1. Potential conflicts of interest
Speaker’s name: Run-Lin Gao, MD
√ I have the following potential conflicts of interest to report:
√ Research contracts: Medfavour Medical, Beijing, China  Consulting
 Employment in industry
 Stockholder of a healthcare company
 Owner of a healthcare company
 Other(s)
 I do not have any potential conflict of interest

2. NOYA I: A Prospective Randomized Trial of NOYATM Sirolimus-Eluting Stent with Biodegradable Coating Compared to FIREBIRD 2® Sirolimus-Eluting Stent with Durable Coating in Patients with Coronary Artery Disease
9-Month Angiographic and 12-Month Clinical Results
(NCT: )
Run-Lin Gao, MD
Cardiovascular Institute and Fu Wai Hospital
National Center for Cardiovascular Disease of China
For the NOYA I Investigators
4:10 PM-4:20 PM, Tuesday, May 17th, Main Arena, Late Breaking Trials

3. NOYA I Background
The biocompatibility of durable polymer used in the 1st generation of DES was considered to be one of the potential reasons for delaying endothelial healing, which may induce very late stent thrombosis
Biodegradable polymer coating may potentially improve endothelial healing
NOYATM, a Co-Cr stent platform, DL-Polylactide biodegradable polymer coated with sirolimus was developed and manufactured by Medfavour Medical (Beijing, China)

4. NOYA DES Components MULTI-LINK VISION® 支架 MULTI-LINK VISION® 支架输送系统
L605 Co-Cr thin strut open-cell stent platform
Complete bioabsorbable coating without base coat
Sirolimus and stable
release curve
Unique delivery system designed of powertrans

5. Comparison of Strut and Coating Thickness
Cypher®
EndeavorTM
XienceTM V
NOYATM
Strut Thickness
140 um
91 um
81 um
Polymer Thickness
12.6 um
5.3 um
7.6 um
6.0 um
PEVA+PBMA PC
Fluoropolymer
DL-Polylactide
Sirolimus
Zotarolimus
Everolimus

6. Pre-Clinical Result and Drug Eluting Kinetics
Release Curve in Vitro
NOYA
Cumulative Rate (%)
L605 Co-Cr BMS
Time (days)
CYPHRE 8.9 ug/mm, NOYA 8.8 ug/mm

7. The Control Group
FIREBIRD 2®, a Co-Cr stent platform, biocompatible durable polymer coated with sirolimus, is manufactured by MicroPort Medical (Shanghai, China)
FIREBIRD 2® is one of the most popularly used DESs in clinical practice in China; more than 300,000 stents have been implanted worldwide; clinical studies and post marketing surveillance confirmed its efficacy and safety
The only difference between NOYATM and FIREBIRD 2® is the polymer, biodegradable or durable; the longterm follow-up would be valuable to determine the significance of biodegradable polymer coating

8. NOYA I Trial Algorithm NOYA FIREBIRD 2
300 pts enrolled at 16 Chinese sites
RVD ≥ 2.25 mm and ≤ 4.0 mm; lesion length ≤ 30 mm
Maximally 2 target lesions in 2 epicardial vessels
Pre-rand: ASA ≥300 mg, clopidogrel ≥300 mg load unless on chronic Rx
Randomization 1:1
NOYA
FIREBIRD 2
Aspirin ≥100 mg QD; clopidogrel 75mg QD for at least 12 mos
Angiogrphic follow-up: 9-month
Clinical follow-up: 1, 3, 6, 9, 12-month and annually to 5-year 8 8

9. Inclusion & Exclusion Criteria
Major Inclusion
Age 18-75yrs
Target lesion no. <=2
Lesion length <=30mm
RVD 2.25mm~4.0mm
DS% >= 70% by visual estimation
Major Exclusion
AMI within 7 days
CTO (TIMI 0), LM, ostial lesion, SVG, bifurcation (side branch RVD>=2.25mm), ISR, three-vessel disease need to treat
NYHA >=III or LVEF<40%
Prior stenting within 1 year

10. Major Endpoints Primary Endpoint Secondary Endpoints
In-stent late loss at 9-month
Secondary Endpoints
Binary restenosis at 9-month
MACE (cardiac death, MI, or TLR) at 1-year
ARC defined stent thrombosis

11. Sample Size
Hypothesis: the in-stent late loss of NOYA at 9-month is non-inferior to FIREBIRD 2
Late loss = 0.14±0.24 mm (FIREBIRD 2 data)
Margin (Delta) = 0.12mm
Alpha = 0.05 (two sides)
Power = 90%
Angio F/U = 60%
Sample size = 300

12. NOYA I Organization Principle Investigator Run-Lin Gao, MD
Angiographic Core Lab Bo Xu, MBBS, Catheterization Lab, Fu Wai Hospital, Beijing
Data Management & Stat Wei Li, PhD, Division of Biometrics, National Center for Cardiovascular Diseases
Clinical Events Committee Guoying Zhu, MD; Wenling Zhu, MD; Jingxuan Guo, MD; Weimin Wang, MD;
Fuchun Zhang, MD; Yong Zeng, MD
Randomization Service Division of Biometrics, National
Center for Cardiovascular Diseases
Monitoring Medfavour Medical, Beijing
Sponsor Medfavour Medical, Beijing

13. NOYA I Enrollers Yuejin Yang, MD 80 Shuzheng Lu, MD 44
Fu Wai Hospital, Beijing An Zhen Hospital, Beijing
Lefeng Wang, MD Haichang Wang, MD
Red Cross Chaoyang Hospital, Beijing Xijing Hospital, Xi’an
Zhanquan Li, MD Lei Wang, MD 20
Liaoning Provincial People’s Hospital Beijing Friendship Hospital
Yundai Chen, MD Yong Huo, MD
Chinese PLA General Hospital, Beijing Peking University First Hospital
Jiyan Chen, MD Zheng Zhang, MD
Guangdong Provincial People's Hospital The 1st Affiliated Hospital of Lanzhou University
Tiemin Jiang, MD Yong Wang, MD 4
Affiliated Hospital to Med. College of CAPF China-Japan Friendship Hospital, Beijing
Xian Wang, MD Bo Yu, MD
The Military General Hospital of Beijing nd Affiliated Hospital of Harbin Medical University
Shanglang Cai, MD Junxia Li, MD
Affiliated Hospital of Qingdao University Bethune International Peace Hospital

14. 9-Month Angio F/U* (N=254; 87.9%) 1-Year Clinical F/U* (N=300; 100%)
NOYA I Patient Flow
Randomized
(N=300)
FIREBIRD 2 (N=150)
NOYA
(N=150)
Protocol denied = 7
4 = Protocol denied
FIREBIRD 2 (N=146)
NOYA
(N=143)
9-Month Angio F/U* (N=254; 87.9%)
FIREBIRD 2 (N=127; 87%)
NOYA
(N=127; 88.8%)
1-Year Clinical F/U* (N=300; 100%)
*F/U window: ± 30 days

15. Baseline Demographics
NOYA n=150
FIREBIRD 2 n=150 P
Age (years)
56.6±10.2
56.7±9.2
0.9099
Male (%)
66.7
72.0
0.3163
Hypertension (%)
52.0
57.3
0.3534
Hypercholesterolemia (%)
30.7
32.0
0.8034
Diabetes Mellitus (%)
22.0
20.0
0.6706
Current Smoker (%)
38.7
44.7
0.5696
Prior PCI (%)
8.0
9.3
0.6814
Prior CABG (%)
0.7
0.0
1.0000
Prior MI (%)
25.3
26.7
0.7924
Unstable Angina (%)
39.2
51.1
0.2383
LVEF (%)
61.9±9.2
60.9±9.4
0.3853

16. Baseline Angiography NOYA n=200 FIREBIRD 2 n=192 P Lesion Location
0.1874
LAD
50.5%
59.4%
LCX
24.0%
18.2%
RCA
25.5%
22.4%
ACC/AHA Classification
0.6136
A/B1
53.0%
58.4%
B2/C
47.0%
41.6%
QCA
RVD (mm)
2.82±0.52
2.82±0.60
0.9151
MLD (mm)
0.80±0.39
0.78±0.43
0.7492
% DS
72.0±12.5
72.6±13.2
0.5984
Lesion Length (mm)
17.7±9.3
18.7±10.0
0.3129

17. Procedural Results NOYA, n=200 FIREBIRD 2, n=192 P Predilatation 75.5%
77.1%
0.7125
Stent Diameter (mm)
3.06±0.40
3.06±0.44
0.9581
Stent Length (mm)
25.8±11.7
26.0±10.7
0.8446
Postdilatation
46.5%
34.9%
0.0193
Lesion Success
99.5%
99.0%
0.6165
Postprocedural QCA
RVD (mm)
2.95±0.49
2.98±0.55
0.4588
MLD (mm)
In-Stent
2.58±0.42
2.65±0.48
0.1248
In-Segment
2.32±0.48
2.27±0.53
0.3512
% DS
12.0±7.8
10.8±7.6
0.1256
18.7±9.5
20.3±10.1
0.1058
Acute Gain (mm)
1.78±0.46
1.86±0.48
0.0807
1.52±0.50
1.48±0.55
0.5293

18. NOYA I Primary Endpoint: In-Stent Late Loss per Patient at 9-Month
0.11±0.20
FIREBIRD 2
0.13±0.19
Primary Non-Inferiority Endpoint Met
Non-inferior
Difference : mm
Upper 2-sided 95% CI: mm
Non-Inferiority
P value
Upper one-sided 95% CI
Zone of non-inferiority
Pre-specified margin = 0.12mm
-0.04
-0.02
0.00
0.02
0.04
0.06
0.08
0.10
0.12
0.14 mm
* Randomly select one lesion in which more than one lesions involved 18 18

19. NOYA I In-Stent Late Loss Distribution per Lesion%
NOYA n= ± 0.18 mm
FIREBIRD 2 n= ± 0.23 mm
Difference -0.03, 95%CI = [-0.08, 0.01]
1.8 mm

20. Angio F/U Results at 9-Month
NOYA, n=167
FIREBIRD 2, n=164 P
Late Lumen Loss (mm)
In-Stent
0.11±0.18
0.14±0.23
0.1614
Proximal Edge
0.12±0.20
0.16±0.29
0.1172
Distal Edge
0.11±0.22
0.09±0.26
0.3143
In-Segment
0.13± 0.23
0.13±0.31
0.8963
Binary Restenosis Rate
1.8%
0.6%
0.6228
0.3682
1.2%
1.0000
4.2%
3.7%
0.8028

21. Clinical F/U Results at 12-Month
NOYA, n=150
FIREBIRD 2, n=150 P
Death
0.7% (1)
1.0000
Cardiac Death -
Non Cardiac Death MI
2.7% (4)
Q Wave
Non Q Wave
Cardiac Death or MI
TLR
2.0% (3)
MACE
4.7% (7)
TLF
Any Stent Thrombosis

22. Conclusions
The present data indicates that the NOYATM SES is non-inferior to FIREBIRD 2 SES with respect to in-stent late loss at 9-month
The in-stent late loss of NOYATM SES at 9-month is 0.11±0.20 mm, and the in-segment binary restenosis rate is 4.2%
The rates of MACE (4.7%) and TLF (4.7%) in NOYA group are the same as that in FIREBIRD 2 group, no stent thrombosis observed in both groups
The efficacy and safety of NOYATM SES are documented by the present randomized trial
Large scale trials and long term follow-up are needed to further evaluate the newly developed SES with biodegradable polymer coating