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Background <p>SELUTION Sustained Limus Release (SEL, Cordis, Miami, Florida, USA) is a novel biodegradable polymer microsphere sirolimus-coated balloon (SCB) characterized by sustained coronary drug retention. A head-to-head comparison to currently available paclitaxel-coated balloons (PCB) is lacking.</p> Objective <p>To compare clinical outcomes after percutaneous coronary intervention (PCI) with SEL SCB and iopromide-based SeQuent Please/NEO (SEQ, B. Braun, Melsungen, Germany) PCB.</p> Methods <p>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, 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 was applied to adjust for baseline differences.</p> Results <p>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). No significant differences were observed in cardiac death, target vessel MI, or TLR (aHR: 1.23; 95% CI: 0.21–7.19). Results were consistent across prespecified subgroups and sensitivity analyses.</p> Conclusions <p>The SELSEQ study suggests comparable outcomes at 12-month follow-up among patients undergoing PCI with the biodegradable polymer microsphere SEL SCB and the iopromide-based SEQ PCB.</p> Graphical Abstract <p>SELSEQ observational, retrospective cohort study. The study compared clinical outcomes in patients with coronary artery disease treated with two different DCBs. At 12-month follow-up, the rate of the primary endpoint, that is, target lesion failure (a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization), was similar in patients treated with SELUTION SLR sirolimus-coated balloon and SeQuent Please/NEO paclitaxel-coated balloon. Outcomes are reported as aHR (95% confidence intervals). DCB: drug-coated balloon. aHR: adjusted hazard ratio.</p> <p></p>

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

  • 期刊论文

  • 发表日期：

    2026年3月9日

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  • Francesco Tartaglia,
  • Pier Pasquale Leone,
  • Mauro Gitto,
  • Alessandro Gabrielli,
  • Gianmaria Calamita,
  • Leon Gramss,
  • Ottavia F. Cozzi,
  • Valentina Bernardini,
  • Marco Luciano Rossi,
  • Gabriele Gasparini,
  • Bernhard Reimers,
  • Damiano Regazzoli,
  • Giulio G. Stefanini,
  • Antonio Mangieri,
  • Azeem Latib,
  • Antonio Colombo

摘要

Background

SELUTION Sustained Limus Release (SEL, Cordis, Miami, Florida, USA) is a novel biodegradable polymer microsphere sirolimus-coated balloon (SCB) characterized by sustained coronary 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, 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 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). No significant differences were observed in cardiac death, target vessel MI, or TLR (aHR: 1.23; 95% CI: 0.21–7.19). Results were consistent across prespecified subgroups and sensitivity analyses.

Conclusions

The SELSEQ study suggests comparable outcomes at 12-month follow-up among patients undergoing PCI with the biodegradable polymer microsphere SEL SCB and the iopromide-based SEQ PCB.

Graphical Abstract

SELSEQ observational, retrospective cohort study. The study compared clinical outcomes in patients with coronary artery disease treated with two different DCBs. At 12-month follow-up, the rate of the primary endpoint, that is, target lesion failure (a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization), was similar in patients treated with SELUTION SLR sirolimus-coated balloon and SeQuent Please/NEO paclitaxel-coated balloon. Outcomes are reported as aHR (95% confidence intervals). DCB: drug-coated balloon. aHR: adjusted hazard ratio.