IAGS 2002 Proceedings: Resolving Existing Restenosis (Part II of II)

Hall Whitworth: There is another subset of patients who will be asking for these new drug-coated stents: those with long, diffuse distal disease. We may decide to treat such patients medically, but they too will be clamoring for the new coated stents. It is often difficult to convince patients to accept medical treatment despite the fact that it may be the best option. Extensive patient education and some sort of governing body or organization will be required to provide practitioners guidelines on how best to treat patients. The practitioner would be able to say to some patients, “This therapy has been analyzed and your prognosis is just as good or better with no intervention.” Raoul Bonan: I think we forget how easy and quick direct stenting is. I can go back to some balloon and radiation studies showing that only 4% of 100 patients developed restenosis. Why doesn’t the news cover that? Why don’t we use IVUS and CRUISE and MUSIC? Because they are more complicated and time-consuming compared to the ease and quickness of implanting a stent. That’s the way things evolve. Jorge Belardi: I was asked to discuss “problems” in drug-coated stenting, but let me go in the other direction and be very simplistic. Let’s say we found the right drug or several drugs that seem to work well at the right dose with the right stent and the right delivery system. And let’s say the thrombosis rate is low and assume that we have found 2 or 3 companies making the right drug-delivery stent. I would like to ask, given this hypothetical scenario, in what percentage of cases clinicians think they would use drug-coated stents in their “real-life” practices? Paul LaViolette: First, we need to see the “real-life” results from the studies. Restenosis rates will be very low with drug-eluting stents, but they will not be 0%. The conundrum we all face will perpetuate the socio-economic issue. We will not force that issue by driving the industry to drug-eluting stents only. Stents will be available and this issue will likely rage on for several years before it is fully resolved. As economic pressures increase, research efforts to find alternatives will also increase and the free market will prevail. Will rapamycin delivered orally be tried to offset the drug-eluting properties of stents? Will there be an alternative? Because when there is financial pressure, alternatives emerge. Thus, if the financial pressure becomes unbearable, either industry will cave in, or the innovation process will come up with alternatives that are equally attractive and more economically viable. I don’t think the pressure will be as untenable as we are predicting because that’s just not the way the market works. We have seen several stainless steel stent trials that deliver with IVUS guidance and 10% TLR. There will be a trend toward the “vanilla,” therapies — the tried and true approaches — because drug-eluting stents are not an excuse for sloppy intervention. The cost pressure of drug-eluting stents, which may be seen as a panacea, will force us to look at improving conventional care in a way that will take advantage of or optimize the economics of intervention. The goal here is to expand intervention, theoretically to provide care for more patients — the greatest good for the greatest number. If we consume all of the money treating the existing population to prevent a benign recurrence, it would not be very smart. If we don’t police ourselves, someone outside of the field will do it for us. Raoul Bonan: I think that there will be a shifting of resources because the coated stent does encourage us to tackle patients we are not currently treating — the double-vessel, triple-vessel patients, for example. We haven’t been tackling these patients because we are afraid of restenosis levels. We could look for the easy 30% of that population: the CABG patients who have a good vessel, no total occlusion, but 2, 3, or 4 lesions, and treat them with coated stents because these patients will have a less than 10% chance of restenosis according to the ART study and the new ART registry. The new population of patients from the SIRIUS trial will likely cause a shift in funds from surgery to intervention. Our task is difficult. I have already sent a letter to my institution and government since the release of the European data, advising them to think ahead and transfer funds to this area. Richard Myler: If we think about it, angioplasty makes no sense at all because it creates injury. For the past 25 years, we have expended considerable time, energy, and enthusiasm trying to fix the problem we caused with early angioplasty — excessive wound healing, or restenosis. We were excited about the new devices — and many of them were terribly exciting. On the other hand, some of these expensive new devices didn’t make much sense and have been relegated to a corner, often with the people who developed them! (laughter) I remember when we placed prosthetic valves — some of which, after a while, were only used by the man whose name appeared on the valve. But that’s the way things go. Will we be talking about these drug-coated stents in two years? Will they be better and cheaper? What we are currently doing is intuitive, but we ought to temper our enthusiasm a bit because we won’t necessarily still be using the same devices. It is incredible, however, that 25 years later we are still talking about a balloon. Obviously, the balloon is a very primitive tool, but it is still effective. Tom Linnemeier: I am one of the few people in the room who can look at this issue from both sides. At this stage of my life, I am wearing two professional hats: that of the interventional cardiologist and that of the businessman who’s slugging it out with this guy and that guy. If the data show that drug-eluting stents are indeed extremely effective, I will use them in all of my patients because I am a physician and I want the best possible outcome for every single one of my patients. My guess is that most people in this room feel the same way. I believe that somehow, over time, the marketplace will figure out a way to pay for these stents. When I performed balloon angioplasty in 1979, I wasn’t paid for it; when I performed directional coronary atherectomy, I wasn’t paid for it; when I started placing stents, I wasn’t paid for it; when I began performing radiation therapy, I wasn’t paid for it — but I did these procedures anyway because I believed they were the best available therapies. I suggest that, as physicians — especially within this International Andreas Gruentzig Society — we continue to do what is best for each and every one of our patients. As for the financial aspect to this issue, let the marketplace slug it out, let society figure it out, let capitalism work out a solution — let the system work the way it has always worked and we will continue to make progress in the treatment of cardiovascular disease as we have for the past 25 years. Howard Cohen: I think we all would agree with you, Tom, that we want to do what’s best for our patients. We have all done procedures for which we were not reimbursed, but I also agree with Kirk Garratt that we need to be the thought leaders on this issue and find a way to determine which patients need the drug-coated stents, because I don’t think the insurance companies will reimburse us for placing them in all of our patients. Just think about a busy lab where 20 to 30 cases are performed each day — and you’re talking about placing 1, 2, or 3 drug-coated stents in all of these patients? Imagine what it will do to a hospital’s budget. This type of spending without reimbursement would have an enormous financial impact on our institutions. I just don’t think the insurance companies will pay for these drug-coated stents right from the start. And you can bet that the hospital administrators will be paying a visit to our labs saying: “Hey, you just placed $60,000 worth of stents today alone, and we won’t be getting reimbursed for them.” As a practitioner, you may want to use these stents, but the hospital won’t let you because it won’t be able to pay for them. We must determine which patients need to have drug-coated stents. It would be great if we could afford to use them in every patient, just like it would be great to be able to use ReoPro in everyone, but our budgets don’t allow such spending. Luis de la Fuente: I believe that we are heading in the right direction. In response to Dr. Myler's question about where we will be 2 years from now, I think there will be a new stent and many of the problems we presently face in interventional cardiology will be solved. In Buenos Aires, we decided to go into the “real world” and treat the patients we see every day in our cath labs, not the patients with Gruentzig-like short, concentric lesions. Thus, we began implanting drug-coated stents in patients with acute infarction, in-stent restenosis, and ostial lesions. We were unable to place drug-coated stents in the left main trunk because there wasn’t a large enough stent available. We only had drug delivery stents of 3.0 mm and 3.5 mm of diameter. In two years, I believe we will have a much better stent than what is currently available. I agree when much of what has been discussed today, but if either drug-delivery stents or brachytherapy can solve all our problems — no restenosis and no complications — wouldn’t you use them if you were the patient? Our patients frequently ask us, “Doctor, if you were in my place, what would you do?” We also must recognize that in-stent restenosis is a big problem. Over one million stents were placed worldwide last year. Someone mentioned today that their center uses stents in 80–90% of their patients, a percentage which is about the same as ours in Buenos Aires. The only patients we don't place stents in are those with small vessels or difficult anatomy. Nevertheless, in-stent restenosis, even with the best stents available today, occurs in about 10-20% of patients. As Dr. Myler said, “we cause restenosis”. Angioplasty produces intimal proliferation. We also cause in-stent restenosis. Placing a stent can cause further disease that may be worse than what already existed. The focus on eliminating in-stent restenosis must continue, either with brachytherapy, drug-delivery stents, or some other therapy, but these therapies must be applicable in “real world” practice. Reginald Lowe: We are all concerned about the cost of these stents, but we haven’t discussed the cost savings aspect of the issue. If we don’t have to see the patients back in follow-up, order the $2,000 nuclear test to check for restenosis, perform stress echos, or worry about the manpower problems that we discussed yesterday — it will all be worthwhile and there will be cost savings. I don’t think cost will be the issue; rather, the issues will involve effectiveness, safety, and freedom from complications that we don’t yet anticipate. Paul LaViolette: There is a complete absence of a global budgeting mindset in healthcare today. We need to connect all of the dots between acute intervention, overall progression of disease, after-care, and disease prevention. We are focused on spending money to intervene, and the bad news is that technology will improve and we will be able to intervene more — not only in cardiology, but in other fields as well. More money will be needed, and until we connect the dots with a global budgeting perspective, we will never find a way to pay for this because we aren’t looking for offsetting costs elsewhere. Also, we need to temper our enthusiasm over the speed of innovation in the area of new therapies. Drug device combinations take considerably longer to evolve than stent-only devices. The pace at which the medical device field moves is lightspeed compared to pharmaceuticals. I think that drug-device combinations will be somewhere in-between. It is likely that we will be talking about these same devices a year or two from now and although there will be improvements on the horizon, they will take longer than in the past. If in fact the “real world” results turn out to be 2%, 3%, or 4% restenosis, the complexity, expense, and magnitude of clinical trials to then prove that this next-generation technology is indeed equivalent or superior will exceed the scale of everything we have done to date. The ability to then leap to something better, even if it is substantially more cost-effective, will be extremely difficult because we will have to prove non-inferiority and economic superiority in trials of 3,000–4,000 patients. Howard Cohen: If the cost is small, we can accept that, but if it’s huge, then it will be difficult. Industry must be very careful in terms of what the premium will be for this new technology. Will we be tightly regulated and not be able to use the technology? Or will there be a premium that would allow for 100% use? In other words, if there is some increase in the cost for the use of this technology and we can use it 100% of the time, that would be very valuable. If in the beginning 1 company gets 100% of the business, then so be it because eventually, competition will emerge and prices will come down. If the technology is priced at 3x, 4x, or 5x what we are currently paying, we will have a hard time using the product because insurance companies simply won’t pay for it. If, however, the premium is moderate, then we will be able to apply the device more uniformly, more safely — and everyone will benefit. It will be a win/win situation for patients and industry. On the other hand, if the premium is huge, there may be 100% of a small profit margin and I am sure industry is considering this issue. Jeff Werner: I don’t think we should take ourselves off the hook. Tom Linnemeier said we want to do what is best for our patients and as a result, we are stenting everyone — 2 to 3 stents in multiple vessels. I am not sure that this is the best way to practice. If I recall correctly, the late-loss in the STRESS and BENESTENT trials was 53 for balloon and 75 for stents. In fact, late loss is greater with stenting than it is with balloon. One reason stents are being placed in certain circumstances is because the results look so good and we can get out of the lab quickly. Practitioners have argued that stents have saved people’s lives because we have gotten out of the lab in acute situations and stopped acute closures. But is a 2.5 mm vessel better off with a regular stent in the middle of the circumflex? I doubt it, or at least I’m not sure. It seems to me that we are overdoing it, and it has become a knee-jerk reaction to place stents in every vessel, every site we can. Chris Cates: I have been extensively involved with regulatory policy, cost, and pricing issues. We don’t realize that this truly is a zero-sum game when it comes to pricing or the cost of healthcare in the U.S. Whenever we increase something on one side, something has to fall out on the other side. Although insurers would like to think in terms of long-term continuity of patient care, what happens, quite honestly, is that patients jump between insurers year after year so the cost is absorbed by the first insurer, while the benefit is reaped by the next insurer. Insurers, therefore, are not willing to pay for the up-front costs unless there is a global cost strategy in place to care for the patients — an issue that we in the US have not addressed very effectively yet. We physicians must not abdicate our leadership role or others will end up making decisions based on factors that have nothing to do with medical care.