DRUG ELUTION FOR ALL? THE CASE AGAINST

1. DRUG ELUTION FOR ALL? THE CASE AGAINST Jim McLenachan Yorkshire Heart Centre, Leeds

2. DRUG ELUTING STENTS • DO WE REALLY NEED THEM ? • DO THEY WORK ? • CAN WE SELECT “AT RISK” PATIENTS ? • ARE THEY SAFE ?

3. Stenting and procedures for restenosis (2000 data from 40 centres) BCIS AUDIT

4. REPEAT PCI IN RAVEL Event Free Survival (%) Days after implantation N Engl J Med 2002;346:1773-80

5. CARDIAC EVENTS AT ONE YEARRAVEL STUDY N Engl J Med 2002;346:1773-80

6. TIMING OF EVENTS IN RAVEL Event Free Survival (%) REPEAT ANGIOGRAPHY Days after implantation N Engl J Med 2002;346:1773-80

7. SIRIUS : Clinical events Holmes et al ACC 2003

8. SIRIUS : Clinical events Holmes et al ACC 2003

9. DRUG ELUTING STENTS • DO WE REALLY NEED THEM ? • DO THEY WORK ? • CAN WE SELECT “AT RISK” PATIENTS ? • ARE THEY SAFE ?

10. DRUG ELUTING STENTS • DO WE REALLY NEED THEM ? • DO THEY WORK ? • CAN WE SELECT “AT RISK” PATIENTS ? • ARE THEY SAFE ?

11. PREDICTION OF RESTENOSIS (%) KEREIAKES Am J Cardiol 2000;86:336

13. DRUG ELUTING STENTS • DO WE REALLY NEED THEM ? • DO THEY WORK ? • CAN WE SELECT “AT RISK” PATIENTS ? • ARE THEY SAFE ?

14. SCORE Trial Binary Restenosis (%) p<0.001 83% Binary Restenosis (%)

15. SCORE Trial MACE (6 months) SAT (%) AMI (%) Death (%)

16. Subacute thrombosis and drug eluting stents Is there a link?

17. Stent thrombosis at 56 hours

18. FDA ALERT 29th October, 2002 • FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents • FDA has received more than 290 reports of thrombosis (clotting) occurring one to 30 days after the procedure to implant the device. In more than 60 of these reports, use of the device was associated with the death of the patient; • FDA has also received more than 50 reports, including some deaths, that Cordis considers to be possible hypersensitivity reactions.

20. E-Sirius (male 59 yrs) Two Cypher Stents (3.0 x 18mm + 2.5 x 18mm) Virmani R, Guagliumi G, Farb A

21. Marked Chronic Inflammation and Medial Destruction Distal Stent Proximal Stent Aneurysm Prominent eosinophils Inflammation within and surrounding stent strutsand in adventitia

22. Inflammatory sequelae to what? Long Term Human Pathology: 18 Months Eosinophils in adventitia (red colored cells, Luna stain) Giant cells surrounding foreign material in aneurysm Polymer coating around stent strut Virmani R, Guagliumi G, Farb A

23. LONG SEGMENT OF LAD DISEASE

24. AFTER 2 TAXUS STENTS

25. 4 MONTHS LATER

26. CARDIAC EVENTS AT TWO YEARSRAVEL STUDY MORICE et al ACC 2003

27. CYPHERMortality from Randomized trials

29. “Selective use of drug eluting stents can further improve the already excellent outcome seen with regular stent technology.” Spencer B King III, Circulation 2003;108:248-249

30. “ As to diseases, make a habit of two things – to help, or at least do no harm.” HIPPOCRATES

31. “I think there is something to this inflammation story” K. DAWKINS, LONDON, 5/12/03

32. DRUG ELUTING STENTS • DO WE REALLY NEED THEM ? • DO THEY WORK ? • CAN WE SELECT “AT RISK” PATIENTS ? • ARE THEY SAFE ?

33. IAIN SIMPSON AND SOUTHAMPTON

35. Dr Liam Penny V. Dr Alison Calver PRIMARY PCI FOR AMI DEBATE, BRIGHTON 24 th October. 2003

36. SIMPO !! - 1980

40. “In no other walk of life does the cloven hoof so quickly display itself. Golf is the infallible test. The man who can go into a patch of rough alone, with the knowledge that only God is watching him, and play his ball where it lies, is the man who will serve you faithfully and well. But the man who is hasty, unbalanced and violent on the links, will display the same qualities in the wider field of everyday life.” PG Wodehouse