DES e BMS: riflessioni e pensieri 23 febbraio 2007, San Donato Milanese

1. Drug-eluting stent meta-analyses & Long-term follow-up of high-risk subsets:Reconciling the evidence DES e BMS: riflessioni e pensieri 23 febbraio 2007, San Donato Milanese

2. Do you remember 2005?The rosy future… Buzzword = ?

4. Do you remember 2005?The rosy future… Buzzword = Late loss

5. Do you remember 2005?The rosy future…

6. Late 2006 surprise:the death/MI/thrombosis iceberg Buzzword = ?

8. Late 2006 surprise:the death/MI/thrombosis iceberg Buzzword = Thrombosis

9. Late 2006 surprise:the death/MI/thrombosis iceberg

10. Major concerns • Should we trust meta-analyses? • What is a meta-analysis? • How can I appraise the internal and external validity of a meta-analysis? • What are the meta-analysis results? • What is the long-term outlook with DES in patients at high risk of restenosis?

11. Major concerns • Should we trust meta-analyses? • What is a meta-analysis? • How can I appraise the internal and external validity of a meta-analysis? • What are the meta-analysis results? • What is the long-term outlook with DES in patients at high risk of restenosis?

12. What is a meta-analysis? • What is a systematic review? • A systematic appraisal of the methodological quality, clinical relevance and consistency of published evidence on a specific clinical topic in order to provide clear suggestions for a specific healthcare problem • What is a meta-analysis? • A quantitative synthesis that, preserving the identity of individual studies, tries to provide an estimate of the overall effect of an intervention, exposure, or diagnostic strategy

13. Should we trust meta-analyses?It depends on their internal validity!

14. Major concerns • Should we trust meta-analyses? • What is a meta-analysis? • How can I appraise the internal and external validity of a meta-analysis? • What are the meta-analysis results? • What is the long-term outlook with DES in patients at high risk of restenosis?

15. Oxman-Guyatt index of internal validity 1. Where the search methods used to find evidence stated? 2. Was the search for evidence reasonably comprehensive? 3. Were the criteria for deciding which studies to include in the overview reported 4. Was bias in the selection of studies avoided 5. Were the criteria used for assessing the validity of the included studies reported? 6. Was the validity of all studies referred to in the text assessed using appropriate criteria 7. Were the methods used to combine the findings of the relevant studies reported? 8. Were the findings of the relevant studies combined appropriately relative to the primary question the overview addresses? 9. Were the conclusions made by the author(s) supported by the data and/or analysis reported in the overview? Oxman, J Clin Epidemiol 1991

17. Major concerns • Should we trust meta-analyses? • What is a meta-analysis? • How can I appraise the internal and external validity of a meta-analysis? • What are the meta-analysis results? • What is the long-term outlook with DES in patients at high risk of restenosis?

18. Synopsis Meta-analyses showing a DES hazard Meta-analyses suggesting DES safety Bavry et al, Am J Med 2006 Camenzind et al, WCC 2006 Kastrati et al, NEJM 2007 Nordmann et al, Eur Heart J 2006 Spaulding et al, NEJM 2007* Stone et al, NEJM 2007* Boston Scientific, FDA 2006* Cordis, FDA 2006* Holmes et al, Eur Heart J 2006* Mauri et al, NEJM 2007* *likely stemming from the same analysis set STOP! GO!

19. Synopsis Meta-analyses showing a DES hazard Meta-analyses suggesting DES safety Bavry et al, Am J Med 2006 Camenzind et al, WCC 2006 Kastrati et al, NEJM 2007 Nordmann et al, Eur Heart J 2006 Spaulding et al, NEJM 2007* Stone et al, NEJM 2007* Boston Scientific, FDA 2006* Cordis, FDA 2006* Holmes et al, Eur Heart J 2006* Mauri et al, NEJM 2007* *likely stemming from the same analysis set STOP! GO!

21. Nordmann, Eur Heart J 2006

22. Nordmann, Eur Heart J 2006

23. Nordmann, Eur Heart J 2006

24. Synopsis Meta-analyses showing a DES hazard Meta-analyses suggesting DES safety Bavry et al, Am J Med 2006 Camenzind et al, WCC 2006 Kastrati et al, NEJM 2007 Nordmann et al, Eur Heart J 2006 Spaulding et al, NEJM 2007* Stone et al, NEJM 2007* Boston Scientific, FDA 2006* Cordis, FDA 2006* Holmes et al, Eur Heart J 2006* Mauri et al, NEJM 2007* *likely stemming from the same analysis set STOP! GO!

29. Synopsis Meta-analyses showing a DES hazard Meta-analyses suggesting DES safety Bavry et al, Am J Med 2006 Camenzind et al, WCC 2006 Kastrati et al, NEJM 2007 Nordmann et al, Eur Heart J 2006 Spaulding et al, NEJM 2007* Stone et al, NEJM 2007* Boston Scientific, FDA 2006* Cordis, FDA 2006* Holmes et al, Eur Heart J 2006* Mauri et al, NEJM 2007* *likely stemming from the same analysis set STOP! GO!

30. Bavry, Am J Med 2006

31. Bavry, Am J Med 2006

32. Bavry, Am J Med 2006

33. Bavry, Am J Med 2006

34. Bavry, Am J Med 2006

35. Synopsis Meta-analyses showing a DES hazard Meta-analyses suggesting DES safety Bavry et al, Am J Med 2006 Camenzind et al, WCC 2006 Kastrati et al, NEJM 2007 Nordmann et al, Eur Heart J 2006 Spaulding et al, NEJM 2007* Stone et al, NEJM 2007* Boston Scientific, FDA 2006* Cordis, FDA 2006* Holmes et al, Eur Heart J 2006* Mauri et al, NEJM 2007* *likely stemming from the same analysis set STOP! GO!

44. Synopsis Meta-analyses showing a DES hazard Meta-analyses suggesting DES safety Bavry et al, Am J Med 2006 Camenzind et al, WCC 2006 Kastrati et al, NEJM 2007 Nordmann et al, Eur Heart J 2006 Spaulding et al, NEJM 2007* Stone et al, NEJM 2007* Boston Scientific, FDA 2006* Cordis, FDA 2006* Holmes et al, Eur Heart J 2006* Mauri et al, NEJM 2007* *likely stemming from the same analysis set STOP! GO!