"Hi everyone. My name is Miravat Alasnag. I'm an interventional cardiologist practicing in Saudi Arabia, and I’m here today to discuss with you three very important trials presented at EuroPCR here in Paris. And I think these are going to be the most impactful on our practice and some we’ve been waiting for, for quite some time.
EBC TWO Five Year Follow-Up: Two-Stent Vs One for Large Bifurcation Lesions
The first is a coronary trial. This is the EBC two five-year outcomes. Now, this is the trial where we already had the twelve-month results previously reported, and it looked at a stepwise provisional strategy compared with a systemic two stent culotte strategy. And they enrolled approximately 200 patients in each arm, and they looked at side branches that were, that fulfilled the criteria of the definition two trial. Basically, those that were longer than 10mm, bigger than 2.5 in diameter, and the primary endpoint was really a composite of all-cause death, myocardial infarction and target vessel revascularization. And the results that were reported at twelvemonths were persistent into the five-year results that were presented here at EuroPCR. So there really was no real difference. And interestingly, they did look at lesions that were5mm and less or 5mm and more in the side branch. And again, the results remained consistent without differences in target vessel revascularization, MI, or all cause death. What the trial does not tell us is the use and uptake of intravascular ultrasound, the use of more potent p2y12 inhibitors. The majority of the patients were actually on Clopidogrel, and of course, the more contemporary and more developed culotte technique such as the, that is the DK culotte technique, which is an evolution of the standard culotte, which was started five years ago when this trial was initiated.
BASILICA Vs Chimney-Stenting for TAVR-Related Coronary Obstruction
So the second trial I'm going to shift to is actually one of the structural trials. And it's very important because many of us, the uptake of coronary protection during transcatheter aortic valve replacement is increasing. The two procedures that are commonly undertaken are either a chimney where we end up stenting the coronary arteries after deploying the transcatheter heart valve, and the other procedure is leaflet laceration, I.e. the basilica. So, it was observational. And they looked at, in terms of basilica, they looked at single leaflet versus two leaflet. The majority ended up getting both leaflets lacerated during the procedure, and the chimney where they looked at left main stenting alone, right coronary artery stenting alone, or both, and the larger number ended up getting stenting in both. And that was up front. Now they looked at the outcomes and overall the hard endpoints were similar between both the chimney and the basilica, bearing in mind that other outcomes, such as paravalvular leak, pacemaker requirement and so on, were slightly higher with the chimney procedure. What that actually means in the future, we don’t really know, because this was a small observational trial. Are we ever going to have randomized trial that is, multicenter will be difficult, primarily because these are niche procedures that cannot be replicated in every center and really do require a very high level of expertise.
KISS: Provisional Stenting in Bifurcation Lesion: Benefit of Side Branch Intervention
The last trial that is also very interesting. I’m going to shift right back to the coronaries is really the KISS trial and this looked at non left main bifurcations and looked at a more conservative approach or no intervention. For the side branch, which had to be bigger than 2.25 mm as opposed to performing a pot kiss repot or some kind of kissing balloon. Inflation involving the side branch and looking at outcomes in these patients. So looking at immediate success, procedural success, looking at use of contrast and time and turnover, which was very similar between them, but also looking at harder endpoints such as target vessel revascularization. Of course, this was again a smaller trial, it was a very short-term follow-up. It would be very interesting to see if we have longer follow up of these patients and if we're going to have higher incidence of spontaneous myocardial infarctions, for example. But it will also be important to replicate a very similar study when we're looking at left main bifurcations because again, this really only looked at non left main bifurcations.”