TIDES-OCT: Randomised multicenter trial comparing Optimax titanium-nitride-oxide coated stent versus Promus-Element stent Tuomas Kiviniemi, MD, PhD Turku University Hospital Finland

Potential conflicts of interest Speaker's name: Tuomas Kiviniemi  I have the following potential conflicts of interest to report: Institutional grant/research support: ASTRAZENECA

Background Rapid vascular healing after PCI could enable shorter dual antiplatelet therapy in patients at high risk for bleeding complications

Background Recent data suggests a paradigm shift in the occurrence of stent thrombosis (ST) – Rate of early and late ST in PtCr- EES < BMS – Uncovered struts and chronic inflammation identified as a nidus for thrombosis Palmerini et al, Lancet 2012

Stent thrombosis with BAS? BASE-ACS, EuroIntervention 2012

New Co-Cr Alloy Platform Optimax ’’ Stainless Steel Stent Platform Cobalt Chromium Stent Platform  20% THINNER STRUTS (75 microns) Stefanini G G et al. Heart doi: /heartjnl BVS Optimax

TIDES-OCT study 40 Patients with Acute coronary syndrome (ACS) Randomisation 1:1 OCT and CFR/FFR at 2 months OPTIMAX-BAS Titanium-Nitride-Oxide coated Bio Active Stent (n = 21) PROMUS-Element-EES Everolimus Eluting Stent (n = 19) Academic, investigator driven trial in 4 Finnish PCI centers

Optical Coherence Tomography (OCT) OCT C7xr TM (St.Jude Medical) OCT Examination - C7xr Cardiology Imaging System (LightLab Imaging inc, Westford, MA, USA) - A motorized pull-back system at 20 mm/s was used  54.0 mm / 2.7 sec - 6 Fr guiding catheter - During image acquisition, contrast media was infused at 3-6 ml/s - Images were stored digitally for subsequent analysis

1. Neointimal hyperplasia (NIH) thickness, µm - Distance between the vessel wall to the endo-luminal surface of the strut - NIH thickness inside every strut was measured Strut Level Analysis: Cross-sectional OCT images were analyzed at 1-mm interval (every 5 frames) 2. Binary Strut Coverage (%) Number of strut sections covered Total number of strut sections examined x 100 OCT Analysis

3. Apposition (%) A) Apposed and covered B) Apposed and uncovered C) Malapposed and covered D) Malapposed and uncovered E) Strut within the side branch

OCT Analysis 3. Apposition (%) A) Apposed and covered B) Apposed and uncovered C) Malapposed and covered D) Malapposed and uncovered E) Strut within the side branch

Coronary flow reserve Rationale: - The cutpoint value for normal CFR is 2.0 If CFR is < 2.0 -with no epicardial stenosis or ISR -IMR normal and no diabetes (microvascular dysfunction)  Endothelial dysfunction?  Delayed vascular healing after stenting? We sought to examine vascular healing after OPTIMAX- BAS and PROMUS-Element-EES implantation with combining data from OCT and CFR measurements

Invasive CFR, FFR and IMR Thermodilution-derived CFR I.v. adenosine infusion * Invasive measurements were performed using PressureWire Certus in the index vessel. * Thermodilution-derived CFR and IMR measurements were carried on during adenosine infusion

Baseline Demographics Optimax* (n=19) Promus-Element (n=19) P value Age (years)59 ± 968 ± Male74 %58 %0.50 Diabetes5 %16 %0.60 Hyperlipidemia58 %84 %0.15 Hypertension63 %84 %0.27 Current smoker37 %21 %0.48 Prior myocardial infarction11 %21 %0.66 Prior PCI16 %21 %1.0 Prior CABG0 %5 %1.0 NSTEMI42 %58 %0.30 STEMI47 %21 %0.21 * 2/21 patients had OCT follow-up later than 5 months after index PCI and were excluded from the analysis

OPTIMAX (n=19pts) PROMUS-Element (n=19pts) P value LAD58 % 1.0 Reference vessel diameter (mm)3.12 ± ± Lesion length (mm)14.0 ± ± Stent diameter (mm)3.33 ± ± Stent length (mm)17.4 ± ± Thrombus aspiration21 %11 %0.66 Post-Dilatation58 %63 %1.0 Stent failure0 % 1.0 Procedural Characteristics

Follow-Up Measurement TIDES-OCT at 2 months Follow-Up Measurement OPTIMAX 19 pts PROMUS-Element P No. of Cross Sections No. of Cross Sections No. of Struts No. of Struts Struts per cross section Struts per cross section 11.3 ± ± Mean NIH Thickness (µm)* 240 ± ± 59.5 < Binary Strut Coverage (%)*98.1%85.3% < Presence of Thrombi n (%) Presence of Thrombi n (%) 0 (0) --- * Stent level analysis

p < % 625 cross-sections / 6872 struts Follow-Up Measurement TIDES-OCT at 2 months Follow-Up Measurement OPTIMAX vs. PROMUS-Element Cross sections with uncovered struts: 8.6% vs. 54.0% (p<0.001) Cross sections with malapposed struts: 3.7% vs. 9.3% (p<0.001)

Uncovered struts with DES 2-3 months % 3.9% - 14% 4.7% - 9% 6.2% - 8.9% * REMEDEE-OCT trial ^ Hatrick-OCT trial ” Kim et al.

Coronary vasodilator function Delayed vascular Healing? Coronary Flow Reserve (CFR)

Take home message Newer generation BAS shows good coverage and functional healing response at 2 months FU