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).
Cohort (n=487)
Sí
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?
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.
Estimación del efecto: aHR 0.97 (95% CI 0.37-2.52)
Tasa de eventos absoluta: 4.3% vs 4%
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.
Tartaglia et al. (Sun,) conducted a cohort in Coronary artery disease (n=487). SELUTION Sustained Limus Release sirolimus-coated balloon (SEL SCB) vs. SeQuent Please / NEO paclitaxel-coated balloon (SEQ PCB) was evaluated on 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). 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).
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