Sirolimus-coated balloons (SCB) have been recently introduced for percutaneous coronary intervention (PCI). Nonetheless, evidence on the comparison of different SCB is scant. We aim to compare clinical outcomes after percutaneous coronary intervention with 2 different SCB. SIROMILANO is an observational, retrospective, investigator-driven cohort study conducted at 2 Italian centers, and enrolling between May 2021 and December 2023, consecutive all-comer patients treated with biodegradable polymer microsphere SELUTION SLR SCB (SLR SCB [Cordis, Miami, FL]) or phospholipid nanocarrier Magic Touch SCB (MT SCB [Concept Medical, Surat, India]) for de novo lesions or in-stent restenosis. Adjustment via inverse probability of treatment weighting was applied. Primary end point was rate of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), at 12-month follow-up. A total of 668 patients (n = 769 lesions) were enrolled, of which 204 patients were treated with SLR (n = 253 lesions, 70% [n = 178] de novo) and 464 patients with MT (n = 516 lesions, 65% [n = 338] de novo). At a median follow-up of 386 [246-606] days, the 12-month rate of TLF was similar with SLR versus MT (7.4% [n = 13] vs 10.5% [n = 35], adjusted hazard ratio [AHR] 0.67,95% confidence interval [CI] 0.34-1.33). No difference in risk of cardiac death (AHR 1.88, 95% CI 0.36-9.91), target vessel MI (AHR 1.81, 95% CI 0.13-25.3) or TLR (AHR 0.60, 95% CI 0.28-1.29) was present between groups. Among patients treated in vessels >= 3 mm in diameter (512 lesions [66.6%]), the risk of TLF at 12-month follow-up was similar between groups (AHR 0.49, 95% CI 0.23-1.06). In conclusion, SIROMILANO identified no statistically significant differences in clinical outcomes at 12-month follow-up after biodegradable polymer microsphere SLR SCB versus phospholipid nanocarrier MT SCB angioplasty among patients with coronary artery disease. (c) 2026 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
Sirolimus-Coated Balloon With Phospholipid Nanocarriers or Biodegradable Polymer Microspheres for Treatment of Coronary Artery Disease
Stefanini, GG;Colombo, A
2026-01-01
Abstract
Sirolimus-coated balloons (SCB) have been recently introduced for percutaneous coronary intervention (PCI). Nonetheless, evidence on the comparison of different SCB is scant. We aim to compare clinical outcomes after percutaneous coronary intervention with 2 different SCB. SIROMILANO is an observational, retrospective, investigator-driven cohort study conducted at 2 Italian centers, and enrolling between May 2021 and December 2023, consecutive all-comer patients treated with biodegradable polymer microsphere SELUTION SLR SCB (SLR SCB [Cordis, Miami, FL]) or phospholipid nanocarrier Magic Touch SCB (MT SCB [Concept Medical, Surat, India]) for de novo lesions or in-stent restenosis. Adjustment via inverse probability of treatment weighting was applied. Primary end point was rate of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), at 12-month follow-up. A total of 668 patients (n = 769 lesions) were enrolled, of which 204 patients were treated with SLR (n = 253 lesions, 70% [n = 178] de novo) and 464 patients with MT (n = 516 lesions, 65% [n = 338] de novo). At a median follow-up of 386 [246-606] days, the 12-month rate of TLF was similar with SLR versus MT (7.4% [n = 13] vs 10.5% [n = 35], adjusted hazard ratio [AHR] 0.67,95% confidence interval [CI] 0.34-1.33). No difference in risk of cardiac death (AHR 1.88, 95% CI 0.36-9.91), target vessel MI (AHR 1.81, 95% CI 0.13-25.3) or TLR (AHR 0.60, 95% CI 0.28-1.29) was present between groups. Among patients treated in vessels >= 3 mm in diameter (512 lesions [66.6%]), the risk of TLF at 12-month follow-up was similar between groups (AHR 0.49, 95% CI 0.23-1.06). In conclusion, SIROMILANO identified no statistically significant differences in clinical outcomes at 12-month follow-up after biodegradable polymer microsphere SLR SCB versus phospholipid nanocarrier MT SCB angioplasty among patients with coronary artery disease. (c) 2026 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
