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  – (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 criteria 1) 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 criteria 1) 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 N=1595 For analysis Exclude Other DES or mixed use: N=73 Excluded after core lab CAG review: N=251 All N=1919

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 SES (n=1033) PES (n=562)p Value Demographic characteristics Age, years62.1 ± ± Male703 (68.1)366 (65.1)0.23 Coexisting conditions or risk factor Clinical presentation< 0.01 Stable angina463 (44.8)205 (36.5) Unstable angina398 (38.5)245 (43.6) Myocardial infarction172 (16.7)112 (19.9) Current smoker242 (23.4)144 (25.6)0.33 Diabetes mellitus298 (28.8)190 (33.8)0.04 Hypertension608 (58.9)333 (59.3)0.88 Dyslipidemia316 (30.6)180 (32.0)0.55 Family history of CAD41 (4.0)21 (3.7)0.82 Peripheral vascular disease11 (1.1)8 (1.4)0.53 Prior myocardial infarction86 (8.3)42 (7.5)0.55 Prior CVA52 (5.0)29 (5.2)0.91 Chronic renal failure34 (3.3)18 (3.2)0.92 Left ventricular ejection fraction, %59.5 ± ± LVEF <50%126 (18.1)68 (15.4)0.24

Samsung Medical Center Cardiac & Vascular Center SES (n=1033) PES (n=562)p Value Vessel involved 0.10 LAD/diagonal809 (78.3)414 (73.7) LCX/OM175 (16.9)113 (20.1) RCA bifurcation49 (4.7)35 (6.2) Medina classification 0.22 True bifurcation703 (68.1)399 (71.0) (49.3)298 (53.0) (7.4)27 (4.8) (11.4)74 (13.2) Non-true bifurcation330 (31.9)163 (29.0) (7.7)36 (6.4) (10.6)49 (8.7) (12.0)71 (12.6) (1.6)7 (1.2)

Samsung Medical Center Cardiac & Vascular Center SES (n=1033) PES (n=562)p Value Stenting technique0.39 Main vessel stenting only850 (82.3)472 (84.0) Stent in both branches183 (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 inflation475 (46.0)192 (34.2)< 0.01 Guidance of intravascular ultrasound370 (35.8)148 (26.3)< 0.01 Use of glycoprotein IIb/IIIa inhibitor33 (3.2)25 (4.4)0.20 Remote site intervention250 (24.2)144 (25.6)0.53 Main vessel Total stent length (mm)30.0 ± ± Maximal stent diameter (mm)3.13 ± ± Side branchN=183N=90 Total stent length (mm)22.3 ± ± Maximal stent diameter (mm)2.77 ± ±

Samsung Medical Center Cardiac & Vascular Center (%) Cardiac death or MI TLR TVR MACE P=0.26 P=0.62 P<0.01 Median FU 22 months [15-32]

Samsung Medical Center Cardiac & Vascular Center SES (N=1033) PES (N=562) Adjusted HR* (95% CI) P Value Cardiac death11 (1.1)2 (0.4)3.46 ( )0.12 Cardiac death or MI18 (1.7)14 (2.5)0.86 ( )0.68 TLR38 (3.7)38 (6.8)0.45 ( )< 0.01 TVR50 (4.8)47 (8.4)0.51 ( )< 0.01 MACE52 (5.0)49 (8.7)0.52 ( )< 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 SES PES No. at risk Months Survival free from MACE (%) P < 0.01 AB Months Survival free from TLR (%) P < 0.01 SES PES SES PES SES PES No. at risk Median FU 22 months [15-32]

Samsung Medical Center Cardiac & Vascular Center TypeARC definitionSESPESP-value Subacute ST (<30D) Definite or Probable5 (0.5%)1 (0.2%)0.339 Late ST (30D – 1Y) Definite or Probable0 (0.0%)2 (0.4%)0.123 Possible3 (0.3%)0 (0.0%)0.556 Very late ST (1Y-2Y) Definite or Probable2 (0.4%)1 (0.4%)0.954 Possible0 (0.0%) - Any ST Definite or Probable7 (0.7%)4 (0.7%)0.937 Possible3 (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 death6 (1.5)2 (0.5)2.32 (0.44–12.17)0.32 Cardiac death or MI8 (2.0) 0.89 (0.33–2.41)0.82 TLR14 (3.4)29 (7.1)0.48 (0.25–0.91)0.02 TVR20 (4.9)36 (8.8)0.55 (0.32–0.95)0.03 MACE19 (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 Survival free from MACE (%) Survival free from TLR (%) 407 SES PES No. at risk Months SES PES No. at risk P < 0.01 AB SES PES SES PES

Samsung Medical Center Cardiac & Vascular Center Subgroups Number of patients Hazard ratio 95% CI P for interaction Age < 65 years ≥ 65 years Presentation Non-ACS ACS Diabetes No Yes True bifurcation No Yes Stenting technique 1-stent stent Favors SES 0 2 Favors PES

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.