1. Disclosure Statement
I, Won Ro Lee, hereby acknowledge the AHA’s conflict of interest policy requirement to scrupulously avoid direct and indirect conflicts of interest and, accordingly, hereby declare that relative to this presentation there are no relationships to disclose.

2. The Korean Multicenter Revascularization Registry (KORR) of Percutaneous Intervention Vs. Coronary Artery Bypass Grafting for Diabetics with Multivessel Coronary Artery Disease
Won Ro Lee
Cardiac and Vascular Institute
Sungkyunkwan University
Samsung Medical Center
Seoul, Korea
Mr. Chairman, dear friends and colleagues, I am very pleased to be a part of this gathering and to have this opportunity to share our information with you. Despite many multicenter trials on PCI vs CABG in multivessel coronary artery disease, the most appropriate treatment remains a matter of debate especially in diabetics.
My task this morning is to bring in the latest information from the East on the relative merits of two revascluarization treatments –PCV Vs CABG in diabetics with multicenter CAD.
I hope that my job would be met by presenting you the results of the Korean multicenter Revascularization Registry of PCI vs CABG for diabetics with multivessel CAD.

3. Major Trials on PCI Vs. CABG in Multivessel Coronary Artery Disease
Pre-Stent /GP IIb/IIIa antagonist Era
BARI (J Am Coll Cardiol 2000;35:1122-9
CABRI (Lancet 1995;346: )
RITA (Lancet 1993;343:573-80)
EAST (N Engl J Med 1994;331: )
GABI (N Enlg J Med 1994;331: )
Post-Stent /GP IIb/IIIa antagonist Era
ERACI II (J Am Coll Cardiol (2001;37:51-8)
ARTS (N Enlg J Med 2001;344: )
AWESOME (J AM Coll Cardiol 2001;38:143-9)
1. Major trials on PCI vs CABG in multivessel CAD on which our current practice is based are shown in this slide. BARI would be representative of the pre-stent/Gp IIbIIIa antagonist era and ARTS representing the post-stent era.

4. Centers Participated in the KORR
Korea
SNU
AMC
Yonsei
Kil
SMC/SKK
Aju
Dong-A
7. A total of 3279 patients were registered at 9 centers throughout Korea from January 1995 through December 2000.
Chon-Nam
CV Medicine
CV Medicin & Surgery

5. Outcomes of BARI - Pre-Stent / Gp IIb IIIa Antagonist Era -
In- Hospital Mortality(%) DM
0.6
1.2 NS ND
1.4
Seven-Year Survival(%)
AII
80.9
84.4
0.043
55.7
76.4
0.0011
86.8
86.4
Repeat Revascularization Rate (%)
69.9
11.1 -
57.8
13.5
P-value
0.0078
0.45
PTCA
CABG
P-value
2. As you all know, BARI demonstrated that CABG was better than PTCA in terms of 7-year survival mainly due to the beneficial effect of CABG in diabetics. In non-diabetics, there was no survival difference between PTCA and CABG. Repeat revascularization rate was much higher in PTCA than in CABG; and, within the PTCA group, the revascularization rate was higher in diabetics than in non-diabetics.

6. BARI Randomized Vs. Registry 7-Year Survival
All
82.7%
85.9%
0.85
CABG
84.4%
85.8%
0.57
PTCA
80.9%
86.1%
<0.01
p=0.043
p=0.66
(Adjusted 0.16)
DM+CABG
76.4%
74.0%
DM+PTCA
55.7%
p=0.0011
p= NS
Randomized
Registry
P value
3. In contrast to the BARI randomized trial, BARI registry showed that 7-year survival was similar for PTCA and CABG. Even within diabetics, PTCA and CABG showed similar 7-year survival.

7. PCI Vs. CABG Outcomes of Major Trials -Post-Stent / GP IIb IIIa Antagonist Era-
ARTS
ERACI-II
AWESOME
PCI
(n=600)
CABG
(n=605)
P value
(n=225)
(n=232)
(n=222)
30 Day Mortality(%)
0.9
5.7
<0.013 3 5 NS
1-Year Mortality(%)
2.5
2.8
3.1
7.5
<0.017
1-Year Repeat Revascularization(%)
16.8
3.5 -
4.8
<0.002
3(2)-Year Mortality(%)
10.8
10.4
0.813 20 21
0.46
3(2)-Year Event-free
Survival(%)
69.5
84.8
<0.001 48 61
0.001
(DM)
(52.7
81.7
0.0001)
4. Post-stent era PCI vs CABG outcomes are shown here. ERACI-II showed better outcomes for PCI than for CABG at 30 days and one year. However, ARTS and AWESOME demonstrated similar 2~3 year mortality for PCI and CABG. Repeat revascularization rates were also significantly higher for PCI than for CABG particularly in treated diabetics.

8. DM Prevalence and CAD Mortality in Korea
CAD mortality (per105 )
5. Similar to other eastern societies, the prevalence of DM is explosively increasing in Korea. So is the mortality from coronary artery disease which is in parallel with the prevalence of DM.

9. The Korean Multicenter Revascularization Registry (KORR)
Aim
To assess the relative merits of PCI vs. CABG in the post-stent era in multivessel coronary artery disease particularly in diabetics
Inclusion criteria
January 1995 – December 2000
Elective cases of two or three vessel disease
Exclusion criteria
Primary PCI
Cardiogenic shock , Mechanical complications
History of CABG, Concomitant valve surgery
Follow-up : MACE at 30 days, 1 year, 2 years & 3 years
MACE = Death, MI, CVE, or Revascularization
6. KORR is a retrospective, non-randomized study with physician guided section of treatment. The aim of the KORR is to assess the relative merits of PCI vs CABG in the post-stent/GP IIbIIIa antagonist era in multivessel coronary artery disease particularly in diabetics. In our KORR registry, elective cases with 2 or 3 vessel disease were included. Patients with cardiogenic shock, primary PCI, mechanical complications, concomitant valve surgery or prior history of CABG were excluded. MACE rates were assessed at 30 days, 1y, 2y and 3 yrs.

10. Baseline Characteristics - Total Population (N=3279) -
PCI
CABG
p-value
Female sex
30.2%
28.5%
0.33
Age65
39.2%
35.6%
0.042
ACS
50.4%
60.9%
<0.001
AMI
18.7%
5.7%
3 vessel ds
30.4%
69.0%
Lesion no.
3.0 0.0
4.00.0
Diabetes
30.5%
34.9%
0.009
Diabetes Tx
23.7%
29.9%
hypertension
54.8%
56.8%
0.29
PCI
CABG
p-value
Smoking
41.4%
54.9%
<0.001
FHx of CAD
5.8%
9.8%
LVEF
57.1 0.3
55.0 0.4
LV Fn WNL
78.0%
71.1%
PCI Hx
10.8%
17.1%
CVE Hx
7.9%
0.005
MI Hx
14.9%
25.7%
PVD Hx
4.3%
6.9%
0.001
Prox LAD
32.9%
58.6%
8. Baseline characteristics of the total population indicate that there was a higher proportion of sicker patients in the CABG group. Statistical adjustments were needed to control for the disparity of independent risk factors for prognosis between the two groups.

11. KORR Study Populations
Total population 3279
Unadjusted
PCI
2097
CABG
1182
Statistical
Adjustments
2154(66%)
Age
Clinical Dx
LVF
CVE Hx
LADp lesion
PCI
1493(71%)
CABG
661(56%)
Adjusted
9. Statistical adjustments were made for age, clinical diagnosis(ACS and MI), LVF, CVE hx, and LADp lesion. KORR Outcomes were based on this adjusted population, 2154 patients-1493 in PCI and 661 in CABG. Diabetics were 31% of PCI and 35% of CABG patients. Stenting was performed in 68% of PCI patients and 92% of CABG patients received arterial grafts. ND
1030 DM
463 ND
431 DM
230
Stent
1022(68%)
Arterial graft
609(92%)

12. Baseline Characteristics - Adjusted Population (N=2154) -
PCI
CABG
p-value
Female sex
30.2%
27.5%
0.43
Age65
36.4%
36.6%
0.91
ACS
56.2%
56.3%
0.99
AMI
9.4%
9.2%
0.98
3 vessel ds
30.6%
68.8%
<0.001
Lesion no.
3.0 0.0
4.1 0.1
Diabetes
31.0%
34.8%
0.083
Diabetes Tx
24.4%
30.4%
0.004
Hypertension
56.6%
0.90
PCI
CABG
p-value
Smoking
40.8%
54.2%
<0.001
FHx of CAD
6.3%
9.3%
0.013
LVEF
56.7 0.4%
55.6 0.5%
0.12
LV Fn WNL
75.5%
75.6%
0.94
PCI Hx
11.5%
16.6%
0.001
CVE Hx
9.8%
9.5%
0.86
MI Hx
16.2%
25.0%
PVD Hx
4.8%
6.4%
0.13
Prox LAD
42.7%
42.8%
0.95

13. Overall Outcomes of KORR
PCI (N=1493)
CABG (N=661)
P-value
Death(%)
30 d
0.8
1.4
0.20
1 y
3.0
3.8
0.37
2 y
5.3
6.5
0.40
3 y
10.7
10.4
0.92
Death, MI, CVE(%)
1.3
4.0
<0.001
5.8
7.8
0.13
10.5
12.0
0.43
18.9
18.8
0.97 MI
0.2
0.78
CVE
0.1
2.8
Death, MI, CVE,
3.1
0.29
Revascularization(%)
24.3
37.0
16.8
53.9
25.6
11. Overall outcomes of KORR are shown in this slide.
Thirty-day and 3-year mortality rates were not significantly different between PCI and CABG. Thirty-day morbidity was higher in CABG than in PCI due to an increased rate of CVE. Three-year event-free survival was much better in CABG than in PCI.

14. Overall Outcomes of KORR3Y 2Y 1Y
1.00
.95
.90
.85
.80 3Y 2Y 1Y
1.00
.95
.90
.85
.80 3Y 2Y 1Y
1.0 .9 .8 .7 .6
P=0.30
P=0.49
P<0.001
Survival
Survival
Without MI, CVE
Survival
Without MI, CVE,
Revascularization
CABG
PCI

15. PCI Vs. CABG Outcomes by Diabetic Status
Non-DM
Treated DM
PCI
CABG OR
P-value
Death(%)
30 d
0.7
0.9
0.75
0.64
1.2
2.5
0.45
0.23
1 y
3.1
0.80
0.55
4.5
5.4
0.82
0.66
2 y
4.4
6.2
0.70
0.27
8.1
7.1
1.15
3 y
8.3
10.0
0.81
0.50
19.8
11.4
1.92
0.14
MACE(%)
3.3
0.93
3.2
5.6
0.17
23.4
9.8
2.81
<0.001
27.2
12.2
2.68
35.8
16.0
2.91
40.9
18.5
3.04
50.9
23.9
3.21
64.2
29.3
4.32
13. The short and long-term mortality rates were not significantly different between PCI and CABG for diabetics as well as for non-diabetics although there was a trend towards an increased 3 year mortality of PCI in diabetics.
Three-year MACE rate of PCI was 4.3 times higher than that of CABG in diabetics and it was 3.2times higher than that of CABG in non-diabetics.

16. Non-DM Vs. DM Outcomes by Treatment
PCI
CABG
Non-DM
TxDM OR
P-value
Death(%)
30 d
0.7
1.2
1.79
0.35
0.9
2.5
2.94
0.095
1 y
4.5
1.81
0.12
3.1
5.4
1.78
0.20
2 y
4.4
8.1
1.90
0.069
6.2
7.1
1.15
0.74
3 y
8.3
19.8
2.74
0.002
10.0
11.4
1.16
0.73
MACE(%)
3.2
1.04
0.92
3.3
5.6
1.74
0.17
23.4
27.2
1.22
0.19
9.8
12.2
1.28
0.39
35.8
40.9
1.24
0.16
16.0
18.5
1.19
0.52
50.9
64.2
1.73
0.003
23.9
29.3
1.32
0.32
14. The PCI group showed significantly higher 3-year mortality and MACE rates in diabetics than in non-diabetics in contrast to the CABG group in which they were not significantly different between the two cohorts.

17. Outcomes by Diabetic Status and Treatment
1.00
.95
.90
.85
.80 3Y 2Y 1Y
1.00
.95
.90
.85
.80
p=0.45 3Y 2Y 1Y
1.0 .9 .8 .7 .6
p=0.19
p=0.20
p=0.11
p<0.001
Survival
Survival
Without MI, CVE
Survival
Without MI, CVE,
Revascularization
Non-DM, CABG
DM, CABG
Non-DM, PCI
DM, PCI

18. MACE by Diabetic Subgroups Within and Between Treatment Cohorts
1.0 .9 .8 .7 .6 .5
p=0.51
p=0.18
CABG
PCI
Non-diabetic
Oral hypoglycemic
Diet only
Insulin

19. Arterial Graft Vs. Stent
Art Graft (N=609)
Stent (N=1022)
P-value
Death(%)
30 D
1.5
0.6
0.081
1 y
2.6
3.0
0.69
2 y
5.0
5.5
0.77
3 y
8.6
11.9
0.25
Death, MI, CVE(%)
3.7
1.0
<0.001
6.3
4.8
10.1
10.0
0.95
16.4
20.2
0.28
MI(%)
0.2
0.1
0.73
CVE(%)
2.4
0.0
0.039
Death, MI, CVE,
2.2
0.096
Revascularization(%)
24.0
14.7
38.6
23.2
59.8
17. In a separate analysis of arterial graft vs. stent, the short and long-term outcomes were similar to that of total adjusted population.

20. Outcomes by Anginal and Diabetic Status
Death, MI, CVE, or Revascularization 3Y 2Y 1Y
1.0 .9 .8 .7 .6 .5 3Y 2Y 1Y
1.0 .9 .8 .7 .6 .5
P=0.0081
P=0.19
P=0.22
PCI group에서는 DMTx와 ACS가 additive effect, CABG에서는 그러한 효과가 없다. DM ACS에서는 CABG의 benefit이 증가하는 듯
PCI
CABG
Non-DM, SA
Non-DM, ACS
DM, SA
DM, ACS

21. Post-Stent Era PCI Vs. CABG in Multivessel Coronary Artery Disease
Clinical Trials
Relative Merits
ARTS
PCI
CABG
Revascularization
All DM
Survival
KORR ND
After RAVEL ?
19. Based on current information, the relative merits of 2 revascularization techniques in the management of multivessel CAD in the post-stent era may be summarized as shown in this slide.
According to ARTS, two techniques stand even in survival and CABG is superior to PCI in terms of less need for repeat revascularization especially in diabetics. KORR also showed similar survival between the 2 techniques in both diabetics and nondiabetics. Although repeat revascularization rate of PCI was higher than that of CABG, the difference of its rate between diabetics and nondiabetics in KORR was not as high as in ARTS.
After RAVEL and TAXUS, the restenosis rate following stenting may be further lowered. Therefore PCI may be able to achieve similar or even better outcomes than that of CABG in the era of drug-coated stent. Only time will tell us.

22. Summary
The short (30 days) and long-term (3 years) survival rates were not significantly different between PCI and CABG for total population as well as for treated diabetics.
The short term morbidity was higher in CABG than in PCI due to an increased rate of CVE.
The PCI group showed significantly higher three-year mortality and MACE rates in treated diabetics than in non-diabetics in contrast to the CABG group in which they were not significantly different between the 2 cohorts.
While three-year MACE rate of PCI was 4.3 times higher than that of CABG for diabetics, it was 3.2 times higher than that of CABG for non-diabetics.

23. Limitations
KORR is a retrospective and non-randomized study with physician guided selection of treatment.
Although measured differences between the 2 treatment groups are controlled, this statistical adjustment may be imperfect.

24. Conclusions
Thirty-day and three-year survival rates were not significantly different between PCI and CABG for treated diabetics as well as for total population.
However, PCI was associated with a greater need for repeated revascularization particularly in treated diabetics.

25. The KORR Participants Sungkyunkwan University Samsung Medical Center
Won Ro Lee, M.D. Hyeon-Cheol Gwon, M.D. Young Tak Lee, M.D.
Seoul National Univ. Hospital
Young-Bae Park, M.D.
Ki-Bong Kim, M.D.
Korea University Hospital
Ro Young Moo, M.D.
Kil Medical Center
Shin Eak Kyun, M.D.
Chon-Nam University Hospital
Myung Ho Jeong, M.D.
Yonsei University Hospital
Seung Yun Cho, M.D.
Byung-Chul Chang, M.D.
Asan Medical Center
Seung-Jung Park, M.D.
Aju University Hospital
Byung-il William Choi, M.D.
Dong-A University Hospital
Moo Hyun Kim, M.D.
Woo Jong Soo, M.D.

26. Overall Outcomes of Total Population3Y 2Y 1Y
1.00
.95
.90
.85
.80 3Y 2Y 1Y
1.0 .9 .8 3Y 2Y 1Y
1.0 .9 .8 .7 .6
P=0.77
P=0.77
P<0.001
Survival
Survival
Without MI, CVE
Survival
Without MI, CVE,
revascularization
CABG
PCI

27. %
ND+PTCA 86.8%
ND+CABG 86.4%
DM+CABG 76.4%
DM+PTCA 55.7%
Treatment Comparisons
ND : p=0.72
DM : p=0.0011
Years
Survival in the BARI trial by assigned treatment and diabetic status (Adapted from J Am Coll Cardiol 2000;35:1122-9)

28. Oral + CABG 84.1%
Insulin+ CABG 67.8%
Oral + PTCA 60.6%
Insulin+ PTCA 49.4%
Survival in the BARI trial by assigned treatment and diabetic treatment at baseline. (Adapted from J Am Coll Cardiol 2000;35:1122-9)

29. (A) (B) (C) Stenting CABG P=0.75 CABG CABG Stenting Stenting
Actuarial Survival(A), event-free survival without MI or CVE(B) and without CVE, MI, or RR (C)
in the ARTS Trial by Assigned Treatment ( Adapted from N Engl J Med 2001;344: )

30. Outcomes Within and Between Treatment Cohorts by Diabetic Subgroups
None
Diet
OHA
Insulin
p-value
Death 1Y
CABG
3.0
4.5
6.1
4.4
0.55
 (%)
PCI
2.2
6.3
4.7
4.0
0.12 OR
0.71
1.40
0.75
0.90
p-value
0.39
0.77
0.61
0.90
Death, MI, CVE 1Y
CABG
7.1
4.5
10.2
8.7
0.70
 (%)
PCI
5.2
9.4
5.8
9.0
0.33 OR
0.71
2.17
0.54
1.04
p-value
0.19
0.48
0.18
0.95
MACE 1Y
CABG
9.9
8.7
12.9
11.3
0.83
 (%)
PCI
23.1
26.7
25.4
30.9
0.35 OR
2.75
3.82
2.30
3.53
p-value
<0.001
0.071
0.012
0.003