OPTIMAX OCT Faster and more complete healing by

OPTIMAX OCT Faster and more complete healing by Ti. NOX coated stents in ACS patients Bernard De Bruyne Cardiovascular Center Aalst, Belgium

Potential COI • Research Support/Grants (for the CV Research Center Aalst): Abbott Vascular, Medtronic, Biotronic, St Jude Medical • Institutional Consultancies (for the CV Research Center Aalst): Boston Scientific, Opsens, Abbott Vascular • Investment Funds/Equities in Medical Companies: Siemens, GE, Philips, Bayer, Heart. Flow, Edwards Life Sciences, Sanofi, Abbott Diagnostics, Celyad • Involvement in Contract Research Organizations (CRO): None • Proprietary claim on technology: None

Background Stainless Steel Stent Platform OPTIMAX-OCT Cobalt Chromium Stent Platform Co. Cr: thin struts and large radial force TNO coating: o Promotes endothelial healing (exposure of NO) o Decreases inflammation o Reduces platelet & fibrin deposition o Minimizes thrombus formation

OPTIMAX-OCT Rationale Trading-Off Safety and Efficacy Clinical Events Safety↓ Efficacy↓ Restenosis Late Stent Thrombosis DES BAS 0 BMS Neo-Intimal Tickness (Late-Loss, mm)

Aim OPTIMAX-OCT To compare the healing process after Co. Cr-TNO vs Pt. Cr-BP EES stent implantation in patients with acute coronary syndromes

Methods OPTIMAX-OCT • • • Patients with STEMI or Non-STEMI Native arteries Length <24 mm • • Cohort A: OCT at 1 month Cohort B: OCT at 6 months • Blinded OCT analysis ü ü ü Luminal area NIH area Percentage uncovered struts Malapposed struts NIH tickness Malapposition distance

Flow Chart OPTIMAX-OCT 110 patients with ACS (STEMI or NSTEMI) COHORT A (n=55) COHORT B (n=55) OCT at 1 month OCT at 6 month 1: 1 Co. Cr-TNO (n=29) Pt. Cr EES (n=26) Co. Cr-TNO (n=28) Pt. Cr EES (n=24) Co. Cr-TNO (n=29) Pt. Cr EES (n=26) Co. Cr-TNO (n=16) Pt. Cr EES (n=14) OCT at 1 mo OCT at 6 mo

Results OPTIMAX-OCT 1. Safety 2. Efficacy 3. Clinical Relevance

Results OPTIMAX-OCT Uncovered Struts (% of pts)

OPTIMAX-OCT Results Uncovered Struts (% of pts) 25 1 Month 19. 6 20 25 20 15 15 10 10 5 8. 7 5 3. 2 0 0 Co. Cr-TNO 6 Months Pt. Cr-EES 0 Co. Cr-TNO 2 Pt. Cr-EES 3

OPTIMAX-OCT Results Malapposed Struts 2. 5 1 Month 2. 5 6 Months 2. 1 2 2 1. 5 1 1 0. 5 0. 4 0. 5 0 0 Co. Cr-TNO Pt. Cr-EES 0. 3 0 Co. Cr-TNO Pt. Cr-EES

Results OPTIMAX-OCT 1. Safety 2. Efficacy 3. Clinical Relevance

Results OPTIMAX-OCT NIH Tickness (micrometer)

OPTIMAX-OCT Results NIH Tickness (micrometer) 300 1 Month 300 250 200 150 100 70 40 50 0 6 Months 230 60 50 0 Co. Cr-TNO Pt. Cr-EES Co. Cr-TNO 2 Pt. Cr-EES 3

OPTIMAX-OCT Results Luminal Area 10 1 Month 10 9 8. 53 9 8 7 9. 01 8 6. 89 7 6 6 5 5 4 4 3 3 2 2 1 1 0 0 Co. Cr-TNO 6 Months Pt. Cr-EES 4. 18 Co. Cr-TNO 2 Pt. Cr-EES 2

Results OPTIMAX-OCT 1. Safety 2. Efficacy 3. Clinical Relevance

OPTIMAX-OCT Results Area Stenosis (%) 100 1 Month 100 90 90 80 80 70 70 60 60 50 50 40 40 30 30 20 20 10 9 0. 6 0 Co. Cr-TNO Pt. Cr-EES 6 Months 39 6. 1 10 0 Co. Cr-TNO 2 Pt. Cr-EES 2

OPTIMAX-OCT Results Diameter Stenosis (%) 60 1 Month 60 50 50 40 40 30 30 20 20 10 5 0 Co. Cr-TNO 6 Months 14. 4 10 1 Pt. Cr-EES 5. 1 0 Co. Cr-TNO 2 Pt. Cr-EES 2

Results OPTIMAX-OCT Restenosis Rate at 6 Months Synergy: 0% OPTIMAX: 0%

Summary OPTIMAX-OCT In patients with ACS, Co. Cr-TNO-stent (OPTIMAX) implantation was associated with lower rates of uncovered and malapposed struts, as compared to Pt. Cr-BP EES (SYNERGY) Neo-intimal thickness was larger and luminal aere was smaller with the Co. Cr-TNO-stent (OPTIMAX) as compared to Pt. Cr-BP EES (SYNERGY) The restenosis rate after 6 months rate is 0% after both stents

Conclusions OPTIMAX-OCT When compared to ‘best in class DES’, the OPTIMAX stent is associated with a faster healing without higher restenosis rate