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Winterswijk, Netherlands

Sen H.,MST Inc | Tandjung K.,MST Inc | Basalus M.W.Z.,MST Inc | Lowik M.M.,MST Inc | And 12 more authors.
EuroIntervention | Year: 2012

Aims: The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome. Methods and results: Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99). Conclusions: Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used. © Europa Digital & Publishing 2012. All rights reserved. Source

van Hoeve J.C.,Netherlands Comprehensive Cancer Organisation | Elferink M.A.G.,Netherlands Comprehensive Cancer Organisation | Klaase J.M.,Spectrum | Kouwenhoven E.A.,Ziekenhuis Groep Twente | And 3 more authors.
International Journal of Colorectal Disease | Year: 2015

Purpose: Introducing care pathways is seen as a method to realise patient-focussed care conform evidence-based guidelines. The goal of this study is to determine the long-term effects of a regional care pathway for patients with rectal cancer. Patients and methods: Data on almost 400 patients with rectal carcinoma from three hospitals were obtained from the Netherlands Cancer Registry and the Dutch Surgical Colorectal Audit. Results on seven structure and process indicators were analysed and compared before and at two time points after implementing a regional care pathway over a total period from 2007 to 2012. To determine motivation and interpret the results, relevant professionals of the participating hospitals were interviewed. Results: After implementing the care pathway, the performance of computed tomography (CT) scans in the diagnostic phase significantly improved (p = 0.007/0.07). The number of patients discussed in the preoperative multidisciplinary team (MDT) meeting improved significantly (p = <0.001), and after implementing the care pathway, 94 % of the patients were discussed. Further, a significant reduction in time between the first tumour biopsy and the MDT meeting was realised (p = 0.01). Professionals stated that the regional care pathway has led to more clarity about the patient route and more awareness about complying with evidence-based guidelines. Conclusions: The regional care pathway provided a solid basis for uniforming care, working according evidence-based guidelines and further cooperation on regional level. For mainly the waiting and throughput times, the guidelines and norms had probably a stronger effect on the results than the care pathway. © 2015, Springer-Verlag Berlin Heidelberg. Source

Den Hartog D.,Rotterdam University | Tuinebreijer W.E.,Rotterdam University | Polinder S.,Rotterdam University | Van Beeck E.F.,Rotterdam University | And 11 more authors.
BMC Musculoskeletal Disorders | Year: 2010

Background. Fractures of the proximal humerus are associated with a profound temporary and sometimes permanent, impairment of function and quality of life. The treatment of comminuted fractures of the proximal humerus like selected three-or four-part fractures and split fractures of the humeral head is a demanding and unresolved problem, especially in the elderly. Locking plates appear to offer improved fixation; however, screw cut-out rates ranges due to fracture collapse are high. As this may lead to higher rates of revision surgery, it may be preferable to treat comminuted fractures in the elderly primarily with a prosthesis or non-operatively. Results from case series and a small-sample randomized controlled trial (RCT) suggest improved function and less pain after primary hemiarthroplasty (HA); however these studies had some limitations and a RCT is needed. The primary aim of this study is to compare the Constant scores (reflecting functional outcome and pain) at one year after primary HA versus non-operative treatment in elderly patients who sustained a comminuted proximal humeral fracture. Secondary aims include effects on functional outcome, pain, complications, quality of life, and cost-effectiveness. Methods/Design. A prospective, multi-center RCT will be conducted in nine centers in the Netherlands and Belgium. Eighty patients over 65 years of age, who have sustained a three-or four part, or split head proximal humeral fracture will be randomized between primary hemiarthroplasty and conservative treatment. The primary outcome is the Constant score, which indicates pain and function. Secondary outcomes include the Disability of the Arm and Shoulder (DASH) score, Visual Analogue Scale (VAS) for pain, radiographic healing, health-related quality of life (Short-form-36, EuroQol-5D) and healthcare consumption. Cost-effectiveness ratios will be determined for both trial arms. Outcome will be monitored at regular intervals over the subsequent 24 months (1, 3 and 6 weeks, and 3, 6, 12, 18, and 24 months). Data will be analyzed on an intention to treat basis, using univariate and multivariable analyses. Discussion. This trial will provide level-1 evidence on the effectiveness of the two mostly applied treatment options for three-or four part and split head proximal humeral fractures in the elderly. These data may support the development of a clinical guideline for treatment of these traumatic injuries. Trial registration. Netherlands Trial Register (NTR2040). © 2010 Den Hartog et al; licensee BioMed Central Ltd. Source

Gerritse R.,Streekziekenhuis Koningin Beatrix | Gerritse R.,Radboud University Nijmegen
Cryo-Letters | Year: 2010

Transplantation of cryopreserved intact ovaries from cancer patients is a technically challenging option for restoring fertility after sterilizing cancer therapy. In this paper we describe an assay based on 17ß-oestradiol (oestradiol) production, to monitor the functional damage sustained by the ovarian tissue during the freeze/thawing procedure. To this end, fresh bovine ovarian cortical biopsies were cultured in vitro for 7 days. As a control, the oestradiol release of biopsies that had sustained maximal cryodamage was analyzed. In addition the oestradiol release by cortical biopsies from two ME2SO perfused and cryopreserved intact ovaries was analyzed. Oestradiol production could be measured in culture supernatants, while oestradiol release of maximal cryo-damaged biopsies was at background levels. In vitro oestradiol release by cortical biopsies can be used as a functional marker for cryo-damage and indicates that our assay is suitable to optimize the cryopreservation procedure of intact ovaries. © CryoLetters. Source

Objectives The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months. Background Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents. Methods The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694). Results Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00). Conclusions After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650). © 2013 by the American College of Cardiology Foundation. Published by Elsevier Inc. Source

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