Drugs Work as Well as Angioplasty, Study Says
[Sorry, the video for this story has expired, but you can still read the transcript below. ]
JIM LEHRER: Now, the growing debate over the use of stents. More than one million Americans a year get a stent — or a tiny metal scaffold — implanted in a clogged artery in a process known as angioplasty.
But a new study of more than 2,000 patients found that, in non-emergency situations, treatment with stents and drugs was no better than simply using medications alone to prevent heart attacks and death. The study has been stirring up much discussion at the annual meeting of the American College of Cardiology in New Orleans.
Dr. Steven Nissen is the outgoing president of that organization.
Dr. Bonnie Weiner is the president-elect of the Society for Cardiovascular Angiography and Interventions.
Did I say that right, Dr. Weiner, angiography?
DR. BONNIE WEINER, Society for Cardiovascular Angiography and Interventions: Angiography.
JIM LEHRER: Angiography. Well, I was close. All right.
Dr. Nissen, starting with you, is the simple message of this study that there are too many stents being used?
DR. STEVEN NISSEN, American College of Cardiology: I wouldn’t characterize it that way. I think what we learned is some very important lessons about what to expect from stenting and what not to expect.
We know that stents do, in fact, help to relieve chest pain, but they really do not prolong life or reduce the risk of a heart attack in patients that are otherwise stable.
What was really surprising about the study is that both the medically treated patients — those that got drugs and lifestyle counseling — had a major reduction in the amount of chest pain they had. And that was almost the same between the group that got the stents and the group that got medicines alone.
This enables us to start with medicines and reserve stents for those people who need them the most.
JIM LEHRER: Dr. Weiner, do you see it the same way?
DR. BONNIE WEINER: I don’t, actually. These are very stable patients and really don’t represent the majority of patients we treat. And despite that, they clearly had a benefit, in terms of reduction in chest pain and quality of life.
And a third of the patients who actually were treated with medicines initially wound up having angioplasty or stents or bypass surgery over the course of the follow-up period.
JIM LEHRER: What about the connection, Dr. Weiner, between stents, medicine, whichever? Usually they’re both, right? It’s not either/or? Am I correct, first of all?
DR. BONNIE WEINER: That’s correct. Medicines really are the underpinning of everything we do, so that it’s definitely not a competition between medicines and angioplasty.
JIM LEHRER: All right. The use of stents and/or medicine, what is the connection, provable thus far, between preventing heart attacks and particularly those that cause death?
DR. BONNIE WEINER: Well, we’ve never said that angioplasty was designed to reduce death or reduce the incidence of heart attacks, in this particular group of patients, who are quite stable. So this really doesn’t come as a surprise to us.
The participants in the study
JIM LEHRER: Now, Dr. Nissen, Dr. Weiner has used this term, "stable." Now, a stable patient -- define a stable patient. Who were these 2,000 people that were part of this study?
DR. STEVEN NISSEN: Yes, stable angina, stable chest pain, are people that have pretty predictable pain. It's usually with exertion. The same amount of exertion will bring on the pain, you know, from day to day.
You have patients that say, when they walk up that ninth green of the golf course, they get a squeezing in the chest. If they stop and/or take a nitroglycerin pill underneath the tongue, it goes promptly away.
Unstable pain is pain occurring at rest, increasing in frequency or increasing in duration. And I agree with Dr. Weiner that those people, in fact, do need to have emergency procedures, usually a stent, because they are having an impending heart attack.
And we know that, in fact, the sooner we get those procedures done, the better. Here we're talking about people that have chronic, stable pain of a pattern that isn't changing.
JIM LEHRER: And it's not leading to a heart attack?
DR. STEVEN NISSEN: Well, it turns out, of course, that these people do sometimes have heart attacks. There's an important understanding here that I perhaps think your viewers will be helped by.
The tightest narrowing in the artery may cause chest pain, but heart attacks are caused because there are many plaques elsewhere in the artery. And if one of those other plaques ruptures, a blood clot forms, shuts down blood flow, and causes a heart attack.
You don't prevent that by putting a stent in the tightest area. In fact, only about one out of every seven heart attacks occurs at the site of a tight blockage in the coronary arteries.
Stents still serve a purpose
JIM LEHRER: But, Dr. Weiner, you would agree, though, that in this unstable group, people who are apparently about to have a heart attack or on the verge of having one, doing an angioplasty procedure and putting a stent in is a logical and legitimate use, right, of a stent?
DR. BONNIE WEINER: Absolutely. And I certainly would not want patients to have the sense that they shouldn't go to the hospital when they're having this unstable pattern of pain or chest discomfort, because it is critical that we get to them as quickly as possible, in order to prevent them from having serious heart damage.
JIM LEHRER: And there's nothing in this study that changes any of that, correct?
DR. BONNIE WEINER: That's absolutely correct. And what I think is also important to note is that one of the things that angioplasty does do in these stable patients is it allows them to walk up to the ninth green without having to take a nitroglycerin.
JIM LEHRER: So it's more about discomfort than it is about preventing a serious malady of some kind, is that correct to say?
DR. BONNIE WEINER: In these patients, that's absolutely correct. It really is about reducing their symptoms and improving their quality of life.
JIM LEHRER: Do you agree, Dr. Nissen, it's more about quality of life than it is about long-term health?
DR. STEVEN NISSEN: Well, I think that what we're really talking about is, we all agree that the study shows no benefit on the rate of heart attack or the risk of death. And that's obviously disappointing, because whenever you do a therapy, particularly one that's relatively expensive, you'd like that to translate into a very important health outcome benefit.
What was also, I think, disappointing on the stent side of the study is that only a few percentage points more patients that got a stent were free of chest pain at the end of one, three, or five years, compared to those that got medicines alone.
For example, 66 percent of patients that got a stent had no more pain after one year, but 58 percent of those that got medicines alone had no pain after one year. So it's only an 8 percentage point difference. And that's a lot of procedures to do.
So that's why I said at the outset, we ought to try medical therapy first. If it works and the pain goes away, everything is fine. Patients are not being put at risk of having a heart attack or dying by trying medicines first. And then, if they need a stent, you can always do a stent.
JIM LEHRER: Dr. Weiner, is there anything he just said that you disagree with?
DR. BONNIE WEINER: In principle, no, but I think it's important to understand that these patients who are on five or more medicines, at fairly high doses for some of those medicines, and the realities are that many patients don't tolerate those drugs at those doses over the long period of time.
Patients within a trial like this, because of the kind of attention they get as part of the trial, frequently do much better with compliance with medicines than they do when we're treating them in our offices.
So many patients would prefer to have something that's going to take care of their symptoms that, in fact, will do that effectively and reduce the amount of medications they're taking, which was, in fact, shown in the course of this trial. And some patients, having undergone angioplasty, were taking less medicines.
The pros and cons of each
JIM LEHRER: I see. OK, now, first to you, Dr. Nissen, and then back to Dr. Weiner, on a bottom-line question, is, what difference does it make? I mean, it's a practical thing. If somebody decides to just do the medicine or take a stent, what difference does it make? What are the pros and cons?
DR. STEVEN NISSEN: Well, first of all, I think you got this right. It's all about patient choice. What we now know after this study is that patients can make their own mind up. If they don't want to have a procedure, they can give medicines a try. If they're doing well on medicines and tolerating it and their pain goes away, then they haven't had to undergo a procedure.
JIM LEHRER: But what's the down side to the stent? Is there a risk factor? Is it a monetary problem? What is the risk?
DR. STEVEN NISSEN: Well, there are issues here. And recently some risks have emerged about late clotting events with stents. I know there's been a lot of discussion about that.
You know, you never want to do a procedure in medicine to a patient. You know, no procedure should be done to somebody who doesn't need it. And it is a costly procedure, and there are risks associated with it.
Now, fortunately, in the modern era, the risks of angioplasty are very small, but we certainly wouldn't want to do unnecessary procedures.
So, from the point of view of the profession, we want to treat those patients that we can treat with medicines first. And if we can't treat them with medicines, we can still do a stent and they can get the benefits.
But we should also realize that those benefits are quite modest. Only a few percentage points more patients are going to actually be free of pain with a stent than with medical therapy.
JIM LEHRER: Dr. Weiner, how would you balance these things out, in terms of the pros and the cons of using a stent versus not using a stent?
DR. BONNIE WEINER: Yes, again, I think the question is about patient choice, but clearly it's a question of what the expectations are. An 80-year-old patient who may not have as much activity and choose to live a different lifestyle than a 40-year-old is likely to make a very different choice, in terms of medicines versus a procedure.
Everything we do in medicine is designed to treat symptoms, for the most part. There are some things that we do that are curative, but at least in heart disease virtually all of them are related to treating symptoms.
And it's important that we keep that in mind and work with the patients to determine what's the best decision for them.
JIM LEHRER: But you agree that any time there's any kind of procedure -- and an angioplasty obviously is a procedure -- there is some risk involved, more so than there would be if you used only medicine, correct?
DR. BONNIE WEINER: Well, I think you need to understand that not all medicines are without risks, either...
JIM LEHRER: Sure, OK.
DR. BONNIE WEINER: ... that medicines are not totally benign. Patients have side effects to medicine. Some of the medicines we're talking about, although important and critical to the care of our patients, cause liver disease. Some cause renal disease. So none of this is without risk. And I don't think you can assume that medical therapy is without risk, as well.
JIM LEHRER: What about the cost differences?
DR. BONNIE WEINER: You know, these are not inexpensive medicines. I don't think we know of all of the cost information related to this particular population of patients and what those benefits are, but neither are inexpensive.
JIM LEHRER: OK. But both of you are saying there's a choice to be made and everybody should be very careful and make their own choice, is that right, Dr. Nissen?
DR. STEVEN NISSEN: Well, let me just say that it's important to understand that both of these groups got medicines, and very aggressive medicines, so it's not medicines versus surgery. It's medicines for everybody and angioplasty in others.
I think there is perhaps one other point that needs to be made that's very important, and that is that bypass surgery has been shown in certain individuals to reduce the risk of death.
And I think, as a result of this study, there's going to be a lot more discussion that people with several blockages in the coronaries might be better off having a bypass rather than having two or three stents put in their coronaries.
JIM LEHRER: Now that's a whole other subject, but thank you both very much.
DR. STEVEN NISSEN: Thank you.
JIM LEHRER: Thank you.