Questions on Drug-Eluting Stents

Do you expect drug-eluting stents to increase your cath lab volume? The U.S has shown a 24% increase in cardiovascular procedures from 1996-1999. This is partly due to the baby boomers’ coming into the age for heart disease. The trend-tracking industry projects an additional 16% inpatient growth for the years 2000-2010. Cardiology should and will grow in the years to come. Cardiac volumes projected by Johnson & Johnson show a 6% reduction across a 3-year period (2003-2006) for angioplasties. We believe cardiac volumes will increase across the board, with the possible exception of coronary bypass. Of course, increased demand will also come from the well-informed and educated generation of the boomers. (Factoid: This group generates the greatest proportion of procedures of any age group.) What is your annual cath lab volume for interventional and diagnostic procedures? We expect to do 1000-1050 interventional procedures within this fiscal year, plus 2500 diagnostic procedures. If the FDA approves all lengths and diameters of the (Cordis) Cypher stent, what percentage of your PCI patients will likely to get Cypher (a.) 30 days after approval; (b.) 6 months after approval? Due to the lack of sufficient reimbursement, I hope we can keep it between 25-40%. Cardiology groups appear to be somewhat divided on this issue. I expect the six-month usage rate to be around 60-80%, based solely on customer demand. If the FDA does NOT initially approve every length and diameter for the Cypher stent, what percentage of your PCI patients will likely get Cypher (a.) 30 days after approval; (b.) 6 months after approval? If approval is limited, we will more then likely focus our usage on 2.5-2.75 mm with a length of 19 mm or less. We also are looking at 3.0 mm for length of 25 mm or greater. This population will equate to approximately 20-25% of all cases. The answers to (b) will not change based on this focus group of patients. Do you plan to use Cypher off-label in lengths, diameters or conditions (i.e. in-stent restenosis, bifurcations, etc)? No, we are waiting for the ongoing trials that may or may not prove this to be effective treatment in these areas. We have, with the help of cardiology, set up exclusion criteria as follows: All non-native coronary vessels; Vessels 3.5 mm; Unprotected left main; Angiographic evidence of thrombus; Calcified lesion which cannot be predilated; Pretreatment with devices other than balloon; Allergy to aspirin or clopidogrel. If you plan to use the Cypher stent for selected subgroups of patients, what would they be and how would you select them? We have inclusion criteria set up as follows: 1. De novo native coronary lesions, diameter 2.5-3.5 mm, length 8-18 mm; 2. Multiple lesions/single vessel; 3. ACC/AHA lesion class A, B1, B2, and C lesions. If you don't plan to switch to 100% drug-eluting stents, what bare stents do you expect to use in addition to Cypher? We will be using Boston Scientific, Guidant or Medtronic stents, which have a much lower documented restenosis rate than the Cordis bare metal stent (at 35.4% per the SIRIUS trial). What's the outlook for Guidant’s new Vision stent (when it's approved)? The cobalt-based stents (Medtronic, Guidant and Cordis) appear to be doing extremely well in the clinical trials, with TLR rates from 3.0-6.2%. This new metal allows for thinner struts and increased flexibility, along with increased radial strength, which then allows for smaller cell design while retaining the deliverability needed to complete the job. If Boston Scientific’s paclitaxel-eluting Express stent gets FDA approval, how would you split your usage between it and Cypher? It depends on how Cordis handles being first with a DES. What will they have learned from their introduction of the Palmaz stent? Will pricing be close to that of our European cohorts? Which stent will be delivered most effectively? Until we know what Cordis is doing with pricing, commitments, refunds on non-deliverable attempts, etc., your guess is as good as mine. Scott Fylling can be reached at scott.fylling@bhsnet.org

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