THE ULTIMATE EVOLUTION IN DES TECHNOLOGY FOR DIABETICS: CRE8 EVO

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1 The ultimate EVOlution in DES technology for diabetics: Cre8 EVO THE ULTIMATE EVOLUTION IN DES TECHNOLOGY FOR DIABETICS: CRE8 EVO Rafael Romaguera, MD Barcelona Spain Rafael Romaguera, MD Hospital de Bellvitge Barcelona

2 Conflicts of interest Speaker honoraria: Abbott vascular, Alvimedica, St Jude Medical

3 Diabetes: A global emergency

4 Lower -limus DES efficacy in Diabetes Direct resistance of VSMCs to limus drugs non-diabetic diabetic Overweight/ Obese patients (90% of diabetics): Effect of Leptin in Pathological status (Hyperleptinaemia) non-diabetic diabetic 9/10 times higher -limus concentration is needed in the diabetic cell to achieve similar inhibition seen in non-diabetic one

5 Unique technology for very high efficacy in diabetes: Abluminal Reservoir Technology Amphilimus formulation

6 Amphilimus formulation Sirolimus Fatty Acid R Immunosuppressant Anti-proliferative action Anti-microbial Inhibitor of inflammatory cell activities High potency Proprietary technology Sirolimus and Fatty Acid are eluted together Combined effect!!! Sustained drug elution timing Modulated drug bioavailability Raised homogeneous drug distribution Enhanced drug stability

7 The key role of Fatty Acids in diabetic cells 30% NON-Diabetic cell 70% DIABETIC cell 100% FATTY ACID + SIROLIMUS Two pathways for ATP generation: 1. Glucose pathway (30%) 2. Fatty acid pathway (70%) Membrane protein overexpression leads to higher fatty acids bindings/ traslocation. Membrane Fatty Acid Transporters as Regulators of Lipid Metabolism: Implications for Metabolic Disease - Glatz J; 2010 Physiol Rev 90:

8 Abluminal Reservoir Technology Alvimedica utilizes a proprietary polymer-free drug release system constituted by reservoirs on the stent's abluminal surface ARTERIAL WALL Drug elution is controlled and directed exclusively towards the vessel wall BLOOD FLOW Lack of any polymer Lack of any drug

9 Abluminal Reservoir Technology Abluminal Reservoir is the ONLY polymer-free technology able to provide the same elution kinetic obtained by the most effective polymeric DES. Results obtained with below reservoir design: Peak drug tissue concentration during the first days 50% drug elution in approximately 18 days 65%-70% drug elution within 30 days Complete drug elution within 90 days

10 Amphilimus TM eluting DES: Results in Patients with Diabetes

11 RESERVOIR Trial AES = Cre8 EES = Xience family Primary endpoint: Neointimal volume obstruction Romaguera R, et al. JACC Cardiovasc Interv. 2016; 9: Hospital Clínico San Carlos Madrid

12 Primary endpoint: Neointimal Volume Obstruction p for non-inferiority = AES = Cre8 EES = Xience family Romaguera R, et al. JACC Cardiovasc Interv. 2016; 9: Hospital Clínico San Carlos Madrid

13 Late Lumen Loss (9months) Romaguera R, et al. JACC Cardiovasc Interv. 2016; 9: Hospital Clínico San Carlos Madrid

14 Participate Study Design Real world" patients with ischemic myocardial symptoms related to de novo coronary artery lesions, treated with Cre patients 30 European Sites PI: A. Colombo - Italy Pre-specified diabetic subgroup Diabetics patients submitted to angio FU OBJECTIVE: evaluate the safety and efficacy performances of Cre8, in patients comparable to the everyday s clinical practice population, with a specific focus on diabetics subjects PRIMARY ENDPOINT: 6-month incidence of clinical composite endpoint: Cardiac death/ Target vessel MI/ Clinically indicated TLR Clinical FU Angiographic FU (diabetic pre-spec. group) 1M 6M Y

15 Diabetic Population - 12month results - Overall Population - 12month results - Device-Oriented MACE at 1year 3% 12month MACE* = CD + TV MI + CI TLR 2,8% CI: 1.93% ; 3.91% 2% 1% 0,9% 0,9% 1,0% CI: 0.47% ; 1.68% CI: 0.53% ; 1.79% CI: 0.41% ; 1.57% 0% 5% 4% Cardiac Death Target Vessel MI CI TLR MACE 4,7% CI: 2.55% ; 7.63% 3% 2% 1% 1,7% 1,7% CI: 0.55% ; 3.90% CI: 0.55% ; 3.90% 1,4% CI: 0.37% ; 3.42% 0% Cardiac Death Target Vessel MI CI TLR MACE *MACE as percent frequencies of the device oriented clinical composite of CD, TV MI, CI TLR up to 6 months - ITT population - Diabetic population (N = 296) - Adjudicated events

16 Cre8 in-stent LLL results in diabetics 0,50 0,40 0,30 0,20 0,10 0,12 ±0,29 0,16 ±0,13 0,14 ±0,24 0,00 NEXT (diabetic subgroup) PARTICIPATE (diabetic subgroup) RESERVOIR Randomized study All-Comers study Randomized study in DM Company sponsored studies Independent study

17 The latest clinical evidence of Amphilimus TM efficacy in Diabetics INSPIRE-1 (Italian Nobori Stent ProspectIve REgistry-1) San Raffaele Scientific Institute Clinica Mediterranea Istituto Clinico Città Studi IRCCS Policlinico san Donato EMO-GVM Centro Cuore Columbus Ospedali Riuniti Marche Nord Ospedale San Giovanni di Dio Ospedale San Pietro, FBF Ospedale Santa Corona San Raffaele Scientific Institute Humanitas Clinical Institute Clinica Mediterranea Ospedali Riuniti Marche Nord EMO-GVM Centro Cuore Columbus Policlinico Umberto I Ospedale San Paolo

18 Matched analysis: Cre8 vs. BES

19 Matched analysis: Cre8 vs. BES in Diabetics TLF TLR -62% -57%

20 Can DES platform design contribute to maximize efficacy?

21 Drug concentration and DES strut location Vessel wall 3. Over a specific distance from the release point, the drug is no more detected Blood 1. Maximum concentration is achieved next to the DES strut 2. Drug concentration decreases in function of the ability of the drug to permeate the vessel tissue A drug eluted alone has limited permeation into the vessel tissue Closer struts allow for better drug coverage of the vessel wall!!!

22 DRUG EFFICACY MATRIX - Example Geometrical Solution (closer struts)

23 Cre8 EVO: New Stent Architecture

24 New Stent Architecture: more flexibility & higher efficacy An innovative stent architecture has been developed to improve even more the homogeneous drug distribution within the vessel wall, in particular in case of complex coronary anatomies and pathologies like those of diabetic patients New stent architecture

25 Pharmaceutical Solution (Amphilimus TM formulation) DRUG EFFICACY MATRIX Geometrical Solution (Reserviors located closer to each others) Cre8 TM Cre8 TM EVO

26 New Stent Architecture The New Stent Architecture, coupled with Abluminal Reservoirs and Amphilimus TM formulation, has been designed for a uniform drug concentration

27 Second-generation drug-eluting stents in diabetes: a Randomized trial (the SUGAR trial) All-comer patients with diabetes mellitus undergoing PCI Amphilimuseluting stents ~1400 patients ~30 Centers in Spain Randomization 1:1 Zotarolimuseluting stent PI: Rafael Romaguera Primary Endpoint: Non-inferior 12 months Target Vessel Failure (TVF) * Study promoted and funded by the Spanish Society of Cardiology

28 Diab8 randomized trial Study design for superiority All-comer patients with diabetes mellitus undergoing PCI Cre8 TM EVO ~2200 patients ~50 International Sites Randomization 1:1 PI: Antonio Colombo Everolimus Eluting Stent (EES) Primary Endpoint: 12 months Target Lesion Failure (TLF) for superiority Clinical FU 1year 3years

29 Conclusions Diabetes represent today a global emergency. Patients with DM are at high risk of coronary events after PCI with the current DES technology. The Amphilimus TM formulation, eluted in a very controlled way from Abluminal Reservoirs, allows for a very effective neo-intimal inhibition as shown in randomized trials, matched analysis and all-comer studies. Cre8 EVO, with its innovative architecture, can further advance DES efficacy specifically in complex patients. The ongoing randomized trials will evaluate how much patients with DM can benefit from this unique technologies.

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