New Revascularization Guidelines: Key Points and Controversies

This transcript has been edited for clarity.

Robert A. Harrington, MD: Hi. I'm Bob Harrington from Stanford University, and I'm here in the Medscape booth on the floor of ACC22. It's certainly fantastic to be back at a live face-to-face meeting and not having to watch a Zoom screen all day. We wanted to take the opportunity to chat about some of the really hot topics at ACC22.

I'm really fortunate today to be joined by a colleague, Dr Jacqueline Tamis-Holland, who is a professor of medicine at the Icahn Medical School at Mount Sinai in New York City. For the purposes of this conversation, Dr Tamis-Holland was the vice chair of the recent ACC/AHA revascularization guidelines that came out at the end of December 2021. Those guidelines have updated many previous statements from the ACC and the AHA, and I thought this would be a good time to catch up on some of the key elements around that.

Dr Tamis-Holland, thanks for joining me here.

Jacqueline E. Tamis-Holland, MD: Thank you. I'm so happy to be here.

Harrington: Let's first talk about process. For the people who are unfamiliar with guidelines, let's let them know how these guidelines are constructed, and in particular for this one, because you had to bring together different disciplines to address the surgical issues, percutaneous issues, and medical issues.

Then I have three areas that I want to delve into if we have time. One is around the opening section on health equity. The second would be a real change in how long we're recommending dual-antiplatelet therapy (DAPT) and then what antiplatelet agents we're recommending. The third is some of the areas that have maybe made for some controversy around choices of surgical vs percutaneous intervention. Let's start first with process.

Tamis-Holland: Sure. The ACC and the AHA strive to have a very balanced writing committee. They need to ensure that greater than 50% of them do not have disclosures with industry. They need to ensure that there's a good balance between men and women, and across geographic diversity, as well as race and ethnic diversity.

The writing committee members are assigned different topics and each author writes up their section. Every week, we meet to discuss the section and the recommendations that were created, and we need to agree or if we disagree, make changes. Ultimately, all recommendations are voted on, and everybody has to vote on the recommendations and approve the entire document. With respect to the voting, we ensure that only people without a disclosure can vote. The voting members are those without disclosures.

Harrington: This is a pretty intensive process in terms of the time commitment and experts coming together. Let's talk about the evidence review. What's the process by which new evidence gets reviewed and old evidence gets re-reviewed? How does all that play out?

Tamis-Holland: We really try to focus on the newer evidence in the past 10 years. Obviously, for certain situations, you need to bring in the old evidence so you can balance the two. We generally say 10 years, but the truth of the matter is we really went back for just about everything to many years ago because some of the data — for example, the data on left main disease — stemmed from trials from 40 years ago without newer data, so we had to take stuff beyond 10 years.

Harrington: That's a good example. We're going to talk about the surgical vs percutaneous issues, but those data were from great randomized trials at the time, but they're relatively small and they do not involve contemporary medical therapy. Part of the question, I imagine, is how do you balance that now that we have really aggressive medical therapy?

Tamis-Holland: If you look at those trials, you'll see that there were no antiplatelets and there were obviously no statins back then. Surgical approaches are much more contemporary now; there have been great advances in surgery as well. You have to balance the totality of the data we have, looking at the older trials, which were powered for mortality and outcomes; the newer ones, which are double, triple, even quadruple the number of patients enrolled; and use contemporary strategies for both revascularization as well as for medical therapy. You have to balance it all.

Harrington: That's very helpful as background. Let me try to get into my three areas and then I'll use Chair's prerogative to move to another topic if we still have time. The health equity piece is fantastic. Certainly, as somebody who has been deeply involved with both organizations and served as AHA president, we're very focused on looking at everything we do at the AHA through a health equity lens. This document actually opens up with health equity — wow.

Tamis-Holland: In general, in all of the guideline documents, the new scope is on the patients. It's about a patient with coronary artery disease. How do we take care of them? It's no longer a procedure-based question of how to do the CABG or the PCI. It starts off about the patient.

Then it's about the fact that there really are data to show that patients of different races and ethnicities have a worse prognosis, and it's directly related to the fact that they're also having less aggressive care. We open up the statement saying that there's not really been any trials that show that women respond differently to men overall — maybe in tiny little areas — or that Black patients respond differently to White patients. The most important thing is about giving the patient care based on their disease, who they are, and what they want.

Harrington: It was very nicely laid out where, as you just said, there doesn't seem to be any heterogeneity of effects of these therapies, so let's treat people in a comparable way. Also, as you said, let's make sure we're meeting people where they are and bringing in their personal experiences and what they value and what their preferences are. I thought that was a powerful part of the document.

A corollary to that is the notion of the heart team. This started really with transcatheter aortic valve replacement (TAVR), and now it's moved to other areas of medicine, which I think is fantastic. Did you have many discussions about that?

Tamis-Holland: Yes. Again, in keeping with the idea that it's about the patient. The scope of the document is bringing these disciplines together to give the patient the best care — that subsequent recommendation about the heart team came directly from focusing on the patients. We start with the disparities in care and ensuring that there are no disparities in care. We go on to say it's about the patient and shared decision-making. The third recommendations are about the heart team.

They are all coming together and saying we should get together. It's not about my procedure or your procedure or medical therapy. It's about what does the patient have and incorporating their beliefs, their desires, as well as what we know might be superior. We then go ahead and come to a conclusion for the patient about how best to treat them.

Harrington: Which is the way that medicine should be practiced. It's interesting. It makes me think of the concept of evidence-based medicine, which sometimes is thought of as, "Oh, that's just cookbook medicine," or "Oh, that's just following an algorithm." It's actually not. If you go back and you look at the original writings from David Sackett, he says, just as you did, it's the use of the best quantitative information combined with expertise and judgment, and put in the context of an individual patient's values and preferences. You can't just take the evidence. You have to put it into context for that particular patient.

Tamis-Holland: In general, there's always an art to being a cardiologist. You have to be the artist.

Harrington: That's fantastic. Let's move on to what I'll call some of the technical issues. I've done a large amount of work over the years in antithrombotic therapy, so I read those sections very carefully. In this one, you've made a departure from some of the older perspective of once you're revascularized, particularly with a stent, you get DAPT for 6, 9, 12 months.

Now you're saying that in the stable patient, think about shorter courses of therapy and also think about what we're starting to see emerge from the literature and from the big trials is switching from dual to single antiplatelet therapy, but — oh, here's the other twist — dropping the aspirin. How did those conversations go?

Tamis-Holland: One thing I do want to make clear, because it's important regarding the process, is that if there are recommendations that haven't changed, we actually refer out to the prior documents. When we reviewed the data on DAPT, and particularly, longer durations of DAPT, we remained with the recommendations in the DAPT guidelines that say it's still a class 1 to say, 6 months in stable patients and 12 months in patients with aches after PCI.

However, we added on additional recommendations to say as an alternative or another way in which you can treat your patient, we want to have you consider that you would use a shorter duration of DAPT, followed by P2Y12 monotherapy. I think we were very comfortable in saying that because we're not taking away prior guideline recommendations. We're saying adding on to it; this is another option.

Harrington: The most recent trials, such as TWILIGHT, are starting to raise the question, particularly in an era of very contemporary drug-eluting stents, that maybe you don't need that long period of DAPT and maybe you can get rid of aspirin, which looks like it causes more bleeding problems than the ADP inhibitor.

Tamis-Holland: Exactly. The recommendation specifically focuses around the fact that the benefit of that strategy is reducing bleeding events.

Harrington: Right.

Tamis-Holland: None of the trials were powered to look at ischemic endpoints. Of course, TWILIGHT showed noninferiority, and many of them showed, when you look at the pooled data, that there was no difference in the ischemic events — if anything, a trend toward lower ischemic events. We really focus on the fact that it's reducing bleeding events.

Harrington: It's reducing bleeding, and in particular, that group of patients has been referred to as high bleeding risk or HBR patients, where taking away one of the antiplatelet therapies earlier probably is a wise thing to do. In my own practice, I'm starting to drop the aspirin and continue my patients on ADP inhibitors, which I suspect a lot of us are going to continue to do. To me, that was an interesting phenomenon that came out of the triple therapy data — that you can start to drop the aspirin, have just the ADP inhibitor, and you get great results.

Tamis-Holland: For sure. If you noticed in the recommendations, it's 1-4 weeks. We're not necessarily saying drop it after the PCI. I think that's because there is a suggestion that — again, none of these trials were powered to look at stent thrombosis — the AUGUSTUS data do show that there is a doubling of the stent thrombosis rate when you drop the aspirin, although not statistically significant. Therefore, when you look at the stent thrombosis rates, they really occur in the first 30 days. Perhaps consider your ischemic risk vs your bleeding risk and decide on the duration of aspirin, but certainly no more than 4 weeks.

Harrington: It gets back to your earlier comment about how you take the data and you put it into the individual context of that patient. You have to look at things like what was the extent of anatomy that was intervened upon. Did they have bifurcation disease? Are there long stents? Did they have diabetes or left main disease? All of this has to enter in. It's not just a one size fits all. The guidelines really read that way, which I think is fabulous.

The last topic I want to get into is the one that's maybe generated a little bit of controversy. Certainly here on Medscape, there's been much written about it and talked about, which was the choice to downgrade the surgical recommendation for complex multivessel disease from a class 1 to a class 2B, and also to say with PCI a survival benefit is uncertain very clearly.

You did a couple of things. You looked at the older data, you looked at the newer data, and then you even pulled in — in full disclosure, I was one of the ISCHEMIA executive committee members — the ISCHEMIA data, which was not a revascularization trial but was more of a strategy trial. How did those discussions go?

Tamis-Holland: It's very difficult to come to the right decision about these sort of things. As we said before, we were looking at older data that were powered for mortality, but the medical therapy arm was not contemporary medical therapy, and we were looking at newer data. I think it's important to recognize that it wasn't just the ISCHEMIA data. There have been newer ISCHEMIA data since we published the guidelines on the relative benefit of invasive strategy in those patients who had really severe disease, so this cohort of patients, and there's no difference in death in that group. There is a lower rate of cardiovascular death or MI in the group of patients who had severe disease.

When you look at the pooled data of all of the trials, there's a lower rate of cardiovascular death with revascularization compared to medical therapy, but there's not necessarily a lower rate of total mortality. I think that our biggest problem in the guidelines overall, and even in the European guidelines, is we focus on either symptom relief or mortality, but sometimes it's not about those two things.

A patient wants to know whether they're going to have another heart attack or have to have another revascularization, etc. When you look at the reduction in cardiovascular events, we see that in patients with multivessel disease, the data suggest that there's a benefit to revascularization to reduce cardiovascular events. Although we downgraded the recommendation for an improvement in mortality because the totality of evidence doesn't support it, we actually provided a new recommendation to say you should consider or it may be reasonable to do revascularization with the intent of reducing cardiovascular events in patients with multivessel disease.

Harrington: Yeah, I'm glad you brought that up because that specific area has been neglected. The focus has been on, "Well, why did this happen in my procedure or why did this happen to my procedure?" What we really said is, "Look, revascularization should be considered in this group of patients. It does seem to offer a benefit, but let's just be careful that we are quantifying and qualifying which benefits it's offering." Again, pointing out that the guidelines have to be put into the context of that individual patient, who they are, what their demographic factors are, what their angiographic factors are, and what they care about and what they're trying to achieve.

One of the one of the biggest lessons for me from ISCHEMIA is that you've got some time to think about these things. You can really engage in shared decision-making, saying, "Look, we don't think there's going to be a benefit overall of an aggressive revascularization strategy in many people, but if you're having a lot of symptoms, well, yeah, it does look like it offers some benefit. If you don't want to take all of these medicines, it might offer some symptom relief."

I think it gives us a chance, to put it bluntly, to do a bit more doctoring.

Tamis-Holland: Yes.

Harrington: On the backdrop of data.

Tamis-Holland: Absolutely. There was a great article in The New England Journal of Medicine right around the COVID-19 pandemic of a physician who had a patient with severe ischemia, just like the ISCHEMIA trial, and she waited because the patient couldn't get intervention, and she was very comfortable knowing that the patient was going to do well.

Harrington: Yes, because the ISCHEMIA data had suggested that was the case. This has been a terrific conversation. Thank you for sharing both your time and your expertise, and certainly, thank you, from an AHA perspective, on donating a substantial amount of your professional time to produce such a helpful document.

Thank you for listening. This has been Bob Harrington from Stanford and Dr Jacqueline Tamis-Holland from Mount Sinai, talking about the revascularization guidelines. Thanks for listening.

Robert A. Harrington, MD, is chair of medicine at Stanford University and former president of the American Heart Association. (The opinions expressed here are his and not those of the American Heart Association.) He cares deeply about the generation of evidence to guide clinical practice. He's also an over-the-top Boston Red Sox fan.

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