Robert J Gil1, Jacek Bil2, Vladimír Džavík3, Dobrin Vassilev4, Adam Kern5, Radoslaw Formuszewicz6, Małgorzata Zalewska-Adamiec7, Sławomir Dobrzycki7. 1. Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland; Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland. Electronic address: scorpirg@gmail.com. 2. Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland. 3. Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada. 4. Alexandrovska University Hospital, Sofia, Bulgaria. 5. Faculty of Medical Sciences, University of Varmia and Masuria, Olsztyn, Poland. 6. 10th Clinical Military Hospital, Bydgoszcz, Poland. 7. Department of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland.
Abstract
BACKGROUND: Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. The aim of the Polish Bifurcation Optimal Stenting I (POLBOS I) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert (Balton, Poland). The second aim was to study the effect of final kissing balloon (FKB) inflation on clinical outcomes. METHODS:Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies: BiOSSExpert stent or rDES implantation. Coronary angiography was performed at 12 months. The primary end point was a composite of cardiac-related death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months. RESULTS: The BiOSS Expert was implanted in 120 patients (49.4%), and an rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In the rDES group, 38.2% received paclitaxel-eluting stents. There were 3 stent implantation failures (2 in the rDES group and 1 in the BiOSS Expert group). Side branch treatment with an rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P = 0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group (11.5% vs 7.3%; P = 0.02). Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert (8.1% vs 13.2%; P < 0.05) and rDES groups (4.9% vs 9.5%; P < 0.05). CONCLUSIONS:MACE rates were comparable between the 2 groups; however, the TLR rate was higher in the BiOSS Expert group. A more aggressive protocol yielded better angiographic and clinical outcomes.
RCT Entities:
BACKGROUND: Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. The aim of the Polish Bifurcation Optimal Stenting I (POLBOS I) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert (Balton, Poland). The second aim was to study the effect of final kissing balloon (FKB) inflation on clinical outcomes. METHODS: Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies: BiOSS Expert stent or rDES implantation. Coronary angiography was performed at 12 months. The primary end point was a composite of cardiac-related death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months. RESULTS: The BiOSS Expert was implanted in 120 patients (49.4%), and an rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In the rDES group, 38.2% received paclitaxel-eluting stents. There were 3 stent implantation failures (2 in the rDES group and 1 in the BiOSS Expert group). Side branch treatment with an rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P = 0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group (11.5% vs 7.3%; P = 0.02). Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert (8.1% vs 13.2%; P < 0.05) and rDES groups (4.9% vs 9.5%; P < 0.05). CONCLUSIONS: MACE rates were comparable between the 2 groups; however, the TLR rate was higher in the BiOSS Expert group. A more aggressive protocol yielded better angiographic and clinical outcomes.
Authors: Robert J Gil; Tomasz Pawłowski; Jacek Legutko; Maciej Lesiak; Adam Witkowski; Mariusz Gąsior; Adam Kern; Jacek Bil Journal: Medicine (Baltimore) Date: 2019-04 Impact factor: 1.817
Authors: Robert J Gil; Jacek Bil; Ricardo A Costa; Katarzyna E Gil; Dobrin Vassiliev Journal: Int J Cardiovasc Imaging Date: 2016-06-17 Impact factor: 2.357
Authors: Jacek Bil; Robert J Gil; Adam Kern; Luis A Inigo-Garcia; Radoslaw Formuszewicz; Slawomir Dobrzycki Journal: Postepy Kardiol Interwencyjnej Date: 2018-09-21 Impact factor: 1.426