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.

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 Good evening, ladies and gentlemen I was very pleased to present this clinical trial in this very important session of this meeting. This clinical trial is Long-DES II study which has been conducted in Korea for the past 2 years. Although, it is also preliminary, the results is being undated since the last presentation at ACC 2006. Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

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. Physician Name Company/Relationship Seung-Jung Park None

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. Let me show you again the background of Long-DES II clinical trial,

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. Let me show you again the background of Long-DES II clinical trial,

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 In this registry, the Cypher stent had lowest angiographic restenosis rate as compared to the Taxus and BMS stents. However, because this study was conducted on a non-randomized basis, a further randomized study was designed to verity this non-randomized long-DES I clinical trial. 20/ / / / / /160 Kim YH et al. Catheter Cardiovasc Interv 2006;67:181

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

Study Administration Principal investigator : Angiographic Core Lab :
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 Angiographic Core Lab : CVRF Independent event committee : Grants : Cordis, Johnson & Johnson Korean Ministry of Health & Welfare as part of the Korea Health 21 R&D Project Seug-Jung Park is the PI this study and this study was sponsorted by CVRF. Five major clinical centers in Korea were incorporated for this study. Angiographic core lab analysis was done by CVRF. Clinical data were moniroted by institutional review board in each center and were centrally monitored by CVRF. Data analysis was done by CVRF and clinical research center in AMC. All the major clinical events that were the primary and secondary end points were adjudicated by independent event committee.

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 Seug-Jung Park is the PI this study and this study was sponsorted by CVRF. Five major clinical centers in Korea were incorporated for this study. Angiographic core lab analysis was done by CVRF. Clinical data were moniroted by institutional review board in each center and were centrally monitored by CVRF. Data analysis was done by CVRF and clinical research center in AMC. All the major clinical events that were the primary and secondary end points were adjudicated by independent event committee.

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 Triple antiplatelet* Standard antiplatelet# Triple antiplatelet Standard antiplatelet This is summary of this study. Lesion longer than 25mm, which were treated with long stents 32mm or longer, included. Total 500 patients were randomly allocated to either Cypher and Taxus stent implantation. And additional randomization was done either to triple and standard antiplatelet regimens on the basis of 2X2 factorial design. 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

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)

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. Exclusion criteria were like these. …

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

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 These are secondary end points.

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). This slide shows our method of sample size estimation.

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. This slide shows our method of sample size estimation.

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.

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 This slide shows our method of sample size estimation.

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. This slide shows our method of sample size estimation.

Results

Baseline Characteristics
Variable SES (N=250) PES p Age, years 61.49.0 60.79.0 0.388 Men 168 (67.2%) 153 (61.2%) 0.162 Hypertension 138 (55.2%) 137 (54.8%) 0.889 Diabetes mellitus 82 (32.8%) 84 (33.6%) 0.849 Total cholesterol 200 mg/dL 72 (28.8%) 74 (29.6%) 0.822 Current smoker 93 (37.2%) 94 (37.6%) 0.958 Previous PCI 21 (8.4%) 29 (11.6%) 0.233 Previous CABG 8 (3.2%) 6 (2.4%) 0.588 Acute coronary syndrome 135 (54.0%) 0.788 LV EF, % 58.8±9.6 58.7±10.0 0.908 Multivessel involvement 149 (59.6%) 167 (66.8%) 0.095 This the comparison of baseline clinical characteristics between the two groups. All the variables were similar between the two groups. Diabetic patients were included in over 30%.

Angiographic Morphology
Variable SES (N=250) PES p TIMI flow grade = 0 or 1 42 (16.8%) 39 (15.6%) 0.716 Ostial location 41 (16.4%) 35 (14.0%) 0.455 Thrombus 14 (5.6%) 15 (6.0%) 0.848 Eccentricity 115 (46.0%) 116 (46.4%) 0.929 Ulceration 58 (23.2%) 47 (18.8%) 0.227 Severe tortuosity 8 (3.2%) 4 (1.6%) 0.261 Severe calcium 12 (4.8%) 5 (2.0%) 0.137 Bifurcation (1.5mm) 104 (41.6%) 84 (33.6%) 0.065 This the comparison of baseline clinical characteristics between the two groups. All the variables were similar between the two groups. Diabetic patients were included in over 30%.

Lesion Location SES PES P=0.954 28% 29% 62% 61% 10% 10% LAD LCX RCA
This the comparison of baseline clinical characteristics between the two groups. All the variables were similar between the two groups. Diabetic patients were included in over 30%. LAD LCX RCA

QCA before Procedure Variable SES (N=250) PES P Proximal reference, mm
3.190.47 3.100.54 0.082 Distal reference, mm 2.490.48 2.490.47 0.982 Reference diameter, mm 2.840.48 2.820.46 0.711 Lesion length, mm 33.911.6 34.512.6 0.527 Minimal lumen diameter, mm 0.700.50 0.700.46 0.999 Diameter stenosis, % 73.516.8 73.515.7 0.953 This the comparison of QCA before procedure. Mean reference diameter was 2

Procedural Findings Variable SES (N=250) PES P
Maximal device diameter, mm 3.480.41 3.500.40 0.357 Maximal inflation pressure, atm 15.93.4 14.93.7 0.013 Use of intravascular ultrasound 105 (42.0%) 99 (39.6%) 0.585 Predilation before stenting 248 (99.2%) 245 (98.0%) 0.450 Use of GP IIb/IIIa inhibitor 2 (0.8%) 6 (2.4%) 0.177 Multivessel stenting 93 (37.2%) 112 (44.8%) 0.084 Side branch Tx after stenting 51 (20.4%) 47 (18.8%) 0.652 Number of used stents at the target lesion 1.40.6 1.50.6 0.142 This the comparison of QCA before procedure. Mean reference diameter was 2

Device Success * Device Success * SES PES P=1.0 P=1.0
Implantation with a Allocated Stent Device Success * SES PES % % 100% 100% 99.2% 99.2% P=1.0 P=1.0 This the comparison of QCA before procedure. Mean reference diameter was 2 * defined as a in-segment final diameter stenosis <50% by QCA using the assigned device only *

QCA after Procedure Variable SES (N=250) PES P Reference diameter, mm
2.700.51 2.710.52 0.761 Stent length, mm 40.613.2 41.113.4 0.696 Minimum lumen diameter, mm In-segment 2.160.46 2.180.46 0.616 In-stent 2.480.40 2.500.37 0.504 Diameter stenosis, % 16.711.6 15.911.8 0.450 6.416.1 5.716.3 0.652 Acute gain, mm 1.460.61 1.480.60 0.701 1.780.55 1.800.54 0.662 This the comparison of QCA before procedure. Mean reference diameter was 2

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

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 Because not all the patients reached the pre-determined eligility period. This presentation show you a bit preliminary outcomes. 80% of patients, who were followed for more than 9 months, were included in this analysis. Angiographic follow-up was done in ( ) % of the eligibile patients. 249 patients (99.6%) of study population 245 patients (98.0%) of study population

Clinical Outcomes at 30 Days
Variable SES (N=250) PES p Death 1.000 MI 21 (8.4%) 27 (10.8%) 0.362 Non-Q Procedural CK-MB elevation 20 (8.0%) Clinical event (SAT) 1 (0.4%) * Q TLR TVR Stent thrombosis Composite of death, MI, and TLR Composite of death, MI, and TVR * One patient underwent TLR for Non-Q MI due to subacute stent thrombosis 3 days after index procedure

QCA at Follow-up Variable SES (N=210) PES (N=205) P
Reference diameter, mm 2.840.48 2.820.46 0.711 Minimum lumen diameter, mm In-segment 2.130.48 1.870.62 <0.001 In-stent 2.350.49 2.040.66 Diameter stenosis, % 20.115.0 31.420.1 13.019.4 26.223.1

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

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.

Binary Restenosis Rate
% SES PES P=0.157 P=0.001 P<0.001 P=0.041 In-segment In-stent Proximal edge Distal edge

Late Loss SES PES P<0.001 P=0.015 P<0.001 P<0.001
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)

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

Pattern of Restenosis Variable SES (N=7) PES (N=30) P Focal 7 (100%)
16 (53.3%) 0.031 IA (Articulation or gap) 1.000 IB (Margin) 6 (20.0%) 0.571 IC (Focal body) 6 (85.7%) 8 (26.7%) 0.007 ID (Multifocal) 1 (14.3%) 2 (6.7%) 0.477 Diffuse 14 (46.7%) II (Intra-stent) 9 (30.0%) 0.160 III (Proliferative) IV (total occlusion) 5 (16.7%) 0.560 Length of in-stent restenosis, mm 5.5±3.1 11.6±7.1 0.016

Clinical Outcomes at 9 Mo
Variable SES (N=250) PES p Death 2 (0.8%) 0.499 Cardiac 1 (0.4%) * 1.000 Non-cardiac 1 (0.4%) MI 22 (8.8%) 27 (10.8%) 0.452 Non-Q 21 (8.4%) 0.362 Q TLR 6 (2.4%) 18 (7.2%) 0.012 TVR 8 (3.2%) 19 (7.6%) 0.030 Stent thrombosis Composite of death, MI, and TLR 28 (11.2%) 42 (16.8%) 0.071 Composite of death, MI, and TVR 30 (12.0%) 43 (17.2%) 0.100 * The patient was dead by Q-MI without angiographic documentation.

TLR-Free Survival Curves
TLR-Free Survival Rate (%) No. at Risk SES PES Months of Follow-up 1 2 3 4 5 6 7 8 9 80 90 100 P=0.012 SES, 97.61.0 % at 9 months PES, 92.71.7 % at 9 months

Impact of DM

Diabetes Mellitus SES (N=250) PES (N=250) 32.8% (83 pt) 33.6% (84 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

Impact of Diabetes Mellitus In-segment Restenosis
% SES PES P=0.007 P=0.005 2/ / / /137 DM Non-DM

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

Impact of Multiple Stent

No. of Used Stents Per Target Lesion
SES (N=250) PES (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 % ≥ 3

Impact of Multiple Stents In-segment Restenosis
% SES PES P=0.016 P=0.001 3/ / / /97 Single Stents Multiple Stents

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

Angiographic Restenosis : “Cypher Better”
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 3.3 3.5 3.0 2.7 3.7 4.3 1.6 4.9 4.6 2.4 14.6 12.3 18.7 16.2 13.9 16.4 11.7 17.6 14.0 15.6 15.5 <0.001 0.010 0.014 0.005 0.042 0.027 0.007 0.002 0.032 0.022 0.004 Relative Risk 95% CI 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 0.9 0.8 0.7

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.

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.

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.

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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.

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Presentation on theme: "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."— Presentation transcript:

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