiac
11
troponin values (≤99th percentile upper reference limit) plus either new pathological
12
Q waves; new left bundle-branch block, angiographically documented new graft, or
13
native coronary artery occlusion; or imaging evidence of new loss of viable
14
myocardium or new regional wall motion abnormality.
15
Stroke was confirmed by a neurologist on the basis of imaging studies and was
16
defined as follows:
17
1. A focal neurologic deficit of central origin lasting >72 hours, or
18
2. A focal neurologic deficit of central origin lasting >24 hours, with imaging
19
evidence of cerebral infarction or intracerebral hemorrhage, or
20
3. A nonfocal encephalopathy lasting >24 hours with imaging evidence of cerebral
21
infarction or hemorrhage adequate to account for the clinical state, or
22
Retinal arterial ischemia or hemorrhage is included in the definition of stroke.
23
Repeat revascularization was defined as any repeat PCI or CABG. All stages of a
24
staged index PCI procedure will be considered part of the index revascularization
25
procedure and not a repeated revascularization.
26
10
1
Online Tables
2
Table 1. Indicators for Either CABG or PCI Procedure
Indicators for Procedure
CABG
Complex coronary anatomy
Unable to take anti-platelet medications
Patient refused PCI
Serious allergic reaction to stainless steel or contrast agent
History of coagulopathy
PCI
Suitable coronary anatomy for stenting
End-stage COPD
No graft material
Patient refused CABG
Emergent revascularization is necessary
Age≥80 years
Poor distal vessel
Prior CABG
3
4
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; COPD =
chronic obstructive pulmonary disease.
5
6
11
1
Table 2. Candidate Patient-Level Covariates for Adjustment
Risk Factors
2
3
1. Age
8. Dyslipidemia
15. eGFR*
2. Sex
9. COPD
16. Ejection fraction
3. Weight
10. PVD
17. No. of diseased vessel†
4. Height
11. Family history of CAD
18. SYNTAX score‡
5. Smoker
12. Previous MI
19. Revascularization procedure
6. Diabetes mellitus
13. Previous PCI
20. Year of procedure§
7. Hypertension
14. Unstable Angina
*The eGFRs were estimated from serum creatinine values with the Chronic Kidney Disease
Epidemiology Collaboration equation.
4
†No. of diseased vessel was included in the propensity score calculation as a covariate in
5
the overall cohort analysis, and age (<65 and ≥65 years), diabetes mellitus, ejection fraction
6
(≥50% and <50%) and EuroSCORE subsets.
7
8
9
10
11
‡SYNTAX score was included in the propensity score calculation as a covariate in the
SYNTAX-score subset and cohorts with coronary ULM bifurcation.
§Year of surgery was included in the multivariable regression model as each class
indicating a calendar of year.
COPD = chronic obstructive pulmonary disease; PVD = peripheral vascular disease; CAD =
12
coronary artery disease; MI = myocardial infarction; PCI = percutaneous coronary
13
intervention; eGFR = estimated glomerular filtration rate; SYNTAX = Synergy between
14
Percutaneous Coronary Intervention with Taxus and Cardiac Surgery.
15
12
1 TTable 3. Discrimination and Calibration Results for Multivariable Logistic
2 RRegression Models
p value for
Models
C statistic
Hosmer-Lemeshow test
Overall cohort
0.831
0.359
Patients with baseline SYNTAX Scores
0.871
0.148
Patients without contraindications to CABG
0.832
0.297
<65 years
0.830
0.148
≥65 years
0.836
0.859
No diabetes
0.840
0.388
Diabetes
0.812
0.732
Ejection fraction ≥50%
0.822
0.004
Ejection fraction <50%
0.853
0.730
Two-vessel disease
0.766
0.875
Three-vessel disease
0.738
0.434
No bifurcation
0.939
0.581
Bifurcation
0.863
0.005
SYNTAX score ≤32
0.819
0.952
SYNTAX score >32
0.717
0.471
EuroSCORE ≤1
0.879
0.420
2≤ EuroSCORE ≤3
0.836
0.327
EuroSCORE >3
0.870
0.182
Subgroups
3
SYNTAX = Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac
4 Surgery; CABG = coronary artery bypass graft; EuroSCORE, the European System for Cardiac
5 Operative Risk Evaluation.
6
13
1
Table 4. Proportional Hazards Assumption of the Cox Regressions
Patient Group
Outcome
Overall cohort
Patients with baseline SYNTAX Scores
Patients without contraindications to CABG
SYNTAX score ≤32
SYNTAX score >32
No diabetes
Diabetes
<65 years
14
p value
All-cause death
0.172
Death, MI, and stroke
0.049
Cardiac death
0.910
Myocardial infarction
0.998
Stroke
0.592
Repeat revascularization
0.001
All-cause death
0.197
Death, MI, and stroke
0.064
Cardiac death
0.357
Myocardial infarction
0.774
Stroke
0.800
Repeat revascularization
0.004
All-cause death
0.089
Death, MI, and stroke
0.017
Cardiac death
0.768
Myocardial infarction
0.907
Stroke
0.801
Repeat revascularization
0.002
All-cause death
0.731
Death, MI, and stroke
0.705
Repeat revascularization
0.003
All-cause death
0.041
Death, MI, and stroke
0.013
Repeat revascularization
0.084
All-cause death
0.850
Death, MI, and stroke
0.309
Repeat revascularization
0.019
All-cause death
0.015
Death, MI, and stroke
0.061
Repeat revascularization
0.012
All-cause death
0.214
≥65 years
Male
Female
Ejection fraction ≥50%
Ejection fraction <50%
Two-vessel disease
Three-vessel disease
No bifurcation
Bifurcation
EuroSCORE ≤1
2≤ EuroSCORE ≤3
EuroSCORE >3
1
Death, MI, and stroke
0.003
All-cause death
0.528
Death, MI, and stroke
0.820
All-cause death
0.360
Death, MI, and stroke
0.035
All-cause death
0.202
Death, MI, and stroke
0.806
All-cause death
0.451
Death, MI, and stroke
0.414
All-cause death
0.235
Death, MI, and stroke
0.065
All-cause death
0.627
Death, MI, and stroke
0.301
All-cause death
0.058
Death, MI, and stroke
0.003
All-cause death
0.228
Death, MI, and stroke
0.091
All-cause death
0.542
Death, MI, and stroke
0.399
All-cause death
0.156
Death, MI, and stroke
0.041
All-cause death
0.505
Death, MI, and stroke
0.093
All-cause death
0.724
Death, MI, and stroke
0.974
SYNTAX = Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac
2
Surgery; CABG = coronary artery bypass graft; EuroSCORE, the European System for
3
Cardiac Operative Risk Evaluation.
4
15
1
2
Table 5. Baseline Characteristics of Patients After Adjustment With Inverse
Probability-of-Treatment Weighting
CABG
PCI
(n = 2604)
(n = 1442)
p value
Age, yrs
61.2 ± 11.7
61.3 ± 18.2
0.74
Women
20.6
20.1
0.57
Hypertension
61.9
61.3
0.54
Hyperlipidemia
55.5
56.8
0.23
Diabetes mellitus
29.5
29.9
0.72
Smoker
50.2
52.1
0.08
COPD
0.9
1.1
0.39
Family history of CAD
19.2
18.6
0.51
Body Mass Index* , g/m2
25.5 ± 3.8
25.5 ± 5.2
0.60
Creatinine, μmol/l†
85.1 ± 28.7
83.4 ± 30.9
0.89
Previous MI
33.0
34.5
0.15
Previous PCI
17.1
15.4
0.03
Peripheral vascular disease
5.2
4.8
0.53
Unstable angina
51.1
50.5
0.50
61.4 ± 10.0
61.5 ± 13.0
0.72
Left main only
2.9
3.0
Left main + 1-vessel disease
10.5
10.6
Left main + 2-vessel disease
24.3
22.9
Left main + 3-vessel disease
62.3
63.5
Variable
Demographics
Risk factors
Cardiovascular conditions
Ejection fraction, %
Diseased coronary vessels
0.52
3
Values are mean ± SD or n (%).
4
*Calculated as weight in kilograms divided by height in meters squared.
5
†To convert μmol/l to mg/dl, multiply serum creatinine values by 0.0113.
6
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; COPD =
7
chronic obstructive pulmonary disease; CAD = coronary artery disease; MI = myocardial
8
infarction.
16
Table 6.
30-Day Outcomes for Patients Treated With CABG and PCI
p value
Adjusted OR†
(95% CI)
p value
2.72 (1.11–6.68)
0.03
5.30 (2.83–9.94)
< 0.001
52 (3.6)
1.23 (0.86–1.76)
0.26
2.14 (1.70–2.70)
< 0.001
8 (0.3)
10 (0.7)
2.27 (0.89–5.75)
0.09
4.44 (2.35–8.41)
< 0.001
Myocardial infarction
55 (2.1)
45 (3.1)
1.49 (1.00–2.23)
0.05
2.44 (1.88–3.18)
< 0.001
Stroke
16 (0.6)
2 (0.1)
0.22 (0.05–0.98)
0.05
0.14 (0.04–0.50)
0.002
0
17 (1.2)
Not effective
0.94
Not effective
0.98
CABG
(n = 2604)
PCI
(n = 1442)
Unadjusted OR
(95% CI)
All-cause death
8 (0.3)
12 (0.8)
Death, MI, and stroke
77 (3.0)
Cardiac death
Outcome, No. (%)*
Repeat revascularization
*Data are Kaplan-Meier estimates of cumulative event rate at 3 years, expressed as percent of patients.
†Inverse probability-of-treatment weighted Cox proportional-hazards regression was used with adjustment for all patient-level variables in
Online Table 1. The HRs were reported for patients undergoing PCI with those undergoing CABG as reference.
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; OR = odds ratio; MI = myocardial infarction.
17
Table 7.
Baseline Characteristics of Patients With Baseline SYNTAX Scores
CABG
PCI
(n = 1310)
(n = 1442)
p value
Age, yrs
62.0 ± 9.2
59.9 ± 10.7
< 0.001
Women
248 (18.0)
308 (21.4)
0.11
Hypertension
874 (66.7)
782 (54.2)
< 0.001
Hyperlipidemia
866 (66.1)
722 (50.1)
< 0.001
Diabetes mellitus
439 (33.5)
348 (24.1)
< 0.001
Smoker
745 (56.9)
671 (46.5)
< 0.001
COPD
15 (1.1)
12 (0.8)
0.38
Family history of CAD
268 (20.5)
168 (11.7)
< 0.001
Body Mass Index* , g/m2
25.4 ± 2.9
25.7 ± 3.1
0.01
Creatinine, μmol/l†
86.8 ± 21.6
81.3 ± 18.7
< 0.001
Previous MI
512 (39.8)
340 (23.6)
< 0.001
Previous PCI
156 (11.9)
324 (22.5)
< 0.001
70 (5.3)
74 (5.1)
0.32
Unstable angina
609 ( 46.5)
962 (66.7)
< 0.001
Ejection fraction, %
60.5 ± 8.5
63.1 ± 7.2
< 0.001
63 (4.8)
106 (7.4)
Left main + 1-vessel disease
193 (14.7)
304 (21.1)
Left main + 2-vessel disease
403 (30.8)
535 (37.1)
Left main + 3-vessel disease
651 (49.7)
497 (34.5)
Variable
Demographics
Risk factors
Cardiovascular conditions
Peripheral vascular disease
Diseased coronary vessels
Left main only
< 0.001
Values are mean ± SD or n (%).
*Calculated as weight in kilograms divided by height in meters squared.
†To convert μmol/l to mg/dl, multiply serum creatinine values by 0.0113.
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; COPD =
chronic obstructive pulmonary disease; MI = myocardial infarction; CAD = coronary artery
disease.
18
Table 8.
Baseline Characteristics of Patients Without Contraindications to CABG
CABG
PCI
(n = 2551)
(n = 1404)
p value
Age, yrs
61.9 ± 9.0
59.4 ± 10.3
< 0.001
Women
465 (18.2)
297 (21.2)
0.03
Hypertension
1637 (64.2)
763 (54.3)
< 0.001
Hyperlipidemia
1505 (59.0)
706 (50.3)
< 0.001
Diabetes mellitus
789 (30.9)
337 (24.0)
< 0.001
Smoker
1364 (53.5)
659 (46.9)
< 0.001
COPD
-
-
-
Family history of CAD
572 (22.4)
165 (11.8)
< 0.001
Body Mass Index* , g/m2
25.5 ± 3.0
25.7 ± 3.1
0.006
Creatinine, μmol/l†
86.2 ± 22.8
81.1 ± 18.6
< 0.001
Previous MI
972 (38.1)
332 (23.6)
< 0.001
Previous PCI
250 (9.8)
314 (22.4)
< 0.001
146/2,551 (5.7)
70 (5.0)
0.33
Unstable angina
1135 (44.5)
933 (66.5)
< 0.001
Ejection fraction, %
60.2 ± 8.2
63.2 ± 7.2
< 0.001
Left main only
18 (0.7)
106 (7.5)
Left main + 1-vessel disease
121 (4.7)
298 (21.2)
Left main + 2-vessel disease
407 (16.0)
522 (37.2)
Left main + 3-vessel disease
2005 (78.6)
478 (34.0)
Variable
Demographics
Risk factors
Cardiovascular conditions
Peripheral vascular disease
Diseased coronary vessels
< 0.001
Values are mean ± SD or n (%).
*Calculated as weight in kilograms divided by height in meters squared.
†To convert μmol/l to mg/dl, multiply serum creatinine values by 0.0113.
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; COPD =
chronic obstructive pulmonary disease; CAD = coronary artery disease; MI = myocardial
infarction.
19
Table 9. Procedural Characteristics of Patients With Baseline
SYNTAX Scores
Total No. /No. (%) of Patients
CABG patients
1310
Off-pump procedure
689/1310 (52.6)
3.4 ± 0.8
Grafts per patient
Mean venous graft
2.3 ± 0.9
Mean arterial graft
1.1 ± 0.5
IMA-to-LAD graft
1237 (94.4)
Intraoperative IABP
3 (0.1)
PCI patients
1442
Ad hoc PCI
92 (6.4)
PCI procedure access
Transradial approach
837 (58.0)
Transfemoral approach
605 (42.0)
Total number of stents per patient
2.2 ± 1.7
Mean diameter of stent, mm
3.4 ± 0.5
27.4 ± 16.0
Total stent length, mm
Two-stent strategy
400 (33.9)
Crush
271 (67.8)
T-stent
55 (13.8)
V- or kissing stent
52 (13.0)
Culotte
22 (5.5)
Final kissing balloon
591 (50.0)
Dissection in target lesion
41 (2.8)
Guidance with IVUS
560 (38.8)
Use of glycoprotein IIb/IIIa antagonist
118 (8.2)
Use of IABP
121 (8.4)
Procedural success
1424 (98.8)
Values are mean ± SD or n (%).
CABG = coronary artery bypass graft; IMA = internal mammary artery; LAD
= left anterior descending branch; IABP = intra-aortic balloon pump; PCI =
percutaneous coronary intervention; IVUS = intravascular ultrasound.
20
Table 10.
Procedural Characteristics of Patients Without
Contraindications to CABG
Total No. /No. (%) of Patients
CABG patients
2551
Off-pump procedure
1,357 (53.2)
Grafts per patient
3.4 ± 0.8
Mean venous graft
2.2 ± 0.9
Mean arterial graft
1.2 ± 0.7
IMA-to-LAD graft
2404 (94.2)
Intraoperative IABP
4 (0.1)
PCI patients
1404
Ad hoc PCI
92 (6.6)
PCI procedure access
Transradial approach
820/ (58.4)
Transfemoral approach
584 (41.6)
Total number of stents per patient
2.2 ± 1.2
Mean diameter of stent, mm
3.4 ± 0.5
27.6 ± 16.1
Total stent length, mm
Two-stent strategy
395 (34.5)
Crush
269 (68.1)
T-stent
54 (13.7)
V- or kissing stent
51 (12.9)
Culotte
21 (5.3)
Final kissing balloon
572 (49.9)
Dissection in target lesion
41 (2.9)
Guidance with IVUS
550 (39.2)
Use of glycoprotein IIb/IIIa antagonist
114 (8.1)
Use of IABP
118 (8.4)
Procedural success
1387 (98.8)
Values are mean ± SD or n (%).
CABG = coronary artery bypass graft; IMA = internal mammary artery; LAD
= left anterior descending branch; IABP = intra-aortic balloon pump; PCI =
percutaneous coronary intervention; IVUS = intravascular ultrasound.
21
Table 11. 30-Day and 3-Year Outcomes for Patients With Baseline SYNTAX Scores
3-Year after the Procedure*
30-Day after the Procedure
CABG
(n = 1,310)
PCI
(n = 1,442)
Adjusted OR†
(95% CI)
p value
CABG
(n = 1,310)
PCI
(n = 1,442)
Adjusted HR†
(95% CI)
p value
All-cause death
3 (0.2)
12 (0.8)
5.30 (2.83–9.94)
< 0.001
32 (2.5)
55 (3.8)
1.27 (1.06–1.53)
0.01
Death, MI, and stroke
37 (2.8)
52 (3.6)
2.28 (1.75–2.98)
< 0.001
120 (9.3)
112 (7.5)
1.04 (0.87–1.24)
0.67
Cardiac death
3 (0.2)
10 (0.7)
4.44 (2.35–8.41)
< 0.001
15 (1.2)
37 (2.6)
3.35 (2.13–5.26)
< 0.001
Myocardial infarction
29 (2.2)
45 (3.1)
1.60 (1.18–2.15)
0.002
40 (3.2)
61 (4.2)
1.78 (1.38–2.29)
< 0.001
Stroke
7 (0.5)
2 (0.1)
0.14 (0.04–0.50)
0.002
57 (4.4)
18 (1.1)
0.22 (0.14–0.34)
< 0.001
0
17 (1.2)
Not effective
0.98
29 (2.4)
146 (9.9)
4.99 (3.76–6.61)
< 0.001
Outcome, No. (%)
Repeat
revascularization
*Data are Kaplan-Meier estimates of cumulative event rate at 3 years, expressed as percent of patients.
†Inverse probability-of-treatment weighted Cox proportional-hazards regression was used with adjustment for all patient-level variables in
Online Table 1. The HRs were reported for patients undergoing PCI with those undergoing CABG as reference.
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; OR = odds ratio; HR = hazard ratio; MI = myocardial
infarction.
22
Table 12. 30-Day and 3-Year Outcomes for Patients Without Contraindications to CABG
3-Year after the Procedure*
30-Day after the Procedure
CABG
(n = 2551)
PCI
(n = 1404)
Adjusted OR†
(95% CI)
p value
CABG
(n = 2551)
PCI
(n = 1404)
Adjusted HR†
(95% CI)
p value
All-cause death
8 (0.3)
12 (0.9)
5.49 (2.93–10.29)
< 0.001
61 (2.4)
52 (3.7)
1.78 (1.36–2.31)
< 0.001
Death, MI, and stroke
75 (2.9)
52 (3.7)
2.29 (1.81–2.88)
< 0.001
228 (8.9)
107 (7.6)
0.98 (0.85–1.14)
0.82
Cardiac death
8 (0.3)
10 (0.7)
4.56 (2.41–8.64)
< 0.001
33 (1.3)
35 (2.5)
2.55 (1.82–3.58)
< 0.001
Myocardial infarction
54 (2.1)
45 (3.2)
2.60 (2.00–3.38)
< 0.001
73 (2.9)
61 (4.3)
2.15 (1.72–2.69)
< 0.001
Stroke
15 (0.6)
2 (0.1)
0.16 (0.04–0.55)
0.004
106 (4.2)
16 (1.1)
0.18 (0.12–0.26)
< 0.001
0
16 (1.1)
Not effective
0.98
48 (1.9)
139 (9.9)
4.98 (3.94–6.29)
< 0.001
Outcome, No. (%)
Repeat
revascularization
*Data are Kaplan-Meier estimates of cumulative event rate at 3 years, expressed as percent of patients.
†Inverse probability-of-treatment weighted Cox proportional-hazards regression was used with adjustment for all patient-level variables in
Online Table 1. The HRs were reported for patients undergoing PCI with those undergoing CABG as reference.
CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; OR = odds ratio; HR = hazard ratio; MI = myocardial
infarction.
23
Online Figures
Figure 1. Patient Flowchart.
24
Figure 2. Revascularization Strategy Selection for Patients with ULMD at Our Institution
During 2004 and 2010.
25
Figure 3. Unadjusted Kaplan-Meier Curves of 3-Year Outcomes According to Revascularization
Strategy and SYNTAX Score.
26
Figure 4. Adjusted Survival Curves of 3-Year Outcomes According to Revascularization Strategy
and SYNTAX Score.
27
Figure 5. Unadjusted Kaplan-Meier Curves of 3-Year Outcomes According to Revascularization
Strategy and Diabetes Mellitus.
28
Figure 6. Adjusted Survival Curves of 3-Year Outcomes According to Revascularization
Strategy and Diabetes Mellitus.
29
Figure 7. Unadjusted Hazard Ratios of Clinical Outcomes According to Selected Major Subgroups.
30
Figure 8. Patients Distribution and 3-Year All-cause Mortality According to Revascularization
Strategy and SYNTAX Score.
31