Ενδοςτεφανιαίεσ προκζςεισ (stents):παρόν και μζλλον. Σ Χατηθμιλτιάδθσ Αναπλθρωτισ Κακθγθτισ Πανεπιςτθμιακό Νοςοκομείο ΑΧΕΠΑ

Transcription

1 Ενδοςτεφανιαίεσ προκζςεισ (stents):παρόν και μζλλον Σ Χατηθμιλτιάδθσ Αναπλθρωτισ Κακθγθτισ Πανεπιςτθμιακό Νοςοκομείο ΑΧΕΠΑ

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3 DES Penetration -(2011) Source: Millenium Research Group

4 Cordis has stopped manufacturing its Cypher stent the first drug-coated stent to be approved by the Food and Drug Administration in 2003 and stopped researching a new one called the Nevo stent (statement on june /15 /2011). Seth Fischer, worldwide chairman of Cordis, said the decision was prompted by changing dynamics and price pressures in an increasingly competitive market.

5 Interventional coronary procedures will not demonstrate important growth in the next decade World wide PCI procedures (source: JP Morgan)

6 DES Average Sales Price (ASP) Source: Goldman Sachs

7 The interventional marketplace is becoming cost and price sensitive-everywhere 1 Guidance 1.1 Drug-eluting stents are recommended for use in percutaneous coronary intervention for the treatment of coronary artery disease, within their instructions for use, only if: the target artery to be treated has less than a 3-mm calibre or the lesion is longer than 15 mm, and the price difference between drugeluting stents and bare-metal stents is no more than 300.

8 The regulatory climate for device approval has intensified

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11 The media impact on medicine has dramatically increased, importantly influencing therapy decisions.

12 Dr OZ show- Nov 2010

13 in pts with at least one lesion with FFR <0.80 only medical therapy

14 The evolution and convergence of PCI technologies have successfully addressed most major coronary issues

15 Thinner Struts May Improve Endothelial Coverage (μm) C. Simon, J. Palmaz, E. Sprague, J. Medical Implants, 10(1): (2000).

16 Stent Thrombogenicity is Driven by Stent Design and Deployment and Protected by Polymer-Drug Coatings Malapposition Kolandaivelu K, et al. Circulation. 2011;123:

17 DES development trends Promus element-bsc Yukon (Translumina)

18 COMPARE trial Primary endpoint result at 3 yrs (all death, non-fatal MI, TVR)

19 COMPARE trial First Stent Thrombosis at 3 yr & DAPT (Definite / Probable according to ARC)

20 COMPARE trial Landmark analysis- increasing risk

21 A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients (The TWENTE Trial) MACE Death MI TLR J Am Coll Cardiol 2012

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23 Stent Coverage Assessed by Optical Coherence Tomography: ISAR TEST 6 OCT

24 COMPARE II trial (biodegradable polymer stent vs permanent polymer stent) P Smits, europcr 2012

25 COMPARE II trial (biodegradable polymer stent vs permanent polymer stent) P Smits, europcr 2012

26 COMFORTABLE AMI trial (biodegradable polymer stent vs bare metal stent) Raiber et al Euro PCR -2012

27 Durable Polymers vs Biodegradable Polymer vs Polymer Free Randomised trial of three rapamycin-eluting stents (ISAR TEST 3) PF DES, polymer-free rapamycin-eluting Microporous surfacestainless steel sirolimus 7 day 67% release Cypher BP DES, biodegradable polymer rapamycin-eluting Heart 2009;95:

28 Novel polymer free drug delivery Solid nano-spheres consisting of merilimus+lipid (<300 nm) SEM picture of struts coated with nanoformulation

29 Novel polymer free drug delivery Drug Filled Stent (DFS) Technology

30 Dedicated bifurcation stents Axxess Sideguard Antares Invatec Twin-Rail Nile Croco/Pax Petal Tryton Multi-Link Frontier Stentys

31 Complete resorption of the Igaki-Tamai stent

32 Reduction in late/very late stent thrombosis Return of the vessel s vasomotion, adaptive shear stress and late luminal enlargement Reduction in bleeding Improvement in future treatment options such as bypass grafting Enabling noninvasive imaging follow-up with MSCT or MRI

33 How Long is Radial Strength Needed? Restenosis Following Balloon Angioplasty

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35 Is there an ugly side? BVS Cohort B TEMECULA 3d generation

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37 FUTURE STENTS Next generation DES incorporate thinner struts and enhanced geometries with newer metallic alloys that preserve/maintain visibility and radial strength. Polymer-free DES may even further decrease polymer related adverse events Fully biodegradable DES platforms will aim to restore vascular biology and physiology and will lead to a paradigm shift in therapy However, the bar is quite high with today s DES proving superiority for either safety or efficacy will be difficult.

38 FUTURE STENTS Wishing for more

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