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Interview with Gregg W. Stone MD
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The following interview was conducted with Gregg W. Stone, MD, Director of Cardiovascular Research and Education, New York-Presbyterian Hospital / Columbia University Medical Center. Dr. Stone is one of the world's leading interventional cardiologists and was principal investigator for the TAXUS IV drug-eluting stent clinical trial.

Dr. Stone is also Vice Chairman of the Cardiovascular Research Foundation ( which sponsors the annual TCT meeting, the largest interventional cardiology symposium in the world.



Q: Drug eluting stents have been called “revolutionary”. Would you characterize these new devices this way?
Dr. Stone: Drug eluting stents are a true revolution in the way we are taking care of patients with coronary artery disease because they, one, obviously reduce the risk of restenosis, both angiographic and clinical, in the patient by approximately 75% compared to a bare metal stent. Therefore it’s much more likely that patients will be symptom-free for an extended period of time after stent implantation, not require repeat procedures, will have a better quality of life and will ultimately avoid the need for bypass surgery. Number two, it’s a true revolution because it’s allowing us to treat more complex patients than we would otherwise in cases previously where we were sure restenosis would occur. So now we’re able to treat much more complex types of patients and those patients are also able to avoid the need for bypass surgery.

Q: What kind of patients do you mean by “more complex"?
Dr. Stone: Well, they’re more complex in that they’re, one, higher risk, such as patients with advanced diabetes, and they’re more complex in that the amount of atherosclerosis, or the amount of plaque in the coronary arteries that we’re treating, is more extensive. So the patients have more lesions, more blockages. They’ve got a greater number of arteries involved than the three main coronary arteries. In the past we might have treated one or two lesions in one artery. Now we may treat three or four. Or sometimes five or six lesions in two or three arteries. And be much more confident that we’re going to be able to get a durable result. In addition, we tend to be treating more complex lesions, such as bifurcation lesions, left main stenoses, types of lesions that before had a very high risk of restenosis that made us less likely to want to treat them.

Q: How were these types of patients treated previously?
Dr. Stone: They would be treated either with stenting with bare metal stents and with a much higher risk of restenosis or by referral in most cases to bypass surgery.

Q: So with these new devices, do you see the bypass surgery option probably shrinking even more than it has?
Dr. Stone: Yes. It certainly is a very important, and remains an important viable option for patients with extremely extensive coronary artery disease, or those who continue to restenose after drug-eluting stents, although that’s becoming less and less common. However I think for general referral, most patients now, we think well over 90% with coronary artery disease can be managed with angioplasty and implantation of a stent like the Taxus stent.

Q: Is there any reason not to use a drug-eluting stent, if you are going to stent a patient?
Dr. Stone: We certainly have proven the safety of drug-eluting stents, and their efficacy in certain types of lesions that have been studied in the randomized trials, and there’s two such stents that have proven to be very efficacious and very safe in these, what I would call, moderately complex lesions, and that’s the Cypher stent which elutes a drug called sirolimus, made by Cordis, and there’s the Boston Scientific Taxus stent, which elutes a drug called paclitaxel. There are many types of lesions though that have not yet been adequately studied with these stents, such as lesions with thrombus or blood clot, acute heart attack or myocardial infarction, bifurcation or left main lesions, saphenous vein graft, in-stent restenosis – so for those types of lesions, it’s hard to recommend drug-eluting stents because we still don’t know that they’re entirely safe or effective. Our anticipation is that they will be proven such in those types of lesions, but those studies are just under way and may take another couple years before we have all the answers.

Q: Angioplasty is the recommended therapy for people presenting with acute MI in emergency rooms. What would happen to a patient like that?
Dr. Stone: Right now the recommended treatment for most of those patients is to put a bare metal stent in. We just don’t have the data yet to know that it’s safe to put a drug-eluting stent in.

Q: In your practice, what percentage of balloon angioplasty cases wind up with stents, and what percentage of stents do you see being drug-eluting stents?
Dr. Stone: In our practice I would say approximately 99% of all cases are getting stents, as opposed to just balloon angioplasty alone. The outcomes clearly are better with bare metal stents compared to balloon angioplasty for most patients and lesions, [if we have] an appropriate size stent. We are kind of atypical at Lenox Hill Hospital. We’re probably implanting drug-eluting stents in more than 95% of lesions in which we’re putting stents. But we’re doing that under a very carefully controlled research setting to collect the outcomes data in those patients. I would say that most hospitals are probably more approximately 65%, although it probably ranges anywhere from still 40% to again we are probably the upper end with 95% or more.

Q: What are the top issues that patients who may be getting an intervention should be concerned about and questions that they may want to ask their physician?
Dr. Stone: I think that for patients, they need to be informed completely about the risks and benefits about drug-eluting stents -- one, in general, and two, for their particular situation. So if, for example, a patient has the type of lesion that drug-eluting stents have been proven safe and effective for, then one, regardless of the cost, they should insist on getting a drug-eluting stent for those types of lesions. Now, on the flip side of things, they also should want to know whether the kind of blockages they have are the type that haven’t been proven yet safe or effective for drug-eluting stents. And for those types of lesions, depending on the risk-benefit ratio, and that’s a discussion that would be very individualized, that the patient would have to have with the doctor. In that case the patient may decide that he or she either should or should not desire a drug-eluting stent. So it’s not a black-and-white issue, and the patient also needs to be informed about the risk and benefits still of surgery as an alternative, and of medical therapy as an alternative. The patient should be informed of what is known about the safety and efficacy of drug-eluting stents, for his or her particular clinical and anatomic situation and what isn’t known about drug-eluting stents for that situation.

Q: When there were negative headlines back in October 2003 about thrombosis with the Cypher stent, worried patients were calling their doctors and hospitals. What do you think is the role of patient education in these situations?
Dr. Stone: I think patient education is tremendously important. An informed patient is a patient who not only understands what is being done to him or her, but is one who can and should participate in the decision-making process. I mean not everything we do as physicians is cut and dried. There are risks and benefits in many of the decisions we make and I think most physicians relish the opportunity to have an informed patient participate in that decision-making process.

Regarding stent thrombosis in particular, I think that whole issue was raised because of the rate that events were occurring were deemed initially to be excessive, but then when cooler heads prevailed, and actually scientifically tried to collect the data and numbers to see whether or not they were similar to what was occurring before the introduction of drug-eluting stents, we did in fact find that the rates were very similar to the bare metal stent thrombosis experience. Stent thrombosis has been with us since the initial days of balloon angioplasty, let alone the initial days of stenting, and in fact in the past it was much higher than it is now, either with bare metal stents or drug-eluting stents. And it seems that people kind of forgot that fact when they were getting so upset. People do die from stent thrombosis. [Stent thrombosis] occurs in about 1% of patients and approximately 10-20% of those may actually die. So coronary artery disease is a dangerous condition that develops in most people over a 50 or 60 year period, and even with our advanced interventional cardiology techniques today, there are still risks of all the procedures we do. And patients need to understand the risks and the benefits. In general the risks are significantly less than if the patient does nothing, and goes along, given the natural history of coronary artery disease in terms of plaques progressing to develop a total occlusion which results in either myocardial infarction or death. And, of course, we know for a long time now that stenting compared to medical therapy alone significantly improves quality of life in terms of reducing angina, reducing hospitalization, improving exercise tolerance, etc.

Q: There have been reports of allergies with stents. Is this a major problem?
Dr. Stone: I think that it’s exceedingly difficult to sort out an allergy to a drug-eluting stent given that these patients are on multiple medications, all of which I think are much more likely to cause hypersensitivity and allergic reactions than the small amounts of the drug on the stents. Now that being said and done, it probably does rarely occur, but again it’s very difficult to sort out, but it’s not a problem that I would tell patients to worry about.

Q: There currently are two drug-eluting stents available on the United States. How does a cardiologist go about choosing which one to use? Patients often come in, having read newspaper articles, asking for a specific product.
Dr. Stone: We often have that experience and it’s a combination of factors that will go into the decision. There are going to be two excellent drug-eluting stents on the market, again the Cordis Cypher stent and the Boston Scientific Taxus stent. There are some potential differences in those products in terms of the way, for example, diabetics behave. Preliminary data suggest that diabetics may have a more favorable long term response with the Taxus stent, for example. There may also be differences in terms of flexibility, and deliverability of these stents. A drug-eluting stent can only work if you can actually get it to the lesion site. And for most patients we can get both stents to either area, but for very complex patients, the newer Taxus stent is a more flexible and deliverable stent, and so that may be preferable. And so again I think that both stents are excellent, both stents are markedly better than any bare metal stent that’s on the market, for the types of lesions that they’ve been studied for and approved for, and the exact decision between one versus the other, is probably less critical than the decision to use a drug-eluting stent. The physician and the patient, you know, should discuss in detail for her particular case, which of the two stents would be more appropriate.

Q: What are patients’ responsibilities after the procedure?
Dr. Stone: I think patients have a very important responsibility. Number one, they’ve got to be compliant with the medications that are prescribed for them. And, it’s aspirin for life; a drug called thienopyridine, most commonly Plavix, or the generic name is clopidogrel, which is very important to take for at least 3 months with the Cypher stent, for at least 6 months with the Taxus stent, although we’re in general prescribing that medication for at least a year in all our patients, based on other studies that suggest they have favorable effects, not stent-related, in terms of reducing death and myocardial infarction. It’s possible that future studies will show that this medication should be used long-term, for the life of the patient, but we don’t know that yet. So we think somewhere between 6 months and a year is appropriate.

In addition patients will be put on other medications and asked to undergo lifestyle changes to significantly reduce their cardiac risk factors for future events. And that’s critically important that patients are very compliant with all efforts to get their cholesterol, especially their LDL level, as low as possible, to quit smoking, to lose weight to obtain more of an ideal body weight, to exercise appropriately, control diabetes and high blood pressure to the extent possible, and all of these makes a difference in the long term progression of coronary artery disease.

Q: In other words, coming into the cath lab is not just going to "fix it".
Dr. Stone: Coronary artery disease is a process that develops in the teens in most people and it’s a life-long illness. I kind of make the analogy that it’s similar to when rust develops on a vintage automobile. You can treat one area of rust that develops, and then you’ve got to worry about two things: one, will the rust recur in the place where you treated it, and two, will rust develop in other places on the body. And once you get a vintage automobile it tends to be prone to rust and so you’ve got to take excellent care of it or else that problem’s going to continue. And the human body, especially atherosclerosis and coronary artery disease is no different. This is a life-long illness, and both angioplasty and bypass surgery are only palliative. They only address the problem in a focal area, potentially for a short period of time.

Q: Sometimes when patients get the diagnosis they just think I’m sick and I’m going to stay sick. And while some of the risk factors are not modifiable, some are. Do you think these new advances can give patients hope?
Dr. Stone: Absolutely. I think there are a whole series of avenues in which there’ll be advances, and certainly genetics is going to play a central role in identifying patients at risk. We may be able to identify which type of patient is going to respond best to certain types of therapy, and that will be from genetic profiling. There’s going to be two stents for probably the next several years; there are several other drug-eluting stents that are undergoing clinical investigation and there will be iterations and improvements in the existing and future ones. We’ll have new better-performing stents, we’ll have multiple drug combinations on these stents, we’ll have stents that are safer, that resist thrombosis, so the future is very bright.

This interview was conducted by Burt Cohen of Angioplasty.Org on February 10, 2004.