Opting for drug-coated balloons (DCBs) over drug-eluting stents (DESs) may prove to be a favourable approach in complex percutaneous coronary intervention (PCI) cases, the latest evidence from the SELUTION DeNovo trial suggest.
Simon Eccleshall (Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK), a co-principal investigator in the trial, presented evidence from a SELUTION DeNovo sub-study at EuroPCR 2026 (19–22 May, Paris, France) focusing on the patients whose PCI was deemed ‘complex’—including the need for treatment of all three coronary vessels, complex bifurcation lesions or device length exceeding 60mm.
SELUTION DeNovo is a prospective, randomised, open-label, multicentre trial, comparing a DCB treatment strategy with the Selution SLR drug-eluting balloon (DEB) to a systematic DES strategy amongst a broad, all-comers population with de novo coronary lesions between 2–5mm.
At one year, the trial’s primary endpoint, target vessel failure (TVF)—comprising cardiac death, target-vessel myocardial infarction (MI), or clinically driven target vessel revascularisation—occurred in 5.3% of the DEB strategy group and 4.4% of the DES strategy group, meeting non-inferiority criteria. Investigators will follow outcomes out to five years with a potential to test for the superiority of the DEB over the DES-first strategy.
“What we were interested in for this subgroup analysis was, when stents really start struggling, does the balloon have a role there to help us both short term and long term,” Eccleshall said at EuroPCR, setting out some of the thinking as to why DCBs may be a preferred option in these complex cases. “If the balloons can deliver the drug so we still don’t have the same problems with restenosis, can they reduce the complexity of the procedure that we’re actually doing, and will this give us perhaps a better safety profile acutely as well as perhaps a lower restenosis rate in the long term?”
A total of 3,323 patients were treated in the trial overall, with 835 meeting the criteria for complexity set out by the investigators. Of these, 421 were treated in the DEB strategy arm and 414 in the DES strategy arm. At one year, the TVF endpoint occurred in 7.2% of complex patients in the DEB strategy arm, compared to 10.2% of patients in the DES strategy group.
“The thing I draw your attention to here is that the curves are instantly quite far apart and they don’t then seem to either come together or move further apart; they remain parallel throughout the year, which we think is of interest,” commented Eccleshall.
Breaking the endpoint down further by component, he detailed that rates of clinically driven target vessel revascularisation (4.3% vs. 4.1%) were similar between the two groups.
“In a lot of balloon trials, there seems to be more clinically driven TVR, and here we seem to see virtually identical results,” Eccleshall said. The difference between the two approaches was largely borne out in differing rates of cardiac death, which stood at 0.7% for patients in the DEB strategy arm and 1.9% of patients in the DES strategy arm, alongside a significantly larger incidence of target-vessel MI in the DES strategy group (7.5%) than in the DEB strategy cohort (2.6%). In addition, the very early separation of the event rates is driven by peri-procedural MI, again suggesting that a balloon-based approach not only simplifies these complex lesions but may provide a better safety profile.
Unlike prior DCB trials, randomisation in SELUTION DeNovo occurred after target lesions were considered suitable for either strategy and prior to lesion preparation, allowing operators to commit to a strategy rather than reacting to procedural results. In the DEB arm operators were given the option to perform provisional stenting if needed for vessel threatening dissection or more than 30% residual stenosis. Investigators reported that provisional stenting was performed in 20.7% of patients in the DEB strategy arm, with Eccleshall noting at EuroPCR that this occurred more frequently in patients undergoing complex PCI (35%).
“I think what we’re talking about here is the concept of the more complex it becomes—the more difficult the angioplasty—you may cross over to a stent more often, but patients that have two-thirds less stents in overall are still doing better in the acute phase because we’re keeping it simpler,” Eccleshall said on this point.
