1. When Should We Use a New DES ? Dr R H Stables Cardiothoracic Centre Liverpool UK

2. Conflict of Interest UK or European advisory boards Boston Scientific, Cordis, Medtronic Educational grants or lecture fees Boston Scientific, Cordis, Medtronic, Guidant Research grants or paid role as trial PI Cordis, Boston Scientific, Medtronic, Biocompat Share holding or other financial interest None

3. What is a New DES ? Established DES Cypher Taxus Characterised DES Endeavour Emerging DES eg Co-Star Xience Developmental DES Pseudo DES

4. Some Facts About DES Technology Difficult to create a safe and efficacious DES Pre-clinical - stage advance hit rate 150:1 Clinical products - fail : success ratio = 4 History of DES product at GUIDANT DES abandoned after launch ZoMax - most recent Similar (identical) drug or components - no guide CE mark - no proof of product efficacy The cautionary tale of the Sorin Janus DES …..

5. The Sorin ‘Janus’ Story CE mark approved DES sold in the UK Typical DES pricing Limited registry type data ‘Plausible’ design - presented as an advance

6. The Sorin ‘Janus’ Story CE mark approved DES sold in the UK Typical DES pricing Limited registry type data ‘Plausible’ design - presented as an advance Implanted in patients with DES indications At UK taxpayers’ expense At whim of UK cardiologists Subsequent RCT - Equivalent to its own control - Carbostent

7. Why Use a New DES ? Formal, quality RCT evaluation of a new DES Performance advantage Handling and deliverability Safety or efficacy? - not proven at this stage Cost advantage Direct (unit) cost Market impact - critical number of competitors Supply and availability Treat more lesions with DES ?

8. But Don’t be Fooled by These…. Its seems new and exciting … I could be one of the first to use it I am just giving it a try …… You cannot ‘try’ the drug eluting part of a DES The components (drug) work in other stents The design has clear, self evident advantages … I am part of a research project ‘Mickey Mouse’ registry - marketing exercise

9. Taking the Plunge Critical mass of data on safety and efficacy Portfolio of research projects At least one powered RCT against standard Angiographic follow-up and analysis Clinical outcomes beyond one year Continued commitment to research and outcome analysis More FDA than CE mark standard

10. Questions and Discussion