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

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.