1. FINAL FIVE-YEAR CLINICAL OUTCOMES OF THE NOBORI2 TRIAL
Dr. G.B. Danzi
On behalf of NOBORI 2 investigators

2. Potential conflicts of interest
Speaker's name: Dr. Gian-Baptista Danzi
 I do not have any potential conflict of interest

3. NOBORI2 - Aims
Our aim was to assess long term clinical outcomes in all-comers patient population treated with bioresorbable polymer DES

4. Nobori DES components Deliverability Efficacy Biolimus A9™ Safety
Excellent Flexibility and Scaffolding
Open cell design for optimal side branch access
Innovative delivery system with hydrophilic M-coating
Efficacy
Biolimus A9™
Anti-proliferative, anti- inflammatory properties
Highly lipophilic with optimal local tissue uptake
Safety
PLA Biodegradable Polymer
Abluminal coating
Controlled biodegradability
Precise drug release kinetics
Simultaneous release of drug and polymer degradation

5. NOBORI2 – Study Design
3067 consecutive patients treated with Nobori DES
125 centers participating
Clinical Follow-Up
1m 6m m y y y y
Primary End point: Target Lesion Failure (TLF):
Composite of cardiac death, target vessel related myocardial infarction and clinically driven target lesion revascularization
Patients are automatically allocated to 2 analysis groups based on baseline lesions/patients characteristics :
Simple patient group included patients with characteristics similar to patients enrolled in pivotal clinical trials
Complex patient group included all patients not fulfilling eligibility criteria for those trials

6. Complex Patients Population
NOBORI2 –
Complex Patients Population
Diabetes 29.5
ACS 53.6
Bifurcation 20.4
Direct stenting 28.6
“REAL WORLD”
SVG 2.0
Multi-stenting 45.6
Occlusion 10.3
Multi-vessel 53.3
Ostial lesion 10.9
Calcification 26.0
Thrombus 9.7
CTO 3.2

7. NOBORI2 - Baseline characteristics
Simple
N=819
Complex
N=2248
Total
N=3067
P-value
Age, years (meanSD)
65±10
64±11 NS
Male (%)
74.0
79.4
78.0
0.002
Previous MI (%)
25.2
36.1
33.0
<0.001
Previous PCI (%)
29.9
32.2
Previous CABG (%)
7.2
9.4
8.8
Diabetes (%)
28.8
29.7
29.5
Hyperlipidemia (%)
74.9
69.7
71.1
0.006
Current smoker (%)
21.6
27.0
25.6
0.004
Hypertension (%)
71.7
68.2
69.1
Renal Impairment (%)
0.0
4.8
3.5
CCI (mean±SD)
2.75±1.53
3.35±1.83
1.24±1.24
CCI=Charlson Comorbidity Index

8. NOBORI2 – Clinical syndrome at admission
Simple
N=819
Complex
N=2248
Total
N=3067
P-value
Stable Angina
64.6
38.9
45.8
<0.001
Unstable angina
22.3
45.2
39.1
Silent ischemia
13.0
15.9
15.1
0.05
ACS
22.2
65.0
53.6

9. Procedural Characteristics
NOBORI2 –
Procedural Characteristics
Simple
N=819
Complex
N=2248
Total
N=3067
P-value
Vessels diseased/pt
1.58±0.72
1.78±0.78
1.73±0.77
<0.001
Vessels treated/pt
1.13±0.34
1.30±0.54
1.25±0.50
Lesions detected/pt
1.68±0.94
2.15±1.16
2.02±1.13
Lesions treated/pt
1.11±0.37
1.59±0.84
1.46±0.77
Stent implanted/pt
1.35±0.71
1.88±1.17
1.74±1.09
Lesions detected
To be completed
Total stent length/patient

10. Procedure Characteristics
NOBORI2
Procedure Characteristics
Access site (%)
Simple
N=819
Complex
N=2248
Total
N=3067
P-value
Femoral
64.9
61.3
62.2 NS
Radial
35.0
38.2
37.3
Other
0.1
0.6
0.5

11. NOBORI2 - Lesion Location
(%)
Simple
N=909
Complex
N=3570
Total
N=4479
P-value
RCA
27.9
30.0
29.6 NS
LAD
43.1
40.4
41.0 Cx
28.9
25.3
26.1
0.03 LM
0.0
1.8
1.4
<0.001
SVG
2.4
2.0
Lesion treatment
(%)
Simple
N=909
Complex
N=3570
Total
N=4479
P-value
Pre-dilatation
65.6
72.8
71.3
<0.001
Post-dilatation
31.6
34.9
34.3 NS

12. NOBORI2 - Lesion complexity%
P=NS
P<0.001
P<0.001
P<0.01

13. NOBORI2 - Lesion characteristics
Simple
N=909
Complex
N=3563
Total
N=4472
P-value
Bifurcation
0.0
25.9
20.4
<0.001
Ostial
6.7
12.0
10.9
Eccentricity
82.8
81.4
81.7 NS
Occlusion
4.7
11.8
10.3
Thrombus
12.3
9.7
Moderate/Severe Calcification
22.0
27.1
26.0
0.003

14. NOBORI2 – Angina status @ 5years
P=0.01
P=0.001
P=NS
P=NS

15. NOBORI2 – Clinical Outcomes
Simple
N=819
Complex
N=2248
Total
N=3067
P-value
Cardiac Death
2.3
3.6
3.2 NS MI
4.0
3.8
TLR - CABG
0.5
0.9
0.8
TLR - PCI
4.3
0.01
TVR, non TL
2.7
4.9
4.4

16. NOBORI2 – Composite endpoints
Total %:
p<0.01
p =NS
p =0.02
TLF = Cardiac death, MI (TV related), TLR; MACE = Cardiac death, any MI, TVR;
POCE = Patient oriented composite endpoint, any death, any MI any revacularization

17. 5-Years TLF per subgroups
NOBORI2
5-Years TLF per subgroups % 17

18. NOBORI2 – K-M survival curves TLF

19. NOBORI2 – Stent Thrombosis
Total %:
P=NS
Definite+probable ST according to ARC

20. NOBORI2
TLR and ST over time

21. NOBORI2 - Conclusions
In this large, real life registry Nobori DES showed:
Favorable long-term clinical outcomes
Very low device related adverse events
No stent thrombosis between year 3 and 5
very low TLR rate over time
These long-term results indicate excellent safety and no late catch-up of neointima in Nobori DES andgive further reassurance of the benefit of DES with biodegradable polymer and abluminal coating for treatment of complex patient and lesion subsets.