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2 Division of Cardiology, University of Turin, Italy

A Prospective, Randomized, Controlled Study Using Optical Coherence Tomography to Evaluate Strut Coverage of Sirolimus-, Paclitaxel-, and Zotarolimus-Eluting Coronary Stents in Long Lesions Requiring Overlapping. ODESSA - OCT for DES SAfety.

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2 Division of Cardiology, University of Turin, Italy

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  1. A Prospective, Randomized, Controlled Study Using Optical Coherence Tomography to Evaluate Strut Coverage of Sirolimus-, Paclitaxel-, and Zotarolimus-Eluting Coronary Stents in Long Lesions Requiring Overlapping ODESSA - OCT for DES SAfety Authors: G. Guagliumi1, G. Musumeci1, V. Sirbu1, N. Suzuki3, G. Biondi Zoccai2, L. Mihalcsik1, A. Matiashvili1, A. Trivisonno1, N. Lortkipanidze1, L. Fiocca1, J. Coletta3, H. Bezerra3, O.Valsecchi1, M. Costa3 1 Division of Cardiology, Ospedali Riuniti di Bergamo, Italy 2 Division of Cardiology, University of Turin, Italy 3 Case Western Reserve University, Cleveland, OH, US

  2. ODESSA Prospective, Randomized, Controlled Study 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 Cypher N=22 Taxus N=22 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 * All patients in dual antiplatelet therapy ClinicalTrial.gov NCT 00693030

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

  4. Lesion characteristics (QCA)

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

  6. p=0.081 Primary Endpoint: Overlap Proportion of uncovered and/or malapposed struts in BMS vs DES “Vulnerable Struts” 98.2% 94.6% 2.7% 1.8% 2.7% 0% 1.8±4.0 5.4±14.3

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

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

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

  10. Conclusions • The ODESSA trialdemonstrated: • 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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