Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM® stent: the randomised, multicentre, open-label, controlled POLBOS II trial
| Autor: | Sławomir Dobrzycki, Radoslaw Formuszewicz, Jacek Bil, Patrick W. Serruys, Luis A Iñigo Garcia, Tomasz Pawłowski, Joanna J. Wykrzykowska, Robert J. Gil, Adam Kern, Dobrin Vassilev, Maik J. Grundeken |
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| Přispěvatelé: | Cardiology |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Target lesion Acute coronary syndrome medicine.medical_specialty medicine.medical_treatment Myocardial Infarction Coronary Artery Disease 030204 cardiovascular system & hematology Coronary Angiography Coronary artery disease 03 medical and health sciences 0302 clinical medicine Restenosis Internal medicine medicine Clinical endpoint Humans 030212 general & internal medicine Myocardial infarction Acute Coronary Syndrome Aged Sirolimus business.industry Coronary Stenosis Stent Drug-Eluting Stents Middle Aged medicine.disease Treatment Outcome Cardiology Female Cardiology and Cardiovascular Medicine business Mace |
| Zdroj: | EuroIntervention, 12(11), e1404-e1412. EuroPCR |
| ISSN: | 1969-6213 1774-024X |
| DOI: | 10.4244/eijy15m11_11 |
| Popis: | AIMS The aim of the POLBOS II randomised trial was to compare any regular drug-eluting stents (rDES) with the dedicated bifurcation sirolimus-eluting stent BiOSS LIM for the treatment of coronary bifurcation lesions. The secondary aim was to study the effect of final kissing balloon inflation (FKBI) on clinical outcomes. METHODS AND RESULTS Between December 2012 and December 2013, 202 patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with an rDES (n=100). Coronary re-angiography was performed at 12 months. The primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target lesion revascularisation (TLR) at 12 months. The target vessel was located in the left main in one third of the cases (35.3% in BiOSS and 38% in rDES). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p |
| Databáze: | OpenAIRE |
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