New Generation Drug Eluting Stent Nobori: 2 Year Clinical Outcome - - PowerPoint PPT Presentation

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Jun 21, 2023 47 likes •249 views

New Generation Drug Eluting Stent Nobori: 2 Year Clinical Outcome of Patients with Chronic Total Occlusion Bernard Chevalier* Dragan Sagic, Carlo Trani, Damras Tresukosol, Peep Laanmets, Mario Lombardi, Enrique Novo Garcia, Stefan Hoffmann,

SLIDE 1

New Generation Drug Eluting Stent Nobori: 2 Year Clinical Outcome of Patients with Chronic Total Occlusion

Bernard Chevalier*

Dragan Sagic, Carlo Trani, Damras Tresukosol, Peep Laanmets, Mario Lombardi, Enrique Novo Garcia, Stefan Hoffmann, Harald Schwacke, Werner Jung, David Hildick-Smith, Gian Battista Danzi On behalf of NOBORI 2 investigators *Institut Cardiovasculaire Paris Sud, Massy, France

SLIDE 2

Disclosure Statement of Financial Interest

In the last five years I, Bernard Chevalier, received research grants or speaker fees

r I am/was consultant for: Abbott

Vascular, Asahi, Astra Zeneca, AVI, Boston Scientific, Biotronik, Cook, Cordis, Daichi-Sankyo, Eli-Lilly, Iroko, Medtronic, Terumo. I am currently minor shareholder & general mamager of CERC

SLIDE 3

Introduction

Successful recanalization of lesions totally
ccluded for more than 3 months (CTO)

remains a challenging and controversial area

f interventional cardiology.
We evaluated efficacy and long-term safety

after treatment of CTO lesions with Nobori, a new generation drug eluting stent, coated only abluminally with a biodegradable polymer and Biolimus A9.

SLIDE 4

Nobori DES Components

Drug Carrier

Biodegradable Poly Lactic Acid Abluminal coating 9 to 12 months degradation

Biolimus A9™

Powerful anti-proliferative, anti-inflammatory properties Stent Platform Excellent flexibility Innovative delivery system with hydrophilic M-coating

Nobori DES

SLIDE 5

Primary endpoint:

Target Lesion Failure (TLF) at 12 months: TLF- composite of cardiac death, myocardial infarction (TV related) and target lesion revascularisation (TLR)

NOBORI – CTO Study

CTO = Chronic Total Occlusion > 3 months old with TIMI 0 TO= Total occlusion < 3 months old 97 patients underwent treatment of a CTO lesion > 3 months old 59 patients underwent treatment of a TO lesion < 3 months old

SLIDE 6

Design # of patients per group # of lesions per group Follow-up Inclusion/Exclusion Criteria Multicentre, prospective, observational study 97 in CTO / 59 in TO 105 in CTO / 59 in TO 1m, 6m, 1y, 2y, 3y, 4y, 5y All commers

NOBORI – CTO Study

2 years FUP = 95%

SLIDE 7

PI: G.B. Danzi Executive Operational Committee:

B. Chevalier
P. Urban
W. Wijns
M. Wiemer
J. Goicolea
A. Serra

Monitoring:

100% monitoring on-line
30% of patients on-site
EMCD and independent monitors

Study management: EMCD-Terumo Data management:

Electronic data collection KIKA

Medical Sponsor:

Terumo Europe

Steering Committee:

E. Stabile
K. E. Hauptmann
P. Kala
J. Koolen
R. Koning
F. Fath-Ordoubadi
D. Carrie

CEC:

C. Hanet
G. Stankovic
J. Vos
M.A. Vogt
B. Rensing
C.J. Royaards

Angiographic Corelab:

MCR – Milan
CorExperts - Belgrade

NOBORI – CTO Study Organization and Management

SLIDE 8

Age, years (Mean ±SD) Male (%) Previous MI (%) Prior PCI (%) Prior CABG (%) Diabetes Mellitus (%) Hyperlipidemia (%) Hypertension (%) Current smoker (%) CTO >3 months N = 97 62±11 85.6 (83 pts) 37.1 (36 pts) 23.7 (23 pts) 10.3 (10 pts) 29.9 (29 pts) 76.3 (74 pts) 70.1 (68 pts) 23.7 (23 pts) TO <3 months N=59 61±14 84.8 (50 pts) 44.1 (26 pts) 23.7 (14 pts) 1.7 (1 pts) 15.3 (9 pts) 61 (36 pts) 66.1 (39 pts) 28.8 (17 pts)

NOBORI – CTO Study Baseline Demographics

SLIDE 9

NOBORI – CTO Study Angina status pre-procedure

Unstable angina Silent ischemia Stable angina CTO >3 months N = 97 % 16.5 19.6 63.9 TO <3 months N = 59 % 47.5 15.3 37.3

SLIDE 10

7 10 1 3

12 8

NOBORI – CTO Study Lesion Location

+ 1 lesion in graft 19 16 3

1 1

23 15

1 1

1 4 1

CTO TO

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No. of diseased vessels
No. of lesions detected pp*
No. of lesions treated pp*
No. of stents pp*

CTO >3 months N = 97 (n ±SD) 1.88±0.79 2.19±1.17 1.53±0.71 2.62±1.54 TO <3 months N=59 (n ±SD) 1.72±0.77 2.02±1.13 1.40±0.69 2.29±1.38

NOBORI – CTO Study Study Procedure

All lesions in patient with at least 1 CTO lesion *per patient

SLIDE 12

STENTS PER LESION 1 2 ≥3 ONLY Balloon PTCA Post-dilatation CTO >3 months N = 105 % 44.8 % 31.4% 17.1% 6.7% 43.8% TO <3 months N=59 52.5% 30.5% 13.6% 3.4% 40.7%

NOBORI – CTO Study Study Procedure

SLIDE 13

Occlusion of small side branch, asymptomatic Dissections CTO >3 months N = 105 1.1 % 9.5% TO <3 months N = 59 3.0 % 8.5 %

NOBORI – CTO Study Procedural complications

None of the reported complications led to SAE during procedure

SLIDE 14

TIMI 0 TIMI 1 TIMI 2 TIMI 3

TIMI pre-procedure CTO

% 91.6 8.4 0.0 0.0

TO

% 81.8 18.2 0.0 0.0

TIMI post-procedure CTO

% 1.9 0.9 3.8 93.3

TO

% 0.0 0.0 1.7 98.3

NOBORI – CTO Study Pre- and Post-Procedure TIMI flow

SLIDE 15

NOBORI – CTO Study Baseline QCA Data

(mean±SD) RVD- pre, mm RVD - post, mm MLD pre, mm MLD post, mm DS – pre (%) DS – post (%) Acute gain in-stent, mm Acute gain in-segment, mm CTO >3 months N=86 2.16±0.73 2.85±0.50 0.06±0.22 2.01±0.54 97.4±9.1 15.2±6.2 2.36±0.44 1.95±0.56 TO <3 months N=48 1.96±0.47 2.84±0.46 0.10±0.24 2.13±0.47 94.1±13.9 15.2±6.4 2.30±0.47 2.04 ±0.59

SLIDE 16

* Moderate / severe

NOBORI – CTO Study Lesion Characteristics

Ostial Bifurcation Calcification* Eccentricity* CTO >3 months N=86 % 8.1 18.6 38.4 58.1 TO <3 months N=48 12.5 16.7 35.4 54.2

SLIDE 17

OUTCOMES up to 2 YEARS

SLIDE 18

Cardiac Death MI TLR - CABG TLR - PCI TVR-PCI, non TL TLF MACE

CTO >3 months

N= 97 % (No)

3.1 (3 pts) 1.0 (1 pt) 1.0 (1 pt) 2.1 (2 pts) 0.0 (0 pt) 5.2 (5 pts) 6.2 (6 pts)

TO <3 months

N=59 % (No)

1.7 (1 pt) 1.7 (1 pt) 0 (0 pt) 0 (0 pt) 3.4 (2 pt) 3.4 (2 pts) 5.1 (3 pts)

NOBORI – CTO Study Clinical outcomes up to 2 years

NO Stent Thrombosis (early, late or very late )

TLF = Target Lesion Failure (Cardiac death, MI, clinically driven TLR); MACE = Cardiac death, any MI and TVR

SLIDE 19

NOBORI – CTO Study Clinical outcomes up to 2 years

TLF = Target Lesion Failure (Cardiac death, MI, clinically driven TLR); MACE = Cardiac death, any MI and TVR

CTO TO 1 year 2 years MI Cardiac Death TLR-CABG TLR-PCI TVR-nTL MACE TLF ST Cardiac Death 3,1 1,7 MI 1,0 1,7 TLR- CABG 1,0 0,0 TLR-PCI 2,1 0,0 TVR-nTL 0,0 3,4 MACE 6,2 5,1 TLF 5,2 3,4 ST 0,0 0,0 0,0 0,0

Total

0.0 0.0 0.0 0.0 0.0

SLIDE 20

NOBORI – CTO Study Conclusions

Nobori stent proves to be safe and efficient when used to treat chronic total occlusions The absence of stent thrombosis up to 2 years despite multiple stent overlapping is particularly appealing and diserves further clincial investigation in the larger cohort

f patients