DISCOVER Ultimaster with Optical Frequency Domain Imaging

Transcription

1 DISCOVER Ultimaster with Optical Frequency Domain Imaging David Hildick-Smith Sussex Cardiac Centre Brighton and Sussex University Hospitals United Kingdom

2 Potential conflicts of interest Speaker's name: David Hildick-Smith I do not have any potential conflict of interest I have the following potential conflicts of interest to report: Consultant, Advisory

3 DISCOVERY 1TO3 Scientific Question to be answered DES are safe and effective, but DAPT duration is a major problem Uncovered or malapposed struts might trigger stent thrombosis Current guidelines recommend a minimum of 6m DAPT after DES What is the optimal duration of DAPT? How to determine when it is safe to stop DAPT?

4 Ultimaster DES DISCOVERY 1TO3 study 6 centers in EU Enrollment: Feb-Dec 2014 Independent corelab (CERC), CEC, DMC 80µm Coating Thickness=15 µm Thin strut CoCr stent Abluminal coating with bioresorbable polymer Bioresorbtion in 3-4 months Sirolimus 3.9 µg/mm stent Primary endpoint: OFDI assessed % stent strut coverage at 3 months post procedure Hypothesis: <20% uncovered stent struts at 3 months assessed by OFDI Main secondary endpoint: OFDI assessed strut coverage at 1 and 2 months

5 DISCOVERY 1TO3 Study Design 60 patients Multivessel disease & Staged PCI procedures Ultimaster DES treatment Clinical Follow-up Procedures Baseline Staged Stent(s) Stent(s) 0d 0d 1 Mo 3 mo 12 mo 6mo PCI + OFDI OFDI OFDI 1 and 3 month OFDI stent strut coverage data PCI + OFDI Staged stents OFDI 2 month OFDI stent strut coverage data

6 DISCOVERY 1TO3 Baseline lesion characteristics N = 59 pts Nr of Vessels diseased, mean±sd 2.24±0.5 Nr of lesions detected, mean±sd 3.19±1.59 Nr of lesions treated - baseline, mean±sd 1.42±0.59 Nr of lesions treated - staged proc. 1M (37pts), mean±sd 1.16±0.44 Total Nr of lesions treated, mean±sd 2.14±0.71 Nr of stents implanted per lesion, mean±sd 1.15±0.44 Total implanted stent length per lesion, mm, mean±sd 22.7±10.8 Total implanted stent length per patient, mm, mean±sd 50.7±21.3

7 OCT Primary Safety Endpoint Frequency of Covered Struts Per Lesion 86% 89% 96% P < % P. Smits/B.Chevalier LBT:PCR 15

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9 How does Ultimaster perform in bifurcation lesions?

10 CENTURY II study Bifurcation lesions Ultimaster N=562 Total population N=1119 Randomization 1:1 Bifurcation lesions N=189 Xience N=557 Ultimaster N=92 Lesions=135 Xience N=97 Lesions=131 Clinical Follow-up 0d 0d 30d 4mo 9mo 12mo 2yr 3yr 4yr 5yr Primary End-point TLF at 9m 2 years FU rate 99%

11 CENTURY II Bifurcation lesions Medina classification 1,1,1 1,0,1 0,1,1 Ultimaster (%) Xience P=0.89 1,1,0 0,1,0 0,0,1 1,0,0 Ultimaster (%) Xience

12 CENTURY II Bifurcation lesions Bifurcation treatment Ultimaster (N lesions =135) Xience (N lesions =131) P Two-stent technique, % T-Stenting V-Stenting TAP Crush Culotte Stent in MB, balloon in SB,% Only MB stenting,% Kissing Balloon post-stent, %

13 CENTURY II Bifurcation lesions Target Vessel Failure 24 months FU Xience 10.3% [5.7% ; 18.3%] Ultimaster 5.4% [2.3% ; 12.6%]

14 CENTURY II Bifurcation lesions Clinical outcomes 24 months FU P=0.06 P<0.05 P=0.95 P=0.59 P=0.57 P=0.75 P=0.59 % ,2 Ultimaster Xience 6, ,1 Any death 0,0 4,1 Cardiac Death 4,3 4,1 3,3 3,1 3,3 2,1 2,1 1,1 1,1 Any MI TV related MI TLR (CD) TVR (CD) ST CD=Clinically Driven ST=Definite and probable stent thrombosis

15 CENTURY II Bifurcation lesions Cardiac Death & MI 24 months FU Xience 7.2% [3.5% ; 14.5%] Ultimaster 3.3% [1.1% ; 9.8%]

16 Value of OFDI in Bifurcation stenting

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19 OFDI e-ultimaster Registry e-ultimaster Prospective, multi-center, non-randomized, observational study. OFDI guided PCI n ~ 1000 pts Approximately 30 centers PCI 3m Clinical endpoints Angio guided PCI n ~19,000 pts Approximately 200 centers 12m Statistical analysis: Comparison of clinical outcomes between the two groups Patient level propensity matching including all relevant clinical, angiographic and procedure parameters. Primary outcome measure: TLF at 12 months

20 CENTURY II Bifurcation lesions Conclusions OFDI-assessed strut coverage of Ultimaster DES at 1, 2 and 3 months is 86%, 89% and 96% respectively. Favorable 24 months clinical outcomes, with low rate of TVF and ST following bifurcation stenting, assure the safe use of Ultimaster DES in daily practice OFDI optimization of complex bifurcation stenting can substantially improve immediate PCI and potentially long term clinical outcomes New data to be generated from OPINION and OFDI e- ULTIMASTER studies will bring additional evidence to support OFDI guided PCI