Patients with non-ST-elevation myocardial infarction (NSTEMI) or unstable angina undergoing a percutaneous coronary intervention (PCI) with a sirolimus-eluting balloon and rescue stenting fared as well as those who underwent revascularization with systematic use of drug-eluting stents at 1 year, according to a new substudy of the SELUTION DeNovo trial.

The full 1-year results of the SELUTION DeNovo trial, which included 3323 patients, were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 meeting in November. The new substudy was restricted to the population with acute coronary syndrome (ACS). Of these 1082 participants, 73% were enrolled with an NSTEMI and 27% were enrolled with unstable angina.

“The strategy of minimalizing stent use in NSTEMI patients seems safe at 1 year even if the long-term benefits are so far unevaluated,” Andrew Ladwiniec, MBBS, MD, interventionalist affiliated with the University Hospitals of Leicester NHS Trust, Leicester, England, said in an interview.

Long-Term Data Needed

The long-term benefits of balloon revascularization are key. By restoring durable vessel patency without leaving stents behind, the promise is a reduction in long-term stent complications, including late thrombosis, according to Ladwiniec.

The NSTEMI substudy data were presented at the Society for Cardiovascular Angiography and Intervention (SCAI) 2026.

In the SELUTION DeNovo trial, patients were randomized to revascularization with Selution SLR sirolimus-eluting balloon (MedAlliance, an affiliate of Cordis) with rescue stenting or to a drug-eluting stent. The study has a planned follow-up of 5 years.

On the primary composite outcome of target vessel failure, which included cardiac death, target vessel-related MI, and clinically driven target vessel revascularization, the events were statistically indistinguishable even if numerically higher in the balloon arm at 1 year (5.3% vs 4.9%; P for interaction = .65).

When evaluated separately, the rate of cardiac death was numerically lower in the balloon arm (0.6% vs 0.8%), while the rates of target vessel MI (3.1% vs 2.8%) and target vessel revascularization (3.1% vs 2.7%) were higher. None of the differences were statistically significant.

The rates for the primary outcome in the population with NSTEMI or unstable angina were consistent with those of the full study population. As reported at TCT 2025, there was also a numerical disadvantage for the balloon in the SELUTION DeNovo trial overall (5.3% vs 4.4%), but this difference was within the predefined margin of noninferiority (P = .02).

As in the total population, bailout stenting in the subgroup of patients with NSTEMI and unstable angina was required in only about 20% of the procedures, when assessed per lesion (18.4%) or per patient (21%). Patient characteristics, such as age, female sex, and requirement for a multilesion intervention were similar between study arms.

The 1-year data are particularly promising because stents are thought to provide their greatest protection against restenosis early after PCI, according to Ladwiniec. With a similar rate of adverse events at 1 year, these initial results provide a basis on which to explore the hypothesis that a “leave-nothing-behind” approach will reduce risk for stent-related late complications.

Although Ladwiniec acknowledged that the full 5 years of planned follow-up will be needed to confirm that balloon revascularization with bailout stenting provides a relative benefit over systematic stenting, the safety data to date have been encouraging for at least some clinicians.

In the UK and Europe, where the experimental device is already available, Ladwiniec said clinicians are seeing a trend toward increased use.

Balloon Coating and Design May Be Critical

It is notable that results from 2004 REC-CAGEFREE I trial showed a paclitaxel-eluting balloon with rescue stenting did not meet the noninferiority threshold when compared with usual stenting. There are several potential explanations.

Unlike paclitaxel, which is an antineoplastic immunomodulating agent, the anti-inflammatory effect of sirolimus is mediated by its inhibition of the mTOR pathway. Moreover, the device evaluated in the SELUTION DeNovo trial features a microreserve technology to prolong the anti-inflammatory effect, according to the authors of a 2022 phase 1 study.

Even if long-term results do confirm the advantage of balloon revascularization with rescue stenting over routine stenting, patient selection might still be important, according to Konstantinos Voudris, MD, PhD, interventionalist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis.

“There are certain lesions and populations where stent placement is known to be suboptimal. If drug-coated balloons succeed in providing an effective and durable result without any footprint at the end, they can revolutionize the way we treat ACS,” said Voudris, who was not involved in this study.

Though the 5-year data is important to “solidify the efficiency and durability of a stent-free strategy,” he considers these substudy data helpful.

“Despite the presence of thrombus and the difference in pathophysiology between stable chronic disease and ACS, the drug-coated balloon performed equally well to stents,” Voudris told Medscape Medical News. Ultimately, these add to reassurance that a leave-nothing-behind strategy is potentially viable, he added.

Ladwiniec reported having financial relationships with Abbott Vascular, Boston Scientific, Brosmed Medical, Cordis, Biotronik, Shockwave, SMT Cardiovascular, and Teleflex. Voudris reported having no potential conflicts of interest.