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PCI vs CABG for Multivessel and
LMCA Disease:
NOBLE vs. EXCEL Trial
Alexander (Sandy) Dick, MD
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Disclosures
• Interventionist
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NOBLE and EXCEL
Clarity for PCI vs CABG Debate
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WindeckerS, Piccolo R. JACC. 2016;68:1010-3
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Capodanno D, et al, JACC, 2011; 58:1426-32
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Cavalcante R, et al. JACC 2016;68:999-1009
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Levine G, et al. JACC 2011;58:44-122
Windecker S, et al Eur Hrt J 2014;35:2541-619
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Need for Updated LM Trial
• SYNTAX, LM subgroup
• 1 yr follow-up insufficient to capture true
benefit accrual of CABG
• 1st generation DES
• IVUS/FFR guidance uncommon
• Discretional angiographic f/u overinflated
number events in PCI arm
• Best standards CABG underused
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Capodanno D, et al. Int J Cardiol 2012;156;1-3
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Patients allocated to CABG in
analysis (n=592)
567 received CABG
23 received PCI
Randomized (n= 1201)
Allocated to PCI (n=598)
• Received PCI (n=585)
• Did not receive PCI (n=13)
• Died before PCI (n=1)
• Patient declined PCI (n=4)
• PCI operator declined (n=4)
• LMCA lesion not significant (n=4)
Allocated to CABG (n=603)
• Received CABG (n=570 )
• Did not receive CABG (n=33)
• Died before CABG (n=1)
• Patient declined CABG (n=15)
• Not eligible for CABG (n=15)
• Cross over by mistake (n=2)
Lost to follow-up (n=6)
• Emigration (n=1)
• Contact lost (n=2)
• Withdrawal (n=3)
Lost to follow-up (n=11)
• Emigration (n=0)
• Contact lost (n=0)
• Withdrawal (n=11)
Patients allocated to PCI in
analysis (n=592)
580 received PCI
7 received CABG
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Enrollment2905 patients enrolledat 126 sites in 17 countries
Registry enrollment
N=1000
Randomized enrollment
N=747
Screening registry closed
Randomized enrollment
N=1158 additional
N=1905 total randomized
PCI with CoCr-EES
N=948
CABG
N=957
Followed through
initial treatment
(no outcomes data)
N=1000
Screening registry phase open
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Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
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ResultsNon-procedural myocardial infarction
HR 2·88 (1·40–5·90); p=0·004
6·9%
1·9%
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ResultsTotal repeat revascularization
HR 1·50 (1·04–2·17); p=0·03
10·4%
16·2%
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ResultsStroke
HR 2·25 (0·92–5·48); p=0·07
4·9%
1·7%
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Conclusions
• PCI did not meet non-inferiority for the primary endpoint of 5-year MACCE compared to CABG
• CABG was superior to PCI
• PCI resulted in higher rates of non-procedural myocardial infarctions
• Repeat revascularization was higher after PCI, primarily due to de novo lesions and non LMCA target lesion revascularization
• All-cause mortality was similar for PCI and CABG
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Primary Endpoint
Death, Stroke or MI at 3 Years
No. at Risk:
PCI
CABG
5%
25%
20%
15%
10%
0%
1 6 12 24 36
850
817
784
763
445
458
HR [95%CI] =
1.00 [95% CI: 0.79, 1.26]
P = 0.98
875
836
0
948
957
896
868
15.4%14.7%
De
ath
, s
tro
ke
or
MI (%
)
CABG (n=957)
PCI (n=948)
Months
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Primary Endpoint Definitions
• Death: Adjudicated due to CV, non-CV, or undetermined causes
• Peri-procedural MI (<72 hrs): CK-MB >10x URL, or >5x URL plus
either i) new pathological Q waves in ≥2 contiguous leads or new
LBBB, or ii) angio documented graft or coronary artery occlusion or
new severe stenosis with thrombosis, or iii) imaging evidence of new
loss of viable myocardium or new regional wall motion abnormality
• Spontaneous MI (≥72 hrs): CK-MB or troponin >1x URL plus new
ST-segment elevation or depression or other findings as above
• Stroke: Requires: 1) Rapid onset of a focal/global neurological deficit
with no other readily identifiable non-stroke cause; 2) Duration ≥24
hrs, or <24 hrs if i) pharmacologic or non-pharmacologic Rx; or ii)
positive brain imaging; or iii) death; 3) Confirmation by neurologist
plus confirmatory brain imaging or LP; 4) ≥1 increase in modified
Rankin Scale (mRS)
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Stone GW, et al. NEJM 2016
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Stone GW, et al. NEJM 2016
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Christiansen EH, et al. Lancet 2016
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Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
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Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
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Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
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Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
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Capodanno D, et al. JACC Card Interv 2016
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SYNTAX Score
Site Reported Core LabLow (≤22)
Intermediate (23-32)
High (≥33)
PCI
CABG
59.2%40.8%
61.8%38.2%
Mean 20.6 ± 6.2
Mean 20.5 ± 6.1
P=0.52
42.8%
25.1%
32.2%
37.3%
23.4%
39.3%
Mean 26.9 ± 8.8
Mean 26.0 ± 9.8
P=0.005
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Results
SYNTAX score subgroups
4.9%
1.9%
K-M estimates
HR 1·88 (1·23–2·89); p=0·0031 HR 1·16 (0·76–1·78); p=0·48 HR 1·41 (0·62–3·20); p=0·41
SYNTAX score assessed by independent corelab (CERC)
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Stone GW, et al. NEJM 2016; Christiansen EH, et al. Lancet 2016
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Core Lab DataPCI (N=942) CABG (N=936)
Qualifying LM lesion*
- LM coronary segment 97.6% 97.0%
- LM equivalent disease** 1.2% 1.5%
- Neither 1.3% 1.5%
Distal LM bifurcation or trifurcation ds. 81.8% 79.2%
# Diseased non-LM coronary arteries*
- 0 17.3% 17.8%
- 1 31.0% 31.2%
- 2 34.5% 31.5%
- 3 17.2% 19.4%
*DS ≥50% by QCA
**DS of both the ostial left LAD and ostial LCX ≥50% by QCA
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PCI Procedure
Planned staged procedures 9.1%
Arterial access site*
- Femoral 72.9%
- Radial 26.9%
- Brachial 0.2%
IVUS guidance 77.2%
FFR assessment 9.0%
Hemodynamic support device* 5.2%
Contrast use* (cc) 256 ± 127
Fluoroscopy time* (min) 24 ± 16
*All procedures (index + planned staged); **Excludes pts with LM equivalent ds;†Max 4 vessels, including LM as a separate vessel
935 patients, 1021 planned procedures, 2287 stents
# Vessels treated per pt*† 1.7 ± 0.8
- LM 100.0%**
- LAD 28.3%
- LCX 16.6%
- RCA 26.7%
# Lesions treated per pt* 1.9 ± 1.1
# Stents implanted per pt* 2.4 ± 1.5
- Total stent length (mm)* 49.1 ± 35.6
Type of stents implanted*
- DES 99.8%
- EES 99.2%
- XIENCE 98.4%
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Registry (n=1000)
Major reasons for exclusion
from randomization
Treatment
of registry patients
CABG PCI No revasc
64.8%33.1%
2.1%17.1%
36.0%
38.1%
29.9%
0% 10% 20% 30% 40% 50%
Heart team consensus ofineligibility for CABG
Heart team consensus ofineligibility for PCI
Site-assessed SYNTAX score ≥33
50-<70% LM stenosiswhich did not meet
criteria for hemodynamicsignificance
Of the 1747 pts enrolled during the registry period, 62% were eligible for PCI (1078; 331 reg +
747 rand), and 80% were eligible for CABG (1395; 648 reg + 747 rand)
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OHI Unprotected LM PCI
• 68 unprotected LM in 10 months
• Only 8 EXCEL or NOBLE like patients
– Too high risk for CABG
– SYNTAX >32
– Refused CABG
• Uniform excellent angiographic results
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Bottom Line EXCEL
• Contemporary PCI (best DES, IVUS) vs
suboptimal standards CABG (minor off-
pump and full arterial revascularization)
• Applicable selected patients amenable to
both procedures
• Noninferiority of PCI met for meaningful
range of endpoints; superiority not met
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Bottom Line EXCEL
• Results largely explained by less
periprocedural MIs (large) in PCI group but
important catch in MIs up to 3yrs (may
continue with ongoing collection)
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Bottom Line NOBLE
• Very long enrollment period
• Reported 5-yr KM estimates while having
a median 3 yr follow up. Portion patients
received first-generation DES at beginning
of trial
• Differences with EXCEL partly explained
by different MI definition, inclusion repeat
revascularization and focus on longer
follow up
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Bottom Line NOBLE
• More thrombosis in NOBLE with SES/BES
than in EXCEL with EES: need stratified
analysis with stent type
• SYNTAX score results at odds with current
guidelines
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Bottom bottom line
• New left main recommendations to be
patient-centered based on the early-and
long-term trade-offs of each procedure
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Circulation, Feb 28, 2017
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“….additional evidence that may influence
current guidelines by broadening the patient
pool that might undergo PCI.”
“….considering each patient’s individual
circumstances, including life expectancy,
comorbidities, extent of disease,
angiographic anatomy, likelihood and
perceived need for complete
revascularization, and patient preference.”
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Revascularization Heart Team
• Most often none on committee has seen
patient
• No responsibility for decision
• If you don’t routinely
– Make evidence based decision (DM,
SYNTAX) in conjunction with referring
physician with special attention paid to
comorbid conditions and patient wishes
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Heart Team Revasc vs TAVI
• Physician presenting has seen patient
• No complex imaging with Revasc
– CT, TEE, Mitral valve assessment,
Dobutamine Echo – contractile reserve
• Allied team members such as geriatric
assessment much more relevant TAVI
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Sample size
• SYNTAX trial MACCE after 2 years*(30% of PCI,23% of CABG)
• A HR of 1·35 was defined accordingly as the clinically acceptable non-inferiority limit not to be exceeded by the one-sided 95% CI
• 1- β (power) = 80%
• 275 events, with 1200 patients, 600 in each group needed
• The primary endpoint assessment was January 2015 changed to include MACCE endpoints occurring between 2 and 5 years to reach a total of 275 events
• September 2015 it was estimated that 275 events could not be reached within full 5 years (January 2020), and the primary endpoint assessment was changed to median 3 years
*Predicted from preliminary 1-year results in the SYNTAX trial