1. A Randomized, Prospective, Intercontinental Evaluation of a Bioresorbable Polymer Sirolimus-eluting Stent: the CENTURY II Trial: an Update with 2 Years Outcomes
Shigeru Saito, MD
Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura, Japan
on behalf of CENTURY II investigators

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit
Terumo Corporation
Non

3. Background
CENTURY II is a large scale, prospective, multicentre, randomized (1:1), single blind, controlled, non-inferiority trial with limited exclusion criteria;
The aims of this trial are:
to establish safety and efficacy of a thin strut abluminally coated DES with bioresorbable polymer, Ultimaster, by comparing it with permanent polymer circumferentially coated DES, Xience,
to make global clinical data compliant with regulatory requirements in Europe and Japan and address the gaps in timely access to new technology around the world
This is the first time report of two years data for total population enrolled from 58 sites from Europe, Japan and Korea.

4. PVDF-HFP non-erodible fluorinated copolymer
Study devices
Ultimaster DES
Xience DES
Platform
Thin-strut (80µm) Co-Cr
2-links
Thin-strut (81µm) Co-Cr
3-links
Drug Carrier
PDLLA-PCL copolymer
resorbed within 3-4m
PVDF-HFP non-erodible fluorinated copolymer
Coating
Abluminal gradient
coating technology
Circumferential
coating
Drug
sirolimus
70 µg/cm²
everolimus
100 µg/cm²

5. Method
Inclusion criteria
Exclusion criteria-general*
Age ≥18 years
Suitable for treatment with DES
RVD matching stents mm
Diameter stenosis >50%
Eligible for DAPT
EF <25%
Renal failure
Cardiogenic shock
Planned staged procedure
Primary endpoint: freedom from TLF at 9 months, which is composite of cardiac death, TV-MI, and clinical indicated-TLR.
* Additional exclusion criteria for Japan see reference
Saito S. et al, Eur Heart J. 2014; 35,

6. Method Total population N=1101 PPS Ultimaster Xience
Randomization
1:1
9-month FU 99.2%
Ultimaster
Xience
Ultimaster
24-month FU 97.2%
Xience
Clinical Follow-up 0d
30d
4mo
9mo
12mo
2yr
3yr
4yr
5yr 0d

7. Patient characteristics
Ultimaster
Npt=551
Xience
Npt=550
P-value
Age, years (mean  SD)
65.2±10.5
65.5±10.6
0.61
Gender, male (%)
78.6
82.4
0.11
DM, %
31.9
30.9
0.71
IDDM, %
16.5
14.7
0.65
Hypertension, %
73.3
67.8
0.047
Dyslipidemia, %
70.3
69.6
0.79
Current Smoker, %
22.2
23.9
0.50
Previous MI, %
28.3
27.6
0.80
Previous PCI, %
37.2
35.0
0.45
Family history of CAD, %
30.8
32.1
0.66

8. Procedure characteristics
Ultimaster
Npt=551
Xience
Npt=550
P-value
Access site
femoral, %
radial, %
0.55
Total stent lengths/pt, mm
29.5±17.0
29.6±18.1
0.66
Pre-dilatation, %
77.4
0.99
Post-dilatation, %
53.5
54.7
Delivery success, %
99.1
99.5
0.23
Procedure success, %
98.0
98.2
0.83
N˚ of stents/lesion, n
1.2±0.4
0.32
N˚ of stents/pt, n
1.5±0.8
1.6±0.9
0.94

9. Basic lesion characteristics
Ultimaster
Npt=551
Xience
Npt=550
P-value
Lesions detected, n
2.0±1.3
0.67
Lesions treated, n
1.3±0.6
0.62
ACC/AHA classification ,% B2 C
0.13
Ostial,%
6.0
8.4
0.08
Calcification , %
moderate
severe
0.70
Thrombus present,%
3.9
4.1
0.90
True bifurcation,%
13.8
14.4
0.74

10. QCA lesion characteristics
Ultimaster
N°pt/lesion=551/711
Xience
N°pt/lesion=550/716
P-value
Lesion length, pre- (mm)
16.9±9.7
15.9±8.7
0.07
RVD, pre- (mm)
2.6±0.6
2.7±0.6
0.14
MLD, pre- (mm)
0.9±0.4
0.35
Diameter stenosis, pre- (%)
67.4±12.2
67.4±13.4
0.33
MLD, post- (mm)
in-stent
in-segment
2.5± ±0.5
2.6± ±0.6
Diameter stenosis, post- (%)
12.4± ±9.9
12.0± ±10.2
Acute gain (mm)
1.7± ±0.5
1.7± ±0.6

11. Primary endpoint (TLF at 9 months)
TLF Kaplan-Meier curves – 9 months
Xience
5.27%
[3.69% ; 7.50%]
Ultimaster
4.36%
[2.94% ; 6.43%]

12. Clinical outcomes at 2 Years
P=0.89
P=0.11
P=0.57
P=0.17
P=0.34

13. TLF at 24 months Ultimaster: 6.5% [4.8% ; 8.9%]
Xience: % [4.8% ; 9.0%]

14. TLF rates were similar for Xience and Ultimaster in all subgroups of high-risk patients at 2 years
Key clinical outcomes remained similar for Ultimaster and Xience for up to 2 years in pre-specified subgroups
Iniguez R. Presented at EuroPCR 2015, abstract OP071; Merkely B. Presented at EuroPCR 2015, abstract OP135;
Valdés M. Presented at EuroPCR 2015, abstract OP043; Lesiak M. Presented at EuroPCR 2015,
abstract OP016;Terumo. Data on file.

15. Cardiac death & MI at 24 months
Ultimaster: 3.6% [2.4% ; 5.6%]
Xience: % [3.2% ; 6.9%]

16. POCE* at 24 months Ultimaster: 13.3% [10.7%; 16.4%]
Xience: % [14.0% ; 20.3%]
*POCE(Patient-Oriented Composite Endpoints)
: all death, MI and revascularization

17. Stent Thrombosis, DAPT and bleeding
Ultimaster
Npt=551
Xience
Npt=550
P-value
Stent thrombosis, Def+prob
6 (1.1)
0.99
early, n (%)
3 (0.54)
3 (0.55)
late, n (%)
very late, n (%)
0 (0.0)
DAPT,
12 months, %
66.1
64.9
0.68
24 months, %
31.1
29.2
0.50
Any bleeding, %
8.0
10.7
0.12
9.8
11.5
0.37
Any angina
5.8
5.3
0.74
5.5
7.4
0.23

18. Conclusions
The long term follow up to 2 years of this large-scale global trial enrolling a patient population representing daily clinical practice, demonstrated good safety and efficacy profile of the thin strut abluminally coated bioresorbable polymer DES, Ultimaster;
The results were similar in both studied stents
There are no very late stent thrombosis reported between 12 and 24 months for Ultimaster, which further demonstrated good safety profile for this stent.

19. Back up slides

20. 19