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

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

2 Division of Cardiology, University of Turin, Italy1 Division of Cardiology, Ospedali Riuniti di Bergamo, Italy3 Case Western Reserve University, Cleveland, OH, US

TaxusN=22

CypherN=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

ODESSAProspective, Randomized, Controlled Study

ODESSAProspective, Randomized, Controlled Study

EndeavorN=22

Libertè BMSN=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 OCTIndependent Core Lab BLIND to the treatment assignment

University Hospitals Cardialysis Cleveland, OH

ClinicalTrial.gov NCT 00693030* All patients in dual antiplatelet therapy

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

Lesion characteristics (QCA) 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

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±4.0Overlap length (mm)

% IH obstruction% IH obstruction 19.3±14.119.3±14.1 31.5±14.3 31.5±14.3 45.2±16 45.2±16 57.8±25.2 57.8±25.2

0%

1.8%

98.2% 94.6%

2.7%

2.7%

“Vulnerable Struts”

p=0.081

Primary Endpoint: OverlapProportion of uncovered and/or malapposed struts in BMS vs DES

Primary Endpoint: OverlapProportion of uncovered and/or malapposed struts in BMS vs DES

1.8±4.0 5.4±14.3

1.9

6.0

0.7 0.0010.01

0.2

7.9±11.3

2.3±4.10.01±0.05 0.5±2.2

p<0.001

p=0.02

p<0.001

p<0.001 p<0.001

Non-overlapProportion of uncovered and/or malapposed struts by stent type

Non-overlapProportion of uncovered and/or malapposed struts by stent type

1.6 0.3

%

2.9

5.8

5.5

2.7

0.040.02

1.8

%

8.7±13.3 8.3±20.90.05±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

Secondary Endpoint: Overlap Proportion of uncovered and/or malapposed struts by stent type

Strut-Lumen Distance (mm)

0

10

20

30

40

50%

Strut Level AnalysisFrequency Distribution of Strut-Lumen Distance

p<0.001

Based on ANOVA test, Kruskal-Wallis test and generalized linear model with complex sample analysis (clustered )

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)