Authors:  G. Guagliumi 1 , G. Musumeci 1 , V. Sirbu 1 , N. Suzuki 3 , G. Biondi Zoccai 2 , L. Mihalcsik 1 ,  A. Matiashvil...
Taxus N=22  Cypher N=22   77 pts /189 stents  Randomization 2:2:2:1 2.4± 0.6 stent/lesion ODESSA Prospective, Randomized, ...
Distal OLP Prox Ospedali Riuniti di Bergamo Six Month OCT: 75/76 eligible patients Analyzed: 250 stented segments every 0....
Lesion characteristics  (QCA)  All patients (n=77) SES  (n=22) PES  (n=22) ZES  (n=22) BMS (n=11) P  RVD  (mm) 2.78±0.52 2...
SES PES ZES BMS % OCT % NIH IVUS % NIH % Intimal Obstruction by Segments: OCT and IVUS Based on ANOVA test and Kruskal-Wal...
0% 1.8% 98.2% 94.6% 2.7% 2.7% “ Vulnerable Struts” Primary Endpoint: Overlap Proportion of uncovered and/or malapposed str...
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 p<0.001 p<0.001 Non-overlap Proportio...
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 p<0.001 Secondary Endpoint: Ove...
Strut-Lumen Distance (mm) 0 10 20 30 40 50 % Strut Level  Analysis Frequency Distribution of Strut-Lumen Distance  p<0.001...
Conclusions <ul><li>The  ODESSA  trial   demonstrated: </li></ul><ul><li>Feasibility of using intravascular OCT in prospec...
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Authors: G. Guagliumi1, G. Musumeci1, V. Sirbu1, N. Suzuki3 ...

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Authors: G. Guagliumi1, G. Musumeci1, V. Sirbu1, N. Suzuki3 ...

  1. 1. 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
  2. 2. Taxus N=22 Cypher N=22 77 pts /189 stents Randomization 2:2:2:1 2.4± 0.6 stent/lesion ODESSA Prospective, Randomized, Controlled Study Endeavor N=22 Libertè BMS N=11 ClinicalTrial.gov NCT 00693030 * All patients in dual antiplatelet therapy Long lesions (> 20 mm in length) requiring stents in overlap 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
  3. 3. 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
  4. 4. Lesion characteristics (QCA) All patients (n=77) SES (n=22) PES (n=22) ZES (n=22) BMS (n=11) P RVD (mm) 2.78±0.52 2.89±0.61 2.70±0.46 2.71±0.55 2.90±0.47 0.647 MLD (mm) 0.64±0.51 0.58±0.60 0.64±0.51 0.68±0.50 0.68±0.43 0.933 % DS 76.4±18.9 80.3±18.5 73.7±23.8 75.4±17.0 76.8±13.9 0.752 Lesion length (mm) 35.9±15.3 36.7±12.2 30.3±13.3 39.3±12.8 37.4±23.1 0.126 Length of stented segment (mm) 38.9±12.7 40.3±12.4 35.7±11.9 41.2±12.2 37.7±15.6 0.504
  5. 5. SES PES ZES BMS % OCT % NIH IVUS % 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
  6. 6. 0% 1.8% 98.2% 94.6% 2.7% 2.7% “ Vulnerable Struts” Primary Endpoint: Overlap Proportion of uncovered and/or malapposed struts in BMS vs DES 1.8±4.0 5.4±14.3 p=0.081
  7. 7. 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 p<0.001 p<0.001 Non-overlap Proportion of uncovered and/or malapposed struts by stent type 1.6 0.3 %
  8. 8. 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 p<0.001 Secondary Endpoint: Overlap Proportion of uncovered and/or malapposed struts by stent type
  9. 9. 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 )
  10. 10. Conclusions <ul><li>The ODESSA trial demonstrated: </li></ul><ul><li>Feasibility of using intravascular OCT in prospective clinical trials </li></ul><ul><li>>90% strut coverage at 6-month follow-up </li></ul><ul><li>Trend towards higher incidence of uncovered and malapposed struts at the OL site of DES than in BMS </li></ul><ul><li>Different degrees of strut coverage and NIH among DES platforms: </li></ul><ul><li>SES : Highest rate of uncovered and malapposed struts ( OL = non-OL ) </li></ul><ul><li>Lowest degree of NIH (OL> non-OL) </li></ul><ul><li>ZES: Lowest rate (≈ 0%) of uncovered and malapposed struts ( OL = non-OL ) </li></ul><ul><ul><li>Highest degree of NIH (OL> non-OL) </li></ul></ul><ul><li>PES: Higher incidence of uncovered and malapposed struts (OL> non-OL) </li></ul><ul><li>Intermediate degree of NIH (OL> non-OL) </li></ul>

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