Tuomas Kiviniemi, MD, PhD Turku University Hospital Finland

TIDES-OCT:Randomised multicenter trial comparingOptimaxtitanium-nitride-oxide coated stent versusPromus-Elementstent 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 Stainless Steel Stent Platform Cobalt Chromium Stent Platform • 20% THINNER STRUTS (75 microns) BVS Optimax 75 81 Optimax 0.0030’’ 156 Stefanini G G et al. Heart doi:10.1136/heartjnl-2012-303522

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 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 OCTC7xrTM(St.Jude Medical)

OCT Analysis Strut Level Analysis: Cross-sectional OCT images were analyzed at 1-mm interval (every 5 frames) 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 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

Coronary flow reserveRationale: • - 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 * 2/21 patients had OCT follow-up later than 5 months after index PCI and were excluded from the analysis

Procedural Characteristics

TIDES-OCT at 2 monthsFollow-Up Measurement * Stent level analysis

TIDES-OCT at 2 monthsFollow-Up Measurement p < 0.001 % 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) 625 cross-sections / 6872 struts

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

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

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

Tuomas Kiviniemi, MD, PhD Turku University Hospital Finland