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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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Disclosure of Financial Interest Consulting Fees/Honoraria: Boston Scientific, CardioSpectra Grant/Research Support: Abbott Vascular, Boston Scientific, Medtronic, Labcoat, LightLab G. Guagliumi, MD Independent investigator-initiated study supported in part by Research grants from Boston Scientific, Medtronic, Lightlab

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DES Delayed Healing at Site of Overlap Rabbit Iliac Artery Model: 28- and 90-days, 9.8 ± 3.6 mm Finn, A. V. et al. Circulation 2005;112:270-278 Lenght of overlap

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Nakasawa, G. et al. Am J Cardiol 2007; 100 suppl: 36M-44M Different Degree of Stent Coverage with DES Rabbit Iliac Artery Model: 21 days 4.6 ± 0.4 mm 3.2 ± 0.5 mm 3.6 ± 0.8 mm Lenght of overlap Cypher Taxus Endeavor ProximalOverlappingDistal Overlap, above struts: SES* 12.5±11.3 PES 32.5±20.2 ZES* 41±15.2 P< 0.028*

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Study Aim To evaluate stent coverage at overlapping sites of DES and BMS in human coronary arteries using high resolution intravascular imaging in vivo

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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 Analysis: 75/76 eligible patients Analyzed: 250 stented segments every 0.3 mm (6968 cross-sections), 53.047 struts

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Quantitative Strut Level Analysis Semi-Automated delineated contours at radial 1degree increments Quantitative Strut Level Analysis Semi-Automated delineated contours at radial 1degree increments Lumen Area, Stent Area, Strut -Lumen distance Strut-wall Distance Strut-Lumen distance 0.38±0.03 0.38±0.03 0.00 0.02 Observer 1 Observer 2 Delta SD R= 0.997 Inter-observer variability: 39 frames, 333 struts

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Strut Polymer Total strut thickness + ½ of the blooming Strut Level Analysis: Malapposition Malapposed distance Strut blooming

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Baseline clinical characteristics All patients (n=77) SES (n=22) PES (n=22) ZES (n=22) BMS (n=11) P Age66.5±9.566.8±9.766.5±8.664.1±9.770.6±10.60.345 Male Gender (%)74.068.281.868.281.80.610 Diabetes (%)32.536.418.250.018.20.098 Hypertension (%)48.150.0 36.40.873 Hyperlipidemia (%)46.836.450.063.627.30.155 Prior MI (%)32.545.522.731.827.30.426 UA (%)51.945.550.054.563.60.785

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Baseline Lesion and Procedural Characteristics All patients (n=77) SES (n=22) PES (n=22) ZES (n=22) BMS (n=11) P Target vessel LAD (%)61.059.163.677.327.30.105 N° Stent per lesion2.4±0.62.5±0.52.4±0.52.5±0.72.4±0.50.926 Stent diameter (mm)2.93±0.393.04±0.402.90±0.392.80±0.342.99±0.410.009 Multiple overlap (%)39.045.536.4 0.773 Inflation pressure (atm)18.3±2.418.5±2.017.8±2.118.3±2.318.6±3.60.741 Postdilation (%)53.963.642.950.063.60.489

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Periprocedural 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 Baseline Post-procedure (in-segment) All patients (n=77) SES (n=22) PES (n=22) ZES (n=22) BMS (n=11) P Length of stented segment (mm) 38.9±12.740.3±12.435.7±11.941.2±12.237.7±15.60.504 MLD (mm)1.81±0.391.79±0.461.87±0.421.74±0.271.89±0.420.683

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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% 99.6% 0.2% 0.3% Vulnerable Struts p=0.517 Proportion of Uncovered and/or Malapposed Struts BMS Proportion of Uncovered and/or Malapposed Struts BMS

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2.6% 2.7% 94.6% 96.8% 0.8% 2.3% Vulnerable Struts p=0.763 Proportion of Uncovered and/or Malapposed Struts DES Proportion of Uncovered and/or Malapposed Struts DES

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1.8±4.0 2.7 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 5.4±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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Refer to glossary All pts (N=77)SES (n=22)PES (n=22)ZES (n=22)BMS (n=11)P Procedural success, n (%)73 (94.8) 21 (95.5) 10 (90.9)0.941 Death (%)0 0000 Q wave MI (%)0 0000 Non Q wave MI, n (%)4 (5.2) 1 (4.5) 1 (9.1)0.941 Six-Month Outcomes All pts (n=77)SES (n=22)PES (n=22)ZES (n=22)BMS (n=11)P Death, n (%)1 (1.3) 1 (4.5)0000.469 Q wave MI, n (%)1 (1.3) 01 (4.5)000.469 Non Q wave MI, n (%)2 (2.6) 1 (4.5)001 (9.1)0.620 TVR, n (%)10 (13) 1 (4.5)2 (9.1)3 (13.6)4 (36.4)0.072 SAT - Probable, n (%)1 (1.3) 1 (4.5)0000.469 LST, (%)0 0000 In-hospital Discharge-Six-month FU

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Study Limitations The amount of strut coverage measured by intravascular OCT must be interpreted with caution as: - OCT does not have endothelial cell level resolution - OCT does not provide functional tissue differentiation link between imaging endpoints and clinical outcome remains unknown

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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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