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The Black Back Yard of D.E.S [D.ES Pitfalls) Ehud Grenadier M.D H.M.C, Assuta , Rambam Med. Ctrs.

The Black Back Yard of D.E.S [D.ES Pitfalls) Ehud Grenadier M.D H.M.C, Assuta , Rambam Med. Ctrs. Israel. D eliverable. E ffective. S afe. D rug. E luting. S tent.

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The Black Back Yard of D.E.S [D.ES Pitfalls) Ehud Grenadier M.D H.M.C, Assuta , Rambam Med. Ctrs.

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  1. The Black Back Yard of D.E.S [D.ES Pitfalls) Ehud Grenadier M.D H.M.C, Assuta , Rambam Med. Ctrs. Israel

  2. Deliverable Effective Safe Drug Eluting Stent

  3. In the first year after coronary stents insertions, clinical failures are driven mainly by procedural complications and restenosis • However: The subsequent relative contributions of restenosis and the disease progression to late failures states are less clear

  4. 5-years clinical outcomes from second generation coronary stent trial 46.4% Composite 37.9% No restenosis Event rate Restenosis 20.3% years Cutlip et al, Circulation 2004

  5. Questions that need to be asked • Are D.E.S effective in prevention of restenosis? • Is there an increased survival by using D.E.S compare to B.M.S ? • Is an acute , subacute or late stent thrombosis events still a continuous risk ? • What are the additional risks of D.E.S therapy ? • What is the appropriate treatment and its duration that should be applied for risks reductions? • Is the risk of side-effect or complications of the applied therapy worth it ?

  6. Or to make a long story short Are we going in the right direction?

  7. One of the most dreadful complication of P.C.I is : Acute stent thrombosis, it has claimed to be of more relevancy in the long term to : D.E.S treatment.

  8. It is frequently presented clinically as :ACUTE M.I or DEATH

  9. Acute stent thrombosis : When it occurs ’Days from the procedure’ is frequently a procedural related complication.Not a D.E.S related.

  10. But : Sub Acute or late acute stent thrombosis is probably D.E.S related and is due to ..

  11. Sub acute-Late Stent Thrombosis Discontinuation of anti-platelet therapy Delayed Endothelialization Late incomplete Stent apposition Late Stent Thrombosis Polymer [sensitivity/inflammation]

  12. It is angiographycaly detected as :

  13. Acute thrombosis , 7 months F.U

  14. POST 15 MONTHS

  15. Acute stent thrombosis: kills !Restenosis : does not !

  16. ENDEAVOR I, II, II CA, III = 0.3% TAXUS II, IV, VI CYPHER SIRIUS, e-SIRIUS, c-SIRIUS, Direct SVELTE, RAVEL, EIII STENT THROMBOSIS RATES Discharge CumulativeTotal >30 daysto 9 months to 30 days 9-12 months In Hospital (4/1317) n=1317 Note: > 12 month follow-up on 679/1317 patients enrolled in Endeavor trials = 1.2% n=1147 Note: > 12 month follow-up max of 928/1147 patients enrolled in Taxus trials (14/1147) = 0.8% n=1317 Note: > 12 month follow-up max of 708/1317 patients enrolled in Cypher trials (11/1317) Sources Taxus clinical trial and registry summary, BSX,NEJM Vol. 349, No. 14 J. Moses presentation ACC04,Cordis analyst meeting March 6, 2005 at ACC05 LANCET Vol 362, Oct 4, 2003,NEJM Vol 346 No. 23 Leon SIRIUS 3-year update ACC05,ESC Congress 2005 – Drug-eluting stents bare metal stents: still an issue in 2005 ?

  17. Clinical events of the 3 major D.E.S9 months F.U

  18. The Risk of Thrombosis Stent thrombosis in Cypher studies - F.U 12 months Urban P et al. ESC 2005

  19. Stent Thrombosis in Cypher Trials 1.0% n=9 0.6% n=5 % Stent thrombosis 1-3 years Cypher 4 pts (0.4%) Control 0

  20. CYPHER RAVEL AMI AT 4 YEARS + 43% 5% 3,5% Cypher increases AMI by 43% versus BMS

  21. CYPHER RAVEL DEATH AT 4 YEARS 11% + 80% 6,1%

  22. CYPHER RAVEL AMI + DEATH AT 4 YEARS 16% +66% 9,6%

  23. DES BENEFIT IN THE LONG TERM Ravel Trial A detailed analysis of the Ravel at 4 yearsshow that DES restrictly improve TLR, while other critical components of MACE such as MI and DEATH are significantlyincreased.

  24. M.A.C.E vs. M.I.C.E CYPHER RAVEL MACE AT 4 YEARS CONCLUSION

  25. Incidence of Stent ThrombosisTaxus II, IV, VI Late Stent thrombosis is more prevalent NEJM 2004

  26. TAXUS THROMBOGENICITY

  27. P=0.07 p=0.03 p=0.02 1.8% 1.7% 1.6% 0.6% 0.4% 0.4% Stent Thrombosis Acute & Subacute ACC 2005. Mary-Claude Morice

  28. Thrombosis Rates Accordingto Selected Patient Characteristics(N=2,000) There are several patient andlesion subgroups with anunacceptably high stentthrombosis rate! *AntiplateletTherapyDiscontinuation PriorBrachy RenalFailure Bifurcations ULM Diabetes UA *Premature discontinuation, From Milan/Sieburg Experience ACC 05/ JAMA-05

  29. Late Stent Thrombosis Discontinuation of anti-platelet therapy Delayed Endothelialization Late incomplete Stent apposition Late Stent Thrombosis Polymer [sensitivity/inflammation]

  30. Premature Discontinuation of Antiplatelet Therapy • Non compliance • Due to procedures: Surgery, dental, biopsy • ASA or Clopidogrel [ plavix ] resistance • Are the most important predictors of stent thrombosis • 29 pts at 9 months F.U (1.3%) • 13/29 (45%) died. Fatality rate - 45% Common reasons Iakovov et al JAMA 2005

  31. Late Stent Thrombosis On the other hand… With The long need of antiplatelets therapy • There is a risk of bleeding from continuation of ASA and or Plavix during surgical procedures. It must be taken in consideration and weighed against the risk of fatal late stent thrombosis. • The requirement of extended (> 1 year?) dual antiplatelets regimen remains uncertain until more data are available

  32. Late Stent Thrombosis Discontinuation of anti-platelet therapy Delayed Endothelialization Late incomplete Stent apposition Late Stent Thrombosis Polymer [sensitivity/inflammation]

  33. Late Stent Malaposition F.U Post stent insertion Positive remodeling Black hole

  34. Sub acute-Late Stent Thrombosis Discontinuation of anti-platelet therapy Delayed Endothelialization Late formation Of aneurysm Late Stent Thrombosis Polymer [sensitivity/inflammation]

  35. Late [ 3 YEARS ] aneurysm formation

  36. Late aneurysm formation

  37. Late formation [ 3 years ] of LAD aneurysm Post Cypher stent insertion

  38. Late LAD aneurysm formation

  39. Late Stent Thrombosis Discontinuation of anti-platelet therapy Delayed Endothelialization Late incomplete apposition Late Stent Thrombosis Polymer [sensitivity/inflammation]

  40. Inflammation • In D.E.S there is a further delay arterial wall healing process and increasedinflammation • Compared to B.E.S , D.E.S induce greater: • Fibrin deposition • Medial cell loss • WBC infiltration • Less Late neointimal hyperplasia

  41. Sub acute-Late Stent Thrombosis Discontinuation of anti-platelet therapy Delayed Endothelialization Late incomplete apposition Late Stent Thrombosis Polymer [sensitivity/inflammation]

  42. Delayed Endothelialization • D.M.S have a decreased endothelialization process compared to D.E.S • Lack of cells coverage in areas of stents overlaps

  43. Basket - Late - Study S.e.s/p.e.s 499 pts. 1/1 ratio 746 pts BMS 244 pts. Plavix ASA 6 months mace free ASA only 12 months (no clopidogrel [plavix]) F.U Pfisterer ACC 2006

  44. Cardiac Death or M.I [ Composite endpoint]

  45. Cardiac Death or M.i

  46. Summary

  47. Basket Late TrialConclusion • Independent predictors of late cardiac death/M.I • Prior M.I • The need for IIb IIIa inhibitors • The use of D.E.S

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