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Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Percutaneous Treatment of LONG native Coronary Lesions with D rug- E luting S tent- II : Cypher versus Taxus Long-DES-II. Seung-Jung Park, MD, PhD for the Long-DES II Study investigators. Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

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Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

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  1. Percutaneous Treatment of LONG native Coronary Lesions with Drug-Eluting Stent-II: Cypher versus Taxus Long-DES-II Seung-Jung Park, MD, PhD for the Long-DES II Study investigators Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

  2. Conflict of Interest Statement Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

  3. Background • Recent reports evaluating follow-up outcomes across various clinical and angiographic subgroups showed that several factors conferred a higher risk of restenosis even after DES use. • A long diseased segment is a key predictor of worse prognostic outcome in terms of restenosis.

  4. Background • The previous Long-DES registry study (Long-DES-I) showed that SES might be more effective in reducing angiographic restenosis compared to PES for treatment of long native coronary artery disease.

  5. Restenosis Rate of Long-DES-I P<0.001 P=0.001 P<0.001 P<0.001 % P<0.001 P<0.001 P<0.001 P<0.001 20/271 32/150 68/160 17/271 24/150 65/160 Kim YH et al. Catheter Cardiovasc Interv 2006;67:181

  6. Purpose • To compare the efficacy of SES with PES using a randomized controlled study design

  7. Study Administration Angiographic Core Lab : • CVRF Independent event committee : • CVRF Grants : • Cordis, Johnson & Johnson • Korean Ministry of Health & Welfare as part of the Korea Health 21 R&D Project Principal investigator : • Seung-Jung Park, MD, PhD, Asan Medical Center Data monitoring : • CardioVascular Research Foundation (CVRF), Seoul, Korea • IRBs Data analysis : • CVRF • Ischemic Heart Disease Clinical Research Center

  8. Investigators in Korea Asan Medical Center Seung-Jung Park, MD, PhD Seong-Wook Park, MD, PhD Cheol Whan Lee, MD, PhD Myeong-Ki Hong, MD, PhD Young-Hak Kim, MD, PhD Seung-Whan Lee, MD, PhD Sung-Cheol Yun, PhD Chonbuk National University Jae-Ki Ko, MD, PhD Hyun-Sook Kim, MD, PhD Chungnam National University In-Whan Seong, MD, PhD Si Wan Choi, MD, PhD Jae-Hwan Lee, MD, PhD Jae-Hyeong Park, MD, PhD Soonchunhyang University Soonchunhyang, Korea Nae-Hee Lee, MD Yoon Haeng Cho, MD Pusan National University Kook-Jin Chun, MD, PhD June Hong Kim, MD, PhD

  9. Study Design Long coronary lesions (>25mm) requiring single or multiple DES (planned total stent length 32mm) 1:1 randomization SES (250 patients) PES (250 patients) 1:1 randomization 1:1 randomization Standard antiplatelet# Standard antiplatelet Triple antiplatelet* Triple antiplatelet Angiographic and IVUS follow-up at 6 months Clinical follow-up at 30 days and 9 months * Triple antiplatelet : aspirin plus clopidogrel plus cilostazol for 6 months # Standard antiplatelet : aspirin plus clopidogrel for 6 months Primary endpoint: 1. Comparison of SES or PES: binary in-segment restenosis at 6 months 2. Comparison of triple and standard antiplatelet: in-stent late loss at 6 months

  10. Inclusion Criteria • Clinical • Patients with angina and documented ischemia or patients • with documented silent ischemia • At least 18 years old • Angiographic • De novo coronary lesion suitable for stenting • Target lesion stenosis >50% by visual estimate • Reference vessel size  2.5 mm by visual estimation • Lesion length  25 mm by visual estimation that is required • for long stent implantation (planned total stent length  32mm)

  11. Exclusion Criteria • Contraindication to aspirin, clopidogrel, or cilostazol • Left main disease (diameter stenosis 50%) • Graft vessel disease • Left ventricular ejection fraction <30% • Leukocyte count <3,000/mm3 and/or platelet <100,000/mm3 • AST or ALT 3 times the upper normal reference limit • Serum creatinine level 2.0 mg/dL • A life expectancy <1 year • Planned bifurcation stenting in the side branch • Primary angioplasty for acute MI within 24 hours • Inability to follow the protocol.

  12. Primary Endpoint The rate of binary in-segment restenosis defined as a diameter stenosis >50% using QCA at 6 months after the index procedure

  13. Secondary Endpoints • Death • MI (Q and Non-Q) • TLR, TVR • Composites of death, MI, and TLR/TVR • Stent thrombosis (angiographical, clinical) • Late loss for in-stent and in-segment

  14. Sample Size Estimation • Using a 2-sided 5% significance level with a statistical power of 90%, we estimated that 201 patients per group were needed to detect difference based on the Long-DES-I. • Expecting that approximately 20% of the patients would not return for angiographic follow-up, total sample size was estimated to 500 patients (250 patients per group).

  15. Randomization • 1:1 randomization using a computer-generated sequence. • In patients with multiple lesions, only one lesion was selected by the operator’s decision. • The same type of stent was used for all lesions in patients with multiple lesions.

  16. PCI Procedures • All patients received aspirin (200 mg daily) and clopidogrel (a loading dose of 300 mg and then 75 mg daily for at least 6 months). • The use of intravenous glycoprotein IIb/IIIa inhibitors was at the operators’ discretion. • CK, CKMB, and troponin I were assessed 8, 12 and 24 hours after the procedure.

  17. Follow-up • Follow-up coronary angiography was performed at 6 months after stenting, or earlier if indicated by clinical symptoms or evidence of myocardial ischemia. • All adverse clinical events were adjudicated by an independent events committee blinded to the treatment groups. • QCA core lab analysis was performed in CVRF

  18. Statistical Analysis • Analyses of the two groups were performed according to the intention-to-treat principle. • Due to a two-by-two factorial design, a possible interaction between types of DES and use of cilostazol was evaluated by logistic regression analysis.

  19. Results

  20. Baseline Characteristics

  21. Angiographic Morphology

  22. Lesion Location SES PES P=0.954 28% 29% 62% 61% 10% 10% RCA LAD LCX

  23. QCA before Procedure

  24. Procedural Findings

  25. Device Success Device Success * Implantation with a Allocated Stent SES PES % % 100% 100% 99.2% 99.2% P=1.0 P=1.0 * defined as a in-segment final diameter stenosis <50% by QCA using the assigned device only *

  26. QCA after Procedure

  27. Stented Segment Angiographic Length of stented segment Ratio of Length of Stent / Lesion SES PES Length (mm) 0.86  0.15 0.87  0.15 41.1  13.4 40.8  13.2 Number of used stents P=0.606 P=0.696

  28. Follow-up Analysis SES (250 patients) PES (250 patients) Angiographic F/U at 6 months 210 patients (84%) of eligible patients 205 patients (82%) of eligible patients Clinical F/U at 9 months 249 patients (99.6%) of study population 245 patients (98.0%) of study population

  29. Clinical Outcomes at 30 Days * One patient underwent TLR for Non-Q MI due to subacute stent thrombosis 3 days after index procedure

  30. QCA at Follow-up

  31. Primary Study End Point In-Segment Restenosis Rate % SES PES Relative risk 0.23 95% CI: 0.10 – 0.51 P<0.001 7 / 210 30 / 250

  32. Possible Interaction of In-Segment Restenosis Rate by 2X2 Study Design Not significant The interaction between types of DES and use of cilostazol was p=0.219 for in-segment restenosis and p=0.191 for in-stent restenosis.

  33. Binary Restenosis Rate % SES PES P=0.001 P=0.157 P<0.001 P=0.041 7 30 2 6 6 24 4 In-segment In-stent Proximal edge Distal edge

  34. Late Loss mm SES PES P<0.001 P=0.015 P<0.001 P<0.001 In-segment * In-stent Proximal edge Distal edge * Maximal regional late loss, (-0.01±0.37 in SES and 0.31±0.53 in PES (p<0.001) if subtracted from the whole segment)

  35. Cumulative Frequencies of DS 100 After procedure Before procedure 80 60 Follow -up Cumulative Frequency Rate of In-Segment Diameter Stenosis (%) P<0.01 in intra-group P=0.001 in inter-group By repeated measure ANOVA 40 20 Sirolimus-Eluting Stent Paclitaxel-Eluting Stent 0 0 20 40 60 80 100 In-Segment Diameter Stenosis (%)

  36. Pattern of Restenosis

  37. Clinical Outcomes at 9 Mo * The patient was dead by Q-MI without angiographic documentation.

  38. 100 90 P=0.012 SES, 97.61.0 % at 9 months PES, 92.71.7 % at 9 months TLR-Free Survival Rate (%) 80 0 0 1 2 3 4 5 6 7 8 9 Months of Follow-up No. at Risk SES 250 249 249 247 247 247 247 244 243 241 PES 250 250 250 250 250 250 246 236 232 227 TLR-Free Survival Curves

  39. Impact of DM

  40. Diabetes Mellitus PES (N=250) SES (N=250) 32.8% (83 pt) of DM 33.6% (84 pt) of DM 6.8% 5.6% 22.8% 23.6% 67.2% 66.4% 3.2% 4.4% Non-DM DM on diet DM on oral agent DM on insulin

  41. Impact of Diabetes Mellitus In-segment Restenosis % SES PES P=0.007 P=0.005 2/74 11/68 5/136 19/137 DM Non-DM

  42. Patients with Diabetes Mellitus % SES (N=74) PES (N=68) P=0.002 P=0.509 P=0.473 P=0.007 In-segment In-stent Proximal edge Distal edge

  43. Impact of Multiple Stent

  44. No. of Used StentsPer Target Lesion PES (N=250) SES (N=250) 40 % (100 pt) of Multiple 44.8 % (112 pt) of Multiple 6.8 % 3.6% 36.4% 38.0 % 60.0% 55.2 % 1 2 ≥ 3

  45. Impact of Multiple Stents In-segment Restenosis % SES PES P=0.016 P=0.001 3/123 15/108 4/87 15/97 Single Stents Multiple Stents

  46. Patients with Multiple Stents % SES (N=87) PES (N=97) P=0.016 P=0.044 P=1.0 P=1.0 In-segment In-stent Proximal edge Distal edge

  47. Angiographic Restenosis : “Cypher Better” Cypher Taxus P-value Overall Male Female DM Non-DM LAD Non-LAD Small Vs (<2.75mm) Stent length<40mm Stent length≥40mm Multiple stent Single stent 14.6 12.3 18.7 16.2 13.9 16.4 11.7 17.6 14.0 15.6 15.5 13.9 3.3 3.5 3.0 2.7 3.7 3.7 2.7 4.3 1.6 4.9 4.6 2.4 <0.001 0.010 0.010 0.014 0.005 0.042 0.027 0.007 0.002 0.032 0.022 0.004 Relative Risk 95% CI 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 0.9 0.8 0.7

  48. Summary • In the present study, SES consistently reduced late loss, the incidence of angiographic restenosis and the need for target lesion revascularization compared to PES in patients with long coronary lesions. In addition, a focal restenosis pattern was more common in SES patients. • Although the efficacy rates differed between SES and PES groups, the incidences of death, MI or stent thrombosis were similarly low for both groups. • SES had a consistently lower angiographic restenosis rate independently from the sex, target artery, reference vessel size, stent length, diabetes mellitus, and number of used stents.

  49. Conclusion • SES appears to be more effective in inhibiting neointimal hyperplasia, and result in a reduced risk of restenosis rate and TLR in patients with long coronary lesions compared to PES.

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