This document summarizes data from studies comparing percutaneous coronary intervention (PCI) using drug-eluting stents to coronary artery bypass grafting (CABG) for treating left main coronary artery disease. Some key findings from meta-analyses of randomized trials presented are that 1-year rates of death and myocardial infarction were similar for PCI and CABG, while 1-year rates of major adverse cardiac and cerebrovascular events (MACCE) were also similar. Subgroup analyses found the risk of MACCE was lower for PCI compared to CABG in patients with less complex coronary artery disease involvement. The document concludes that based on these studies, guidelines recommending CABG over PCI for left main disease should be revised to provide a

1. Transradial approach for left main stenting
Tift Mann, MD, FACC
Duke advanced TR 2011

2. Meta-analysis of randomized LM Trials:
(1y death and MI same)
Capodanno et al. JACC2011;58:1426

3. Meta-analysis of randomized LM Trials:
1y MACCE
Ferrante et al Eurointervention 2011

4. MACCE to 3 Years
LM Subset
CABG (N=348) TAXUS (N=357)
P=0.20
Cumulative Event Rate (%)
40 Before 1 year* 1-2 years* 2-3 years*
13.7% vs 15.8% 7.5% vs 10.3% 5.2% vs 5.7%
26.8%
P=0.44 P=0.22 P=0.78
20
22.3%
0
0 12 24 36
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates ITT population
TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 4

5. Effect of PCI on MACCE Stratified by
Burden of Coronary Artery Disease
Capodanno et al. JACC2011;58:1426

6. MACCE to 3 Years in LM Subgroups
CABG TAXUS
40 P=0.20 P=0.52 P=0.33 P=0.09 P=0.20
31.7 31.1
30
26.8 26.7
Patients, %
22.3 22.8
21.2
19.4
20 17.0
11.9
10
0
n= 348 357 49 42 71 67 106 112 122 136
All LM LM LM LM LM
Isolated + 1VD + 2VD + 3VD
TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 6

7. Pooled meta-analysis:
Stratification by Burden of Disease
Capodanno et al. JACC2011;58:1426

8. PCI for unprotected left main
I IIa IIb III PCI of the left main coronary artery using
stents as an alternative to CABG may be
considered in patients with anatomic
conditions that are associated with low
risk of PCI procedural complications and
Clinical conditions that predict an
increased risk of adverse surgical
outcomes
“Based on the present study, revision of the guidelines
regarding left main PCI is warranted, raising the level of
evidence of current recommendations from B to A.”
Capodanno et al JACC 2011
8

9. 5 Years after LM/LAD TAXUS…
stopped Plavix for a nonsurgical procedure

10. Symptomatic Graft Occlusion &
Stent Thrombosis to 3 Years
LM Subset
CABG (n=348) TAXUS (n=357)
Patients (%) P=0.80
3.7 4.1
n=12 n=14
CABG TAXUS
Post-procedure; ITT population
TCT 2010 • Three-year Outcomes of the SYNTAX Trial: Left Main Subgroup • Serruys • Slide 10

11. EXCEL
Evaluation of XIENCE PRIME™ or XIENCE V®
versus
CABG
for Effectiveness of Left Main Revascularization
(syntax score <32)

12. Once the guide catheter is in place,
there is no difference between
radial and femoral access
Complex PCI in daily practice
Women
Age > 75
ACS/STEMI
Type C lesions
Multivessel
Rotational athrectomy
Bifurcations
CTO
SVBG/IMA
Left Main disease

13. Left Main PCI:
Outcomes According to Vascular Access
Transradial Transfemoral P Value
(n = 353) (n = 468)
Cardiovascular 0.6% 0.6% 1.00
Death
Nonfatal MI 2.8% 1.5% 0.22
LM-Specific TVR 0.6% 1.1% 0.70
MACE 4.0% 3.2% 0.57
Hospital Stay 8.5 ± 5.9 days 9.9 ± 5.9 days 0.001
TIMI Major and 0.6% 2.8% 0.02
Minor Bleeding
Yang et al JACCInt 2010

14. TR vs TF in UPLM Patients
Yang et al. JACCIntv 2010

15. OSTIAL LM 1,0,0 :
DIRECT TAXUS STENTING
RAO CRANIAL
6F KIMNY guide

16. Second generation stents:
Ostial Recoil

17. Current ostial/main stem(1,0,0) technique:
Prepare the lesion prior to stenting
Predilate to ensure complete
balloon expansion…
Consider cutting balloon or
roational atherectomy
6F guide

18. Finish with IVUS 6F

19. Longitudinal stent compression

20. Use guidewire or buddy wire to keep
guide catheter away from proximal stent

21. What about LM bifurcations?
STRATEGY:
STENT MAIN BRANCH WITH
PROVISIONAL STENTING OF SB

22. LEFT MAIN 0,1,0
TAXUS, 6F KIMNY guide

23. Provisional sidebranch stenting

24. TAP

25. 6F Kissing Balloons
Yes Maverick(Boston)
Voyager/Trek(Abbott)
NO Apex(Boston)

26. Planned 2 stent techniques for true LM
distal bifurcation disease
• T
• TAP
• Mini-crush (or step crush)
• Culotte
• V stent
• SKS (simultaneous kissing stents)

27. Generally speaking, a planned 2 stent
strategy with today‟s second generation
stents requires 7F guide

28. 6F SHEATH
7F GUIDE

29. Sheathless: smaller diameter catheter
improves transition
(7F 100cm guide with 4F 125cm dx)

30. “Proximal optimization”
SHORT BALLOON to
„optimize” prox stent

31. “Sloppy kiss”

32. MACCE to 3 Years by SYNTAX Score
Tercile Left Main SYNTAX Score 33
CABG (N=149) CABG PCI P value
TAXUS (N=135)
Left Main
Death 7.6% 13.4% 0.10
40
P=0.003
Cumulative Event Rate (%)
37.3 CVA 4.9% 1.6% 0.13
30
%
20 MI 6.1% 10.9% 0.18
21.2%
Death,
10
CVA or 15.7% 20.1% 0.34
MI
0
0 12 24 36 Revasc. 9.2% 27.7% <0.001
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported data; ITT population
Two-year Outcomes of the SYNTAX Trial • EOC unblinding

33. When considering all the variables when
making a left main stent decision in a
given patient, whether or not to go
transradial is the easiest

37. Effect of PCI on MACCE and the
Composite of Death, MI, or Stroke
Capodanno JACC2011;58:1426-1432

38. PCI for unprotected left main
DELETED
Recommendation
It is reasonable that patients
I IIa IIb III undergoing PCI to unprotected left
main coronary obstructions be
followed up with coronary
angiography between 2 and 6
months after PCI.
38

39. Meta-analysis of randomized LM Trials:
MACE
Ferrante et al Eurointervention 2011