Publications by authors named "Bronislav Janek"

5 Publications

  • Page 1 of 1

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

Cardiovasc Drugs Ther 2020 06;34(3):335-344

Centre Hospitalier d'Avignon, Avignon, France.

Objectives: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.

Methods: Patient-level data from two all-comers observational studies ( Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel.

Results: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis.

Conclusion: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.
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June 2020

Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice.

Medicine (Baltimore) 2020 Feb;99(8):e19119

Städtische Kliniken Esslingen, Esslingen, Germany.

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol ( Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.
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February 2020

Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes.

PLoS One 2020 13;15(1):e0226606. Epub 2020 Jan 13.

Gachon University Gil Medical Center, Incheon, South Korea.

Background: The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe.

Methods: Two all-comers observational studies based on the same protocol ( Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months.

Results: Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe.

Conclusions: PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.
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April 2020

Clinical safety and efficacy of a novel thin-strut cobalt-chromium coronary stent system: results of the real world Coroflex Blue Registry.

Catheter Cardiovasc Interv 2010 Jan;75(1):78-85

Department of Cardiology, Charité-Universitaetsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.

Objectives: The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt-chromium stent in real-world practice.

Background: The development of cobalt-chromium bare-metal stents (BMS) with thinner struts has lead to better deliverability and lower target-lesion revascularization rates compared with stainless steel BMS.

Methods: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target-lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in-hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months.

Results: The registry included 2,315 patients (mean age 64.3 +/- 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B(2)/C-lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6-month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event-free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction.

Conclusions: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt-chromium stent platform in real-world practice. In the era of drug-eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified.
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January 2010

Risk factors for the development of coronary artery disease of a grafted heart as detected very early after orthotopic heart transplantation.

Transpl Int 2007 Aug 23;20(8):666-74. Epub 2007 May 23.

Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

Orthotopic heart transplantation (OHTx) represents a well established method of end-stage heart failure treatment. Allograft coronary artery disease (CAD) still remains to be one of the most important limiting factors for OHTx recipients' long-term survival. Unfortunately, allograft CAD can be detected very early after OHTx. Our study was designed to identify risk factors for early allograft CAD development. Eighty-three OHTx recipients (18 females, 65 males, mean age 50.55 +/- 11.04 years) with coronary intravascular ultrasound examination performed early after OHTx (29.81 +/- 12.45 days) formed the study population. The impact of a number of pre-, peri- and early post-transplant possible risk factors on early allograft CAD development was studied. By multivariate analysis, only higher donor age (P < 0.001) and higher recipient's body mass index (P = 0.003) were found to represent risk factors for the early development of allograft CAD.
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August 2007