So, I'm going to present some of the more recent data evidence that we have for drug-coated balloons. Am I, is it true I heard you don't have drug-coated balloons here? No. Correct. Oh. Okay. Well, you've got something to look forward to whenever they get approved. So, so this is good. The reason for that color of, is because of this. This is a bifurcation, trifurcation, apropos the last comments, it really is truly a trifurcation. And beginning and final result, I just wanted to show this as a introduction, but I'll be perfectly honest, I made mistakes here. This was actually a complex LAD to left main with all kinds of rotablation, and it took quite a long time by the time we got to the circumflex and the intermediate. And in reviewing these films, this was from last year, and in reviewing these films, I was going to show this case, and I thought, I can't show this case, I can't show this case. Why? I can't wire any of the side branches. And there must have been a good reason why I didn't do it, because I never not wire side branches. I think I may have thought foolishly that this actually isn't, the ostium of the circ is actually okay, and that I didn't really have to wire it. But when you actually look at it, there was marked carinal shift by the time I did the pot with the 5mm balloon, and so then I had quite a little job recrossing it. And thankfully I did, and actually wired both of those branches, and then did a drug-eluting balloon from the intermediate right into the ostium, and got that result. And that was a year ago, and she hasn't represented, so I think things went okay. These are my disclosures. I'll leave them up for a while, so you can study them carefully. I notice disclosures usually go up for half a second, and it's like a page full. And so, you know, these are my disclosures. Why do we need drug-eluting balloons? Well, I think we have some controversy regarding data. There's the Asian side, and I think we in North America tend to follow some of that a little bit, one stent versus two stent. And then there's the European side, European Bifurcation Club, where it's all about provisional, all about trying to put a stent in the main vessel first only, and then if you need to, then you stent the side branch. Well, sometimes it's very difficult to stent that, to get anything into the side branch in some cases, so probably 15-20% of cases should be two stent bifurcations up front. And things like the DK Crush, or if you wish, you do a DK Culotte, they actually allow you to retain access in the side branch and not lose that side branch ever. So I think there's still a discrepancy there. I see more and more in Europe that complex bifurcations probably should be treated with a two stent approach. The DK Crush 5 actually, in high-risk patients especially, showed a marked effect. So we know that in complex bifurcations, whether you call it by syntax score—this is greater than 32—provisional does much, much worse than a two stent, which is DK Crush, of course. And in NERS 19 or higher, same thing. It's interesting because I think they have now said that in simple bifurcations you should do a one stent or provisional technique, but yet if you look at these three-year data from DK Crush 5, this is just a matter of numbers. There's no interaction here. It's all going in the same direction. Whether it's complex bifurcation by definition criteria or simple bifurcation, you see the same trends, and in fact a trend, strong trend, P.08 towards better outcome with DK Crush stenting. So to me it's a question of definition of what they defined as a simple versus complex bifurcation. And they did a good validation study to do that, but I think we don't know everything about this yet. On the other hand, we have the EBC main, which showed better outcome with provisional stenting. These were simple bifurcations, and so probably simple true bifurcations, all true bifurcations. And so it's probably true that these patients, for the most part, should have had provisional stenting, and most of them ended up in fact with one stent only. But however you look at it, whether it's two stent or one stent, even the one stent, you have a MACE rate of 15% at one year in EBC. You have a MACE rate, we go back to DK Crush 5, of 15% with provisional stenting at three years. So we haven't done everything yet. And of course, a lot of that is we have probably up to 20% restenosis rate from various studies in the side branch, in the osteomyelitis side branch, in provisional stenting. So can we do a little bit better? And I think one of the ways we potentially can do better is with drug-eluting balloons, which you don't have here, I'm sorry, I'm terribly sorry. Drug-eluting balloons, probably most, I would say, compelling data is in small vessels actually. And this is some of the small vessels. This is actually a study that was just published, I think earlier this month, three-year data from Picoletto, where they showed significant improvement with drug-eluting stenting across the main vessel to main branch, and then plain balloon versus drug-coated balloon in the side branch. And you can see the outcomes are much better with drug-coated balloon. So that's small coronary vessels. What about bifurcations? Several analyses have been done. There's no, I would say, compelling data, no data that's definitive as yet. So this is a propensity-matched analysis from Pan and colleagues in China, drug-eluting drug-coated balloon in the treatment of coronary left main bifurcations. There's a lot of—there's no way you can see that from there, but let me highlight a few things. So noncompliant balloon in 82 percent of the DCB, 40 percent of the DES group. This is versus DES, actually. Maximum pre-dilatation balloon diameter was bigger in the DCB, as well as the diameter to reference diameter ratio. Balloon length was the same, and as you can see, these were complex. More than half had very complex disease, syntax score greater than 32. And this was the outcome, again, in this matched cohort analysis where drug-coated balloons—I call them drug-eluting balloons, I do, actually, but drug-coated balloons, probably the same thing—did much better in terms of target lesion failure, mortality, or survival was the same. This is a small study, prospective randomized trial called BEYOND, again, in China, just over 100 patients per group, all true bifurcations, side branch. As you can see, the main vessel, they did no left mains in this particular study. No characteristics, again, you can see, very similar in all of the aspects. Procedure success was the same, 100 percent. The only thing is that they used smaller balloons in the non-paclitaxel-coated balloon group, so I'm not sure that this is entirely true, what this suggests, but it suggests that the target lesion stenosis, or MLD, is better at follow-up with drug-coated balloon than with plain old balloon angioplasty. And all of the endpoints, in fact, target lesion stenosis endpoints in all the analyses favor PEB or paclitaxel-eluting balloon, as they say. This is a meta-analysis of very few, I think a few, randomized controlled trials, few nanorandomized controlled trials, all of it going in the direction of drug-coated balloon versus plain balloon angioplasty. There are many currently available drug-coated balloons, none in the United States, and we have one, and we've had it for probably at least 15 years, as far as I can remember. It's the Biotronic Panteralux. It's the only one we have, but thankfully it's a good one. Paclitaxel is the drug that's most commonly used. It's hydrophobic, and that tends to mean that it gets better across the cell membrane into the cells and do its action. There are a couple of new sirolimus-eluting stents that are being developed, one on this particular slide, I'm sorry? Balloons. Balloons, sorry, balloons, that are being developed, thank you, that are being developed, but paclitaxel is the most commonly used and most effective one. There are some predictors of bailout stenting when we use a drug-coated balloon. I guess that would be when we use a balloon, period. So bailout stenting, whether you use the drug-coated balloon or a regular balloon, these are the univariate factors. I'll just simplify that and say that these are the independent predictors of having to go on to stent when you're trying to do a drug-eluting, drug-coated balloon procedure or a balloon procedure, for that matter, if you wish. And it's the drug-coated balloon to reference vessel diameter ratio. The greater it is, the worse the outcome. The tortuosity, tortuous vessels, tend to do worse. They tend to dissect. When you have distal disease beyond the bifurcation, that's an independent predictor of having to go on to a stent and a type C lesion as well. As I say, the data are thus far spotty, not definitive. This in the pipeline, so here's a randomized control trial that Xiaoliang Chen and colleagues are doing. It's a DCB-BIF trial. Total of 784 patients will be enrolled with true bifurcation, side branch at least 2.5 millimeters or greater in diameter, and lesion length less than 10, so greater than 10 for them. In the definition, criteria constitutes a complex bifurcation. So, they clearly feel that you have to be less than 10 in order to have success with this type of a technique. The primary endpoint is MACE at 12 months. Here are a few, I had a, yeah, here is another study also in China, actually comparing cutting balloon versus cutting balloon and DCB in a much smaller study, but also in recruitment. At this point, with a primary endpoint of MACE at 12 months and with other secondary endpoints, as you can see, safety endpoint of stent thrombosis. So, these are some of the things down the line. Let me finish with a case. This was a 74-year-old woman with ACS. Now, she wasn't just a 74-year-old woman with an ACS. A year previous to this, she had a bowel surgery, which was complicated. She ended up in a rehab hospital, and she was still in the rehab hospital a year later, very deconditioned. When she developed an ACS, was transferred to our center, in fact, for an angiogram, which showed this. The angiographer thought this was better for surgery. Surgeons wanted to have nothing to do with this, so she has end-stage renal disease. She has bronchiectasis. She's hypothyroid, what, a number of other things. She's kind of a, you know, she is a bit of a train wreck and very deconditioned, very frail from a rehab hospital. So I ended up doing this, and here's just a brief summary of what we did. So WIRED both obviously started with a 3-5-15 noncompliant balloon in the LAD and showed that in fact it cracked and it actually opened up very nicely with that, which was a bit of a surprise. I thought I might have to go to Rota here, but didn't have to. Then actually ballooned the rest of that proxal to mid-segment all the way up to that large diagonal and beyond, which we also WIRED to protect it. I really didn't want to deal with that diagonal only to protect it, because I thought it was more important to have it open than to have a perfect result with a 30-millimeter stent in it and a decay crush technique in a relatively small vessel. So here we are further on down the road. This is after stenting the mid to proximal segment, and as you can see, the diagonal has TIMI-3 flow and is doing just fine. We then stented next right into the left main with the next stent, did the left main pot here, as you can see, and this was our final result. I think I can probably speed up this—no, sorry, I could—well, we can just play it, but I try to—this is what I try to do, okay. Okay, there we go. So here we have the LED stent right here—never mind, I'll just let it run, I'm sorry. So it's a pretty good result overall. Here I think we probably had coming up perhaps the calcified nodule, but I thought the stent area was still pretty large, and I thought the better part of Valor was to actually not work on it any further, as I had a really good stent area right there. And now we're into the left main and a very nicely opposed stent—not as nice as just But, you know, pretty good, pretty good, okay. And I did use imaging as well to confirm that. So this is a frail lady with end-stage kidney disease. This is—we're a couple of hours into it. I thought I would stage this, and so let her be at this point, let her rest, and brought her back the following week to work on the CERC. So this took a 1.5 balloon. I could not cross that distal CERC with anything but a 1.5 balloon. And this is now—we were able to take a pretty big non-compliant balloon to open it up after we pried it open with the 1.5. I think that I missed. So now we're positioning our stent, and I thought I would use a short stent here. And that went nicely. A pot after the stent to optimize the entry into the side branch through the struts. It just changes the angle so that your wire can see it better. You have better access to it when you do the pot in the proper position, just proximal to the carina. And so this is our result after post-OM balloon. Now we have a 3.0 x 10 DCB. It's not completely open, but I don't want to tear it. I don't want to dissect it. So I'm quite happy with how big this is at this point. And then with the DCB balloon, we do a kissing balloon inflation. And then finally I end up with this distal circumflex DCB, which is a small vessel. And I thought DCB was going to be better here than a stent. And there's our final result from the two procedures. You can see a little bit of, I would say, less density at the osteum of the LED. That's because I think we did have probably a little bit of a nodule there, and we had more of an elliptical opening, but still a large one as confirmed by the IVAS. Now, she went back to her rehab hospital, and we were going to give her a rest at this point for a couple of months and bring her back to do the RCA, which as you saw was severely stenosis as well and would need no doubt rotational arthrectomy, and Lord knows what else. About a month and a half later, she had severe pulmonary hemorrhage on dual anti-palliative therapy. She had bronchiectasis, as you recall, and her respirologist deemed that she could no longer be on any anti-palliative therapy at this point or she'll die. They actually tried just aspirin. They tried just aspirin, and even with that, she had a pulmonary hemorrhage, not as extensive one. She's back in her rehab hospital, and this was March 8, the second procedure. Other than that, so she recovered from her pulmonary hemorrhage. She went back to the rehab hospital to do more rehabbing, and I actually just looked her up on our EPR, and she's actually doing fine. The point about that, she's only had a couple of months of dual anti-palliative therapy, but if you optimize everything well, and you ensure with intravascular imaging that you have a good result, good apposition, no malapposition, I think your patients, for the most part, are going to do okay, even with relatively complex stenting, at least she is at this point. So should we use drug-coated balloons? We can't here, but hopefully you will be able to at some point. Here's a nice algorithm from the European Bifurcation Club group. So bifurcation with the large side branch, greater than 2.5, significant myocardial supply, we wire both branches, dilate the main vessel with the drug-eluting stent, followed by a POT, a good POT that's guided by imaging, so that you know you get complete apposition of that proximal stent. In a non-left main, if your side branch is less than 70%, so LAD diagonal, if you're diagonal, less than 70% residual stenosis, you have TIMI 3 flow, you're done. With left main, if you have less than 50% stenosis and TIMI 3 flow, you're done. If you don't, then you go on to further work, you recross the side branch, dilate with the balloon at low pressure, and after one-to-one dilatation, they suggest here with a scoring balloon, I think that's not a bad idea, treat with a drug-coated balloon, followed by kissing balloon inflation, a re-POT. The re-POT, I think, is not necessary if you've done a high-pressure POT to begin with, like Jusvinder, I don't believe that the final POT is necessary if you do low-pressure kissing, okay, because you've already done that, so I don't think it's essential, even though that's what all the literature says. So if you have a flow-limiting dissection after that, then you consider a second stent. With TAP, reverse crush, I think, works really well, because with reverse crush, you don't end up with struts in the main vessel. If you have an acute angle, reasonably large side branch, you can have a lot of stent in the main vessel, so I don't like that, I prefer a reverse crush, which I think works very well, and with today's very thin-strutted stents, I don't think it's an issue, just like DK crush is not an issue. So I think that's it for drug-eluting balloons. I hope you get to join us one of these days in using them, and thank you for your attention.

drug-coated balloons

coronary artery disease

CAD

bifurcation lesions

predictors of bailout stenting

end-stage renal disease