ACC/AHA STEMI Guidelines: Judging Time and
Choosing Reperfusion Methods (08/2005)
DOLPH HUTTER, MD: Hello. I’m Dolph Hutter. Welcome to the American Thank
you both for joining me. This is obviously a very important topic, and people
have to make fast decisions. Sid, what are the guidelines? How do you decide
between fibrinolytic therapy and PCI, and how does
time enter into it? SIDNEY SMITH, MD: Well, I think if we look at the new guidelines, the
really important message is that primary PCI, if it can be performed in the
appropriate environment with the right timing, is the preferred approach for
most patients. This
is based on the Keeley-Grines analysis that came
out in Lancet in 2003 in 23
randomized clinical trials showing favorable outcomes for PTCA versus fibrinolysis. Now,
the new guidelines contain... DOLPH HUTTER, MD: Let me just stop you there. So if you’re in a
center where you’ve got the PCI lab right there, that’s a pretty clear-cut
decision. Is that what you’re saying? SIDNEY SMITH, MD: It’s a clear-cut decision if you have
door-to-balloon times in the range of 90 minutes and if you have experienced
personnel and if you have onsite surgery or you have an established plan to
transfer to onsite surgery. So there are criteria for doing PCI which are
very important. DOLPH HUTTER, MD: Okay. Now, Deepak, do you agree with that? I mean,
that’s at least a subset that’s pretty clear-cut. DEEPAK L. BHATT, MD: Yes. I think this new set of
guidelines, which Sid, of course, was part of writing, are really terrific
inasmuch as it gives lots of practical advice on how to triage patients for lytic versus primary PCI, with some real advice about
time to treatment, which has always been a little bit of a difficult point, I
think, for practitioners to know, when should you pull the trigger, say to
transfer for primary PCI? When should you just go ahead and lyse? So I think this set of guidelines is really helpful
to clinicians in that respect. DOLPH HUTTER, MD: All right. Now, Sid, are you talking about
door-to-balloon time or symptom-to-balloon time? SIDNEY SMITH, MD: Well, the new guidelines are talking about
door-to-balloon time and door-to-needle time. DOLPH HUTTER, MD: Okay, good. That makes it easy, doesn’t it? SIDNEY SMITH, MD: Yes. Although there are people that would argue
that symptoms to balloon would be a little bit better. DOLPH HUTTER, MD: Oh, yes. I understand. But at least we’ve got to go
with what the guidelines say. SIDNEY SMITH, MD: Exactly. DOLPH HUTTER, MD: What are some of the other caveats from these guidelines? SIDNEY SMITH, MD: Well, you know, some of the things that have been
observed, certainly, with thrombolytic therapy,
that the higher risk group that you’re treating, the more likely you are to
see a benefit from PCI. And especially patients in shock, patients in
failure. So in that group of patients, you’re more likely to see a benefit
from PCI. On
the other hand, there are some fairly compelling data to suggest that
patients who arrive within two to three hours, very early on, where your labs
may be full, let’s say you want to do a PCI, but you can’t get them there
promptly for one reason or another, fibrinolysis is
not a bad way to go early on, within two to three hours. DOLPH HUTTER, MD: And of course, that can also be in the community
hospital, where it might take more than 90 minutes to get them to balloon
time, in that setting fibrinolysis might be the way
to go. SIDNEY SMITH, MD: That’s right. DOLPH HUTTER, MD: Deepak, do you agree with that? What kind of a time
setting would you use? DEEPAK L. BHATT, MD: Yes, I would agree with all those
points Sid made. I think especially if shock or near shock-like states are
present, you’ve really got to more strongly consider PCI over lysis. DEEPAK L. BHATT, MD: And when it’s outright shock, I
think that everyone would agree on that. But a lot of times, even if the
patient’s just starting to show some hemodynamic
instability and it’s an anterior MI, I think really that would push me,
assuming that it could be done within an appropriate time frame to go towards
PCI over lysis. The
other sort of issue, beyond just ischemic risk, that is a large territory at
risk, as would be the case with cardiogenic shock,
would also be bleeding risk. That is, if a patient I perceive is at high risk
of intracranial hemorrhage, there again I think is something that would push
me away from lysis but towards primary PCI. DOLPH HUTTER, MD: And Sid, that’s what the guidelines say, also,
isn’t that right? SIDNEY SMITH, MD: That’s right. But, you know, the other area you get
into is this whole emerging area of prehospital fibrinolysis, where you see reduction in treatment delay
up to an hour and reductions in mortality. DOLPH HUTTER, MD: Let me come back to that. I want to stay on the
simple things first, because I’ve got tougher questions for you guys later
on. Your in the community hospital and its more than 2 hours to a PCI
institution. What do you do? [Do you use] thrombolysis
alone and keep the patient there? Do you go with thrombolysis
and transfer the patient in? What do you think? What do the guidelines say? SIDNEY SMITH, MD: Well, you’re at an outlying hospital, and you are
two hours into the infarct and you can give fibrinolysis
in a patient that does not have congestive failure, does not have any
problems, and no contraindication to fibrinolysis.
Then you have to weigh what is the time to ship to your next center? Are they
able to get into the cath lab? If you’re looking at
an hour to transfer and another hour and a half to get in for a PCI, you may
be better off staying there and going ahead with fibrinolysis. DOLPH HUTTER, MD: Yes. Well, that’s exactly the situation I’m trying
to establish. Your at a community hospital, you can’t make that 90-minute
window, you have no complications. You can make a good argument for fibrinolysis alone. Is that fair? DEEPAK L. BHATT, MD: Yes, I think that’s a reasonable
option, though I would still vote to transfer that patient after they got
their lytic so they can do PCI. SIDNEY SMITH, MD: Absolutely. DOLPH HUTTER, MD: Yes. And I think we would all agree with that. You
can never know if the patient’s going to become unstable. SIDNEY SMITH, MD: I would agree with that. I think that Deepak is
exactly right. And when you look at trials, like the DANAMI trial comparing
shipping to giving fibrinolysis, the major
difference in the two groups was the group that got fibrinolysis
stayed at the hospital and did not have an option for reperfusion with PCI. DOLPH HUTTER, MD: Yes. SIDNEY SMITH, MD: So I think that if you were to have shipped those
patients and opened the option for PCI, it might have been a pretty, pretty
close endpoint for the two groups. DOLPH HUTTER, MD: Yes, and you know, I think that’s just a very good
argument conceptually. Why not get them to a place so that if something
occurs, either a recurrent ischemia occurs or infarct extension, you can go
right to the cath lab? SIDNEY SMITH, MD: Right. DOLPH HUTTER, MD: Now, this leads us to another question, what about
facilitated PCI? You know you start fibrinolysis on
the way to the cath lab either in your institution
or another institution. Sid, do you want to comment on that, and then Deepak? SIDNEY SMITH, MD: Well, you’ve got two groups. You have prehospital lysis. That is lysis initiated in the field, and you’ve got CAPTIM,
which shows very favorable outcomes for prehospital
lysis that’s initiated in less than two hours.
Actually, none of the patients going into shock. After two hours, PCI looking
better. So very, very early prehospital lysis in CAPTIM looking pretty good. DOLPH HUTTER, MD: Was that full-dose lysis? SIDNEY SMITH, MD: Yes. DOLPH HUTTER, MD: Okay, all right. SIDNEY SMITH, MD: However, facilitated PCI, which happens to be a
concept that appeals to me, get to them in the field, give a modified dose of
fibrinolysis, got a 2B recommendation in the
guidelines, and interestingly, ASSENT-4 has been stopped early. It was
actually a surprise to me. So I think we have a lot more to learn. DOLPH HUTTER, MD: Stopped early because of what? Why was it stopped
early? SIDNEY SMITH, MD: There was poorer outcomes
in the group undergoing PCI. And Deepak, you may have some information on it.
Were you involved in ASSENT-4? DEEPAK L. BHATT, MD: I wasn’t involved with ASSENT-4,
but interestingly, as you mentioned, Sid, that trial was stopped prematurely.
Actually, I should say the DSMB apparently recommended to the steering
committee to stop it. And it wasn’t just that there was increased bleeding.
In fact, that’s what one might have anticipated, more intracranial hemorrhage
or something like that. But in fact, the so-called facilitated arm, that is
getting lytic and going on to PCI, actually had a
higher rate of ischemic events. So we don’t have the final data, but at least
this is what’s been out there. And that really makes me a little bit nervous
about facilitated PCI, if by facilitation we mean giving some dose of lytic and then routinely proceeding to the
catheterization laboratory for PCI. DOLPH HUTTER, MD: So you’re both expressing caution about using a
partial lytic dose, and then routinely going to
PCI. Is that fair? SIDNEY SMITH, MD: That’s very fair. DOLPH HUTTER, MD: Okay. SIDNEY SMITH, MD: The fascinating thing is,
it’s sort of shades of what we were seeing earlier in the fibrinolytic
area was just balloon angioplasty with a higher complication rate. DOLPH HUTTER, MD: Well, that’s a pretty good negative point. Maybe
that’s not the thing to do at this time. So either start fibrinolysis and get into a hospital where PCI
could be done if indicated, depending on the situation, or send them directly
to a facility for PCI if you can get there within a balloon time of 90
minutes. That’s pretty clear-cut, then? SIDNEY SMITH, MD: Yes. DEEPAK L. BHATT, MD: Yes, I like that algorithm. You
know, lytics, of course, can induce platelet
activation and of course activated platelets and PCI don’t necessarily mix
well. DOLPH HUTTER, MD: That’s right. DEEPAK L. BHATT, MD: So maybe that’s why ASSENT-4 gave
us those surprising results. DOLPH HUTTER, MD: Well, that’s a very good cautionary point about
facilitative PCI. Now what about the sick patient? The patient is three hours
into the infarct, but they have either cardiogenic
shock or hypotension with heart failure. Isn’t the time frame longer for that
patient, to get them in for a PCI? SIDNEY SMITH, MD: Yes. DOLPH HUTTER, MD: In terms of hours? SIDNEY SMITH, MD: Well, I don’t know. I think you still want to get
there as quickly as you can. DOLPH HUTTER, MD: Yes. SIDNEY SMITH, MD: But I think that we really need to look at our
systems of care, because the EMT needs to make a decision about whether or
not to get to an emergency room, or maybe it’s
another 20 minutes to get to a facility where they would have a cath lab and can put a balloon in. DOLPH HUTTER, MD: And of course, that could be made with physician
input by radiophone. DEEPAK L. BHATT, MD: I think so. DOLPH HUTTER, MD: Yes. I guess my point I’m trying to get at, do you
think if it’s six hours in the MI and they’re hemodynamically
unstable, that’s not too late to open the artery, is it? DEEPAK L. BHATT, MD: No. No, I think really there’s a
circumstance where you want to get a patient to a cath
lab as quickly as possible and go ahead and open up the artery. You know,
certainly, the SHOCK data support the value of PCI in patients with cardiogenic shock. I think the problem, really, with a
shock patient is, quite obviously, many times they’re very ill, and that can
sometimes create this sort of reluctance in the system to proceed with PCI,
despite the fact that the data supports that. DOLPH HUTTER, MD: By the way, the SHOCK Trial, what was the time
frame for benefit in the SHOCK trial that was published by Judith Hochman? Was it eighteen hours? SIDNEY SMITH, MD: 36 hours after the onset of symptoms. DEEPAK L. BHATT, MD: Yes. The window is much longer
than, I think, many clinicians appreciate. DOLPH HUTTER, MD: Okay, I guess what we’re saying, if its going to be longer than 90 minutes to PCI and there
are no contraindications to thrombolysis, thrombolysis is the way to go, but if you can get to the
balloon in 90 minutes PCI wins. And clearly, if you’re at an institution with
experienced people in the lab, there PCI definitely wins, Is that a fair
summary? DEEPAK L. BHATT, MD: It is. You know, in fairness, in
real life, that 90 minutes is hard to achieve. That is, lots of hospitals are
shooting for that, but it is a bit easier said than done. A lot of practical
impediments. But I think as these guidelines are more widely promulgated,
it’s a target that we’re all shooting for, shooting to hit and even surpass. SIDNEY SMITH, MD: Hey Dolph, let me just
clear up that the SHOCK recommendations are within 18 hours of the onset of
shock. 36 hours for symptoms. DOLPH HUTTER, MD: Right. 18 hours for shock. That’s the number I was
thinking of, but 36 hours from the onset of symptoms, very important point.
Thank you for clarifying that Sid. SIDNEY SMITH, MD: Okay. DOLPH HUTTER, MD: Okay, guys. That’s very helpful, and particularly
the negative point about facilitated PCI. That’s not quite ready for prime
time use yet. DEEPAK L. BHATT, MD: I guess it also depends on what’s
meant by facilitation. A lot of different people use it differently. For the lytic part, I think we really ought to wait, especially
given ASSENT-4 and the neutral, if not negative, findings there. But there is
an ongoing facilitated PCI trial, FINESSE, that’s a little over halfway
through, and perhaps we’ll have more data regarding what to do in terms of
facilitation with lytic, with IIb/IIIa
inhibitors, which were another part of the potential facilitation strategy.
And the other thing to throw out there, too, in terms of facilitation would
be oral antiplatelet agents. Of course, everyone
will get aspirin, but perhaps higher loading doses of clopidogrel. DOLPH HUTTER, MD: That’s right. And of course, then, you get into clopidogrel and you find out that you need emergency
surgery, that’s a topic for another time. But I think the common thing is
that this scene is changing yearly and we all better stay tuned. SIDNEY SMITH, MD: Absolutely. And I think look for more discussion
about how centers can work together in a system. DOLPH HUTTER, MD: Yes. Good point. DEEPAK L. BHATT, MD: You know, Sid mentioned the DANAMI
study, and it’s really quite remarkable. I had the opportunity to host some
physicians from Denmark a couple of years ago, and they’ve really got an
excellent system of health care in terms of delivering facilitated PCI or
primary PCI, or just care in general to the patient with STEMI. DOLPH HUTTER, MD: Well you both make a good point. You know, develop
those relationships between outside hospitals and PCI hospitals before the
fact so that the machinery is well oiled when the event occurs. SIDNEY SMITH, MD: Yes. The door-to-balloon times in DANAMI were 93
minutes. Similar in PRAGUE-2. So the systems are important. DEEPAK L. BHATT, MD: Of course, those are smaller
countries and, you know, more homogeneous health care systems, but I think
there’s a lot we could learn from them. DOLPH HUTTER, MD: So to briefly summarize, you should consider
primary PCI when door to balloon times are expected to be in the range of 90
minutes; and if you have experienced personnel, onsite surgery, and if you
have an established plan to transfer the patient for PCI. Also, PCI has shown
to provide greater benefit for patients at higher risk, for example, patients
in cardiogenic shock or with heart failure. Fibrinolysis within the 2-3 hour time frame period is a
good option when PCI is expected to be delayed in an institution with PCI or
in a community hospital setting when long transfer times would delay
mechanical perfusion. Pre-hospital fibrinolysis is
being explored and beginning to some benefit. The use of facilitated PCI has
conflicting data about its use. Well gentlemen, thank you very much, this was
an excellent discussion. SIDNEY SMITH, MD: It’s a pleasure. DEEPAK L. BHATT, MD: Yes. Thank you very much, Dolph. DOLPH HUTTER, MD: And thank you for joining us. I’m Dolph Hutter. Related References/Reading: 1. Antman EM, Anbe
DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients
with ST-elevation myocardial infarction; A report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2004 Aug 4;44(3):E1-E211. 2. Keeley EC, Boura
JA, Grines CL. Primary angioplasty versus
intravenous thrombolytic therapy for acute
myocardial infarction: a quantitative review of 23 randomised
trials. Lancet. 2003 Jan
4;361(9351):13-20. 3. Hochman JS, Sleeper LA, Webb JG, et al.
Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We
Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. |