So, I am going to talk about the drop equilibrium angioplasty for side branch during provisional slanting technique. This is a prospective mode design, randomized DCB, a mode for disclose the background, basically provisional slanting technique is recommended for greater majority of coronary bifurcation lesion. Following the side branch slanting is often required, also leading to results, drop could be better. So, this is a possibility balloon DCB for the side branch, however, the benefit of DCB for coronary bifurcation lesion still remains unclear. So this is the aim of this trial, to investigate if DCB compared with non-common line balloon for the side branch improves the clinical outcomes of provisional slanting technique in patients with simple but true coronary bifurcation lesion defined by a definition criteria. So, these are major inclusion criteria, so we include age 18 years of a patient present with a sudden ischemia, angina or one-week acute myocardial infarction. So the reference vessel diameter in both side, side branch and main vessel, minimal 2.5 mm, so the baseline diameter synopsis, minimal 50%, the key very important point is the side branch lesion less, shorter than 10 mm by visual estimation. Also you know, for the content of this trial, so after provisional slanting main vessel, so it also shows side branch diameter synopsis should be minimal 70%, so rather than show the short side branch lesion less, and after slanting main vessel, so the side branch diameter synopsis minimal 70%, this is the key point to include the patient in the trial. I think there are no more specificities for major inclusion criteria, basically you know, patient with resistant aortic lesion will be excluded from the trial, another thing is that the severe calcification requiring rotation arthritectomy of patient head, the unstable hemodynamic will be excluded too. So the primary end point was one-year composite of target lesion failure, TRF, including cardiac death, target vessel myocardial infarction, or clinical-driven TLR. Secondary end point included target vessel failure without the procedure myocardial infarction, individual components of the primary end point, TEVR, as well as stern thrombosis. So the estimated one-year rate of TRF in the provisional slanting with non-compliant balloon for the side branch will be 17%, we assume the 51% risk rate in provisional slanting with the DCP4, so finally we included 784 patients with simple but true coronary failure in this study. This is the study structure. In general, the study was conducted in four countries in 28 sites, including China, Italy, and Indonesia. So from the study flowchart, you can see from a total of 1,231 patients with true coronary myofascial lesion, so 373 patients were excluded after slanting main vessel. So the 784 patients, the inclusion and exclusion criteria, and finally randomized to DCP, and in the TCB group, 10 patients did not, DCP was not used in 10 patients, but in the NCB group, DCP was used in the 4 patients. It's a primary operator decision. So finally, we performed intention to treat ITT and SS. So this is the standing procedure and the technical flow. So in general, two wires in main vessel side branch, the upper way by port, so after port, if the osteosarcoma branch diameter is not at least a minimum of 70%, so patients were randomized to NCB and DCP group. So in the DCP group, immediately after slanting main vessel, we need to use NCB to dilate the side branch and to dilate the stent struts, followed by DCP angioplasty, followed by casein boron inflation, final port. A very important thing is that after dilating side branch, if the timi flow less than 3, or the presence of type B or type C dissection, so the second stent will be required in the side branch. I think this is a brief introduction of the preliminary slanting technique with either DCP or NCB group. So as a randomized clinical trial, there are no significant differences in terms of the baseline clinical characteristics. So from the table, you can see diabetes was in almost 36%, and most of the patients present, almost 60% of the patients present non-stent vagina. So the remaining 40%, 30% presented acute myocardial infarction, including non-STEMI as well. Multiversal disease was in 75% of all patients. Most of the lesions are classified by Medina 1-1-1 or 0-1-1 with 93%. So an unprotected distal left ventricle condition was in 15% of patients. Mostly, PCR was performed from transradial approach. Predilation for side branch was required for 20.5% in the DCP group, not significant to the 17.3% of the NCB group. According to the slanting protocol, patient for side branch was not recommended routinely used for patient including the trial. But according to primary operator decision, some side branch was a very, very critical disease. So this is why high rate of predilation for side branch in both group. After slanting myovasal port was performed in greater than 87% of the patients. Kissing balloon inflation after side branch balloon port performed greater than 76%. I think another very important point is a very low rate of crossover from provision with one stent to two stent tending. It was only 3.8% in the DCP group, very similar to 3.3% in the NCB group. This is the primary and secondary endpoints table show the one-year follow-up. The tidal lesion failure was 7.2% in the DCP group, very, very lower than 12.5% in the NCB group with very significant p-value. From the table, also you can see there was no significant difference in terms of the cardiac death, TLF without PMR, periplegic myocardial infarction, and also clinical-driven TLR. On the other hand, you also can see the tidal vessel myocardial infarction was 5.6% in the DCP group compared to 10.9% in the NCB group, mainly driven by high rates of spontaneous myocardial infarction in the NCB group. So, this is the final curve show the very early separation of two lines studying, I think it's because of the high rate of myocardial, periplegic myocardial infarction by one-year follow-up, so very high rate of one-year tidal lesion failure in the NCB group. Also, we performed subgroup analysis, so from the table, there was no interaction between subgroups, but inside the group analysis, so we can find probably patient aged 60 years or greater, non-left-map biofugality, non-introvascular image-guided biofugality study will benefit more from the DCP, but this is the subgroup analysis, I think we could not reach the final conclusion about the post-hoc analysis. I think it will be very important for us to design next clinical trial. So, in general, in question, DCP biofugality is the first part of the RCT to compare DCP with NCB during provisional study in a large population with simple coronary biofugality lesion. Standing memory of a sub-branch DCP results in a lower one-year rate of tidal lesion failure than standing memory of a sub-branch NCB. The high rate of myocardial infarction did not lead to reverse secularization. I think the clinical significance is unclear, maybe due to a naturally very low TLR rate among patients with simple coronary biofugality lesion. So, the paper was already published in JAG when I presented it at TCT, so thank you very much. Well, congratulations on the trial. I think it's a hot topic, the DCP, and particularly for bifurcation. And it's difficult to design the trials. And I'm interested, there's two school of thoughts, right? DCP is the last application, but in your study you went back after. How did you decide that? I'm glad to be invited to the meeting, and she will not be able to get on. Alan, can you mute yourself? Alan, can you go on silent? That's when she may not start the meeting. Alan, can you mute yourself? Sorry, sorry. Yeah, so just the decision to have the decision for the DCP before the kissing versus the last, you know, getting a good optimization, and then a low-pressure DCP delivery. Yeah, actually, thanks for your question again. Yeah, actually, you know, from the study design, we study merversal firstly. So, I think also there is another option. It means before studying merversal, we can use a DCP for sub-branch. But for this study design, you know, keep the SAOP of prominence learning technique. We don't want to put more study in sub-branch to follow the SAOP of prominence learning technique. So, this is why we need to study merversal first. And if there is a requirement, we can deploy same study in sub-branch. I think for this study design, one very important thing is that before the conduction of the study, we measured how much amount of the drug could be scratched by merversal struts. In our paper, we provided the exact data in our supplemental materials. So, finally, we found very small particles, almost probably 15% of the drug could be scratched by the merversal struts. So, this is why we use a DCP for sub-branch after studying merversal. Secondly, you know, after the DCP to do casein boolean inflation using two NCB boolean, one in merversal, another one in sub-branch. So, probably another concern about the NCB to affect the drug penetration filtration into the vascular wall. I think almost there are three or four previous clinical trials to show of the DCP, we can use the NCB to post-dilate by a very low pressure, as you said. This is the key point. Is that for your question? Yes. Yes. No, exactly. Because, you know, with the introduction into the U.S., it's sort of more of an application balloon, and you don't use it for the actual modification of the vessel, or to post-dilate stents, or to optimize. So, it's just where you put it in the algorithm for these trials is very interesting. Was there a need to do casein booleans after DCP, Shaoling? Did you need to do that after you do DCP? Because going back again, you can again produce... Yes. It was a 98%, I think, in this trial. And do you have any theories? Oh, no, the connection, sorry. Because of the periprocedural MI difference, it really doesn't make a lot of sense that the DCP would be lower. Were there differences in the diameter, or the deployment pressures, or anything else? Or you think it was chance? Or how do you explain that? Yeah, I think a low MI rate in DCP group is multifactorial. I think one thing is that, as you said, probably we inflate sub-branches using DCP at a relatively low pressure. I think this is one. The second one, I think, probably is because we used the party test of elutine boolean. So, from the previous experimental and clinical trial, both reported low rate of myocardial infarction after DCP RCT. But I think we still need more basic science and clinical trial to confirm our findings.

drug-coated balloons

coronary bifurcation lesions

randomized clinical trial

myocardial infarction

provisional slanting technique