Young Bin Song , Joo -Yong Hahn, Seung-Hyuk Choi ,

1. Sirolimus- Versus Paclitaxel-Eluting Stents for the Treatment of Coronary Bifurcations: Results From the COBIS (COronaryBIfurcationStenting) Registry Young Bin Song, Joo-Yong Hahn, Seung-HyukChoi, Jin-Ho Choi, Sang Hoon Lee, Myung-Ho Jeong, Hyo-Soo Kim, In-WhanSeong, Ju-Young Yang, SeungWoonRha, Seung-Jung Park, Jung Han Yoon, Seung-JeaTahk, KiBaeSeung, Yangsoo Jang, Hyeon-CheolGwon For the COBIS Investigators

2. Trial Sponsors • Supported by research grants from the Korean Society of Interventional Cardiology • None of the authors had disclosures with regard to the present study Disclosures

3. PreviousComparative Study: SES Versus PES • 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

4. SES Versus PES in Bifurcation lesion • 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

5. Coronary Bifurcation Stent Registry • 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.

6. Study Subjects • 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

7. Subjects for Analysis

8. The Aim of Study 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

9. Method • 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).

10. Results • 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

11. Baseline Characteristics

12. Lesion Characteristics

13. Procedural Characteristics

14. Clinical Outcomes Total population (%) P<0.01 P=0.62 P<0.01 P=0.26 P<0.01 TVR MACE Cardiac death or MI TLR Cardiac death Median FU 22 months [15-32]

15. Clinical Outcomes Total population * 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]

16. Survival Analysis: Overall patients A B P < 0.01 P < 0.01 Survival free from TLR (%) Survival free from MACE (%) SES SES PES PES 12 12 18 18 24 24 6 6 Months Months No. at risk No. at risk 487 674 484 SES 672 SES 1033 1015 985 1033 1015 983 216 PES 304 214 PES 301 562 546 511 562 543 507 Median FU 22 months [15-32]

17. Stent Thrombosis Median FU 22 months [15-32]

18. Clinical Outcomes Propensity-Matched Population * 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]

19. Survival Analysis: Matched patients A B P < 0.01 P < 0.01 Survival free from TLR (%) Survival free from MACE (%) SES SES PES PES 12 12 18 18 24 24 6 6 Months Months No. at risk No. at risk 194 255 193 SES 255 SES 407 399 393 407 399 393 155 PES 219 154 PES 218 407 397 371 407 396 369

20. Subgroup AnalysisMACE : cardiac death, MI, TLR 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 0.30-0.99 Presentation Non-ACS 668 0.51 0.25-1.00 ACS 927 0.60 0.37-0.99 Diabetes No 1107 0.51 0.31-0.84 Yes 488 0.66 0.32-1.34 True bifurcation No 493 0.51 0.23-1.12 Yes 1102 0.58 0.36-0.93 Stenting technique 1-stent 1322 0.56 0.36-0.89 2-stent 273 0.51 0.21-1.25 0.93 0.68 0.57 0.80 0.85 2 0 1 Favors SES Favors PES

21. Summary • 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

22. Conclusion 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.