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Authors: G. Guagliumi 1, G. Musumeci 1, V. Sirbu 1, N. Suzuki 3, G. Biondi Zoccai 2, L. Mihalcsik 1, A. Matiashvili 1, A. Trivisonno 1, N. Lortkipanidze 1, L. Fiocca 1, J. Coletta 3, H. Bezerra 3, O.Valsecchi 1, M. Costa 3 2 Division of Cardiology, University of Turin, Italy 1 Division of Cardiology, Ospedali Riuniti di Bergamo, Italy 3 Case Western Reserve University, Cleveland, OH, US

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Taxus N=22 Cypher N=22 Long lesions (> 20 mm in length) requiring stents in overlap 77 pts /189 stents Randomization 2:2:2:1 2.4± 0.6 stent/lesion ODESSA Prospective, Randomized, Controlled Study ODESSA Prospective, Randomized, Controlled Study Endeavor N=22 Libertè BMS N=11 Primary end-point: proportion of stent struts uncovered and/or malapposed at overlap in OCT at 6 month (BMS vs DES and among DES) * QCA, IVUS and OCT Independent Core Lab BLIND to the treatment assignment University Hospitals Cardialysis Cleveland, OH ClinicalTrial.gov NCT 00693030 * All patients in dual antiplatelet therapy

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Distal OLP Prox Ospedali Riuniti di Bergamo Six Month OCT: 75/76 eligible patients Analyzed: 250 stented segments every 0.3 mm (6968 cross-sections), 53.047 struts

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Lesion characteristics (QCA) All patients (n=77) SES (n=22) PES (n=22) ZES (n=22) BMS (n=11) P RVD (mm)2.78±0.522.89±0.612.70±0.462.71±0.552.90±0.470.647 MLD (mm)0.64±0.510.58±0.600.64±0.510.68±0.500.68±0.430.933 % DS76.4±18.980.3±18.573.7±23.875.4±17.076.8±13.90.752 Lesion length (mm)35.9±15.336.7±12.230.3±13.339.3±12.837.4±23.10.126 Length of stented segment (mm) 38.9±12.740.3±12.435.7±11.941.2±12.237.7±15.60.504

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SES PES ZES BMS % OCT % NIHIVUS % NIH % Intimal Obstruction by Segments: OCT and IVUS Based on ANOVA test and Kruskal-Wallis test p<0.005 3.6±1.8 3.1±1.9 3.8±2.2 3.9±4.0 Overlap length (mm) % IH obstruction 19.3±14.1 31.5±14.3 45.2±16 57.8±25.2

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0% 1.8% 98.2% 94.6% 2.7% Vulnerable Struts p=0.081 Primary Endpoint: Overlap Proportion of uncovered and/or malapposed struts in BMS vs DES Primary Endpoint: Overlap Proportion of uncovered and/or malapposed struts in BMS vs DES 1.8±4.05.4±14.3

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1.9 6.0 0.7 0.001 0.01 0.2 7.9±11.3 2.3±4.1 0.01±0.05 0.5±2.2 p<0.001 p=0.02 p<0.001 Non-overlap Proportion of uncovered and/or malapposed struts by stent type Non-overlap Proportion of uncovered and/or malapposed struts by stent type 1.6 0.3 %

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2.9 5.8 5.5 2.7 0.04 0.02 1.8 % 8.7±13.3 8.3±20.9 0.05±0.19 1.8±4.0 p<0.001 p=0.04 p<0.001 Secondary Endpoint: Overlap Proportion of uncovered and/or malapposed struts by stent type Secondary Endpoint: Overlap Proportion of uncovered and/or malapposed struts by stent type

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Strut-Lumen Distance (mm) 0 10 20 30 40 50 % Strut Level Analysis Frequency Distribution of Strut-Lumen Distance p<0.001 Based on ANOVA test, Kruskal-Wallis test and generalized linear model with complex sample analysis (clustered )

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Conclusions The ODESSA trial demonstrated: Feasibility of using intravascular OCT in prospective clinical trials >90% strut coverage at 6-month follow-up Trend towards higher incidence of uncovered and malapposed struts at the OL site of DES than in BMS Different degrees of strut coverage and NIH among DES platforms: SES : Highest rate of uncovered and malapposed struts (OL = non-OL) Lowest degree of NIH (OL> non-OL) ZES: Lowest rate ( 0%) of uncovered and malapposed struts (OL = non-OL) Highest degree of NIH (OL> non-OL) PES: Higher incidence of uncovered and malapposed struts (OL> non-OL) Intermediate degree of NIH (OL> non-OL)

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