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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, Robert J; Kern, Adam; Bojko, Krystian; Gziut-Rudkowska, Aneta; Vassilev, Dobrin; Bil, Jacek.
Afiliación
  • Gil RJ; Department of Cardiology, State Medical Institute of the Ministry of Interior and Administration, 02-507 Warsaw, Poland.
  • Kern A; Department of Cardiology and Internal Medicine, School of Medicine, Collegium Medicum, University of Warmia and Mazury, 10-719 Olsztyn, Poland.
  • Bojko K; Department of Cardiology and Internal Medicine, School of Medicine, Collegium Medicum, University of Warmia and Mazury, 10-719 Olsztyn, Poland.
  • Gziut-Rudkowska A; Department of Cardiology, State Medical Institute of the Ministry of Interior and Administration, 02-507 Warsaw, Poland.
  • Vassilev D; Medica Cor University Hospital, University of Ruse, 7017 Ruse, Bulgaria.
  • Bil J; Department of Invasive Cardiology, Centre of Postgraduate Medical Education, 01-826 Warsaw, Poland.
Biomedicines ; 12(5)2024 Apr 23.
Article en En | MEDLINE | ID: mdl-38790900
ABSTRACT
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Biomedicines Año: 2024 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Biomedicines Año: 2024 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Suiza