Samsung Medical Center Cardiac & Vascular Center Young Bin Song , Joo-Yong Hahn, Seung-Hyuk Choi, Jin-Ho Choi, Sang Hoon Lee, Myung-Ho Jeong, Hyo-Soo Kim, In-Whan Seong, Ju-Young Yang, Seung Woon Rha, Seung-Jung Park, Jung Han Yoon, Seung-Jea Tahk, Ki Bae Seung, Yangsoo Jang, Hyeon-Cheol Gwon For the COBIS Investigators
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Samsung Medical Center Cardiac & Vascular Center Young Bin Song, Joo-Yong Hahn, Seung-Hyuk Choi, Jin-Ho Choi, Sang Hoon Lee, Myung-Ho Jeong, Hyo-Soo Kim,
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Samsung Medical Center
Cardiac & Vascular Center
Young Bin Song, Joo-Yong Hahn, Seung-Hyuk Choi,
Jin-Ho Choi, Sang Hoon Lee, Myung-Ho Jeong, Hyo-Soo Kim,
In-Whan Seong, Ju-Young Yang, Seung Woon Rha,
Seung-Jung Park, Jung Han Yoon, Seung-Jea Tahk,
Ki Bae Seung, Yangsoo Jang, Hyeon-Cheol Gwon
For the COBIS Investigators
Samsung Medical Center
Cardiac & Vascular Center
Supported by research grants from
the Korean Society of Interventional Cardiology
None of the authors had disclosures with regard
to the present study
Samsung Medical Center
Cardiac & Vascular Center
SES is superior to PES in terms of late loss SIRTAX REALITY
Not all studies found SES to be superior in terms of clinical outcomes
Samsung Medical Center
Cardiac & Vascular Center
Coronary bifurcation lesions remains at a higher risk of unfavorable outcomes even after the use of DES
Limited data exist regarding the comparison of these 2 leading DES for the treatment of bifurcation lesions
Samsung Medical Center
Cardiac & Vascular Center
Study design Multi-center retrospective real-world registry of
drug-eluting stenting in coronary bifurcation lesions
2004.1 – 2006.6 (2.5 years)
Study purpose To find out the current status of bifurcation drug-
eluting stenting and determine the prognostic factors for long-term outcome in Korea.
Samsung Medical Center
Cardiac & Vascular Center
Inclusion criteria1) Age 18 years
2) Any type of de novo bifurcation lesion with a parent vessel 2.5 mm and side branch 2.0 mm by visual estimation
3) Treated with SES or PES
Exclusion criteria1) Cardiogenic Shock
2) ST elevation MI within 48hours
3) Expected survival less than 1 year
4) Left main bifurcation
5) Allergy to the antiplatelets
6) Treated with other type of DES or mixed use
Samsung Medical Center
Cardiac & Vascular Center
Samsung Medical Center
Cardiac & Vascular Center
In Patients undergoing PCI with DES for Bifurcation Lesions
To compare the long-term clinical outcomes after implantation of SES vs. PES for coronary bifurcation lesions using data from a dedicated, large, multicenter real-world registry
Primary outcome : the composite of cardiac death, MI requiring hospitalization, or target lesion revascularization
Samsung Medical Center
Cardiac & Vascular Center
Statistical analysis To reduce the impact of treatment-selection bias and
potential confounding in an observational study, we performed rigorous adjustment for significant differences in characteristics of patients by use of the propensity-score matching.
The propensity scores were estimated using multiple logistic-regression analysis.
discrimination and calibration ability of propensity-score model was assessed by means of the c-statistic (=0.65) and the Hosmer-Lemeshow statistic (p=0.78).
Samsung Medical Center
Cardiac & Vascular Center
Overall population : a total of 1595 patients SES : 1033 (64.8%) vs. PES : 562 (35.2%) Median follow-up : SES 23 [15 to 34] months
PES 20 [14 to 29] months a total of 101 events during the entire study period
Propensity-Matched Population : 407 matched pair Median follow-up : 22 months a total of 54 events
Samsung Medical Center
Cardiac & Vascular Center
Samsung Medical Center
Cardiac & Vascular Center
SES(n=1033)
PES(n=562) p Value
Vessel involved 0.10
LAD/diagonal 809 (78.3) 414 (73.7)
LCX/OM 175 (16.9) 113 (20.1)
RCA bifurcation 49 (4.7) 35 (6.2)
Medina classification 0.22
True bifurcation 703 (68.1) 399 (71.0)
1.1.1 509 (49.3) 298 (53.0)
1.0.1 76 (7.4) 27 (4.8)
0.1.1 118 (11.4) 74 (13.2)
Non-true bifurcation 330 (31.9) 163 (29.0)
1.0.0 80 (7.7) 36 (6.4)
0.1.0 109 (10.6) 49 (8.7)
1.1.0 124 (12.0) 71 (12.6)
0.0.1 17 (1.6) 7 (1.2)
Samsung Medical Center
Cardiac & Vascular Center
SES(n=1033)
PES(n=562) p Value
Stenting technique 0.39Main vessel stenting only 850 (82.3) 472 (84.0)Stent in both branches 183 (17.7) 90 (16.0)
Cardiac death 11 (1.1) 2 (0.4) 3.46 (0.75-16.00) 0.12
Cardiac death or MI 18 (1.7) 14 (2.5) 0.86 (0.42-1.78) 0.68
TLR 38 (3.7) 38 (6.8) 0.45 (0.28-0.72) < 0.01
TVR 50 (4.8) 47 (8.4) 0.51 (0.33-0.78) < 0.01
MACE 52 (5.0) 49 (8.7) 0.52 (0.34-0.79) < 0.01
* Adjusted covariates included age, gender, acute coronary syndrome, diabetes mellitus, true bifurcation, stenting techniques, final kissing ballooning, use of intravascular ultrasound, type of stent used, stent diameter, and total stent length.
Median FU 22 months [15-32]
Samsung Medical Center
Cardiac & Vascular Center
1033
562
SES
PES
No. at risk
1015
543
983
507
672
301
Months
Su
rviv
al
fre
e f
rom
MA
CE
(%
)
P < 0.01
A B
Months
Su
rviv
al
fre
e f
rom
TL
R (
%)
P < 0.01
SES PES
SES PES
80
85
90
95
100
80
85
90
95
100
6 18 2412 6 18 2412
484
214
1033
562
SES
PES
No. at risk
1015
546
985
511
674
304
487
216
Median FU 22 months [15-32]
Samsung Medical Center
Cardiac & Vascular Center
Type ARC definition SES PES P-value
Subacute ST
(<30D)Definite or Probable 5 (0.5%) 1 (0.2%) 0.339
Late ST(30D – 1Y)
Definite or Probable 0 (0.0%) 2 (0.4%) 0.123
Possible 3 (0.3%) 0 (0.0%) 0.556
Very late ST
(1Y-2Y)
Definite or Probable 2 (0.4%) 1 (0.4%) 0.954
Possible 0 (0.0%) 0 (0.0%) -
Any ST
Definite or Probable
7 (0.7%) 4 (0.7%) 0.937
Possible 3 (0.3%) 0 (0.0%) 0.556
Median FU 22 months [15-32]
Samsung Medical Center
Cardiac & Vascular Center
SES(N=407)
PES(N=407)
Adjusted HR*(95% CI)
P Value
Cardiac death 6 (1.5) 2 (0.5) 2.32 (0.44–12.17) 0.32
Cardiac death or MI 8 (2.0) 8 (2.0) 0.89 (0.33–2.41) 0.82
TLR 14 (3.4) 29 (7.1) 0.48 (0.25–0.91) 0.02
TVR 20 (4.9) 36 (8.8) 0.55 (0.32–0.95) 0.03
MACE 19 (4.7) 35 (8.6) 0.52 (0.30–0.91) 0.02
* Adjusted covariates included age, gender, acute coronary syndrome, diabetes mellitus, true bifurcation, stenting techniques, final kissing ballooning, use of intravascular ultrasound, type of stent used, stent diameter, and total stent length.
Median FU 20 months [14-30]
Samsung Medical Center
Cardiac & Vascular Center
Su
rviv
al
fre
e f
rom
MA
CE
(%
)
Su
rviv
al
fre
e f
rom
TL
R (
%)
80
85
90
95
100
80
85
90
95
100
407
407
SES
PES
No. at risk
399
396
393
369
255
218
Months Months
6 18 2412 6 18 2412
193
154
407
407
SES
PES
No. at risk
399
397
393
371
255
219
194
155
P < 0.01
A B
P < 0.01
SES PES
SES PES
Samsung Medical Center
Cardiac & Vascular Center
Subgroups Number of patients Hazard ratio 95% CI P for interaction
Age < 65 years 917 0.57 0.33-0.98 ≥ 65 years 678 0.55 0.30-0.99Presentation Non-ACS 668 0.51 0.25-1.00 ACS 927 0.60 0.37-0.99Diabetes No 1107 0.51 0.31-0.84 Yes 488 0.66 0.32-1.34True bifurcation No 493 0.51 0.23-1.12 Yes 1102 0.58 0.36-0.93Stenting technique 1-stent 1322 0.56 0.36-0.89 2-stent 273 0.51 0.21-1.25
1Favors SES
0 2
Favors PES
0.93
0.68
0.57
0.80
0.85
Samsung Medical Center
Cardiac & Vascular Center
We compared the long-term clinical outcomes after implantation of SES vs. PES for coronary bifurcation lesions using data from a dedicated, large, multicenter real-world registry In a crude analysis
- SES is better : HR 0.53 (p<0.01) for composite outcomes mainly driven by lower TLR
- No differences in death, MI, or stent thrombosis
In a propensity-matching analysis- SES is still better : HR 0.52 (p=0.02) for composite outcomes
- No differences in death, MI, or stent thrombosis
Samsung Medical Center
Cardiac & Vascular Center
SES implantation for the treatment of coronary bifurcation lesion was associated with a lower incidence of MACE than PES implantation mainly driven by the lower incidence of TLR.
Rates of cardiac death, MI, or ST between the groups were similar.