Streekziekenhuis Koningin Beatrix

Winterswijk, Netherlands

Streekziekenhuis Koningin Beatrix

Winterswijk, Netherlands
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Von Birgelen C.,Spectrum | Von Birgelen C.,University of Twente | Basalus M.W.Z.,Spectrum | Tandjung K.,Spectrum | And 12 more authors.
Journal of the American College of Cardiology | Year: 2012

Objectives: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up. Background: Only 1 randomized trial previously compared these stents. Methods: This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat. Results: Acute coronary syndromes were present in 52% and "off-label" feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: -2.8% to 3.0%, p noninferiority = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy. Conclusions: Resolute ZES were noninferior to Xience V EES in treating "real-world" patients with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650) © 2012 American College of Cardiology Foundation.

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.

Tandjung K.,Spectrum | Basalus M.W.Z.,Spectrum | Sen H.,Spectrum | Stoel M.G.,Spectrum | And 10 more authors.
Catheterization and Cardiovascular Interventions | Year: 2013

Background Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE - a prospective, randomized, comparative DES trial - real-world patients were stratified for gender before randomization for Resolute or Xience V stents. Methods Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint. Results Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n = 192) and Xience V (n = 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P = 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P = 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P = 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P = 0.50). Conclusions This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute- and Xience V-treated females. © 2013 Wiley Periodicals, Inc.

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.

Lam M.K.,Spectrum | Tandjung K.,Spectrum | Sen H.,Spectrum | Basalus M.W.Z.,Spectrum | And 11 more authors.
EuroIntervention | Year: 2015

Aims: To investigate the prognostic value of coronary dominance for various adverse clinical events follow-ing the implantation of drug-eluting stents. Methods and results: We assessed two-year follow-up data of 1,387 patients from the randomised TWENTE trial. Based on the origin of the posterior descending coronary artery, coronary circulation was cat-egorised into left and non-left dominance (i.e., right and balanced). Target vessel-related myocardial infarc-tion (MI) was defined according to the updated Academic Research Consortium (ARC) definition (2x upper reference limit of creatine kinase [CK], confirmed by CK-MB elevation), and periprocedural MI (PMI) as MI 48 hours following PCI. One hundred and thirty-six patients (9.8%) had left and 1,251 (90.2%) non-left dominance. Target lesions were more frequently located in dominant arteries (p<0.005). Left dominance was associated with more severe calcifications (p=0.006) and more bifurcation lesions (p=0.031). Non-left domi-nance tended to be less frequent in men (p=0.09). Left coronary dominance was associated with more target vessel-related MI (14 [10.3%] vs. 62 [5.0%], p=0.009). Left dominance independently predicted PMI (adjusted HR 2.19, 95% CI: 1.15-4.15, p=0.017), while no difference in other clinical endpoints was observed between dominance groups. Conclusions: In the population of the TWENTE trial, we observed a higher incidence of periprocedural myocardial infarction in patients who had left coronary dominance. © Europa Digital & Publishing 2015. All rights reserved.

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.

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.

Kessler A.,Reference Institute for Bioanalytics | Siekmann L.,Institute for Clinical Chemistry and Clinical Pharmacology | Weykamp C.,Streekziekenhuis Koningin Beatrix | Geilenkeuser W.J.,Reference Institute for Bioanalytics | And 3 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2013

We describe an External Quality Assessment Scheme (EQAS) intended for reference (calibration) laboratories in laboratory medicine and supervised by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine and the responsible Committee on Traceability in Laboratory Medicine. The official EQAS website, RELA (, is open to interested parties. Information on all requirements for participation and results of surveys are published annually. As an additional feature, the identity of every participant in relation to the respective results is disclosed. The results of various groups of measurands (metabolites and substrates, enzymes, electrolytes, glycated hemoglobins, proteins, hormones, thyroid hormones, therapeutic drugs) are discussed in detail. The RELA system supports reference measurement laboratories preparing for accreditation according to ISO 17025 and ISO 15195. Participation in a scheme such as RELA is one of the requirements for listing of the services of a calibration laboratory by the Joint Committee on Traceability in Laboratory Medicine.

Weykamp C.,Streekziekenhuis Koningin Beatrix | Lenters-Westra E.,European Reference Laboratory | Van Der Vuurst H.,Streekziekenhuis Koningin Beatrix | Slingerland R.,European Reference Laboratory | And 2 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2011

Background: We report an evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyser (HA-8180V), the fifth generation Menarini/ARKRAY ion-exchange HPLC for the measurement of HbA1c. Methods: We evaluated the analytical performance, the measurement of haemoglobin variants and the performance in comparison to major analytical methods. Results: Within-run, between-run and total CV were 0.2%, 0.4% and 0.7% at low HbA1c concentrations and 0.2%, 0.2% and 0.4% at high HbA1c concentrations, respectively. Trueness revealed a maximum deviation of 0.8 mmol/mol (IFCC units) or 0.1% (NGSP units) over the relevant analytical range. Linearity, carry-over and linear drift were excellent. Labile-HbA1c, carbamylated haemoglobin, icteric samples and variation in hematocrit did not affect HbA 1c outcome. Haemoglobin variants AS, AC and F do not affect HbA 1c outcome and are explicitly identified and correctly quantified. HbA1c can not be measured in samples with AE and AD, but these variants are identified correctly. In comparison to other methods used at present, the HA-8180V shows excellent performance. Conclusions: The HA-8180V performs at a high level and is fit for any clinical application. © 2011 by Walter de Gruyter Berlin New York.

Van Der Horst J.C.,Rijnstate Ziekenhuis | Frunt M.H.A.,Streekziekenhuis Koningin Beatrix
Nederlands Tijdschrift voor Geneeskunde | Year: 2016

A 57-year-old woman presented with a progressive ulceration of her left nasal ala. We made the diagnosis of trigeminal trophic syndrome. This rare disorder may develop after injury of the trigeminal nerve, which causes local paraesthesia. Subsequent manipulation - whether intentional or unintentional - results in ulceration.

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