1. Robbert J de Winter, MD PhD FESC
TCT 63:
One Year Results of the REMEDEE Registry Clinical Outcomes After Deployment of the Abluminal Sirolimus-Coated Bioengineered Stent (COMBO) in a Multicenter, Prospective Postmarket Registry
Robbert J de Winter, MD PhD FESC
On behalf of the REMEDEE Registry Investigators
One Year Results REMEDEE Registry TCT 2015

2. Disclosure Statement of Financial Interest Robbert J de Winter
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
OrbusNeich; Astra Zeneca; Abbott;
Stentys; Tryton; St Jude Medical
OrbusNeich -

3. One Year Results REMEDEE Registry TCT 2015
COMBO stent design
Stainless Steel 100 µm
Abluminal biodegradable polymer matrix
Sirolimus elution
EPC capturing technology for accelerated endothelial coverage
One Year Results REMEDEE Registry TCT 2015

4. Abluminal Sirolimus Drug Delivery
from a completely biodegradable polymer matrix
In vivo elution profile of COMBO and Cypher (% of total drug eluted over time) Polymer matrix resorption within 90 days
Granada J et al., Circ Cardiovasc Intervent. 2010; 3: 3

5. Luminal Endothelial Progenitor Cell (EPC) Capture
So this is Genous mechanism
One Year Results REMEDEE Registry TCT 2015
G Rev 02 4

6. Combo Dual Therapy Stent Clinical Trial Program
Completed
Clinical FU Ongoing
Prospective, Multicenter Randomized Study
REMEDEE
N= 61
2-5, 9, 24 Months
Completed
Single Center Study with Longitudinal OCT Assessment of COMBO’s Healing Profile
EGO COMBO
REMEDEE OCT
Prospective,
Multicenter, Randomized
Study
N= 60
30d, 6, 12 Months
Completed
N= 1000
Prospective, Multicenter, All-comers Post-market Registry
Enrolment
Completed
REMEDEE
Registry
Enrolment Commenced
Feb 8, 2014
N= 572
Prospective, Multicenter, Randomized Study for Japan and U.S. Approval
HARMONEE
Japan & US
Enrolling
N= 1500
Prospective, Multicenter, Randomized Study with Reduced DAPT in ACS Patients
REDUCE
N= 2500
Prospective, Multicenter, Worldwide All-comers Post-market Registry
Enrolling
MASCOT
Enrolment commencing Q2 2015
N= 436
Prospective, Multicenter, Randomized Study for China Approval
COMBO
China
COSTA
N= 900
Prospective, Multicenter, Randomized Study with short Dual Therapy in Patients on Oral Anti-Coagulants
In Preparation

7. One Year Results REMEDEE Registry TCT 2015
Primary objective:
To evaluate the immediate and long term safety and performance of the abluminal sirolimus coated bio-engineered stent (COMBO) in routine clinical practice
Primary endpoint:
Target Lesion Failure
Cardiac Death
Non-Fatal Target Vessel MI
Target Lesion Revascularization
One Year Results REMEDEE Registry TCT 2015

8. One Year Results REMEDEE Registry TCT 2015
All-comers Registry
Patients are only excluded from registration if ANY of the following conditions apply:
High probability of non-adherence to the follow-up requirements;
Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned;
A life expectancy of <1 year;
Explicit refusal of participation in the registry.
One Year Results REMEDEE Registry TCT 2015

9. One Year Results REMEDEE Registry TCT 2015
Participating sites
Amsterdam, The Netherlands Academic Medical Centre Prof. Dr. de Winter Blaricum, The Netherlands Ter Gooi Ziekenhuizen Dr. Arkenbout Breda, The Netherlands Amphia ziekenhuis Dr. den Heijer Craigavon, UK Craigavon Cardiac Centre Dr. Menown
Luxembourg Centre Hospitalier de Luxembourg Dr. Muller
Nijmegen, The Netherlands Radboud University Nijmegen Prof. Dr. Suryapranata
Riga, Latvia Stradina University Hospital Prof. Dr. Erglis
Vigo, Spain Meixoeiro Hospital Dr. Iniguez
Zwolle, The Netherlands Isala Klinieken Dr. van ‘t Hof
One Year Results REMEDEE Registry TCT 2015

10. All-comers flash type registry
March 14th 2014
June 3rd 2013
One Year Results REMEDEE Registry TCT 2015

11. Registration per hospital
One Year Results REMEDEE Registry TCT 2015

12. True all-comers registry
Min Max
Age years
Length cm
Number of risk factors 0/8 - 8/8
Systolic blood pressure mmHg
Lesion length mm
Number of stents
One Year Results REMEDEE Registry TCT 2015

13. Patient Characteristics n=1000
Age, years
65±11
Sex, male
73.9%
Risk Factors
Medical History
Diabetes
18.4%
Congestive heart failure (EF<30%)
3.2%
No medication/unknown
9.7%
Chronic renal failure
6.1%
Oral medication
55.7%
Peripheral vascular disease 7%
Insulin
34.6%
Previous stroke 6%
Hypertension
58%
Prior myocardial infarction
25.3%
Hypercholesterolemia
56.2%
Unknown
27.3%
Family history of CAD
45.5%
In current PCI area
24.9%
Smoker
52.3%
In other than PCI area
47.8%
Previous
28.2%
Prior PCI
30.1%
Current
24.1%
Prior CABG
6.8%
One Year Results REMEDEE Registry TCT 2015

14. One Year Results REMEDEE Registry TCT 2015
Indication for PCI
Urgent
30.4%
STEMI
58.7%
NST-ACS
27.4%
Unstable angina
13.9%
Elective
69.6%
Stabilized STEMI
3.0%
Stabilized NST-ACS
15.4%
Stabilized unstable angina
9.6%
Stable angina and/or documented ischemia
43.6%
Angiographic driven
23.2%
Other
5.2%
One Year Results REMEDEE Registry TCT 2015

15. Lesion Characteristics
Multivessel disease (>1 vessel, >70%)
21.1%
Treated lesions (n=1511)
Left main
1.3%
LAD
50.6%
LCx
20.2%
RCA
26.1%
Bypass graft
1.8%
Number of vessels treated
One vessel PCI
89.5%
Multivessel PCI
10.5%
AHA/ACC lesion type A
16.4% B1
24.9% B2
37.5% C
21.1%
TIMI flow pre-procedure
14.5% 1
4.5% 2
9.8% 3
71.3%
50% }
One Year Results REMEDEE Registry TCT 2015

16. Lesion Characteristics
Length
17.7±10.3 mm
Reference vessel diameter
3.2±0.5
Percentage diameter stenosis*
88.4±31.2 %
* By visual estimate
Thrombus present
15.2
Indication for treatment
Native coronary artery
95.4
Venous bypass graft
1.5
Bypass graft
0.1
In-stent restenosis
1.8
In-stent thrombosis
Other
1.0
One Year Results REMEDEE Registry TCT 2015

17. Procedural Characteristics
Pre-dilatation
69.9%
Number of stents per lesion
1.1±0.37
1 stent per lesion
89.8%
>1 stent per lesion
10.2%
Stent length
19.3±6.4
Stent length ≤ 15mm
38.7%
Stent length > 15mm
61.3%
Stent Diameter
3.2±0.4
Stent diameter ≤ 3.0mm
59.4%
Stent diameter > 3.0mm
40.5%
Stent max pressure (atm)
13.6±3.8
Thrombus aspiration
10.8%
Thrombus aspiration in STEMI
83.3%
Device success*
98.7%
Procedural success†
97.7%
One Year Results REMEDEE Registry TCT 2015

18. One Year Results REMEDEE Registry TCT 2015
Primary Endpoint N
(%)
Primary endpoint: TLF 57
5.7
TLF: target lesion failure: a composite of cardiac death, myocardial infarction (MI) (unless documented to arise from the non-treated coronary artery), and target vessel revascularization (TVR).
One Year Results REMEDEE Registry TCT 2015

19. One Year Results REMEDEE Registry TCT 2015
Primary Endpoint N
(%)
Primary endpoint: TLF 57
5.7
Cardiac death 17
1.7
Target vessel MI 7
0.7
TLR 43
4.4
TLF: target lesion failure: a composite of cardiac death, myocardial infarction (MI) (unless documented to arise from the non-treated coronary artery), and target vessel revascularization (TVR).
One Year Results REMEDEE Registry TCT 2015

20. One Year Results REMEDEE Registry TCT 2015
Primary Endpoint N
(%)
Primary endpoint: TLF 57
5.7
Cardiac death 17
1.7
Target vessel MI 7
0.7
TLR 43
4.4
TVR 48
4.9
Definite ST 5
0.5
Probable ST 1
0.1
TLF: target lesion failure: a composite of cardiac death, myocardial infarction (MI) (unless documented to arise from the non-treated coronary artery), and target vessel revascularization (TVR).
One Year Results REMEDEE Registry TCT 2015

21. Primary endpoint: Target Lesion Failure
5.7%
One Year Results REMEDEE Registry TCT 2015

22. One Year Results REMEDEE Registry TCT 2015
Secundary endpoints
Cardiac Death MI
1.7%
0.7%
TVR
TLR
4.8%
4.4%
One Year Results REMEDEE Registry TCT 2015

23. Comparing REMEDEE Registry with other recent all-comers DES Trials
REMEDEE Registry
TWENTE
DUTCH PEERS
LEADERS
COMBO
Resolute ZES
Xience V EES
Promus EES
Biomatrix BES
Cypher SES N
1000
697
694
906
905
857
850
TLF
5.7
7.9
6.8
6.0
5.0
6.5
7.4
TVF
6.2
8.2
8.1
10.6
12.0
TV-MI
0.7
4.6
2.0
1.0
5.8*
4.6*
Cardiac death
1.7
4.9
4.8
4.0
2.1
2.7
Clinically indicated TVR
3.3
3.0
5.8
7.1
Definite ST
0.5
0.6
0.0
0.3
Probable ST (1Y)
0.1
0.8
1.2
0.2
Data are in N or %.The primary outcome is target lesion failure (TLF): a composite of cardiac death, myocardial infarction (MI) (unless documented to arise from the non-treated coronary artery), and target vessel revascularization (TVR). ZES: Zotarolimus Eluting Stent, EES: Everolimus Eluting stent, BES: Biolimus Eluting stent, SES: Sirolimus Eluting Stent . TLR: target lesion revascularization. * TVR and non-TVR myocardial infarction
One Year Results REMEDEE Registry TCT 2015

24. Patient Characteristics Stent Thrombosis
Baseline presentation
Treated Lesion
Days post COMBO stent placement
Thrombosis type
Repeat revascularization
40-year male
STEMI
RCA distal
<1
Definite
balloon angioplasty
83-year female
LAD proximal
52-year male
77-year male
Stable angina
LAD mid
stent placement
69-year male
Stabilized NST-ACS 9
41-year male 8
Probable*
n/a*
One Year Results REMEDEE Registry TCT 2015

25. One Year Results REMEDEE Registry TCT 2015
Stent thrombosis
Definite and probable ST
0.6%
One Year Results REMEDEE Registry TCT 2015

26. Strengths & Limitations
REMEDEE Registry is a true all-comers study
Few exclusion criteria
Fast enrollment
Balanced contribution of participating centers
All events adjudicated by independent clinical events committee
The REMEDEE Registry will collect FU untill 5Y
REMEDEE Registry is a registry
One Year Results REMEDEE Registry TCT 2015

27. One Year Results REMEDEE Registry TCT 2015
Conclusions
REMEDEE Registry is a 1000 patient, true all-comers study
Excellent procedural success with COMBO
Primary endpoint 1Y was 5.7%
This compares well with results from recent other all-comer trials
Definite / probable ST was low and no ST occurred after 9 days post procedure
The ongoing COMBO clinical program will provide more data regarding safety and efficacy in different patient populations
One Year Results REMEDEE Registry TCT 2015

28. One Year Results REMEDEE Registry TCT 2015
Study Team
Investigators:
R.J. de Winter
E.K. Arkenbout
P. den Heijer
I. Menown
P. Muller
H. Suryapranata
A. Erglis
A. Iniguez
A. van ‘t Hof
Research Fellows:
D.N. Kalkman
P. Woudstra
H. Lu
M. Beijk
Study Nurses:
M.I. Klees
N. Van Daalen
Y. Kwan Chan
Vinken
Senior Statistician:
J.G.P. Tijssen
CEC:
B. Rensing
F. Eeftink
Trial Management:
G. Peeters
One Year Results REMEDEE Registry TCT 2015

29. One Year Results REMEDEE Registry TCT 2015
This slide shows a list of all the staff and researchers involved in our cardiac emergency department
I thank you for your attention
Thank You
One Year Results REMEDEE Registry TCT 2015 29