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Objectives

The aim of this study was to assess the safety and effectiveness of a next-generation low-dose drug-coated balloon (DCB) designed to optimize the amount of drug transferred into the vessel wall and to maximize the amount of time the drug resides in the vessel wall.

Background

Several randomized controlled studies evaluating various DCBs have demonstrated a significantly higher patency rate compared with noncoated percutaneous transluminal angioplasty balloons at 1 year. However, the data are limited and vary by DCB at longer follow-up time points. An earlier generation low-dose DCB failed to demonstrate significant treatment effect at 2 years, raising questions regarding the durability of low-dose DCBs.

Methods

In this prospective, multicenter trial, 294 patients were randomized (3:1) to treatment with a DCB or an uncoated percutaneous transluminal angioplasty balloon. Assessments at 2 years included primary patency with duplex ultrasonography, clinically driven target lesion revascularization, and functional outcomes.

Results

Primary patency at 2 years was significantly higher in the DCB cohort (75.9% vs. 61.0%; p = 0.025), and the rate of clinically driven target lesion revascularization was significantly lower (12.1% vs. 30.5%; p < 0.001). There were no major limb amputations in either group. The rates of all-cause (6.5% vs. 5.1%; p = 1.00) and cardiovascular-related (1.6% vs. 1.7%; p = 1.00) mortality were similar between groups. Functional improvements over baseline were sustained in both groups, with 60% fewer reinterventions in the DCB group.

Conclusions

A sustained treatment effect is achievable with a low-dose DCB with an optimized coating formulation. This trial demonstrated for the first time a statistically significantly higher primary patency rate for a low-dose DCB versus PTA at 2 years. (CVI Drug Coated Balloon European Randomized Clinical Trial; NCT01858363)  相似文献   
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Werner C  Fürster T  Laufs U 《Herz》2012,37(1):68-71
Myocardial remodeling comprises changes in cardiac shape, mass, diameter, and function in response to changes in hemodynamic load, cardiac damage, or neurohumoral stimulation. Adaptive remodeling is a consequence of physiological stimuli such as physical activity. Maladaptive remodeling results from pathologic conditions such as myocardial ischemia and cardiac valve disease. Since regular vigorous endurance exercise can result in cardiac remodeling cardiologic screening is recommended for athletes to identify individuals with cardiomyopathies. Moderate physical activity is cornerstone of primary and secondary prevention of cardiovascular diseases. In secondary prevention, individual training recommendations need to be adapted to the underlying myocardial disease and individual risk factors. Experimental and clinical studies show that specific training interventions exert cardioprotective effects and reverse remodeling. However, clinical and basic science studies are needed to understand the mechanisms of adaptive and maladaptive remodeling and to better utilize this powerful therapeutic tool in the treatment of myocardial diseases.  相似文献   
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BackgroundAntimicrobial resistance poses a risk for healthcare, both in the community and hospitals. The spread of multidrug-resistant organisms (MDROs) occurs mostly on a local and regional level, following movement of patients, but also occurs across national borders.AimThe aim of this observational study was to determine the prevalence of MDROs in a European cross-border region to understand differences and improve infection prevention based on real-time routine data and workflows.MethodsBetween September 2017 and June 2018, 23 hospitals in the Dutch (NL)–German (DE) cross-border region (BR) participated in the study. During 8 consecutive weeks, patients were screened upon admission to intensive care units (ICUs) for nasal carriage of meticillin-resistant Staphylococcus aureus (MRSA) and rectal carriage of vancomycin-resistant Enterococcus faecium/E. faecalis (VRE), third-generation cephalosporin-resistant Enterobacteriaceae (3GCRE) and carbapenem-resistant Enterobacteriaceae (CRE). All samples were processed in the associated laboratories.ResultsA total of 3,365 patients were screened (median age: 68 years (IQR: 57–77); male/female ratio: 59.7/40.3; NL-BR: n = 1,202; DE-BR: n = 2,163). Median screening compliance was 60.4% (NL-BR: 56.9%; DE-BR: 62.9%). MDRO prevalence was higher in DE-BR than in NL-BR, namely 1.7% vs 0.6% for MRSA (p = 0.006), 2.7% vs 0.1% for VRE (p < 0.001) and 6.6% vs 3.6% for 3GCRE (p < 0.001), whereas CRE prevalence was comparable (0.2% in DE-BR vs 0.0% in NL-BR ICUs).ConclusionsThis first prospective multicentre screening study in a European cross-border region shows high heterogenicity in MDRO carriage prevalence in NL-BR and DE-BR ICUs. This indicates that the prevalence is probably influenced by the different healthcare structures.  相似文献   
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Electrocopolymerization of 3-thiopheneacetic acid ( 1 ) and 3-methylthiophene ( 2 ) under various conditions produces poly{(3-methylthiophene-2,5-diyl)-co-[3-(carboxymethyl)thiophene-2,5-diyl]} ( 3 ). By activation of the carboxy groups with dicyclohexylcarbodiimide (DCC) lactate oxidase (LOD) is covalently bonded to the surface of the electrode. In this way a lactate sensor was formed which is applicable for the determination of lactate in micromolar concentrations.  相似文献   
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