EPIC03-BIOSS observational prospective study. Performance analysis of the BIOSS LIM C dedicated stent in coronary bifurcation lesion angioplasty

Blanco, Bruno García del; Gomez‐Lara, Josep; Merchán, Juan Carlos Rama; Goncalves-Ramírez, Luis Renier; Irurueta, Imanol Otaegui; Peligero, Eduard Bosch; Garrido, Julio Carballo; Molinero, Jorge Palazuelos; Ramírez, Juan Antonio Bullones; Sandoval, Joan Casanova; Cuevas, José Ramón Rumoroso; Pérez, Germán Calle; Nofrerías, Eduard Fernández; Ramírez, and María Ángeles Carmona; Prado, Armando Pérez de

doi:10.24875/recice.m22000314

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“…In the EPIC3-BIOSS prospective study, 124 patients in whom the BiOSS LIM C stent was deployed were enrolled [25]. The stent was successfully deployed in 97.6% of patients, and in 14.5% of cases, a double-stenting technique was used.…”

Section: Discussionmentioning

confidence: 99%

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results

Gil,

Kern,

Bojko

et al. 2024

Biomedicines

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This multicenter, randomized study aimed to compare the sirolimus-eluting BiOSS LIM C dedicated coronary bifurcation stent with second-generation -limus drug-eluting stents (rDESs) in the treatment of non-left main (non-LM) coronary bifurcation. The deployment of a single stent in the main vessel–main branch across a side branch was the default strategy in all patients. The primary endpoint was the rate of major cardiovascular events (cardiac death, myocardial infarction, and target lesion revascularization) at 48 months. We enrolled 230 patients, allocating 116 patients to the BiOSS LIM C group and 114 patients to the rDES group. Most procedures were elective (BiOSS vs. rDES: 48.3% vs. 59.6%, p = 0.09) and performed in bifurcations within the left anterior descending/diagonal branch (BiOSS vs. rDES: 51.7% vs. 61.4%, p = 0.15). At 48 months, there were no statistically significant differences between the BiOSS and rDES groups in terms of major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) as follows: MACEs—18.1% vs. 14.9%, HR 1.36, 95% CI 0.62–2.22, and p = 0.33; cardiac death—4.3% vs. 3.5%, HR 1.23, 95% CI 0.33–4.56, and p = 0.75; MI—2.6% vs. 3.5%, HR 0.73, 95% CI 0.17–3.23, and p = 0.68; and TLR—11.2% vs. 7.9%, HR 1.66, 95% CI 0.75–3.71, and p = 0.21. The implantation success rate of the BiOSS LIM C stent was very high, and the cumulative MACE rates were promising. The POLBOS 3 trial sets an important benchmark for treating non-LM coronary bifurcations (ClinicalTrials.gov NCT03548272).

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Section: Discussionmentioning

confidence: 99%