Transcript Comparison of optical coherence tomography and

Left Main PCI:
What is Best Practice?
Interventional Fellows Course, Egypt
November 19th, 2012
Theodore A Bass, MD FSCAI, FACC
President-Elect SCAI
Professor of Medicine, University of Florida
Medical Director and Chief UF Shands CV Center,Jacksonville
Disclosures
Left Main Coronary PCI: Best Practice
Theodore A. Bass MD, FSCAI
The following relationships exist related to this presentation

none
Left Main PCI:
Patient Selection and Technique
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•
•
•
Patient Selection (Risk Models)
IVUS and FFR
Procedure Technique (Cases)
Surveillance : Follow-up
Left Main Disease
Benefit of Revascularization
Long-term CASS Experience
Cumulative survival estimates
In 1484 CASS Registry patients
with 50% LM coronary artery
stenosis who were initially
treated with CABG surgery or
non surgical therapy.
Surgical Revasc for LMCA CLASS IA
Caracciolo et al. Circulation 1995; 91: 2325
The ULTIMA registry
13.7% In Hosp mortality
Urgent and elective treatment
“...on the basis of the 1-2% per month death rate among
hospital survivors noted over the first 6 months after hospital
discharge, probably partly a result of restenosis, we strongly
urge routine surveillance angiography at 2 and 4 months after
treatment.”
Consecutive patients undergoing LMCA PCI in 25 centres from 1993 to 1998
15% acute MI (13% shock)
46% not eligible to CABG
Historical Recommendation:
Unprotected Left Main PCI
In patients eligible for CABG
• Class IIb C in ESC guideline (2005)
• Class III in ACC/AHA/SCAI guideline
(2006)
MAIN COMPARE Outcomes
Propensity Match Model for 396 Pairs
Mortality: p=0.26
MACCE: p=0.16
TVR: p<0.001
Seung K et al. N Engl J Med 2008;358:1781-1792
Contemporary Trials of LM PCI vs CABG
Clinical Equipoise and Reassessment of Guidelines
Trial*
N
Death
MI
Stroke
Revasc
Sanmartin 2007
341
Suggested
IIa for ostial/shaft
LM and IIb for distal LM 1-2 V CAD
MAIN-COMPARE
2008
1102
Makikallio 2008
105
311
249
173
287
Brener 2008
287
White 2008
343
SYNTAX 2008
705
LEMANS 2008
Palmerini 2006
Chieffo 2006
Lee 2006
ND
PCI better
ND
ND
n/a
CABG
better
PCI better
ND
ND
n/a
n/a
n/a
ND
PCI better
CABG
better
*Studies
with >100 patients per arm reported 2000-2008
ND=no difference; n/a=not available/not reported
New classes of recommendations
for Left Main PCI 2009
IIb Level of Evidence: B
“PCI of the left main coronary artery with stents as
an alternative to CABG may be considered in
patients with anatomic conditions that are
associated with a low risk of PCI procedural
complications and clinical conditions that predict an
increased risk of adverse surgical outcomes”.
“The best case for PCI as an alternative to
CABG for left main is in ostial and midbody lesions without additional MVD”
Indications for CABG vs PCI in stable patients
with lesions suitable for both procedures and
low predicted surgical mortality
Subset of CAD by anatomy
Favours CABG
Favours PCI
Left main (isolated or 1VD, ostium/shaft)
IA
IIa B
Left main (isolated or 1VD, bifurcation)
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≤ 32
IA
IIb B
Left main + 2VD or 3VD, SYNTAX score ≥ 33
IA
III B
ESC guidelines 2010
PRECOMBAT Trial
Cumulative Incidence, %
Primary End Point of MACCE (600 patients)
20
PCI
CABG
15
Non-inferiority p= 0.001
8.7
10
8.1
5
6.7
p=0.39
p=0.12
0
360
Days Since Randomization
720
300
300
272
276
236
239
0
No. at Risk
PCI
CABG
12.2
Park et al NEJM April 4, 2011
Noninferiority Test for
Primary End Point of 1-Year MACCE
1-year MACCE rate
CABG: 6.7%
PCI: 8.7%
Prespecified noninferiority margin: 7%
Difference, 2%
95% CI, -1.6 to 5.6%
Non-inferiority p= 0.001
1 year MACCE SYNTAX
CABG 13.7%,
PCI 15.8%
-2
-1
0
1
2
3
4
5
6
7
8
9
10
Difference (%) of 1-year MACCE rate between (PCI – CABG)
95% CI
Park et al NEJM April 4, 2011
2011 Guideline Update
Revascularization to Improve Survival:
Left Main CAD Revascularization
I IIa IIb III
CABG to improve survival is recommended for patients
with significant (≥50% diameter stenosis) left main
CAD.
I IIa IIb III
PCI to improve survival is reasonable as an alternative
to CABG in selected stable patients with significant
(≥50% diameter stenosis) unprotected left main CAD
with: 1) anatomic conditions associated with a low risk
of PCI procedural complications and a high likelihood
of a good long-term outcome (e.g., a low SYNTAX
score [≤22], ostial or trunk left main CAD); and 2)
clinical characteristics that predict a significantly
increased risk of adverse surgical outcomes (e.g., STSpredicted risk of operative mortality ≥5%).
Revascularization to Improve Survival:
Left Main CAD Revascularization (cont.)
I IIa IIb III
PCI to improve survival may be reasonable as an
alternative to CABG in selected stable patients with
significant (≥50% diameter stenosis) unprotected left
main CAD with: 1) anatomic conditions associated with
a low to intermediate risk of PCI procedural
complications and an intermediate to high likelihood of
good long-term outcome (e.g., low-intermediate
SYNTAX score of <33, bifurcation left main CAD); and
2) clinical characteristics that predict an increased risk
of adverse surgical outcomes (e.g., moderate-severe
chronic obstructive pulmonary disease, disability from
previous stroke, or previous cardiac surgery; STSpredicted risk of operative mortality >2%).
Revascularization to Improve Survival:
Left Main CAD Revascularization (cont.)
I IIa IIb III
PCI to improve survival is reasonable in
patients with UA/NSTEMI when an
unprotected left main coronary artery is the
culprit lesion and the patient is not a
candidate for CABG.
I IIa IIb III
PCI to improve survival is reasonable in
patients with acute STEMI when an
unprotected left main coronary artery is the
culprit lesion, distal coronary flow is TIMI
(Thrombolysis In Myocardial Infarction) grade
<3, and PCI can be performed more rapidly
and safely than CABG.
Revascularization to Improve Survival:
Left Main CAD Revascularization (cont.)
I IIa IIb III
Harm
PCI to improve survival should not be
performed in stable patients with significant
(≥50% diameter stenosis) unprotected left
main CAD who have unfavorable anatomy for
PCI and who are good candidates for CABG.
Why do we need risk stratification in
complex coronary artery disease?
 Diagnostic and prognostic models:
 Drive informed clinical decisions because they allow the
selection of the most appropriate strategy of treatment based on
the patient's individual characteristics
 Help patients and their families to get a better
understanding of issues relevant to treatment strategies and
subsequent risks as part of the process to obtain informed
consent
 Assist quality-of-care monitoring and facilitate a fair
comparison of procedures performed in different clinical
scenarios
 Are valuable aids for stratifying patients by disease
severity in clinical trials
Capodanno et al, Am Heart J 2011;161:462-70
Prognostic Models in Left Main Disease
 Clinical stand-alone tools
 EuroSCORE
 ACEF score
 Angiographic stand-alone tools
 SYNTAX score
 Combined (angiographic+clinical) tools
 Global Risk Classification (GRC)
 Clinical SYNTAX score (CSS)
 New Risk Classification (NERS)
< 19
EuroSCORE
0-2
3-6
>6
19-27
> 27
L
L
I
L
L
I
I
I
H
* log rank test; n = 255 LM patients undergoing PCI
100
96.1%
94.6%
90
78.1%
P = 0.004*
80
70
LOW
MIDDLE
HIGH
60
0
Cardiac death free survival (%)
SYNTAX score
Cardiac death free survival (%)
The Global Risk Classification (GRC)
SYNTAX score
12
Time (months)
24
98.4%
100
90
84.0%
80
P < 0.001*
70
LOW
MIDDLE
HIGH
60
0
Capodanno, Tamburino, et al.
Am Heart J 2010:159:103-9
12
Time (months)
68.6%
GRC
24
Left Main PCI:
Patient Selection and Technique
• Patient Selection
• IVUS and FFR Intermediate LMCA
stenosis cases
• Procedure Technique (Cases)
• Surveillance: Follow-up
Intermediate LMCA Stenosis
Correlation of FFR and Angiographic Assessment
23% of patients with <50% diameter stenosis angiographically
had a hemodynamically significant lesion by FFR
Hamilos M: Circulation 2009;120
LMCA FFR
Survival Estimates and Strategy
• Patients with FFR > 0.8
have an excellent
prognosis with medical
management
• FFR wire placement in
less diseased vessel
(LAD vs Cx)
• Ostial lesions require
guide disengagement
• High doses of
intravenous adenosine
must be used to ensure
accurate FFR
Hamilos M et al. Circulation 2009;120:1505-1512
Intermediate LMCA Stenosis IVUS
Correlation of FFR and IVUS
•
MLA >7.5mm2 safe to defer
revascularization. Fassa JACC;45;204 2005
•
MLA <6.0mm2 correlated with
angiographically significant
stenosis Sano Am Heart J. 2007
Nov;154(5):983-8. 2007
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MLA <4.8 mm2 predicted FFR<0.80
MLA <4.0 mm2 predicted FFR<0.75
Kang et al JACC CV Interv 2011
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Currently, in patients with
angiographically intermediate
disease, IVUS MLD < 2.8 mm or
MLA < 6 mm2 suggests a
physiologically significant lesion
and may benefit from revasc.
• IVUS does provide procedural
assistance in LMCA PCI
Kang SJ et al JACC Cardiovasc Interv. 2011 Nov;4(11):1168
Left Main PCI:
Patient Selection and Technique
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•
•
•
Patient Selection
IVUS and FFR
Procedure Technique (Cases)
Surveillance: Follow-up
LMCA PCI Cases
Surveillance: Follow-up
Stent Thrombosis Restenosis (SCD)
• Non bifurcation elective LMCA PCI with DES: Risk of
ST and restenosis is very low
Chieffo et al Circ 2007;116:158
• All DES elective PCI UPLMCA with normal LV function
very low Stent Thrombosis (<1% incidence definite or
probable ST over 3-5 years) Lee CCI 77:945-51,2011, Chieffo
EHJ;29.2108, 2008, Meliga (DELFT Reg)JACC ;51:2212, 2008.
• Clinical Restenosis (TLR) for DES PCI UPLMCA is
quite low 6-10%) in most Registries, no SCD signal
•
Current guidelines support long-term aspirin treatment and at least 1
year of thienopyridine therapy in post-PCI patients (Class I, Level of
Evidence: B) however this is not specific for UPLM coronary stenting.
Given low risk of very late stent thrombosis in UPLM, risks and benefits
of greater than 1 year of dual antiplatelet therapy may need to be
tailored to patient specific co-morbidities.