1. The Guidelines Should Be Change!
PCI for Left Main CAD:
The Guidelines Should Be Change!
Jeffrey J. Popma, MD
Director, Innovations in Interventional Cardiology
Senior Attending Physician
Beth Israel Deaconess Medical Center
Associate Professor of Medicine
Harvard Medical School
Boston, MA

2. Jeffrey J. Popma, MD DISCLOSURES Grants/Contracted Research Honoraria
Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson company, Medtronic CardioVascular, Inc.
Honoraria
Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson company
I intend to reference unlabeled/unapproved uses of drugs or devices in my presentation.
I intend to reference transcatheter aortic valves.

3. Guidelines Should Be Changed!
Left Main PCI:
Guidelines Should Be Changed!
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Evidence for CABG over Medical Therapy for Left Main CAD
Appropriateness Guidelines
Syntax and Other RCT
Assessing Outcomes and CE
2009 ACC-AHA Guidelines Update
Perspectives

4. The Evidence for CABG over Medical Therapy
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Non
Randomized
Comparative
Outcomes
Not Superior
In All Subset
CAAS contains a registry of 24,179 patients who underwent coronary angiography between August 1974 and June 1979 at 15 medical centers.
1,492 registry patients with left main coronary artery disease (> 50 percent)
Chaitman AJC (4) p765-77

5. Survival is Improved over Med Rx Alone
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Chaitman AJC (4) p765-77

6. The Benefit is Related to the LM Severity
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Chaitman AJC (4) p765-77

7. CABG Not Beneficial in Everyone
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
CABG did not significantly improve survival in:
a nonstenotic dominant right or balanced coronary circulation
a stenotic dominant right coronary artery and normal LVEF,
LM coronary stenosis of 50 to 59 percent and normal or mildly abnormal left ventricular function.
Chaitman AJC (4) p765-77

8. Not All LM Disease is the Same

9. Guidelines Should Be Changed!
Left Main PCI:
Guidelines Should Be Changed!
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Evidence for CABG over Medical Therapy for Left Main CAD
Appropriateness Guidelines
Syntax and Other RCT
Assessing Outcomes and CE
2009 ACC-AHA Guidelines Update
Perspectives

10. “Appropriateness” Criteria
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Patel et al JACC (February):

11. Definition Used for Analysis
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Coronary revascularization is appropriate when the expected benefits in terms of survival and health outcomes (symptoms, functional status, and/or quality of life) exceed the expected negative consequences of the procedure
Patel et al JACC (February):

12. Appropriateness Rankings
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Appropriate: Score Coronary revascularization is generally accepted and is a reasonable approach for the indication and is likely to improve the patient’s health outcome or survival
Uncertain: Score Coronary revascularization may be acceptable and may be a reasonable approach for the indication but with uncertainty meaning that more research and/or patient information is needed to further classify the indication
Inappropriate Score: Coronary revascularization is not generally accepted and is not a reasonable approach for the indication and is unlikely to improve the patient’s health outcome or survival
Patel et al JACC (February):

13. Appropriateness: PCI v CABG
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
The Appropriateness Guidelines do not provide much room for PCI in patients with left main disease
Patel et al JACC (February):

14. Guidelines Should Be Changed!
Left Main PCI:
Guidelines Should Be Changed!
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Evidence for CABG over Medical Therapy for Left Main CAD
Appropriateness Guidelines
Syntax and Other RCTs
Assessing Outcomes and CE
2009 ACC-AHA Guidelines Update
Perspectives

15. Strong Conclusions for CABG
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.

16. SYNTAX Trial Design + TAXUS n=903 PCI n=198 CABG n=1077 n=897 N=198
62 EU Sites +
23 US Sites
TAXUS
n=903
PCI
n=198
CABG
n=1077
n=897
no f/u
n=428
5yr f/u
n=649
all captured w/
follow up
2500
750 w/ f/u vs
Total enrollment N=3075
Stratification: LM and Diabetes
Two Registry Arms
Randomized Arms
n=1800
N=1275
N=1800
Heart Team (surgeon & interventionalist)
N=198
N=1077
Amenable for only one treatment approach
TAXUS*
N=903
N=897
Amenable for both
treatment options LM
33.7%
3VD
66.3%
34.6%
65.4%
71% enrolled (N=3,075)
All Pts with de novo 3VD and/or LM disease (N=4,337)
Treatment preference (9.4%)
Referring MD or pts. refused informed consent (7.0%)
Inclusion/exclusion (4.7%)
Withdrew before consent (4.3%)
Other (1.8%)
Medical treatment (1.2%)
USVC.TBD.October 2007.Page 16 of 157 DM
28.5%
Non DM
71.5%
NonDM
71.8%
28.2%
*TAXUS® Express® Stent 16 16

17. Adverse Events to 12 Months Left Main Subset
Stent (N=357)
CABG (N=348)
All-Death
CVA (Stroke)
P=0.88*
P=0.009*
Number Needed to Prevent
4.4%
2.7%
Number of CABGs needed to prevent one re-PCI = 19
4.2%
0.3%
Myocardial Infarction
Revascularization
At the cost of 9 times as many strokes
P=0.97*
P=0.02*
12.0%
4,1%
6.7%
4.3% 17

18. Presented at ESC September 2009 by A. Pieter Kappetein MD PhD
Two Year Outcome in LM Subgroup
TAXUS® Express® Stent
CABG
P=0.01
P=0.48
P=0.27
Number Needed to Prevent
Number of CABGs needed to prevent one re-PCI = 15
Patients, %
This means 14 of every 15 CABGs were unnecessary!
2-Year_Randomized_Draft_dryrun2.doc Exhibits 18 & 20
Death/CVA/MI
Revasc
MACCE
Left Main Disease
n=705
ITT population
Presented at ESC September 2009 by A. Pieter Kappetein MD PhD
The safety and effectiveness of the TAXUS® Stent Systems have not been established in the following patient populations: lesions located in the unprotected left main coronary artery, or patients with multi-vessel disease. 18

19. SYNTAX Score
A prospective angiographic tool to grade the complexity of coronary artery disease
Goal: Obtain evidence-based guidelines for selecting revascularization technique (surgery or PCI)
The SYNTAX Score will be retroactively weighted based on MACCE at 1 and 5 years to optimize its prognostic value 19

20. MACCE to 12 Months by SYNTAX Score Tertile High Scores (33+)
CABG
PCI
P-value*
Death
4.1%
9.7%
0.06
CVA
3.4%
0.8%
0.22 MI
6.0%
7.6%
0.65
Death, CVA or MI
10.8%
14.1%
0.40
Revasc.
4.9%
17.8%
0.001
TAXUS (N=135)
CABG (N=150)
LM Subset† 40 50 20 30 10
P=0.008*
25.3%
Cumulative Event Rate (%)
12.9% 6 12
Months Since Allocation
†Patients with isolated LM or LM +1, +2 or +3 vessel disease
KM Event rate ± 1.5 SE, *chi square or Fisher exact test
Site-reported Data; ITT population 20 20

21. Guidelines Should Be Changed!
Left Main PCI:
Guidelines Should Be Changed!
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Evidence for CABG over Medical Therapy for Left Main CAD
Appropriateness Guidelines
Syntax and Other RCT
Assessing Outcomes and CE
2009 ACC-AHA Guidelines Update
Perspectives

22. Left Main White Paper
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Kandzari et al JACC :1576–88

24. No Difference In Mortality Up To 3 Years CABG n PCI Summary OR 95% CI
1932
1393
1.00
Year 2
890
528
1.27
Year 3
578
263
1.11
No Difference In
Mortality
Up To 3 Years

25. No Difference In Death, MI and Stroke Up To 3 Years CABG n PCI
Summary OR
95% CI
Year 1
1614
1239
0.84
Year 2
652
432
1.25
Year 3
451
236
1.16
No Difference In
Death, MI and Stroke
Up To 3 Years

26. Increased TVR Up To 3 years CABG n PCI Summary OR 95% CI Year 1 1692
1240
4.36
Year 2
699
417
4.20
Year 3
447
211
3.30
Increased TVR
Up To 3 years

27. Guidelines Should Be Changed!
Left Main PCI:
Guidelines Should Be Changed!
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Evidence for CABG over Medical Therapy for Left Main CAD
Appropriateness Guidelines
Syntax and Other RCT
Assessing Outcomes and CE
2009 ACC-AHA Guidelines Update
Perspectives

28. 2009 ACC-AHA PCI Updates J. Am. Coll. Cardiol. 2009;54;2205-2241
Kushner FG JACC 2009;54;

29. Guidelines Should Be Changed!
Left Main PCI:
Guidelines Should Be Changed!
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Evidence for CABG over Medical Therapy for Left Main CAD
Appropriateness Guidelines
Syntax and Other RCT
Assessing Outcomes and CE
2009 ACC-AHA Guidelines Update
Perspectives

30. Current Evidence Justifies Left Main PCI as a Class IIa Recommendation
----- with qualifications
Control is required for study validity, to avoid the fallacy
of post hoc ergo propter hoc reasoning.
Is the syntax score high?
Is it a simple ostial or mid-shaft lesion?
Can we achieve complete revascularization?
Is revascularization of an occluded RCA important?
Is the left main heavily calcified?
Is the left main small, and/or tortuous?
Is the patient an insulin dependent diabetic?
Do co-morbid consisderations make the patient a poor candidate for CABG?
Teirstein PS SCRIPPS 2009 31