Questions and Answers (May 16, 2002)

May 16, 2002 Scott McMahon: The first question this evening is as follows: What is your estimate of the aggregate increase or decrease in PCI procedures at one, two and five years following the introduction of drug-eluting stents? William O’Neill: That sounds like a question for an analyst. I will pass that one to Dean. Dean, what do you think will happen in the short- and medium-term with regard to the impact of drug-eluting stents on PCI? Dean Kereiakes: We estimate close to a 10% increase annually for the first three years. Multi-vessel and small-vessel disease have potential as well. As you know, a smaller, simpler trial is planned. Multi-vessel disease and diabetic patients will expand the market for drug-eluting stents. Restenosis will probably not reach zero, as we will hear from various trial results next week, but if restenosis is extremely low, then it will be a very viable option. William O’Neill: We will now see the impact you talked about in terms of the decrease in the number of restenosis interventions. Our cath lab has a 12% rate of restenosis interventions that has remained constant over the last 12 years. Even new stents did not seem to decrease restenosis interventions, so what impact would that have? Dean Kereiakes: According to a JP Morgan analyst, in 2000, almost 18% of all PCI cases treated were for restenosis. The number is thus a little higher — 161,000 procedures to be specific. I think you are generally correct, Bill, about this being a big load of later reimbursable and profitable business. It will be a significant cut out of our current hospital and physician reimbursements. William O’Neill: Steve, you have a very interesting situation at the Ochsner Clinic and I wonder if you could tell us what your people are thinking in terms of an increase in PCI procedures and the effect on bypass surgery rates. Stephen Ramee: I was actually speaking this evening with my administrator who is scared to death of drug-eluting stents, not just because of the impact they will have on bypass surgery — which could be profound — but because of the increased cost of treating multi-vessel and multi-lesion disease patients. Our breakpoint of profitability is approximately $2,500. If we spend more than that on the hardware, then the hospital loses money. Thus, the $3,000 price for a drug-eluting stent at the outset appears to be a money-loser, at least for our institution. We will likely invoke a strategy using drug-eluting stents for single-vessel and single-lesion cases and bare-metal stents for multi-vessel cases, with vascular brachytherapy for restenosis. William O’Neill: That is a very interesting strategy. We must remember that when angioplasty began to take off for the treatment of angina, the slice of the pie that was cut into was the medical treatment arm. There are far fewer patients treated medically now compared to treatment with percutaneous intervention. We will not be getting into that group which is now well revascularized. If angioplasty procedures increase, they will do so at the expense of bypass surgery. This will involve cases of complex multi-lesion, multi-vessel interventions which are going to be incredibly expensive due to the cost of the coated stents. There will be profound implications in terms of decreasing profitable procedures such as bypass and increasing unprofitable procedures such as multi-lesion, multi-stent implants. Coated stents will have some unintended consequences that none of us have fully begun to appreciate yet. Scott McMahon: A question has come in for Dean. Dean’s financial analysis is quite disconcerting, especially if you anticipate that every stent will be a drug-eluting one. Can we define a strategy of restenosis risk stratification that would use bare-metal stents in the low-risk patients, i.e., those with local disease and large vessels, and reserve drug-eluting stents for the higher-risk patients, i.e., diabetics, patients with smaller vessels, and then use vascular brachytherapy for those who do restenose? Dean Kereiakes: First, a limited model can be developed that involves, for example, MLD, stent length and diabetes. An algorithm like that would apply to Steve Ramee’s approach. First, how do we monitor and police that? Secondly, what do you do about patient requests for drug-eluting stents? We do not want to have a confrontation with the patient about whether or not to put one of these stents in! An easier strategy might be to simply not have the technology on the shelf (in the absence of adequate reimbursement). William O’Neill: That is certainly a provocative approach, Dean. As you pointed out, patients and referring physicians will be clamoring for these new stents and it will be interesting to see if that approach works. What we often fail to remember is that restenosis is really not a lethal disease. It’s a nuisance, but it doesn’t really cause acute infarct or sudden death. Subacute thrombosis, on the other hand, can be catastrophic. Treating restenosis is almost always an elective intervention. Restenosis is not a safety issue or a health issue, it’s a nuisance issue and a convenience issue for patients. Dean Kereiakes: To that effect, Bill, is it worth going bankrupt? We can also try to reduce restenosis with better metal stents and vascular brachytherapy. Stephen Ramee: What do you think the chances are of getting reimbursement to adequately cover the implantation of multi-vessel drug-eluting stents? Coronary bypass surgery has a higher reimbursement than angioplasty because of the fixed cost. What do you think our chance is of getting to move the bar up for angioplasty? William O’Neill: Dean, can you answer that one? You talked at some length about the reimbursement issue in your presentation. Perhaps you can also give us an idea of what the time frame would be for a potential coated stent DRG. Dean Kereiakes: The fact that Medicare has assigned an ICD-9 time tracking code at this point, before product approval, is precedent-setting. Even though Medicare is still the minority of our payors, this would be a significant precedent. Once Medicare is on board, then we can have our private payers sign a payment waiver. We have had our legal counsel look at this issue. We may have “private payor” patients pay for uncovered technology if we are not discriminating against Medicare patients. Stephen Ramee: In some ways the multi-vessel patients are much like the surgery patients and I think there should be a move toward reimbursing for multi-vessel procedures like bypass surgery. Certainly with private payors that might be more likely, but even in the Medicare environment, we may be treating multi-vessel disease with drug-eluting stents in the future. William O’Neill: Let’s just consider August and October as the two key time frames. Those dates will come and go before anyone has any of these stents on the market. Scott McMahon: Here is another question from an audience member: Do you foresee a reduction in the use of IIb/IIIa inhibitors with drug-eluting stents? William O’Neill: Greg, why don’t you tackle that question. Greg Braden: I think that the issue with drug-eluting stents really has to do with restenosis. The major impact of IIb/IIIa inhibitors involves acute complications that are more platelet thrombose-mediated, so I really don’t think there will be a trade-off now that we are placing drug-eluting stents. We don’t need IIb/IIIa inhibitors. Also, I think our practice patterns will be relatively unchanged with regard to the use of IIb/IIIa inhibitors. If these agents were previously indicated for bare-metal stents, then they will continue to be indicated for drug-eluting stents. William O’Neill: I think the use of glycoprotein receptor blockers will remain constant. The market for these agents is currently somewhere between 60% and 70% of all coronary interventions in the U.S. At the Paris PCR meeting next week, Bill Matthew will present the 1-month safety results from the DELIVER trial. The 30-day endpoint shows a dramatic safety profile for the device, but interestingly, there was less than a 2% rate of acute myocardial infarction. This largely related back to the 65% IIb/IIIa inhibitor use in patients in the DELIVER trial. I think glycoprotein receptor blockers do nothing but add to the safety of the procedure and I really doubt there will be any decrease in the number of patients treated with them. Scott McMahon: There is a question for all of the panelists: What are your centers’ timetables and plans for the introduction of drug-eluting stents? William O’Neill: That is a terrific question for the panel. Let’s start with the West Coast. Greg, you are out in Seattle at the SCA&I meeting. Why don’t you tell us what your thoughts are? Greg Braden: We will use drug-eluting stents as soon as they are clinically available to our center. We already have a fair number of patients and referring physicians who are requesting them. However, we will make some attempt not to make a wholesale switchover from bare-metal stents to drug-eluting stents. The lesion subsets most likely to benefit from the drug-eluting stents are the diabetic long lesions and smaller vessels. In the case of total occlusions and other subsets that have not yet been studied, we will probably only use drug-eluting stents very selectively. We will try not to use them in larger vessels and shorter lesions and see where the market pressures end up forcing us to use them in those patient subsets. I have a nice slide showing Johnnie Cochran waving his flag and shouting: “Doctor, why didn’t you put this drug-eluting stent in my patient? You did this because you wanted to save money!” Many of are worried about this issue. The wholesale adoption of drug-eluting stents in the first quarter of 2003 would, in my view, be an inappropriate clinical decision and certainly not a very viable economic one either. William O’Neill: It sure sound like “deja vu” to me. I can remember people scaring cardiologists about tPA. Here we go again. Dean, what do you plan to do at your institution? Dean Kereiakes: I don’t think Greg’s argument holds up because when the FDA approves and releases a product, it doesn’t establish it as standard care. I have been over this very carefully with legal counsel. I definitely don’t think it’s an argument. I am not sure we have a medical, legal, or ethical obligation to go bankrupt in order to provide $3,000 stents without reimbursement. That’s the real issue, Bill. As good as cardiologists want to be for their referring physicians, if the hospital goes out of business it will not help any of us. William O’Neill: Let’s hear briefly from Stephen and then I will bring this program to a close. Stephen Ramee: I agree with both of my colleagues and will add that the prudent approach might be to follow the guidelines of the trials and use these stents for the types of patients who were initially included in the trials. We would need to explain to our patients that we don’t know what the efficacy rate is in long-lesion vessel cases. Initially, I think the minority of patients we treat will qualify for the drug-eluting stents because if we follow the trial guidelines, only the simplest lesions will fall within these guidelines. William O’Neill: Fortunately our institution has a terrific group of interventionists who are trying to work with the hospitals to make another program economically viable. I think we will be able to employ the type of strategy Stephen mentioned such as limiting drug-eluting stent placement to patients whose lesions resemble those treated in the clinical trials and perhaps use these stents in some complex multi-vessel cases. We will all have to struggle with how to absorb the additional cost in our practices. I want to thank our terrific panelists for participating in this program. I hope the audience enjoyed this as much as we did. Obviously, this will be enormously important for everyone and I am sure that further updates will be needed as these breakthrough technologies roll out into clinical practice. Thank you all for joining us. Scott McMahon: Thank you, Dr. O’Neill. That completes our webcast. You can review this presentation beginning tomorrow at the Medical Programs website.