Gregg Stone, MD, on CABG vs Drug-Eluting Stents for Left Main Coronary Disease

In this podcast, Gregg W. Stone, MD, talks about the take-home messages from the EXCEL Clinical Trial, which evaluated the effectiveness of drug-eluting stents vs coronary artery bypass grafting for left main revascularization. He also presented the results at the recent 2021 VEITHsymposium.

Additional Resource:

• EXCEL Clinical Trial (EXCEL). ClinicalTrials.gov. April 7, 2020. Accessed October 20, 2021. ClinicalTrials.gov Identifier NCT01205776. https://clinicaltrials.gov/ct2/show/NCT01205776

Gregg Stone, MD, is the director of academic affairs for the Mount Sinai Heart Health System, a professor of medicine in cardiology, and a professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY.

TRANSCRIPT:

Amanda Balbi: Hello, everyone, and welcome to another installment of Podcasts360—your go-to resource for medical news and clinical updates. I’m your moderator Amanda Balbi with Consultant360. 

Today we’ll be speaking with Gregg Stone, MD, who is the director of academic affairs for the Mount Sinai Heart Health System, a professor of medicine in cardiology, and a professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY.

He will be answering our questions about research that he presented recently at the 2021 VEITH Symposium.

Thank you for joining us today, Dr Stone. To start, can you tell us about the study you presented at VEITH?

Gregg Stone: I'm going to be presenting data that's already been presented, but to help put it in perspective, it'll be the perspectives from the final 5-year results from the EXCEL randomized trial of coronary bypass graft surgery vs percutaneous coronary intervention with drug-eluting stents and patients with unprotected left main coronary artery disease.

Amanda Balbi: What would you say are the clinical takeaway messages from that study and how can health care providers implement those takeaways into clinical practice?

Gregg Stone: Well, in this trial we randomized 1905 patients who had left main disease with visually assessed low or moderate anatomic complexity. These patients also had equipoise as to where the interventional cardiologist thought they could do a good job with PCI, and the cardiac surgeons thought they could safely bypass the patient. And so, they were randomized to 1 of the 2 procedures with contemporary drug-eluting stents specifically the XIENCE everolimus-eluting stent.

And we found that at the end of the 5-year follow-up period, the primary endpoint, which is a composite rate of death, myocardial infarction, or stroke, was not significantly different between the 2 procedures. That's the main take-home from the study, but of course there's a lot of nuanced interpretations that you can make, because not each procedure would apply equally to every single patient in the community with left main coronary disease.

Amanda Balbi: Is there any role for anticoagulation or any oral treatments, instead of the invasive options?

Gregg Stone: These are patients with significant left main disease in whom it's widely believed that survival is much improved with revascularization compared to even best medical therapy, so there's really no role for medical therapy.

Bypass surgery has traditionally been the standard for left main disease, and now PCI with drug-eluting stents has emerged as an alternative in selected patients. So, PCI is certainly an easier procedure to go through. There are fewer peri-procedural complications, including fewer strokes, fewer large myocardial infarctions, less acute kidney injury, etc, and faster discharge, less chest pain from the procedure, and more rapid return to work.

So, the question is, “That's made PCI an attractive option for many patients, but who will get similar long-term outcomes with PCI?” And I think, with many patients with simple and noncomplex coronary disease, PCI is a good alternative.

When disease gets very complex, then patients still fare better with coronary artery bypass graft surgery, so I think each patient needs to have an individualized risk assessment for that particular man or woman's set of circumstances and then the doctors of the heart team—that is, the general cardiologist, the surgeon, and the interventional cardiologist—need to discuss the pros and cons of the particular procedure for that particular patient.

In other words, PCI will usually afford some early benefits, bypass surgery usually has better durable outcomes, so I think that, depending on the complexity of the coronary disease and other risk factors and comorbidities as well as the patient's own preferences for early vs late outcomes, that information can be given to the patient to allow the patient to make their best decision for him or her.

Amanda Balbi: I think it's interesting that you bring up the individualized treatment approach and the multidisciplinary care approach. Those are 2 big things that we noticed that medicine is moving toward in the past couple of years. Can you talk a little bit more about that and the importance of using a multidisciplinary team approach?

Gregg Stone: Right. It's clear that when we do all these big studies, we get outcomes in different populations of patients, but even within the study populations, not all patients are different; some are young, some are old, some are men, some are women, some may have normal left ventricular function, some may have depressed left ventricular function. So, one therapy just doesn't fit all.

In addition, randomized trials often enroll a select patient population compared to the much broader group of patients out in the community. You have to decide whether the results of the randomized trial apply to the individual patient in front of you. Sometimes they may not apply at all. Other times, it'll apply somewhat. Other times, it'll be spot on.

When you look at an outcome, even though EXCEL, for example, was the largest randomized trial of left main PCI vs CABG, clearly, when you look at the outcomes being overall relatively similar, there's no doubt that there were some patients who did better with PCI and some patients who did better with surgery. So, risk scores are developed to try to be able to come up with overall statistical predictions as to who is going to do better with one vs the other.

And then, in addition, very importantly we're trying to make decisions now for patients, but the patient needs to be the center of the heart team. The informed patient, who wants to be involved in the decision-making process for themselves, needs to be able to receive information on the pros and cons of alternative therapies to make their own decision. After all, it is their life, and these are very different procedures. Ultimately, the patient has to decide what is going to work for them.

Amanda Balbi: What would you say is the next step for this research?

Gregg Stone: Well, the next step is that we need to combine the results for all of the completed trials of PCI vs CABG for left main disease. There have been 4 large trials that have randomized such patients and followed them out to at least 5 years.

And when you perform an individual patient data pool that analysis like that you can understand better the temporal outcomes, the differences between the 2 therapies, you have more power to look at subgroups, you have more power to look at low-frequency endpoints.

For example, mortality not any of the 4 completed trials have been powered to be confident whether there's a difference in mortality between the 2 therapies, but when you start aggregating a large number of patients, then you can get better confidence in that outcome. We've completed such a process and will be reporting those data later this year.

Amanda Balbi: Is there anything else that you might want to add?

Gregg Stone: The main issues are that patients, in general, want to live longer and live better. They want longevity, and they want good quality of life. Again, there's a lot of differences between left main PCI and CABG.

We've learned that the overall long-term mortality—when you look at the results of the 4 main drug-eluting stent vs PCI studies, there have been numerous meta analyses performed—there's not a major difference in mortality.

The studies have shown, overall, not statistically significant differences when you aggregate them, and if there is any difference it's very small. So then it really comes down to secondary endpoints. There certainly are fewer strokes after PCI, and there's fewer procedural MIs. There's more long-term myocardial infarctions after PCI compared to surgery, and there's more repeat revascularization after PCI compared to surgery. When you look at overall quality of life, you see that within the first 30 days, the quality of life is better for PCI than surgery, but then between 1 and 5 years, it seems to be very, very similar.

So, for many patients in whom there is equipoise—and that is where the interventionist and the surgeon both feel that they can safely do a good job completely revascularizing all the major myocardial territories—the patient can be told that overall they'll have similar, comparable long-term outcomes, although the path to that journey may be quite different.

For some people, the early benefits may favor PCI. For some patients, they'll say “okay I'll go through more difficult procedure early, but then I want the comfort of knowing that for 4 or 5 or 10 years I may be less likely to have late complications.” All of that needs to be fairly communicated to the patient to let them make their own decision.

Amanda Balbi: Great. Thank you so much for speaking with me today. I really appreciate your time.

Gregg Stone: Great. My pleasure. Thanks so much.