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When Should We Use a New DES ?

When Should We Use a New DES ?. Dr R H Stables Cardiothoracic Centre Liverpool UK. Conflict of Interest. UK or European advisory boards Boston Scientific, Cordis, Medtronic Educational grants or lecture fees Boston Scientific, Cordis, Medtronic, Guidant

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When Should We Use a New DES ?

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

  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

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