For the better part of a decade, the role of intravascular imaging in PCI and peripheral intervention has been organized around the stent. Image before the stent to size the vessel and characterize the lesion. Image after the stent to confirm expansion, apposition, and edge dissection.

The 2025 ACC/AHA/ACEP/NAEMSP/SCAI Acute Coronary Syndromes Guideline elevated imaging guidance for complex PCI to a Class I recommendation. The 2024 ESC Chronic Coronary Syndromes Guideline did the same. The big randomized trials — RENOVATE-COMPLEX-PCI, ILUMIEN IV, OCTIVUS, OCCUPI, IVUS-ACS, DKCRUSH VIII — all used stent placement as the procedural anchor.

The 2026 trial readout calendar shows the anchor moving. The drug-eluting balloon category is maturing fast in both coronary and peripheral indications, and the device decision tree is getting more branches.

What SirPAD and SELUTION DeNovo actually said

SirPAD was presented at ACC 2026 in March. Sirolimus-coated balloon angioplasty versus plain uncoated balloon angioplasty in symptomatic peripheral artery disease. The sirolimus arm reduced major adverse limb events and repeat revascularization, with no difference in safety outcomes. SCAI coverage described the readout as a meaningful advance in PAD treatment.

SELUTION DeNovo, presented at SCAI Scientific Sessions 2026 in April, compared a sirolimus-eluting balloon strategy against drug-eluting stents in patients with NSTEMI or unstable angina. A DEB strategy showing competitive outcomes against DES in acute coronary syndromes is a notable extension of the modality’s clinical envelope.

Together with earlier paclitaxel-coated balloon evidence in femoropopliteal disease and the broader RANGER and IN.PACT trial families, the drug-eluting balloon category has graduated from a salvage tool for in-stent restenosis to a primary treatment option in multiple anatomical contexts.

Why the device decision tree gets more imaging-dependent

When the only meaningful procedural decision is which stent to deploy, the imaging pullback answers a relatively narrow set of questions. Sizing, lesion length, calcium burden enough to indicate preparation, post-deployment apposition and expansion. The DEB option changes the question set.

DEBs work best in specific anatomical and procedural conditions. The lesion needs to be adequately prepared with predilatation. Residual stenosis after prep should be acceptable. Significant flow-limiting dissection is a contraindication to leaving a balloon-treated lesion without a scaffold. Calcium burden affects both drug uptake and the mechanical adequacy of the prep. Vessel sizing relative to balloon diameter influences drug delivery and acute lumen gain.

Each of those decision inputs is something the angiogram describes poorly and that intravascular imaging describes well. Imaging-derived calcium arc and thickness. Dissection grading on OCT. Minimal lumen area on IVUS. Lumen gain post-prep relative to reference vessel diameter. The operator who is weighing stent versus DEB needs more imaging information at the prep step than the operator who is committed to stenting from the start.

The same dynamic plays out in peripheral. Imaging-guided BTK intervention has been building an evidence base — the 2024 multispecialty consensus, the Medicare retrospective showing IVUS-associated reductions in amputation and acute limb ischemia, the propensity-matched Japanese cohort. The SirPAD readout adds another reason to characterize the lesion thoroughly before deciding on the device strategy. A DEB-first approach to PAD requires the operator to know the calcium morphology, the true vessel diameter, and the post-prep result with enough confidence to forgo the scaffold.

The structural implication

For most of the last decade, intravascular imaging in the cath lab and the vascular lab has been treated as a quality-improvement layer. The imaging makes the stent placement better. The randomized trials demonstrated that benefit and the guidelines codified it. Adoption still lags the evidence in both coronary and peripheral, mostly because of reimbursement architecture and operator-specialty variation that have been written about extensively.

The DEB maturation reframes the workflow question. When the device decision is itself imaging-dependent — when the angiogram cannot reliably distinguish a good DEB candidate from a patient who needs a stent — imaging stops being a quality layer and starts being a precondition for rational device selection. That is a different kind of necessity than the one the outcomes trials established.

This is similar in shape to the calcium-modification-selection shift that showed up at EuroPCR 2026. The ShortCUT IVUS substudy showed that lithotripsy and cutting balloon perform differently depending on calcium morphology and preparation sequence. The right modality for a given lesion can only be selected by characterizing the calcium first, which only the imaging can do. The DEB category extends that same logic to the stent-versus-no-stent decision itself.

What to watch through the rest of 2026

Three threads.

First, whether the appropriate-use criteria and society guidance documents start codifying imaging characterization as a precondition for DEB strategy selection. Right now the DEB literature describes lesion preparation requirements in general terms. If documents emerge that specify imaging-defined thresholds for dissection grade, residual stenosis, or calcium arc above which a stent is required, the imaging becomes formally load-bearing rather than informally so.

Second, whether the imaging vendors begin tailoring their software analytics to the DEB decision workflow. The current generation of AI-assisted image interpretation is largely organized around stent optimization. Algorithms that help the operator decide stent versus DEB at the prep step would be a different product category.

Third, whether the DEB platform vendors themselves push for imaging integration. Companies whose commercial success depends on operators choosing balloons over stents have an incentive to make the imaging part of the decision as fast and accurate as possible. The Selution, Ranger, IN.PACT, and other DEB programs have not historically marketed alongside imaging. That could shift.

The intravascular imaging category has spent years arguing for adoption on outcomes grounds. The drug-eluting balloon category may end up being the workflow event that makes imaging structurally necessary in a way the outcomes argument alone never quite achieved. The clinical evidence for DEBs is the door. The imaging requirement comes along behind it.

Citations

1. SirPAD trial. Sirolimus-coated balloon angioplasty versus uncoated balloon angioplasty in symptomatic peripheral artery disease. Presented at ACC 2026, March 30, 2026. SCAI ACC 2026 coverage.

2. SELUTION DeNovo (ACS subset). Sirolimus-eluting balloon versus drug-eluting stents in NSTEMI/unstable angina. Presented at SCAI Scientific Sessions 2026, April 2026.

3. Secemsky EA, et al. Intravascular Ultrasound Use in Peripheral Arterial and Deep Venous Interventions: Multidisciplinary Expert Opinion from SCAI/AVF/AVLS/SIR/SVM/SVS. JSCAI / JVIR / JVS-VI, January 9, 2024.

4. Baron S. Intravascular lithotripsy vs. cutting balloon by calcium type: IVUS substudy of the ShortCUT trial. Presented at EuroPCR 2026, Paris, May 19, 2026.

5. Rao SV, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes. J Am Coll Cardiol. 2025;85:2135-2237.

6. Vrints C, et al. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024;45:3415-3537.

7. VIVA 2025 Late-Breaking Clinical Trials, Disrupt PAD BTK II one-year outcomes. November 2025.

8. ACC Cardiology Magazine “Peripheral Matters.” Medicare retrospective analyses of peripheral IVUS, July 2024.