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,

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



Supported by research grants from

the Korean Society of Interventional Cardiology

None of the authors had disclosures with regard

to the present study



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



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



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.



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





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



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).



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





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)



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)

T-stenting 86 (47.0) 42 (46.7) Crush 72 (39.3) 22 (24.4) Kissing stenting 20 (10.9) 21 (23.3) Culottes 5 (2.7) 5 (5.6)Final kissing balloon inflation 475 (46.0) 192 (34.2) < 0.01Guidance of intravascular ultrasound 370 (35.8) 148 (26.3) < 0.01Use of glycoprotein IIb/IIIa inhibitor 33 (3.2) 25 (4.4) 0.20Remote site intervention 250 (24.2) 144 (25.6) 0.53Main vessel Total stent length (mm) 30.0 ± 12.1 31.1 ± 13.9 0.12 Maximal stent diameter (mm) 3.13 ± 0.31 3.14 ± 0.32 0.92Side branch N=183 N=90 Total stent length (mm) 22.3 ± 8.9 20.8 ± 8.5 0.18 Maximal stent diameter (mm) 2.77 ± 0.29 2.69 ± 0.25 0.02



(%)

Cardiac death

Cardiac deathor MI

TLR TVR MACE

P=0.26 P=0.62 P<0.01 P<0.01 P<0.01

Median FU 22 months [15-32]



SES(N=1033)

PES(N=562)

Adjusted HR*(95% CI)

P Value

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.




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




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




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.




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



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



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



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.

Documents

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,