1. The OPTIMAX first-in-man study Mid-term clinical outcome of Titanium-Nitride-Oxide-coated Cobalt Chromium stents in patients with de novo coronary artery lesions
P Karjalainen, MD, PhD, adj Professor
Heart Center, Satakunta Central Hospital,
Pori, Finland

2. Potential conflicts of interest
Speaker’s name: PASI P KARJALAINEN
 I have the following potential conflicts of interest to report:
 Research contracts + Consulting:
Biotronik, Boston sc, St Jude Medical
 Employment in industry
 Stockholder of a healthcare company
 Owner of a healthcare company
 Other(s)
 I do not have any potential conflict of interest X X 2

3. OPTIMAX first-in-man study
PURPOSE OF THE STUDY
In a prospective first-in-man observational study design, we explored the 6-month clinical outcome of a Titanium-Nitride-Oxide coated OPTIMAX-stent based on cobalt-chromium platform, in de novo coronary lesions.
Between january 2013 and october 2013, all consecutive patients scheduled for stent implantation were considered for this prospective registry

4. 20% THINNER STRUTS (75 microns)
New Platform
(Co-Cr Alloy)
20% THINNER STRUTS (75 microns)
Improved Radio-Opacity
Higher Radial Force
91μm
75μm
Stainless Steel
Stent Platform
Cobalt Chromium
Stent Platform

5. Enhanced Coating Process
100% INCREASED TiNO COATING THICKNESS
Higher Titanium-Nitride-Oxide concentration
Low Thrombogenicity
Fast Re-endothelialization
Stent Strut
Stent Strut

6. Titan-Optimax Strut Thickness vs. DES Cobalt-Chromium *
(Microns) *
Optimax offers the lowest strut thickness among all Active Stents
available on the market.

7. Inclusion / Exclusion Inclusion: Exclusion: OPTIMAX-FIM study
- De Novo lesion
- Age > 18yrs
- Stable angina or ACS
- RVD
- Stent length ≤ 28mm
- Target lesion >50% stenosed
Exclusion:
- Cardiogenic shock
- Unprotected left main
- Prior stent in the target vessel
- Diffuse distal disease
- A > 30% stenosis prox or distal
that cannot be covered with same stent
- Calsified lesion that cannot be
adequately pre-dilated
- Known allergy to aspirin, heparins,
clopidogrel/prasugrel/ticagrelol or
contrast agent
OPTIMAX-FIM study

8. Primary Endpoint The primary endpoint:
Major adverse cardiac events (MACE) at
6-month follow-up, defined as a composite of
- Cardiac death
- Non-fatal myocardial infarction (MI) or
- Ischemia-driven target lesion
revascularization (TLR)
OPTIMAX-FIM study

9. Baseline Clinical Characteristics
OPTIMAX stent
(n=184)
Age (years)
69 ± 9
Male, n (%)
129 (70)
Diabetes, n (%)
28 (15)
Current smoking, n (%)
35 (19)
Hypertension, n (%)
105 (57)
Hypercholesterolemia, n (%)
92 (50)
Previous MI, n (%)
17 (9)
Previous PCI, n (%)
20 (11)
Previous CABG, n (%)
5 (3)
STEMI, n (%)
26 (14)
NSTEMI, n (%)
82 (45)

10. Procedural and Lesion Characteristics
OPTIMAX stent
(n=184)
Number of Lesions treated per patient
1.12 ± 0.37
Number of Stents per lesion
1.14 ± 0.33
Target vessel, n (%)
LAD
88 (48)
LCX
39 (21)
RCA
50 (27)
Left Main
2 (1)
Lesion type, n (%) A
36 (20)
B1/B2
130 (71) C
18 (10)

11. Procedural and Lesion Characteristics
OPTIMAX stent
(n=184)
Thrombus, n (%)
19 (10)
Calsified lesion, n (%)
64 (35)
Bifurcation involved, n (%)
33 (18)
Reference vessel diameter (RVD), mm
3.03 ± 0.37
Lesion length, mm
17.3 ± 6.4
Stent diameter, mm
3.10 ± 0.38
Stent length (Total stent length), mm
19.5 ± 5.5 (21.4 ± 8.4)
Thrombus apiration, n (%)
14 (8)
Direct stenting, n (%)
50 (27)
Post-dilatation, n (%)
140 (76)
DURATION of DAPT*, months
4.6 ±2.5
* Aspirin 100mg + Clopidogrel in 95.1% of patients (Prasugrel in 2.7% and Ticagrelol in 2.2%)

12. OPTIMAX-FIM study 6-Months* MACE Composition%
* Follow-up 100%

13. OPTIMAX vs TITAN* 6-Months MACE Composition%
 Titan stent (n=201)
 Optimax stent (n=184)
* Eurointervention 2006;2: (Pori registry).

14. Conclusions In a prospective first-in-man observational study:
Titanium-Nitride-Oxide coated OPTIMAX-stent based on cobalt-chromium platform, showed relatively low rates of both safety and efficacy outcomes
Six months clinical outcome tend to be better when compared to Titan-2 stent

15. Case Presentation 1 History: Male 65 years - Hypertension
- Hyperchlolesterolemia
- IDDM (~40 years)
- TTE: EF 65%
NSTEMI
- Angiography: 1 VD  Culprit in proximal LAD
- PCI < 24 hours after admission

16. PCI TnI 28, CkMBm 55 Pre-dilatation with 2.5 x 10 Rafale balloon
Stent: OPTIMAX 3.0 x 16 (14 atm)
Post-dilatation with non-compliant 3.25 x 12 balloon 16

17. After PCI Discharge Aspirin lifelong
Clopidogrel 12 months due to acute MI!
Hypertension: B-blockade, ACE-inhibitir, Ca-blockade, diuretics
IDDM: Long-and short acting insulin
Dyslipidemia: Statin 17

18. OCT at 20 days 18

19. Case Presentation 2 History: Female 60 years - Hyperchlolesterolemia
- Aspirin allergy
NSTEMI
- Angiography: 1 VD  Culprit in LOM
- PCI < 24 hours after admission 19

20. PCI Procedure Pre-dilatation with 2.0 x 10 Rafale balloon
Stent: OPTIMAX 2.75 x 16 (12 atm)
Post-dilatation with non-compliant 3.0 x 12 balloon 20

21.  Ticagrelol (Brilique) 90mg x 2 for 1 month
After PCI
Discharge
Aspirin lifelong ALLERGY!
Clopidogrel? Dose? === Prasugrel??
 Ticagrelol (Brilique) 90mg x 2 for 1 month 21

22. Ticagrelol monotherapy 0-30 days Clopidogrel monotherapy > 30 days
OCT at 20 days
Ticagrelol monotherapy 0-30 days
Clopidogrel monotherapy > 30 days 22

23. The OPTIMAX first-in-man study Thank You
P Karjalainen, MD, PhD, adj Professor
Heart Center, Satakunta Central Hospital,
Pori, Finland