I enjoy a bit of emotion in the main arena — otherwise, what’s the point of being there? Just like you could watch a football match (or whatever you like) from your couch instead of going to the stadium, or stream a movie instead of seeing it at the cinema. But here, this colleague is absolutely right: there’s reason and reason to applaud. It’s one thing to celebrate a long-awaited trial showing a mortality reduction; it’s quite another to clap for the noninferiority of stent area with a noncompliant balloon (yes, that actually happened yesterday — I couldn’t believe my ears). I had the same thought at the ESC: at one point, people started clapping for a blood pressure reduction with baxdrostat of a few mmHg. The next drug reduced it too — maybe even more — but no applause. So yes, let’s applaud, by all means… but let’s keep a sense of proportion, please. #TCT2025

The most anticipated trial at next #TCT2025 is SELUTION DeNovo. So let’s take a closer look. This study represents an important crossroads for drug-coated balloons (DCBs) in de novo lesions, since—apart from small vessels—the results so far have been far from impressive. Let’s start with the study population, which includes patients with at least one vessel to be treated, ranging from 2 to 5 mm in diameter. This means that some vessels would typically be treated with a DCB, while others would more commonly receive a drug-eluting stent (DES). Naturally, a proportion of patients initially intended for DCB treatment will end up with a stent—for example, in the case of a dissection or when, after predilatation, the operator feels uncomfortable leaving the vessel without one. This should not be interpreted as a crossover, but rather as part of the treatment strategy being tested. In fact, randomization occurs before predilatation, unlike in other studies. Investigators expect this to happen in no more than 30% of cases—which is not negligible. In other words, the trial aims to avoid stenting and pursue a “leave nothing behind” approach in about 70% of cases. Then there is the DCB itself, which is coated with sirolimus. In theory, sirolimus is not the perfect drug for this use, given its low lipophilicity. However, it has other advantages—lower cytotoxicity and stronger inhibition of neointimal proliferation. In this specific balloon, the microreservoir design is meant to retain the drug, preventing distal embolization and ensuring homogeneous drug delivery for up to 90 days. This means that negative results from previous DCB trials should not automatically be generalized to all DCBs—though this, of course, remains to be seen. Finally, the study hypothesis: noninferiority at 1 and 5 years (with 1-year results expected at TCT). If noninferiority is demonstrated, superiority will also be tested. Investigators expect a 6% event rate in both arms at 1 year and have set a noninferiority margin of 3%. Should the observed event rate be lower than expected—which, as we know, often happens in this type of trial—the margin will be tightened to 2.5%, with statistical power reduced from 95% to 90%. A smart and pragmatic choice. Moreover, the sample size is substantial: 3,326 patients, making this the largest trial ever conducted in this field. Since current guidelines recommend DCBs only for in-stent restenosis, SELUTION DeNovo has the potential to expand indications to de novo coronary lesions—potentially shifting part of the field from drug-eluting stents to drug-coated balloons, if the trial results are positive. It’s an evolving landscape, with emerging contenders such as bioadaptors and, inevitably, a comeback of bioresorbable scaffolds sooner or later.

Even though we conducted it, this is not the study that will settle the question once and for all. However, I find this result increasingly plausible and compelling: if you plan a short DAPT after PCI and wish to de-escalate, stop aspirin, not the P2Y12 inhibitor. jacc.org/doi/10.1016/j.jcin.…