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Featured researches published by Radoslaw Formuszewicz.
Eurointervention | 2012
Robert J. Gil; Dobrin Vassilev; Aleksandra Michałek; Adam Kern; Radoslaw Formuszewicz; Sławomir Dobrzycki; Jarosław Wójcik; Maciej Lesiak; Piotr Kardaszewicz; Andrzej Lekston
AIMS Dedicated bifurcation stents seem to be the most promising solution for treating bifurcations. The aim of our study was to present the 12 months results of a new dedicated stent for coronary bifurcation lesions -the paclitaxel-eluting stent- BiOSS® Expert (Bifurcation Optimisation Stent System, Balton, Warsaw, Poland). METHODS AND RESULTS Sixty-three patients with 65 lesions were enrolled in the registry. Forty-six % of the patients were classified as NSTEMI or unstable angina, 27% were diabetics, 30% had previous myocardial infarction and 48% had a history of previous revascularisation. In addition, hypertension and dyslipidaemia were the most common risk factors (58% and 40%). Sixty-five stents were successfully implanted (100% device success rate). The analysis of 30 days follow-up for 63 patients revealed good clinical results showing lack of death, target lesion revascularisation procedures (TLR) and target vessel revascularisation procedures (TVR). There were six (9,5%) cases of in-hospital raised troponin, however, only one showed an additional increase in CK-MB levels and was qualified as non-Q myocardial infarction (MI). There was a need for percutaneous coronary intervention (PCI) in a non-index vessel in one patient due to exertional angina. The analysis of 12-month follow-up for 63 patients revealed good clinical results. There were two (3.2%) cases of death (three and 10 months after index procedure). The first patient, in good physical shape, drowned, while the second was found dead by his family. There were no incidents of MI or stroke in the rest of the population. At 12 months there were seven (10.8% per lesion; 11.1% per patient) cases of TLR and nine (13.8% per lesion; 14.3% per patient) TVR. There were also 15 (23.8%) cases of PCI on vessels not related to BiOSS® Expert stent implantation. CONCLUSIONS Our registry showed that bifurcation treatment with a single dedicated paclitaxel-eluting bifurcation stent, BiOSS® Expert is feasible and successful. The long-term clinical results are satisfactory in this high-risk patient population.
Eurointervention | 2016
Robert J. Gil; Jacek Bil; Maik J. Grundeken; Adam Kern; Luis A. Iñigo Garcia; Dobrin Vassilev; Tomasz Pawłowski; Radoslaw Formuszewicz; Sławomir Dobrzycki; Joanna J. Wykrzykowska; Patrick W. Serruys
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<0.05). CONCLUSIONS MACE rates as well as TLR rates were comparable between the BiOSS LIM and rDES. At 12 months, cumulative MACE incidence was similar in both groups (11.8% vs. 15%), as was the TLR rate (9.8% vs. 9%). Significantly lower rates of restenosis were observed in the FKBI subgroup of the BiOSS group.
Journal of the American College of Cardiology | 2016
Robert J. Gil; Jacek Bil; Dobrin Vassilev; Adam Kern; Natalia Pietraszek; Matylda Kaźmierska; Kamil Humaidi; Maciej Bobko; Luis A. Iñigo-García; Radoslaw Formuszewicz; Sławomir Dobrzycki
The aim of this study was to analyze the outcome predicting factors and long-term results of patients enrolled into two randomized clinical trials POLBOS I (5-year follow-up,[NCT02192840][1]) and POLBOS II (3-year follow-up,[NCT02198300][2]). The BiOSS (Balton, Poland) stent is a coronary bottle-
Cardiology Journal | 2013
Robert J. Gil; Jacek Bil; Adam Kern; Luis A. Iñigo Garcia; Radoslaw Formuszewicz; Sławomir Dobrzycki; Dobrin Vassilev; Agnieszka Segiet
BACKGROUND Coronary bifurcation treatment poses a therapeutic challenge. The aim of this study was to analyze pooled data of two randomized clinical trials, POLBOS I and POLBOS II, to compare 1-year follow-up results and identify possible prognostic factors. METHODS In POLBOS trials dedicated bifurcation BiOSS® stents were compared with regular drug eluting stents (rDES) in patients with stable coronary artery disease or non ST-segment elevation acute coronary syndrome (POLBOS I: paclitaxel eluting BiOSS® Expert vs. rDES; POLBOS II: sirolimus eluting BiOSS® LIM vs. rDES). Provisional T-stenting was the default strategy. Angiographic control was performed at 12 months. The primary endpoint was major adverse cardiovascular events (MACE) rate defined as the rate of cardiac death, myocardial infarction (MI) or target lesion revascularization (TLR). RESULTS 445 patients, with 222 patients in the BiOSS group and 223 patients in the rDES group, were analyzed. In 26.7% cases procedures were performed within distal left main, and true bifurca-tions which accounted for 81.6% of treated lesions. At 12 months the whole population exhibited no statistical differences in terms of MACE, TLR, MI or cardiac death between rDES and BiOSS groups. In multivariate analysis odds for MACE decreased with female sex (OR 0.433, 95% CI 0.178-0.942, p = 0.047) and with proximal optimization technique use (OR 0.208, 95% CI 0.097-0.419, p < 0.001), whereas the odds for MACE increased with main vessel predilatation (OR 2.191, 95% CI 1.042-5.066, p = 0.049) and diabetes mellitus treated with insulin (OR 2.779, 95% CI 1.1-6.593, p = 0.024). CONCLUSIONS Pooled data showed no significant difference between MACE and TLR rates for BiOSS® group vs. rDES group.
Advances in Interventional Cardiology | 2018
Jacek Bil; Robert J. Gil; Adam Kern; Luis A. Iñigo-García; Radoslaw Formuszewicz; Sławomir Dobrzycki
Corresponding author: Jacek Bil MD, PhD, Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior and Administration, 137 Woloska St, 02-507 Warsaw, Poland, phone: +48 22 508 16 86, e-mail: [email protected] Received: 11.02.2018, accepted: 9.04.2018. Mehran in-stent restenosis classification adapted for coronary bifurcations: the impact on 4-year follow-up from randomized clinical studies POLBOS I and II
Canadian Journal of Cardiology | 2015
Robert J. Gil; Jacek Bil; Vladimír Džavík; Dobrin Vassilev; Adam Kern; Radoslaw Formuszewicz; Małgorzata Zalewska-Adamiec; Sławomir Dobrzycki
Kardiologia Polska | 2012
Robert J. Gil; Dobrin Vassiliev; Aleksandra Michałek; Adam Kern; Radoslaw Formuszewicz; Sławomir Dobrzycki; Maciej Lesiak; Jarosław Wójcik; Piotr Kardaszewicz; Andrzej Lekston
Journal of the American College of Cardiology | 2011
Dobrin Vassilev; Robert J. Gil; Aleksanda Michalek; Sławomir Dobrzycki; Radoslaw Formuszewicz; Adam Kern; Tomasz Kulawik; Tomasz Pwlowski
publisher | None
author
European Heart Journal | 2018
Robert J. Gil; Jacek Bil; Adam Kern; L A Inigo-Garcia; Radoslaw Formuszewicz; Sławomir Dobrzycki; Dobrin Vassilev