What is the clinical evidence from this study?

Study design: Cohort. Population: Coronary artery disease (n=487). Intervention: SELUTION Sustained Limus Release sirolimus-coated balloon (SEL SCB) vs. SeQuent Please / NEO paclitaxel-coated balloon (SEQ PCB). Primary outcome: Target lesion failure (composite of cardiac death, target vessel MI, and target lesion revascularization) at 12-month follow-up (aHR 0.97, 95% CI 0.37-2.52).

April 1, 2026

A novel sirolimus-coated balloon versus a paclitaxel-coated balloon for coronary artery disease: the SELSEQ registry

Key Result

PCI with a novel sirolimus-coated balloon yielded similar 12-month rates of target lesion failure compared to a paclitaxel-coated balloon (4.3% vs. 4.0%; aHR 0.97; 95% CI 0.37-2.52).

Key Points

To evaluate the clinical outcomes of a novel sirolimus-coated balloon versus a paclitaxel-coated balloon after percutaneous coronary intervention.
Included all-comer patients undergoing PCI with SEL SCB or SEQ PCB for de novo lesions and in-stent restenosis.
Conducted an observational, retrospective cohort study at two Italian centers from January 2021 to December 2024.
Primary endpoint measured was target lesion failure at 12-month follow-up using inverse probability of treatment weighting for adjustments.
A total of 487 patients with 589 lesions were included, 250 treated with SEL SCB and 237 with SEQ PCB.
The 12-month target lesion failure rate was similar between SEL SCB (4.3%) and SEQ PCB (4.0%).
No significant differences found for cardiac death, target vessel myocardial infarction, or target lesion revascularization.

Study Design

Type

Cohort (n=487)

Multicenter

Yes

Structured PICO

Does a sirolimus-coated balloon improve target lesion failure compared to a paclitaxel-coated balloon in patients undergoing percutaneous coronary intervention for coronary artery disease?

Population

487 consecutive all-comer patients (589 lesions) undergoing percutaneous coronary intervention (PCI) for both de novo lesions and in-stent restenosis at two Italian centers.

Intervention

Sirolimus-coated balloon (biodegradable polymer microsphere) during percutaneous coronary intervention.

Comparator

Paclitaxel-coated balloon (iopromide-based) during percutaneous coronary intervention.

Outcome

Target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR) at 12-month follow-up.composite

A novel sirolimus-coated balloon demonstrated comparable 12-month clinical outcomes to a standard paclitaxel-coated balloon in patients undergoing PCI for de novo lesions and in-stent restenosis.

Main Result

Effect estimate: aHR 0.97 (95% CI 0.37-2.52)

Absolute Event Rate: 4.3% vs 4%

Abstract

Abstract Background SELUTION Sustained Limus Release (SEL, MedAlliance, Nyon, Switzerland) is a novel biodegradable polymer microsphere sirolimus-coated balloon (SCB) characterized by sustained coronary artery drug retention. A head-to-head comparison to currently available paclitaxel-coated balloons (PCB) is lacking. Objective To compare clinical outcomes after percutaneous coronary intervention (PCI) with SEL SCB and iopromide-based SeQuent Please / NEO (SEQ, B. Braun, Melsungen, Germany) PCB. Methods Consecutive all-comer patients undergoing PCI with SEL SCB or SEQ PCB for both de novo lesions and in-stent restenosis between January 2021 and December 2024 at two Italian centers were included in this observational, retrospective, investigator-initiated cohort study. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR) at 12-month follow-up. Inverse probability of treatment weighting (IPTW) was applied to adjust for baseline differences. Results A total of 487 patients (589 lesions) were included: 250 patients (302 lesions) treated with SEL SCB and 237 patients (287 lesions) with SEQ PCB. At a median follow-up of 403 223–617 days, the 12-month rate of TLF was similar between SEL SCB and SEQ PCB (4.3% vs. 4.0%; adjusted hazard ratio aHR: 0.97; 95% confidence interval CI: 0.37–2.52) (Figure 1). No significant differences were observed in cardiac death (aHR: 2.84; 95% CI: 0.53–15.3), target vessel MI (aHR: 0.21; 95% CI: 0.03–1.79), or TLR (aHR: 1.23; 95% CI: 0.21–7.19). Results were consistent across prespecified subgroups (Figure 2). Conclusions The SELSEQ study suggests comparable clinical outcomes at 12-month follow-up among patients undergoing PCI with the biodegradable polymer microsphere SEL SCB and the iopromide-based SEQ PCB.For image description, please refer to the figure legend and surrounding text. For image description, please refer to the figure legend and surrounding text.

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