ArticleClinical research in cardiology : official journal of the German Cardiac Society2026
A novel sirolimus-coated balloon versus a paclitaxel-coated balloon for coronary artery disease: the SELSEQ registry.
Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundSELUTION 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.
objectiveTo compare clinical outcomes after percutaneous coronary intervention (PCI) with SEL SCB and iopromide-based SeQuent Please/NEO (SEQ, B. Braun, Melsungen, Germany) PCB.
methodsConsecutive 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.
resultsA 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.
conclusionsThe 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.
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