1 / 28

“Current DAT duration following DES implantation and CID polymer-free DES technology”

“Edge Technologies: CID Drug Release & Stent Surface developments”. “Current DAT duration following DES implantation and CID polymer-free DES technology”. Federico Piscione, MD, PhD Federico II University, Naples Italy. Disclosure Statement of Financial Interest.

meir
Download Presentation

“Current DAT duration following DES implantation and CID polymer-free DES technology”

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. “Edge Technologies: CID Drug Release & Stent Surface developments” “Current DAT duration following DES implantation and CID polymer-free DES technology” Federico Piscione, MD, PhDFederico II University, Naples Italy

  2. Disclosure Statement of Financial Interest I, Federico Piscione, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  3. DES efficacy Reduced neo-intima growth → lower late loss (LL) as well as target lesion revascularization (TLR) rates vs. BMS Angio efficacy = LL Clinical efficacy = TLR

  4. DES safety First available clinical data on DES Death, MI & MACE rates (1-2 years) were satisfactory SIRIUS @ 1 Yr

  5. The available clinical results on the first DES studies led the medical community to conclude the following: DES efficacy > BMS efficacyDES safety = BMS safety

  6. But……First concerns on long term DES safety started to come…

  7. ESC06: DES safety data

  8. ESC06: DES safety data (II) ROTTERDAM & BERN experience Overall thrombosis rate in 8146 patients enrolled in Bern (SIRTAX and POST-SIRTAX studies) and Rotterdam (RESEARCH and T-SEARCH) treated with either Cypher (47%) or Taxus (53%) stents* *: Presentation at ESC06

  9. EARLY 75% (n=71) LATE 23% (n=22) VERY LATE 2% (n=2) Overall incidence of stent thrombosis 95 of 6058 patients (1.6%) BMS Wenaweser P et al. Eur Heart J 2005 EARLY 61% (n=33) LATE 20% (n=11) VERY LATE 19% (n=10) Overall incidence of stent thrombosis 54 of 3376 patients (1.5%) DES Wenaweser P et al. ACC/i2, 2006, Poster Session 2902-74 Stent Thrombosis timing

  10. DES benchmark & REAL DAT duration in clinical studies Following ESC06, DAT duration in DES clinical studies has been extended more and more. In some cases it’s been extended beyond 3years (much longer than the suggested DAT duration in product IFUs) Knowing that DAT extension may mask late stent thrombosis events, this should be taken into account when a DES has to be selected. ***: Spirit III study results presented at TCT2009 - *: Leader trial results presented at TCT10 - **: Endeavor IV – Presented TCT2009

  11. Bad news assessed after DES implantation We are treating an ageing patient population… Hidden comorbidities may show themselves with dual antiplatelet therapy!

  12. 100% 58.7% 52.2% Absolute Clopidogrel discontinuation (%) 43.7% 11.2% Attributable Clopidogrel discontinuation (%) 3.9% Patient non-compliant to DAT* Among 2360 unselected patients undergoing successful DES implantation, 837 reported bleeding events (32,4% of the overall population). The type of bleeding has been assessed during the routine clinical follow-up. Knowing the high risk of stent thrombosis consequent to a premature DAT termination, the impact of “Nuisance bleeding” on attributable Clopidogrel discontinuation resulted much higher than expected. *: The American Journal of Cardiology, Volume 102, Issue 12, Pages 1614-1617 (15 December 2008)

  13. Patients non-responders to Clopidogrel: The Re-Close study results* Definite/Probable stent thrombosis for Responders & Non-Responders to Clopidogrel Long-term event-free survival for primary endpoint Primary endpoint: definite/probable DES thrombosis during the first 6 months follow-up *: Re-Close study results presented by Dr Antoniucci during TCT08

  14. What about new anti-platelet compounds? Is stronger/ longer/ infinite DAT regimen the solution? Trials data on new drugs have been recently disclosed, but the benefits (less ST, MI, CVA…) remain mainly focused on short term vs. the potential long-term risks (bleeding)

  15. Which is the economic impact of DAT duration extension? In this simulated case, DAT treatment with a current DES is compared to a foreseen DES which can allow for a DAT treatment of max 6-month (the number of procedures and the cost of Clopidogrel remain the same for 5 years) • Assumptions: • 2M pts per year receive DES • “ON-label” use (=6 months DAT) = 30%* • “OFF-label” use (≥12 months DAT) = 70%* • Cost of Clopidogrel = 100 US$/month 28% > 12 months 42% = 12 months *: data presented at EuroPCR07 (70% Off-label DES use, 40% of which requires the longest possible DAT duration)

  16. CID DES – Optima Polymer-free CID Carbostent™ Technology Polymer coated DES vs Stent + Drug Stent + Polymer + Drug • Lack of inflammatory polymers • No thrombogenic surface towards the bloodstream and the vessel wall • NO polymer drawbacks

  17. CID DES - Optima Jet Abluminal Reservoir Technology • Drug release only towards the vessel wall • 100% drug release • Deep reservoir maintains the drug concentration gradient vs. vessel wall drug release maintained for 2-3 months • The clinically proven* bio & haemo-compatible CarbofilmTM coating* is the only contact surface with the blood and the vessel wall. *Data on CarbofilmTM thromboresistance available in published clinical studies (SAFE, ANTARES, HURRICANE, SIMPLE)

  18. DES endothelializationin complex settings: Animal studies results Two DES in overlapping implantation (results at 28days)* Endothelialization of Carbostent DES located over the ostium of a side branch** Other DES Carbostent DES *: study performed by Virmani. Presented at EuroPCR05 & EuroPCR06 **: Presented during TCT07 (Courtesy of dr. Perez De Prado, Leon – Spain)

  19. Randomized clinical trial: 8-months results* - 60% - 54% p = 0.038 p = 0.059 *: Han et al. Chin Med J 2007; 120 (7): 552-556

  20. Matrix Registries I* & II** MATRIX I REGISTRY - 553 patientsEvaluation of safety and efficacy of Tacrolimus Eluting Carbostent in real world patients who underwent PCI, with two period of dual anti-platelet therapy (DAT) Vs 6 months DAT 2 months DAT MATRIX II REGISTRY – 392 patientsEvaluation of safety and efficacy of OPTIMA Tacrolimus-Eluting Carbostent in real world patients undergoing PCI, followed by only two months of dual anti-platelet therapy (DAT) 2 months DAT *: S.Cassese et al – Catheterization and Cardiovascular Intervention, IN PRESS **: Presented during GISE2010 – Dr S.Cassese

  21. Matrix I Registry - 12 m results* *: S.Cassese et al – Catheterization and Cardiovascular Intervention, IN PRESS

  22. Matrix II Registry Primary Endpoint - Incidence of Major Adverse Cardiac Events (MACE) within 12 and 24 months after implant procedure. Secondary Endpoint - Thrombosis rate within 30 days, 6, 12 and 24 months after implant procedure Lesion classification ACC/AHA Vessel distribution Presented during GISE2010 – Dr Cassese

  23. Matrix II Registry – Results (I) Results at 12 months - Primary Endpoint 95,11 % 93,80 % Cumulative incidence of TLR 4,89 % Presented during GISE2010 – Dr Cassese

  24. Matrix II Registry – Results (II) Results at 12 months – Secondary Endpoint 99,1 % Presented during GISE2010 – Dr Cassese

  25. ESC Guide lines for PCI in AF patients …..”The use of DES of first and second generation, due to the prolonged need of dual antiplatelet therapy, should be avoided in patients with an indication for long-term OAC”…. AF patients who would benefit from DES efficacy? ...”the new third generation DES seem to have accelerated re-endothelialisation and might become of interest. Retrospective registries (e.g.Italian Matrix registry) and trail to test their usefulness are currently performed”… Thromb Haemost. 2010 Jan;103(1):13-28

  26. CONCLUSIONS • Following ESC06, DAT duration in real-world PCI with DES has been extended much beyond 1 year heavily impacting on countries’ health budget. • Clopidogrel hypo-responsiveness, DAT compliance or bleeding may expose patient to higher risk of DES thrombosis with a consequent increased risk of cardiac death or MI. • The OPTIMA DES (polymer-free, abluminal reservoir, integral CarbofilmTM, Tacrolimus drug elution and the new delivery system) has been specifically developed to optimize DES efficacy and safety. • All the clinical data collected up to today confirm excellent CID DES technology safety & very positive outcomes in “real world” population, including high risk patients. These results have been achieved with short dual antiplatelet therapy duration. • OPTIMA is the only DES to allow 2 months DAT - Specific patients’ populations such as AF and high risk of bleeding today can benefit from the DES efficacy thanks to CID DES

More Related