1. 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

2. Disclosures Left Main Coronary PCI: Best Practice
Theodore A. Bass MD, FSCAI
The following relationships exist related to this presentation
none

3. Left Main PCI: Patient Selection and Technique
Patient Selection (Risk Models)
IVUS and FFR
Procedure Technique (Cases)
Surveillance : Follow-up

4. 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

5. The ULTIMA registry Urgent and elective treatment
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 5

6. 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)

7. 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:

11. Suggested IIa for ostial/shaft LM and IIb for distal LM 1-2 V CAD
Contemporary Trials of LM PCI vs CABG
Clinical Equipoise and Reassessment of Guidelines
Trial* N
Death MI
Stroke
Revasc
Sanmartin 2007
341 ND
CABG better
MAIN-COMPARE 2008
1102
n/a
LEMANS 2008
105
Palmerini 2006
311
Chieffo 2006
249
PCI better
Lee 2006
173
Makikallio 2008
287
Brener 2008
White 2008
343
SYNTAX 2008
705
Suggested IIa for ostial/shaft LM and IIb for distal LM 1-2 V CAD
*Studies with >100 patients per arm reported ND=no difference; n/a=not available/not reported

12. IIb Level of Evidence: B
New classes of recommendations for Left Main PCI
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 mid-body lesions without additional MVD”

13. 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)
I A
IIa B
Left main (isolated or 1VD, bifurcation)
IIb B
Left main + 2VD or 3VD, SYNTAX score ≤ 32
Left main + 2VD or 3VD, SYNTAX score ≥ 33
III B
ESC guidelines 2010

14. PRECOMBAT Trial Primary End Point of MACCE (600 patients)
PCI
CABG
Non-inferiority p= 0.001
8.7
12.2
6.7
8.1
p=0.39
p=0.12
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Park et al NEJM April 4, 2011 15

15. Noninferiority Test for Primary End Point of 1-Year MACCE
1-year MACCE rate CABG: 6.7% PCI: 8.7%
Prespecified non-inferiority margin: 7% -2 -1 1 2 3 4 5 6 7 8 9 10
1 year MACCE SYNTAX
CABG 13.7%,
PCI 15.8%
Difference, 2%
95% CI, -1.6 to 5.6%
Non-inferiority p= 0.001
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Difference (%) of 1-year MACCE rate between (PCI – CABG)
95% CI
Park et al NEJM April 4, 2011 16

16. Revascularization to Improve Survival: Left Main CAD Revascularization
2011 Guideline Update
Revascularization to Improve Survival: Left Main CAD Revascularization I
IIa
IIb
III B
CABG to improve survival is recommended for patients with significant (≥50% diameter stenosis) left main CAD.
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., STS-predicted risk of operative mortality ≥5%). I
IIa
IIb
III B 18

17. Revascularization to Improve Survival: Left Main CAD Revascularization (cont.)
IIa
IIb
III B
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; STS-predicted risk of operative mortality >2%). 19

18. Revascularization to Improve Survival: Left Main CAD Revascularization (cont.)
IIa
IIb
III B
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.
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. I
IIa
IIb
III C 20

19. Revascularization to Improve Survival: Left Main CAD Revascularization (cont.)
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. I
IIa
IIb
III B
Harm 21

20. 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

21. 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)
Discrimination does not reflect absolute predictive accuracy, but only ranking

23. Cardiac death free survival (%) Cardiac death free survival (%)
The Global Risk Classification (GRC)
Cardiac death free survival (%)
100 90 80 70 60
Time (months) 12 24
SYNTAX score
96.1%
94.6%
78.1%
LOW
MIDDLE
HIGH
P = 0.004*
SYNTAX score
< 19
19-27
> 27
0-2 L L I
3-6 L L I
EuroSCORE
Cardiac death free survival (%)
100 90 80 70 60
Time (months) 12 24
GRC
98.4%
84.0%
68.6%
LOW
MIDDLE
HIGH
P < 0.001*
> 6 I I H
* log rank test; n = 255 LM patients undergoing PCI
Capodanno, Tamburino, et al.
Am Heart J 2010:159:103-9

24. Left Main PCI: Patient Selection and Technique
IVUS and FFR Intermediate LMCA stenosis cases
Procedure Technique (Cases)
Surveillance: Follow-up

25. 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

26. Survival Estimates and Strategy
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
Figure 5. Kaplan–Meier mortality curves showing percent survival (A) and major adverse cardiac events (MACE; B) in the 2 study groups. There is no difference between the nonsurgical and surgical groups.
Hamilos M et al. Circulation 2009;120:

27. Intermediate LMCA Stenosis IVUS
Correlation of FFR and IVUS
MLA >7.5mm2 safe to defer revascularization. Fassa JACC;45;
MLA <6.0mm2 correlated with angiographically significant stenosis Sano Am Heart J Nov;154(5):
MLA <4.8 mm2 predicted FFR<0.80 MLA <4.0 mm2 predicted FFR<0.75 Kang et al JACC CV Interv 2011
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 Nov;4(11):1168

28. Left Main PCI: Patient Selection and Technique
IVUS and FFR
Procedure Technique (Cases)
Surveillance: Follow-up

29. LMCA PCI Cases

30. 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; , 2008, Meliga (DELFT Reg)JACC ;51:2212,
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.