A narrowed coronary artery can be widened without a permanent metal scaffold remaining in the vessel. This is made possible by a drug-eluting balloon (DEB), which delivers the active substance sirolimus directly into the vessel wall and is then removed again. At the TCT congress 2025, SELUTION DeNovo was presented as the largest randomised trial to date on this procedure for first-time narrowings. The result: in carefully selected patients, the balloon strategy can match stent treatment. We at Dein Team Herzzentrum in Zürich set out here what this means for you in concrete terms.
What does stent-free coronary treatment with the SELUTION DEB mean?
In a stent-free coronary treatment, the narrowed coronary artery is widened with a drug-coated balloon. The SELUTION DEB carries a sirolimus coating that passes into the vessel wall during inflation and inhibits renewed narrowing there. The balloon is then fully withdrawn. No implant remains in the vessel. A stent is used only if the result of the dilatation is inadequate (so-called bail-out). In the SELUTION DeNovo trial with more than 3,300 patients, the rate of target vessel failure after one year was 5.3 percent in the balloon group compared with 4.4 percent in the stent group. The balloon strategy was therefore non-inferior to stent treatment [Spaulding TCT 2025]. The procedure is suitable above all for first-time narrowings and smaller vessels. We assess suitability individually.
How the drug-coated balloon works
A drug-eluting balloon (DEB), also called a drug-coated balloon (DCB), is an ordinary balloon catheter with a layer of active substance on its outer surface. The procedure in four steps:
- The catheter is advanced via the groin or the wrist to the narrowed section.
- The balloon is inflated at the narrowed site for a short time.
- On contact with the vessel wall, the coating releases the active substance sirolimus. Sirolimus slows the cell growth that could otherwise lead to renewed narrowing.
- The balloon is deflated and withdrawn. The vessel remains free of foreign material.
The SELUTION technology releases the active substance gradually via so-called MicroReservoirs. Sirolimus is thus intended to act in the vessel wall over several weeks.
What does the SELUTION DeNovo trial show?
SELUTION DeNovo is a prospective, randomised, multicentre trial. It compared the balloon strategy with provisional stenting against routine implantation of a drug-eluting stent (DES) in first-time coronary narrowings. The results were presented in October 2025 at the TCT congress in San Francisco by Prof. Christian Spaulding on behalf of the study group [Spaulding TCT 2025].
| Feature | Detail |
|---|---|
| Study type | Prospective, randomised, multicentre |
| Participants | more than 3,300 patients |
| Comparison | SELUTION DEB (balloon) versus DES (stent) |
| Primary endpoint | Target vessel failure (TVF) at 12 months |
| TVF balloon group | 5.3 percent |
| TVF stent group | 4.4 percent |
| Statistical result | Non-inferiority demonstrated |
| Follow-up | planned for up to 5 years |
The primary endpoint, target vessel failure, combines cardiac death, myocardial infarction in the target vessel and clinically driven repeat treatment of the target vessel. The rates for serious individual events such as cardiac death were low and comparable in both groups [Spaulding TCT 2025].
A subanalysis in patients with acute coronary syndrome (NSTEMI and unstable angina) was presented in 2026 at the SCAI sessions. Here too, the balloon strategy was non-inferior to stent treatment after one year, with a TVF rate of 5.3 percent versus 4.9 percent. Additional stent implantation as a bail-out was needed in about one in five procedures in this group [SCAI 2026].
How do the procedure and aftercare work?
In its first steps, the procedure resembles an ordinary cardiac catheterisation. Via the wrist or the groin, we guide the catheter to the narrowed section. Before the drug-coated balloon is used, the narrowing is usually prepared with an ordinary balloon so that the active substance later reaches the vessel wall evenly. Only then does the SELUTION DEB follow. We observe the result on the X-ray image. If blood flow is good and the vessel is stable, the balloon treatment stands on its own. If the result is inadequate, we place a stent as a safeguard.
After the procedure, depending on your situation, you remain under observation for a few hours up to one day. Essential for long-term success are the prescribed antiplatelet therapy, consistent treatment of your risk factors and regular check-ups. We record in writing which medications you take and for how long, and we discuss this with you and, where appropriate, with your family doctor.
What are the advantages of the stent-free strategy?
In suitable cases, the drug-coated balloon can offer advantages over a stent. Important: these points apply to selected findings and cannot be generalised to every narrowing.
- No permanent implant. The vessel remains free of a metal scaffold. Should a narrowing recur, all treatment routes remain open, including later stent implantation or bypass surgery.
- Preserved vessel motion. Study data suggest that the natural movement of the vessel wall (vasomotion) may be better preserved after balloon treatment than after a stent [Cortese 2024].
- Possibly shorter blood thinning. After balloon-only treatment of first-time narrowings, dual antiplatelet therapy can in some cases be shorter, sometimes around four weeks. This may be particularly relevant for people with an elevated bleeding risk [Cortese 2024].
The evidence for smaller vessels is not new. The randomised BASKET-SMALL 2 trial with 758 participants had already shown that the drug-coated balloon can match a modern stent in first-time narrowings in small vessels, regardless of bleeding risk [Jeger 2022].
Who is eligible for this treatment in Switzerland?
The stent-free strategy is particularly suitable for first-time narrowings (de novo lesions) and in smaller coronary vessels. Whether it is right for you depends on the vessel anatomy, the size and shape of the narrowing and any accompanying conditions. We make this decision after careful diagnostic work-up and in discussion with you.
The 2024 ESC guideline on chronic coronary syndromes recommends the drug-eluting stent for in-stent restenosis (recommendation IA). For first-time narrowings in small vessels, the drug-coated balloon is considered a reasonable treatment option on the basis of the available trial data [ESC 2024]. The new SELUTION DeNovo data extend this evidence base.
At Dein Team Herzzentrum in Zürich we offer the full spectrum of interventional cardiology. Billing follows the tariffs applicable in Switzerland (TARDOC, the Swiss tariff for outpatient physician services). Which costs your insurance covers is something we clarify with you transparently before the procedure.
Frequently asked questions about stent-free coronary treatment
What is a drug-coated balloon (DEB)?
A DEB is a balloon catheter with a sirolimus coating. When the narrowed artery is widened, the active substance passes into the vessel wall and inhibits renewed narrowing there. Unlike with a stent, no implant remains in the body.
Is treatment without a stent just as safe as with a stent?
The SELUTION DeNovo trial with more than 3,300 participants showed that the balloon strategy was non-inferior to stent treatment after one year. The rate of target vessel failure was 5.3 percent versus 4.4 percent. Serious events were rare in both groups [Spaulding TCT 2025].
How many patients still need a stent?
In the acute coronary syndrome subanalysis, additional stent implantation as a bail-out was needed in about one in five procedures. Around four in five patients managed without a permanent implant [SCAI 2026].
Do I have to take blood thinners after the balloon treatment?
As a rule, yes, for a limited period. After balloon-only treatment of first-time narrowings, the duration of dual antiplatelet therapy can in some cases be shorter than after a stent. We set the exact duration individually [Cortese 2024].
Which narrowings is the procedure suitable for?
Above all first-time narrowings and smaller vessels. For complex or heavily calcified findings, a stent may be the better choice. We judge this on the basis of the imaging and your overall situation.
Does Dein Team Herzzentrum offer this treatment?
Yes. We use stent-free balloon dilatation with the SELUTION DEB in suitable cases and discuss with you beforehand whether it is an option for your findings.