Transcript What is 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
• Research grants or paid role as trial PI
• Cordis, Boston Scientific, Medtronic, Biocompat
• Share holding or other financial interest
• None
What is a New DES ?
• Established DES
• Cypher Taxus
• Characterised DES
• Endeavour
• Emerging DES
• eg Co-Star Xience
• Developmental DES
• Pseudo DES
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 …..
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
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
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 ?
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
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
Questions and Discussion