6‐year results of BiOSS stents in coronary bifurcation treatment

Gil, Robert; Witkowski, Adam; Formuszewicz, Radoslaw; Garcia, Luis A Iñigo; Dobrzycki, Sławomir; Vassilev, Dobrin; Bil, Jacek

doi:10.1111/eci.13555

Cited by 2 publications

(1 citation statement)

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“…Results obtained from registries, clinical randomized trials such as POLBOS 1 and POLBOS 2, as well as everyday clinical practice were deemed satisfactory. However, room for improvement remained [7][8][9]. Relatively large neointimal growths associated with thick struts (120 µm) were a reason to design a cobalt-chromium sirolimus-eluting version-the BiOSS LIM C stent [10].…”

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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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