29 Oct 2025
1-year SELUTION DeNovo results: drug-eluting balloon strategy vs. systematic drug-eluting stent in de novo coronary disease
Reported from TCT 2025
Guillaume Bonnet interviews Christian Spaulding about the SELUTION DeNovo Trial he presented at TCT 2025, in San Francisco, and Salvatore Brugaletta provides his take on the clinical reading and interpretation for clinical practice.
Why this study?
Drug-eluting stent (DES) studies with long-term clinical follow-up have shown a 2.4 % annual adverse event rate. A drug-coated balloon (DCB) approach with minimal stenting is therefore seen as attractive.Whereas trials with paclitaxel DCB have produced mixed results, few data are available about sirolimus DCB.
Methodology
This was a prospective, randomised, open label multicentre non-inferiority trial that randomised 3,341 patients undergoing PCI 1:1 to a Selution sirolimus-eluting strategy (DEB) or DES strategy.DEB strategy consisted of mandatory 1:1 lesion pre-dilatation, minimum DEB inflation time of 30 seconds, and use of DES in case of residual stenosis/recoil > 30 %, dissection type C or greater, FFR < 0.80 or iFR < 0.89.Primary endpoint was 1-year TVF (cardiac death, TV-MI or CD-TVR) for non-inferiority, assuming 6 % of event rate in both arms, with 50 % of non-inferiority margin.
What is the main result?
Primary endpoint occurred in 4.4 % of patients in the DES arm vs. 5.3 % in the DEB arm, reaching the non-inferiority margin. Cardiac death, target vessel MI and clinically driven TVR were 0.7 % vs. 1.0 %; 2.7 % vs. 2.6 %, and 3.3 % vs. 2.1 % in the DEB vs. DES arm, respectively.No differences were found in terms of the safety secondary endpoints, such as all-cause death, stroke, any MI, periprocedural MI, acute/subacute lesion thrombosis, late lesion thrombosis and BARC 3-5 bleeding.A significant interaction between the two arms was found with respect of sex, high-bleeding risk and any sever or moderate calcification, favouring all DES.
Clinical reading and interpretation for clinical practice
The Selution trial represents the first randomised clinical trial comparing DEB vs. DES. Nowadays, interventional cardiologists are very much interested to this kind of technology and its use is very diffuse in our practice, so it is good to have finally some data to interpret.
Some considerations should be taken in this regard. First, it is interesting to see that 20 % of those patients randomised to DES eventually received a DES, due to huge dissection, positivity of FFR or iFR or residual stenosis/recoil: this means that we should not be dogmatic when using this technology, but think to reach the best angiographic result possible in our patient. With respect to it, the Selution trial tested the concept of treating systematically all the lesions with different strategies.
However, we know that, in clinical practice, there could be lesion more amenable to either DES (calcified lesions, ostial lesions, etc) or DCB (long lesions, side branch, small vessels, etc). This means that, beyond the Selution trial, we may still say that, in a same patient with multivessel disease, we may treat different lesions with different technologies.
Another point to make is about the statistical consideration behind the non-inferiority margin chosen by the investigators. A non-inferiority trial usually tests a new device which should be comparable to the so-called gold standard, with a non-inferiority margin, which is the one everyone should consider acceptable in clinical practice: the choice in the trial design of 50 % non-inferiority margin means that DEB was estimated effective if it would have been at least 50 % less effective than DES.
I wonder if this margin may be considered too wide or acceptable in our practice. A narrow margin would have had more clinical sense, but with important implications in increasing the sample size of the study.Eventually, the trial is powered for superiority of DEB vs. DES at 5-year follow-up so to understand if this 1-year no-inferiority will be compensated by a 5-year superiority: we need to wait until then.
Is the Selution trial going to influence the use of DEB in your practice?
Authors
2 comments
Christian Spaulding :Thanks for the comments The non inferiority margin was not 50% but 50% of the actual total event rate.We expected a 6% event rate and therefore would have had a 3% margin. The rate was 4.88% and therefore the margin was 2.44. This method accounts for less than expected event rates which is often the case in PCI studies and is recommend to avoid large margins and conclude erroneously on non inferiority (Greco A et al JACC ADV 2024).
thanks for the comment Dr. Spaulding. much appreciated!