Transcription
Dear German ladies and gentlemen, um, my name is Paulo Schella from Zarahan University in Germany. Um, it's a great honor for me to be invited to the EBC 2021 Bifurcation Club Meeting.
My talk is about drug-eluting balloons for coronary artery disease. Why is there a need for alternative treatments to current generation drug-eluting stents? Because we know that there is a stent-related yearly event rate of up to four percent, and according to current knowledge, this event rate, increasing event rate, never stops.
This meta-analysis compares the clinical outcomes in randomized trials comparing DCB for coronary artery disease with alternative treatments. And as you can see, within the first year, there's a reduced rate of myocardial infarction when using DCB only. And after three years, there is a lower all-cause mortality after DCB use, especially driven by cardiac mortality at three years.
To date, the European guidelines have only a recommendation for the treatment of coronary in-stent restenosis for DCB. This recommendation is supported by a large number of randomized clinical trials comparing DCB and DCS for ISR treatment. And as you can see, overall, there's a somewhat higher TRL rate after DCB use compared to standard stent. However, if you look at the clinical endpoints, death or myocardial infarction, there's a trend with lower numbers in the DCB group for reduced events.
The basic principle of DCB only is presented here. Lesion preparation is the most important part of the interventional procedure. And after having the result of your lesion preparation, you have to decide if this lesion is suitable for DCB only or if there's a need for a permanent stent. And we defined a so-called acceptable angiographic result, which means no flow-limiting dissections. Type A and B dissections are fine because they are not flow-limiting. A residual stenosis of less than 30 percent. And if you want to include functional measurements, the recommendation is an FFR rate of at least 0.8.
It has been shown in clinical data that this recommendation of the acceptable angiographic result is very suitable to predict the long-term outcome in terms of target lesion revascularization, as in this work from the Columbus group for Milano.
What about the new vessel disease, which is not yet supported in the guidelines? We have several clinical scenarios for DCB: small vessels, acute coronary syndrome, patients with high bleeding risk, or bifurcation. From the consensus paper here, you can see an overview of the randomized trials on DCB only in new vessel disease and data supporting the use of DCB also in vessels from at least three millimeter diameter. The largest randomized trial so far is the BASKET SMALL 2, 758 patients randomized to either DCB only or current generation drug-eluting stents in coronary arteries up to three millimeter in diameter. And as you can see, MACE overall was no difference up to three years with the two concepts.
What about drug-eluting balloons and bifurcation lesions? We have different scenarios here. One initially investigated was a DCB-covered metal stent in the main branch and DCB in the side branch. Um, it turned out that this is not a good idea in general. The combination of DCB with a newly implanted stent, especially the metal stent, leads to inferior results compared to a drug-eluting stent.
Next scenario in bifurcations is using a drug-eluting stent in the main branch and treating the side branch with a DCB. Here we have registry and randomized status for this approach. This is the Biolux One trial using an everolimus-eluting stent in the main branch with very good acceptable late lumen loss and a paclitaxel-coated balloon in the side branch with a late lumen loss of 0.1 and very good clinical outcomes. The trial from Herrad and colleagues was randomized, 50 patients in each group, focusing on the treatment of the side branch either with conventional balloon angioplasty or with the drug-coated balloon. And as you can see here, late lumen loss was highly significant reduced by the use of the drug-coated balloon compared to balloon angioplasty alone. And similar outcomes have been reported from the randomized BIFF trial, drug-eluting balloon versus drug-eluting stent, 32 patients each. And here we also see a significant reduction of late lumen loss, 0.08 with the drug-coated balloon versus 0.47 in the drug-eluting stent, and restenosis rate six versus 26 percent.
The next approach is a more puristic approach, leaving nothing behind: main branch DCB and side branch DCB. For this approach, they are there, we have some case series, 39 patients reported. Then we have the registry data published by the Appropriate colleagues, 70 patients with DCB only in the bifurcation, 57 combination of stenting. And as you can see, if you look at the nine-month MACE rate, these were very acceptable data: DCB only 6.1 percent, DCB plus stenting 7.3 percent event rate.
Here you can see now a clinical example. This was one of the early trifurcation cases we did. As you can see, we used three DCBs in all three branches of this right coronary artery. And this was the initial result. And after 13 months, you see an increase in lumen in all side branches, which is very common after DCB only treatment. And we call this effect "bloom," late lumen enlargement. And here you can see the distribution of MLD distribution of a series of patients at four months follow-up. And as you can see, there's a shift from the left to the right in MLD distribution, which is unique for this DCB only treatment. This finding has been confirmed by other groups. Here, for example, IVUS VH investigation. This increase in total lumen area from post-procedure to follow-up is in line with an increase in total vessel area, which may be one of the main reasons why we see lumen enlargements.
And we have a last scenario for bifurcations: treatment of the main branch with DCB and no treatment at all of the side branch. Why is this an approach? Because we have also seen from IVUS data that if we do treat the main branch, you see an increase in main vessel lumen area at the origin of the side branch over time, which is also an effect of this late lumen enlargement.
So, my conclusion is for DCB coronary. So far, paclitaxel-coated balloons are the standard of care. You should strictly follow the rules of DCB only, including lesion preparation, which is the most important procedural step. After lesion preparation, the decision is if you use the DCB only or a current generation drug-eluting stent. One of the interesting effects of DCB only treatment is late lumen enlargement. You can expect no stent-associated late events. And in bifurcations, we have different scenarios. The most frequent will be drug-eluting stent in the main branch, drug-eluting balloon in the side branch, if you have not that much experience in DCB only so far. If you want to go a more heuristic approach, it makes sense to try leaving nothing behind, either with DCB in main and side branch, or a very simple approach using DCB only in the main branch. Thank you very much.
Dear Chairman, thank you for the invitation to present at the EBC 2020 year meeting. The title of my presentation is "Feasibility, Safety, and Efficacy of Drug-Coated Only Treatment in Left Main Coronary Stenosis." Left main disease with diameter stenosis over than 50 percent requires revascularization to improve the prognosis. Among them, PCI is recommended as a Class 2A up to a SYNTAX score of 32.
Drug-eluting balloon is basically working as a balloon angioplasty mechanism. So we need to know the balloon angioplasty effect. The benefit of one RCT compared balloon angioplasty to bare metal stent, and there was no difference in hard endpoints such as deaths and myocardial infarction. Only repeat PCI was more involved in balloon angioplasty.
It is due to these stenoses which can be resolved with local drug treatment like drug-coated balloon. To resolve this problem of balloon angioplasty, bare metal stent and drug-eluting stent were developed, but hard endpoints such as deaths and myocardial infarction were not improved.
Then what about drug-coated balloon? Can DCB improve outcomes in this era? We performed PCI in 42 consecutive patients with left main disease. In patients with adequate balloon angioplasty, 23 patients were treated with drug-coated balloon and the remaining 19 patients were treated with DES. Dominant was 63 years old in DCB and 67 years old in DES, and most of the patients were men. There were mainly unstable angina patients, and there were three acute myocardial infarction patients in the DES group. The SYNTAX score was higher in the DES group, median value 27.5, and three-vessel disease was also more common, 68 percent in both groups. Most of the patients were bifurcation region. The mean DES diameter was 3.7 millimeter, which was larger than the drug-coated balloon, 3.4 millimeter. And IVUS was almost used in the drug-eluting stent group. There was no bare metal stent in the DCB group. In the QCA of 23 patients we treated, diameter stenosis at baseline was 72 percent, and post-DCB was a 30 percent residual diameter stenosis. In follow-up, the follow-up duration is around six months. Diameter stenosis was unchanged, 31 percent, and late lumen loss was 0.1 millimeter. When patients had binary stenosis, we successfully retreated it by drug-coated balloon again. In the drug-eluting stent, one patient died from myocardial infarction. This patient had already had a left main myocardial infarction when he came to our hospital and died several hours after stent PCI.
After one year follow-up, there are two target lesion revascularization in drug-coated balloon and two events in drug-eluting stent, including one cardiac death and one subdural hemorrhage. This is a 61-year-old man. He had a very tight stenosis in the left main bifurcation. I have to check my IVUS. Balloon angioplasty was performed with the Reptain to approach my ready and treated with the drug-coated balloon. Although some residual stenosis remains, the procedure was to finish it because the lumen was much bigger than baseline. After six months, left main stenosis was not absorbed. This patient has been well for three years without any angina symptoms.
This is a 57-year-old man and has a left main CTO. After wiring, angioplasty was done with a small size 1.5 millimeter balloon first. After ballooning, flow appeared. I did sequential range of plastic, increasing balloon size. After that, the flow improved a lot. I also performed the drug-coated balloon for middleware radi is tight region. I did several range of plastic with optimal sized balloon from left main to ready and from left main to LCx, followed by drug-coated balloon treatment. This is the final result after drug-coated balloon treatment. After six months, left main trifurcation regions were much dilated and it looks normal coronary. So we successfully treated left main trifurcation lesion with drug-coated balloon only treatment. The patient is currently doing well without any symptom for over one year.
This is a target lesion revascularization case. A 45-year-old man with very tight stenosis of left main shaped and decreased integrated flow, it's just a TIMI 2 flow. After balloon angioplasty and local balloon treatment, the lumen increased significantly and the flow was normalized, TIMI 3 flow. His angina was gone. However, the patient had followed loss after discharge and was voluntarily discontinuing all drugs, including antiplatelet drugs. After six months, chest pain developed and left main disease recurred because he had further compliance. We retreated the region with a drug-coated balloon. This is a balloon angioplasty angiogram follow-up. Angiogram showed good result without recurrence after 8 months. Now he has no symptom.
So why do you have to work so hard for drug-coated balloon? Duration of dual antiplatelet therapy for patients of poor drug compliance, especially in young men, for high bleeding risk patients. And drug-coated balloon has no stent-related events like stent thrombosis. And you may have the opportunity for bypass surgery or biologic treatment in the future.
Here is the take-home message. The purpose of PCI is to reduce deaths and myocardial infarction. Drug-coated balloon treatment is increasing with a low rate of hard endpoint death and myocardial infarction and acceptable rate of clinical outcome in left main disease. And this treatment without stenting is a feasible and well-tolerated method for the novel left main regions if the pre-dilation result is good. However, are we randomized and controlled trial necessary to further evaluate the safety and efficacy of drug-coated treatment in left main disease? Thank you for your attention.
Dear Chairman, thank you for the invitation to present at the EBC 2021 meeting. The title of my presentation is "Stentless Procedure: Effective DCB Treatment." This is my disclosure slide.
In current guidelines for the treatment of bifurcation region, single stent strategy is the major method in the United States. Also, European countries, also, of course, Japan too. When I considered about the current situation, I have some questions. As I showed, single stent strategies, reliable treatment method. Will I need stentless procedure in this day and age? What lesion will need stentless procedure? What will be the reliable stentless procedure? Concerning about the candidates for stentless procedure, some conditions may apply like the following.
As regarding patient background, we can say these things. In Japan, many doctors want to avoid to use stent for young patients, especially less than 50s. As regarding needs more hearty, I think these two situations are important. About the reliable stentless procedure, DCB is paid attention recently. In the last EBC, there were some comments about it. This paper reported the effect of paclitaxel-coated balloon on side of branch into bifurcation region from China. In comparison with conventional balloon group, late lumen loss in DCB group was significantly smaller and incidence of MACE was also significantly lower.
From Japan, Dr. Kitani's group reported the efficacy of DCB after plaque reduction. They evaluated outcomes of 129 DCA-DCB cases without stent use in this study. Through bifurcation region was 14 percent, and more than 70 percent of main target was in the main branch. TLR at 12 months was 3.1 percent, and it was quite good. Clinical outcomes were pretty good. Totally in this study, there are no differences in minimum lumen diameter and post-PCI diameter stenosis between post-DCA and follow-up despite stentless procedure. This may mean that aggressive plaque reduction facilitates the effect of DCB. According to the data of 247 patients treated with DCB in my hospital, lesion preparation less than 58.5 percent in plaque area was important in stentless PCI using DCB.
Let me show my case. This patient had severe stenosis in proximal circumflex and myostenosis in proximal area. To avoid the compromise of a ready, I performed directional atherectomy to the circumflex. After atherectomy, angio and IVUS image looked pretty good. And then I directed the proximal circumflex with cutting balloon and DCB. Final angiogram showed good result. One year later, there were no restenosis.
Next case was a 60-year-old male with 1-1-1 left main disease. As I wanted to avoid complex stenting and coronary or product shift, I performed atherectomy to both branches. After atherectomy, I directed proximal rest circumflex with cutting balloon on the DCB, and then I put two Synergy stents because the main branch lesion was very diffused. After putting stent, pot and minimum kissing was performed to fix this trifurcation. Final angiogram showed good result. Although dissection was recognized at proximal circumflex, I decided to observe it because this dissection was not a magnet or I have a smidge and the percent plaque area was 46 percent. This dissection healed completely and there was no restenosis at home.
Ladies and gentlemen, this is my conclusion. Although the cases which need stent strategy may be rare currently because of the development of DES, there will be some situations in which stenting seems to be beneficial for the patient. DCB may be a potential strategy for the treatment of bifurcation region when we opt for stentless procedure. However, some kind of lesion preparation, such as plaque reduction, will be needed to make DCB more effective. Thank you for your attention.
I am Hong Joon Zhu from Korea University Alam Hospital, and thank you for having me in EBC 2021. My topic is "Repeat PCI for Left Main Bifurcation ISR Lesion." I have nothing to disclose.
Current guidelines recommend both CABG and PCI for left main coronary disease, depending on its anatomical consideration. PCI for left main coronary artery disease became feasible and safe as CABG. Therefore, the proportion of PCI for left main coronary artery disease is significantly increasing. The problem is that the PCI for left main coronary artery disease is associated with higher risk for restenosis and repeat revascularization. In SYNTAX trial, five-year incidence for repeat revascularization after PCI for left main coronary artery disease was 26.7 percent. In PRECOMBAT trial, even target-based revascularization was 11.4 percent. Importantly, as you can see in the SYNTAX trial, there are patients who underwent repeat revascularization after left main coronary artery disease PCI. I feel that some left main in-stent restenosis cases might be included in this population, and repeat PCI was a more common revascularization strategy for this population than CABG.
Let me show one case. The case was a 47-year-old man. In 2007, PCI with Endeavor stent was performed at proximal circumflex artery. One year later, in-stent restenosis was developed. We implanted another stent from left circumflex ostium. Final angiography showed good angiographic result. However, two years later, chest pain was redeveloped, and coronary angiography shows severe ISR at LED ostium and left circumflex ostium. So we implanted two stents with final kissing balloon technique. Post-procedure, I would show good stent position. Only one stent strut at the proximal edge of left main stent was insufficiently opposed, but we think we thought this result was quite optimal. However, one year later, severe in-stent restenosis was redeveloped at the LED ostium. So we performed drug-coated angioplasty for that lesion. Final angiography showed good result.
What we can learn from this case is that the lesions and the procedural involvement of left main bifurcation could be a significant predictor for in-stent restenosis. As you already know, the guidelines recommend drug-coated balloon angioplasty and repeat drug-eluting stenting implantation for in-stent restenosis lesions as Class 1A. However, the clinical prognosis between drug-coated balloon angioplasty and repeat drug-eluting stenting implantation, especially for left main bifurcation lesion, is largely uncertain.
We compared the clinical outcome between drug-coated balloon angioplasty and repeat drug-eluting stenting implantation in patients with left main bifurcation ISR lesion. This is a single-center retrospective study and included only 75 patients with left main bifurcation ISR lesion who underwent repeat PCI. Baseline characteristics showed that the drug-eluting stent group tended to have a higher incidence of acute myocardial infarction presentation at index PCI than the drug-coated balloon group. Previous PCI characteristics showed that 33 percent had non-left main bifurcation lesion at the previous PCI. Drug-coated balloon group tended to have a higher percentage of stent-in-stent cases and a little bit larger previous stent diameters compared to the drug-eluting stent group. True bifurcation rate was 27 percent in DES group and 29 percent in drug-coated balloon angioplasty group. At the time before 2015, intravascular imaging was performed only 25 to 35 percent. QCA data showed that the post-procedural target lesion minimum lumen diameter was significantly smaller in the drug-coated balloon angioplasty group. I feel that the selection bias on drug-coated balloon angioplasty favoring smaller vessel diameter and acute recoil after drug-coated balloon angioplasty might contribute to this result. However, follow-up target lesion minimum diameter showed only both line significance difference of follow-up target lesion involvement diameter was attenuated.
Considering that the heterogeneous baseline clinical and angiographic characteristics between two groups, we performed propensity score matching analysis to compare the clinical prognosis between two groups. May show similar clinical outcome even after propensity score matching. Low rank p value in Kaplan-Meier curve was 0.64. Cox proportional hazard models for MACE suggest that the true bifurcation lesion was the only important risk factor for MACE in patients who underwent repeat PCI for left main bifurcation ISR lesion.
In summary, 33 percent of patients with left main bifurcation ISR lesion had non-left main bifurcation lesions at the previous PCI. It suggests that the initial PCI strategy for proximal segment of main branch is very important. Patients in the drug-coated balloon angioplasty group had a trend of less acute myocardial infarction presentation at index PCI and more stent-in-stent cases and smaller post-PCI target lesion minimum diameter was also noted in drug-coated balloon angioplasty. This suggests that the non-urgent clinical situation and lesion complexities might make the operator conservative and suppress aggressive procedure. Finally, it might result in clinical outcome of repeat PCI for these patients. However, the incidence of MACE remained to be similar between two groups during the follow-up period. Multivariate Cox regression analysis demonstrated that the true bifurcation lesion is the only important independent risk predictor for MACE after procedure. So we have to consider CABG in these cases. Thank you for your listening.