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Revascularization Guidelines Series
Panel Discussion Part 2
Panel Discussion Part 2
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Video Transcription
Thanks so much, Mario. I would like, we have a few minutes left. I would like Dr. O'Reilly to lead the discussion. Oh, well, thanks very much, Mauricio. I'll ask you, you know, you described the diabetic patient and it's the coronary angiogram of smaller vessels, more diffuse and more difficult disease, but maybe not all diabetic patients have that type of anatomy. Do you think that diabetes is too broad a brush? Should we, you know, are all diabetics created equal, if you will, as we kind of use that? If we just had someone who happened to be diabetic, but had a vocal proximal lesion, you know, how much, how does that factor into your decision for re-vascularization? So, so a point well taken. I think that we need to keep in the back of our minds that we're taking care of diabetic patients and like it or not, they have all these mechanisms of disease that make, that brings complexities to pertinent treatment. But, but keeping in mind your question, I think that if I see a type A lesion in a vessel that is more than three millimeters or more than 2.5 millimeters in a branch or more than three millimeters in a main, in a major coronary vessel, I think I would probably go ahead and stent it. Even though the patient is well controlled, if I see those vessels in a diabetic requiring insulin that are like threads, then maybe the surgeon won't even want to touch those patients. So as a point well taken, we have to keep the, you know, the general rules, you know, we have agitated discussions during the, during the guidelines with Mario. So I would like to see what Mario has to say from the surgical standpoint, because we, we were always fighting in this, in this, in this guidance committee meetings. Well, thank you Maurizio, but they were friendly fights. So I think, I think, you know, the guidelines are for the average patient and there are always exceptions. They, they provide general guidance, but then clearly in a case by case situation, there is a room for exception. Diabetes for sure come also at the price of end organ dysfunction and, and also diffuse atherosclerosis that can lead to like a situation of a hostile or unclampable ascending aorta. There is no doubt that smaller vessels are bad, not only for you guys that do PCI, but also for us as a surgeon. So, I mean, I, I clearly stand by our recommendation that CABGES prefer the, the preferred revascularization strategy in patients with diabetes, but I also totally accepted that there are exceptions and it is a case by case evaluation. And I think that when you look at the recommendation, you know, it's really geared towards people with that severe triple vessel disease. It, you know, the recommendation stands as multi-vessel, but if you look at the FREEDOM trial, I think close to 90% had triple vessel and close to 90% had LAD involvement. So it's either people with LAD involvement and double vessel disease or people with triple vessel disease, as opposed to sort of like, you know, sort of more distal disease or non-LAD involvement. So we have a few minutes, I'm sorry that, but there is a very, very controversial topic that was addressed by, by, by Sripal in his, in his, in his lecture. And it's been, we have been heavily criticized by some surgical, by some surgical colleagues that were not part of the guidelines. And there has been a fracture also, along we have, so, you know, that's kind of the elephant in the room with these guidelines. So I would like, what do you think, Jackie, and would you want to direct the discussion in that regard? Yeah, you know, I think that it's, it's a very difficult thing, but I think that, you know, if you go by the letter of the law, there, the data just doesn't show a mortality benefit. But I guess my question is, why do we always have to focus on mortality as an endpoint? It's a little bit more objective and that's why guidelines use it. And that's traditionally why our guideline used it because it was the mortality endpoint. But for the same reason, we do see a benefit to revascularization and reducing other cardiovascular events. And that's why we came up with a two-way for revascularization to reduce more other events, because it's not all just about mortality. And I think, you know, Sripal shows some really great data about the studies that were done in the days of guideline-directed medical therapy versus the ones that were done without the guideline-directed medical therapy and the benefit of surgery over medical therapy were in the studies when there was no guideline-directed medical therapy. Any comments from our surgical colleagues? I want to add, however, and I mean, I agree with everything Jacqueline has said, and I think that when we wrote the guideline, the evidence was just not there to support the survival benefit. I was surprised by this strong reaction and the focus of people, mostly surgeons, on the mortality outcome because, I mean, for the cardiac events outcome, there was a good support for revascularization. But just for completeness of information, Sripal didn't mention that recently, and based essentially on our guideline discussion, we performed the individual patient data analysis of a trial that compared CABG versus medical therapy using at least aspirin-statins and beta-blocker in the medical therapy arm. There were four trials, and STICH, BARI-2D, and the two mass trials, and we found that there was a survival benefit for CABG that became apparent after, significant after the fourth postoperative year and was statistically more evident in younger patients or in patients with longer life expectancy. So it's not perfect data because even though there was no treatment interaction with ejection fraction, STICH was clearly more than half of the sample size, and the data were not contemporary. But after the guideline, there has been a signal that at least CABG may improve survival, even though it's a far from perfect signal. Yeah, I think you put it well, Mauricio. I think the one recommendation that raised the most consternation was the downgrade for bypass surgery in patients with multivessel disease from class 1 to class 2b. The downgrade was something the surgeons had difficulty accepting, and the fact that bypass surgery and PCI were given the same level, the same class of recommendation of 2b, even though the language was different and the language means a lot. But I just, I think it's a shame that the fracture occurred post hoc, and I mean, we had a great, very collegial writing committee that worked together extremely well. I wish we could have found common ground. I've heard that even a class 2a recommendation would not have been acceptable. So it would have been impossible for us, given the results of the ischemia trial, to maintain a class 1 recommendation for surgery in patients with multivessel disease. On the other hand, you know, my concern about ischemia as a trial is that, I mean, they did not separate out the bypass patients from the PCI patients. It's not a perfect set of evidence that we're used to. It's not a clean comparison of just bypass versus medical therapy. I mean, it was revascularization considered as a sort of a common type of therapy. So time will tell. I mean, I think that when we get five and ten year outcomes, we might see that we were justified in giving a 2b recommendation. Time will tell, and there's always the option of an update. Yeah, I think that the other thing to remember is the original recommendations were based on those, quote, three pivotal trials. When you do a deep dive into the three pivotal trials and you look at the subgroup of patients with normal LV, triple vessel disease, two of the three didn't show a benefit. So really, you know, the original recommendations from 20 years ago were made on one clinical trial of about 650 patients and one meta-analysis. And then we did develop additional recommendations not based on mortality, based on cardiovascular outcomes overall that were bypass surgery did get the class 1a indication, right? But John, can I tell you something? I think the communication has been poor, and I am surprised that you said we couldn't give a class 1 recommendation based on ischemia. That is exactly the point that surgeons are criticizing. But we didn't, I mean, for me at least, and that at least was my approach, it was not ischemia that shown that the CABG could not be associated with survival benefit, but for sure ischemia was a red flag because a traditional concept, revascularization lead to improved survival, may not be true. Then I looked more critically at the past evidence and I found out exactly what Jacqueline has said. I mean, I honestly believe that even the previous guideline recommendation was far too generous, I think ischemia was important in driving a change in the perspective, but not in providing data on the CABG versus medical therapy comparison. However, when we then communicated to the surgical society, the message was the guideline, the recommendation was changed based on ischemia. And that really opened the door to the fact that there was no direct comparison and that was a mistake. So I think that was the spiral. So probably if we haven't made a mistake, it has been a mistake in communication. Frank, any comments? You know, stable ischemic heart disease, people with reduced ejection fraction, I don't think CABG plays a major role, and people with normal ejection fraction and severe three-vessel disease, they have normal ejection fraction for the reason, they probably have preserved blood flow through collateral vessels. So there's a reason for that. The other issue is medical therapy has gotten so much better over the last 30, 40 years, as has coronary bypass surgery, so that the difference has actually diminished. But I still think bypass surgery has a role in silent ischemic heart disease when there is a reduction in ejection fraction. I think most people would agree with that. There's no question about that. So I think that we are seven minutes past the time of this webinar. It's been an amazing experience to share the forum again with this group. Thank you very much, and have a wonderful night, and thanks for sharing your time with us.
Video Summary
In this video, Dr. O'Reilly leads a discussion about the treatment of diabetic patients with coronary artery disease. The participants debate whether diabetes is too broad of a category and if all diabetics should be treated equally. They discuss the criteria for revascularization and the importance of considering the patient's specific anatomy. The guidelines for treatment are discussed, with the surgeons expressing their disagreement with the downgrading of bypass surgery in patients with multivessel disease. The participants also mention the importance of considering non-mortality endpoints when evaluating treatment options. Additionally, they mention the controversy surrounding the guidelines and the need for better communication. The video ends with the participants thanking each other and expressing gratitude for the discussion.
Keywords
treatment
diabetic patients
coronary artery disease
revascularization criteria
patient anatomy
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