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High Tech - Marseille 25 au 27 janvier 2011 Marie-Claude MORICE, MD, FESC, FACC Massy, France

Moins de 6 mois d’antiagrégants après DES ?. High Tech - Marseille 25 au 27 janvier 2011 Marie-Claude MORICE, MD, FESC, FACC Massy, France Pas de conflit d’interet. Was optimal duration of DAPT already established for BMS?. Stable&unstable angina. 2,116 pts. 1 year vs. 30 days of DAPT.

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High Tech - Marseille 25 au 27 janvier 2011 Marie-Claude MORICE, MD, FESC, FACC Massy, France

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  1. Moins de 6 mois d’antiagrégants après DES ? High Tech - Marseille 25 au 27 janvier 2011 Marie-Claude MORICE, MD, FESC, FACC Massy, France Pas de conflit d’interet

  2. Was optimal duration of DAPT already established for BMS? Stable&unstable angina 2,116 pts 1 year vs. 30 days of DAPT Acute coronary syndromes median DAPT duration8 months No difference in bleeding Slight increase in bleeding (P=0.07) :

  3. Are DES particularly vulnerable to thrombosis? From autopsies of 23 patients treated with DES >30 days and 25 matched BMS-treated autopsies 100 BMS 90 80 70 60 Endothelisation (%) 50 40 DES 30 20 10 0 1 2 3 4 5 6 7 8 9 11 15 16 17 20 >40 Duration (months) Joner et al, JACC 2006

  4. Are DES particularly vulnerable ? PES SES BMS Stettler et al. Lancet 2007

  5. Everolimus-eluting stents vs. non-everolimus-eluting stents Baber et al. JACC in press

  6. 1 Year ST Rate (ARC Def/Prob)Overall Population 3% p = 0.002 0.84% 0.7% XIENCE V TAXUS XIENCE V XIENCE V USA 1 Kedhi E. et al Lancet. 2010; 375 (9710): 174-6. COMPARE1 6

  7. Biolimus is a semi-synthetic sirolimus analogue with 10x higher lipophilicity and similar potency as sirolimus. Biolimus is immersed at a concentration of 15.6 g/mm into a biodegradable polymer, polylactic acid, and applied solely to the abluminal stent surfaceby a fully automated process. Biolimus is co-released with polylactic acid and completely desolves into carbon dioxide and water after a 6-9 months period. The stainless steel stent platform has a strut thickness of 120 m with a quadrature link design. BioMatrix FlexTM

  8. NOBORI – DAT StudyNobori DES components

  9. 6.0 3.0 3.0 3.0 4.0 2.0 2.0 2.0 2.0 1.0 1.0 1.0 3-year HR 0.28 [0.08 to 1.03] P = 0.04* LEADERS: Definite ST in Complex Patients 3-year HR 0.46 [0.16 to 1.35] P = 0.15* STEMI High SYNTAX SCORE (>16) 6.0 3-year HR 0.50 [0.18 to 1.34] P = 0.16* 3-year HR 0.45 [0.16 to 1.31] P = 0.14* BES 6.0 10.0 6.0 SES 5.0 5.2% 5.2% 8.1% 5.1% 5.0 4.3% 5.0 Δ 4.3% 5.1% 8.1% 8.0 8.1% 4.6% 3.8% 3.8% 4.0 3.4% 4.0 4.0 % 2.5% Δ 4.3% Δ3.5% Δ3.7% Δ3.7% Δ2.0% Δ3.5% % % % Δ 5.1% 3.8% Δ1.9% Δ2.3% 3.0% Δ1.8% 2.6% 2.6% 2.6% Bifurcation Multi Vessel Δ0.5% 2.0% 2.0% 2.0% 1.5% 1.5% 1.5% 0 0 0 0 0 12 36 6 18 24 30 0 6 12 18 24 30 36 0 Months 12 36 6 6 12 18 24 30 36 18 24 30 0 Months Months Months *P values for superiority Windecker, S., oral presentation ,TCT 2010

  10. LEADERS :Effect of DAPT Discontinuation Overall Population Patient who d/c DAPT P = 0.12* % P = 0.24* N=19/857 N=24/850 N=0/165 N=4/169 N=0/540 N=2/515 *P values for superiority (Fisher Exact Test) ** KM estimates

  11. Late ST Rates (30 Days - 1 Year)After DAPT Interruption Overall Subsequent Late ST (ARC Def/Prob) (%) 13/3500 2/435 1/378 0/292 No Interruption Interruption After 30 Days* Interruption After 180 Days* Interruption After 90 Days* *Out to 1 year 11

  12. NOBORI 2- DAT Study 12 months data for DAT available for 2971 patients DAT group: Patients under DAT at 1 year n=2303 non-DAT group: Patients who stopped DAT earlier n=668 Clinical Follow-Up up to 5 years Primary Endpoint: Target Lesion Failure at 12 months Composite of Death, MI Target vessel related and TLR 12 Months FU = 97%

  13. NOBORI – DAT StudyBaseline Demographics

  14. DAPT Interruption Pattern* *Out to 1 year **Adverse Events include all events regardless of their severity and/or relationship with drugs or device

  15. NOBORI – DAT StudyClinical outcomes at 1 year TLF = Target Lesion Failure (Cardiac death, MI, clinically driven TLR); ST = Definite/Probable according to ARC; MACE = Cardiac Death, any MI, TVR

  16. NOBORI – DAT StudyPatients that stopped DAT before 1 year TLF = Target Lesion Failure (Cardiac death, MI, clinically driven TLR); ST = Definite/Probable according to ARC; MACE = Cardiac Death, any MI, TVR

  17. Conclusions • In 3 large trials, real-world population of respectively 3000, 1400, 5000 patients, NOBORI, BIOSENSOR and XIENCE V stents demonstrates very low stent thrombosis rates for the whole population • In a real-world experience of unanticipated DAPT interruption, the 3 stents had an observed near zero ST event rate afterDAPT interruption.

  18. Conclusions • Shorter dual antiplatelet treatment is vital for some patients, • If confirmed by prospective comparative studies ( 3 or 6 months compared to 1 year), these new generation of stent will fullfill our expectations

  19. And even less than 3 months? .- the ZEUS trial (PI Marco Valgimigli) who is randomizing patients at risk of bleeding to Endeavor or BMS with a minimum length of DAPT of 1 month. - The Leaders free trial

  20. BioFreedom™ Hypothesis: Polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings. Selectively micro-structured surface holds drug in abluminal surface structures • Potential advantage • Avoid long term late adverse effects that might be attributable to the polymer • Improved surface integrity since there is no polymer to be sheared or peeled away from the stent struts • Possible shorter need of dual antiplatelet therapy Proprietary Highly Lipophilic Limus drug

  21. Pre-Clinical Safety Evaluation Tada et al., Circ Cardiovasc Interv 2010;3;174-183

  22. In-Stent LLL at 12 Months FU 2nd Cohort PRIMARY ENDPOINT P = 0.001* (p=0.11**) P = 0.21* (p=0.55**) (mm) N = 31 N = 35 N = 31 *Non-inferiority tests. **Superiority tests. Grube E., oral presentation, TCT 2010

  23. A PROSPECTIVE RANDOMIZED COMPARISON OF THE BIOFREEDOMTM BIOLIMUS A9TM DRUG COATED STENT VERSUS THE GAZELLE™ BARE METAL STENT IN PATIENTS AT HIGH RISK FOR BLEEDING

  24. LEADERS FREE PROTOCOL Title: LEADERS FREE Devices Used: - Biosensors BioFreedom™ BA9 Drug Coated Coronary Stent - Biosensors Gazelle™ Bare Metal Coronary Stent Antiplatelet Therapy:ASA once a day for one month (indefinitely at the discretion of the investigator) AND Clopidogrel or P2Y12 inhibitor (choice of the investigator) for one month

  25. LEADERS FREE:PROTOCOL Design: multi center, multi-national out of US double blinded, randomized, trial designed to enroll 2500 patients at up to sixty centers worldwide. Patients will be randomized at 1:1 ratio to the stent treatment. All patients will be followed for two years. Organisation: PI: P Urban, I Meredith, A Abizaid Sponsor/ BIOSENSORS CRO: CERC

  26. PROTOCOL Objectives: Safety: 1) To demonstrate in symptomatic CAD patients who are unsuitable for >1 month treatment with dual antiplatelet therapy (DAPT) that the Biosensors BioFreedom™ Drug Coated Stent (DCS) followed by one month DAPT is non-inferior to the Gazelle™ Bare Metal Stent (BMS) followed by one month DAPT as measured by the composite primary endpoint of cardiac death, myocardial infarction, stent thrombosis and urgent target lesion revascularization (TLR) at one year. Efficacy: 2) To demonstrate in symptomatic CAD patients who are unsuitable for >1 month treatment with DAPT that the Biosensors BioFreedom™ DCS followed by one month DAPT then followed by aspirin only indefinitely is superior to the Gazelle™ BMS followed by one month DAPT as measured by the incidence of clinically driven TLR at one year.

  27. LEADERS FREE/ INCLUSION CRITERIA • Any indication for PCI-S in patients Deemed at high risk for bleeding and candidates for 1 month DAPT • 1- Adjunctive oral anticoagulation treatment planned to continue after PCI • 2- Age ≥ 75 years old • 3- Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) • 4- Any prior intracerebral bleed • 5- Any past <=1 year stroke • 6- Hospital admission for bleeding during the prior 12 months • 7- Cancer diagnosed or treated <= 3 years • 8- Planned daily NSAID (other than aspirin) or steroids for >=30 days after PCI • 9- Planned major surgery (within 1 year) • 10- Expected non-compliance to prolonged DAPT for other reasons

  28. Alors, les BMS…… au musée?

  29. Thank you for your attention

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