For cardiology colleagues and interventional trainees.
The question
Drug-coated balloons (DCBs) have moved steadily outward from in-stent restenosis and small vessels toward de-novo disease. The open question has been whether a DCB-first strategy is safe in acute coronary syndromes, where plaque is unstable, dissection risk is real and the temptation to scaffold is strongest. The prespecified ACS analysis of SELUTION DeNovo, presented at SCAI Scientific Sessions 2026 (Montréal, 23 April 2026) and highlighted again in the ACC's July/August 2026 Cardiology magazine SCAI roundup, is the largest randomised look at that question to date.
What was done
SELUTION DeNovo randomised patients with de-novo coronary lesions to a sirolimus-eluting balloon (Selution SLR) strategy with provisional bailout stenting versus systematic drug-eluting stent implantation. The prespecified ACS substudy analysed the subgroup presenting with NSTEMI or unstable angina — reported as more than 1,000 ACS patients.
What was found at one year
| Endpoint | SEB strategy | DES | Note |
|---|---|---|---|
| Target vessel failure (primary composite) | 5.3% | 4.9% | Statistically indistinguishable; P for interaction = 0.65 |
| Cardiac death | 0.6% | 0.8% | Numerically lower with SEB |
| Target vessel MI | 3.1% | 2.8% | Numerically higher with SEB |
| Target vessel revascularisation | 3.1% | 2.7% | Numerically higher with SEB |
The interaction test is the important number: the ACS subgroup behaved no differently from the overall trial population. Procedural safety was maintained.
Provenance note: the figures above are drawn from conference presentation and secondary conference coverage rather than a peer-reviewed manuscript, and should be read as provisional pending full publication.
How to read it
This is a non-inferiority-flavoured subgroup signal at one year, not a mandate. Three caveats worth stating out loud in any teaching session:
- Bailout stenting was permitted and used. This is a DCB-first strategy, not a stent-free one. The honest description is "fewer permanent implants", not "no metal".
- One year is short for the argument being made. The theoretical case for leaving nothing behind — no stent thrombosis, no neoatherosclerosis, preserved future revascularisation options, restored vasomotion — is a late benefit argument. Equipoise at 12 months is the entry ticket, not the proof.
- Lesion preparation is the hidden variable. DCB results track closely with aggressive predilatation, dissection assessment and flow. These were experienced operators; the result may not transfer to a lower-volume setting without the same discipline.
Why it matters for central Gujarat patients
- Younger, diabetic, diffuse disease. The typical ACS patient presenting to us is a decade younger than in Western series, frequently diabetic, and often has long diffuse segments where total stent length is the problem rather than any single lesion. A DCB-first approach in the smaller, distal or diffusely diseased segments — with DES where a stent is genuinely needed — reduces total metal burden in exactly the population most likely to need repeat revascularisation over the next 20 years.
- DAPT duration and cost. Fewer permanent implants may eventually support shorter mandatory DAPT. In a population where drug cost and adherence are real constraints, and where premature DAPT discontinuation is a recurring problem, that is not a trivial benefit — though it must be said clearly that SELUTION DeNovo does not itself establish a shortened DAPT recommendation.
- Future revascularisation. A 45-year-old with multivessel disease will very likely be back in the cath lab. Keeping options open matters more here than in a 78-year-old cohort.
Bottom line
Reasonable to consider a sirolimus-DCB-first strategy with provisional stenting in selected NSTEMI/unstable angina lesions — good lesion preparation, acceptable acute result, no flow-limiting dissection — while continuing DES as default for large-vessel proximal disease, suboptimal DCB result, or anything that bails out. Watch for longer-term follow-up before changing default practice.
Sources
- ACC Cardiology Magazine, July/August 2026 — SCAI 2026 Roundup: Major Coronary, Structural and Vascular Trials From Montréal
- SCAI — Sirolimus Eluting Balloons for Patients with Acute Coronary Syndrome: Evidence from the SELUTION DeNovo Trial
- TCTMD — SELUTION DeNovo: Sirolimus DCB Safe and Effective in ACS Patients