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Evaluating the Use of New Drug-Eluting Stents: Evidence, Safety, and Efficacy

This presentation addresses the critical considerations for using new drug-eluting stents (DES), evaluating their safety and efficacy. Dr. R.H. Stables, from the Cardiothoracic Centre in Liverpool, delves into the history and technology behind DES, highlighting examples such as Cypher, Taxus, and the controversial Sorin Janus stent. The session emphasizes the importance of rigorous research trials and the need for solid clinical evidence before adopting new devices in practice. Key factors like market impact, cost, and handling are also discussed for a comprehensive assessment.

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Evaluating the Use of New Drug-Eluting Stents: Evidence, Safety, and Efficacy

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Presentation Transcript

  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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