Smits P.C.,Maasstad Ziekenhuis |
Hofma S.,Medisch Centrum Leeuwarden |
Togni M.,HOpital Cantonal de Fribourg |
Vazquez N.,Hospitalario Juan Canalejo |
And 10 more authors.
The Lancet | Year: 2013
Background Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents. We aimed to compare the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer. Methods This open-label, prospective, randomised, controlled, non-inferiority trial was undertaken at 12 sites across Europe. We used limited exclusion criteria (age p>18 years, life expectancy p>5 years, reference vessel diameter 2•0-4•0 mm) to enrol patients eligible for percutaneous coronary intervention. Patients were randomly allocated (2:1) by computer-generated random numbers to receive either a biodegradable polymer biolimus-eluting stent (Nobori, Terumo, Tokyo, Japan) or a durable fluoropolymer-based everolimus-eluting stent (Xience V or Prime, Abbott Vascular, Santa Clara, CA, USA, or Promus, Boston Scientific, Natick, MA, USA). The primary endpoint was a composite of safety (cardiac death and non-fatal myocardial infarction) and efficacy (clinically indicated target vessel revascularisation) at 12 months, analysed by intention to treat. Patients received dual antiplatelet therapy for 12 months after discharge. The trial is registered with ClinicalTrials.gov, number NCT01233453. Findings From Jan 12, 2009, to Feb 7, 2011, we enrolled 2707 patients (4025 lesions), 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99•3%) patients completed 12 months' follow-up. Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 [5•9%] vs 19 [2•1%]; p<0•0001). The primary endpoint occurred in 93 (5•2%) patients in the biolimus-eluting stent group and 44 (4•8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1•07 [95% CI 0•75-1•52]; p non-inferiorityp<0•0001). Analysis per protocol did not change the outcome of this trial (pnon-inferiorityp<0•0001). Interpretation Biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. We need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent. Funding Terumo Europe (Leuven, Belgium) and the Research Foundation of the Cardiology Department, Maasstad Hospital (Rotterdam, Netherlands).
Kerstjens H.A.M.,University of Groningen |
Disse B.,Boehringer Ingelheim |
Schroder-Babo W.,Krankenhaus Gelnhausen |
Bantje T.A.,Amphia Ziekenhuis |
And 4 more authors.
Journal of Allergy and Clinical Immunology | Year: 2011
Background: Some patients with severe asthma remain symptomatic and obstructed despite maximal recommended treatment. Tiotropium, a long-acting inhaled anticholinergic agent, might be an effective bronchodilator in such patients. Objective: We sought to compare the efficacy and safety of 2 doses of tiotropium (5 and 10 μg daily) administered through the Respimat inhaler with placebo as add-on therapy in patients with uncontrolled severe asthma (Asthma Control Questionnaire score, ≥1.5; postbronchodilator FEV1, ≤80% of predicted value) despite maintenance treatment with at least a high-dose inhaled corticosteroid plus a long-acting β2-agonist. Methods: This was a randomized, double-blind, crossover study with three 8-week treatment periods. The primary end point was peak FEV1 at the end of each treatment period. Results: Of 107 randomized patients (54% female patients; mean, 55 years of age; postbronchodilator FEV1, 65% of predicted value), 100 completed all periods. Peak FEV1 was significantly higher with 5 μg (difference, 139 mL; 95% CI, 96-181 mL) and 10 μg (difference, 170 mL; 95% CI, 128-213 mL) of tiotropium than with placebo (both P < .0001). There was no significant difference between the active doses. Trough FEV 1 at the end of the dosing interval was higher with tiotropium (5 μg: 86 mL [95% CI, 41-132 mL]; 10 μg: 113 mL [95% CI, 67-159 mL]; both P < .0004). Daily home peak expiratory flow measurements were higher with both tiotropium doses. There were no significant differences in asthma-related health status or symptoms. Adverse events were balanced across groups except for dry mouth, which was more common on 10 μg of tiotropium. Conclusion: The addition of once-daily tiotropium to asthma treatment, including a high-dose inhaled corticosteroid plus a long-acting β2-agonist, significantly improves lung function over 24 hours in patients with inadequately controlled, severe, persistent asthma. © 2011 American Academy of Allergy, Asthma & Immunology.
Cohen D.J.,University of Missouri - Kansas City |
Van Hout B.,University of Sheffield |
Serruys P.W.,Erasmus University Rotterdam |
Mohr F.W.,University of Leipzig |
And 9 more authors.
New England Journal of Medicine | Year: 2011
BACKGROUND: Previous studies have shown that among patients undergoing multivessel revascularization, coronary-artery bypass grafting (CABG), as compared with percutaneous coronary intervention (PCI) either by means of balloon angioplasty or with the use of bare-metal stents, results in greater relief from angina and improved quality of life. The effect of PCI with the use of drug-eluting stents on these outcomes is unknown. METHODS: In a large, randomized trial, we assigned 1800 patients with three-vessel or left main coronary artery disease to undergo either CABG (897 patients) or PCI with paclitaxeleluting stents (903 patients). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the use of the Seattle Angina Questionnaire (SAQ) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary end point was the score on the angina-frequency subscale of the SAQ (on which scores range from 0 to 100, with higher scores indicating better health status). RESULTS: The scores on each of the SAQ and SF-36 subscales were significantly higher at 6 and 12 months than at baseline in both groups. The score on the angina-frequency subscale of the SAQ increased to a greater extent with CABG than with PCI at both 6 and 12 months (P = 0.04 and P = 0.03, respectively), but the between-group differences were small (mean treatment effect of 1.7 points at both time points). The proportion of patients who were free from angina was similar in the two groups at 1 month and 6 months and was higher in the CABG group than in the PCI group at 12 months (76.3% vs. 71.6%, P = 0.05). Scores on all the other SAQ and SF-36 subscales were either higher in the PCI group (mainly at 1 month) or were similar in the two groups throughout the follow-up period. CONCLUSIONS: Among patients with three-vessel or left main coronary artery disease, there was greater relief from angina after CABG than after PCI at 6 and 12 months, although the extent of the benefit was small. (Funded by Boston Scientific; ClinicalTrials.gov number, NCT00114972.). Copyright © 2011 Massachusetts Medical Society. All rights reserved.
Heidbuchel H.,Catholic University of Leuven |
Verhamme P.,Catholic University of Leuven |
Alings M.,Amphia Ziekenhuis |
Antz M.,Klinikum Oldenburg |
And 6 more authors.
Europace | Year: 2013
New oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with non-valvular atrial fibrillation (AF). Both physicians and patients will have to learn how to use these drugs effectively and safely in clinical practice. Many unresolved questions on how to optimally use these drugs in specific clinical situations remain. The European Heart Rhythm Association set out to coordinate a unified way of informing physicians on the use of the different NOACs. A writing group listed 15 topics of concrete clinical scenarios and formulated as practical answers as possible based on available evidence. The 15 topics are: (1) Practical start-up and follow-up scheme for patients on NOACs; (2) How to measure the anticoagulant effect of NOACs; (3) Drug-drug interactions and pharmacokinetics of NOACs; (4) Switching between anticoagulant regimens; (5) Ensuring compliance of NOAC intake; (6) How to deal with dosing errors; (7) Patients with chronic kidney disease; (8) What to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a risk of bleeding? (9) Management of bleeding complications; (10) Patients undergoing a planned surgical intervention or ablation; (11) Patients undergoing an urgent surgical intervention; (12) Patients with AF and coronary artery disease; (13) Cardioversion in a NOAC-treated patient; (14) Patients presenting with acute stroke while on NOACs; (15) NOACs vs. VKAs in AF patients with a malignancy. Since new information is becoming available at a rapid pace, an EHRA Web site with the latest updated information accompanies this text (www.NOACforAF.eu). © 2013 Published on behalf of the European Society of Cardiology. All rights reserved.
Andriesse G.I.,Amphia Ziekenhuis
Nederlands tijdschrift voor geneeskunde | Year: 2010
OBJECTIVE: To determine the percentage of hepatitis E virus (HEV) infections in serum samples from patients with negative serology for hepatitis A, B and C and to find out what may be the harmful consequences of a missed diagnosis of acute HEV infection. DESIGN: Retrospective study. METHOD: Serum samples were selected from patients with infectious hepatitis who tested negative for hepatitis A, B and C virus. Serum samples that had elevated alanine aminotransferase (ALT; > 34 U/l) were included in this study. All samples were then tested for HEV using an enzyme-linked immunosorbent assay (ELISA) and immunoblot assay. Of patients with serological evidence of acute HEV, files were checked for the originally documented diagnosis at hospital discharge. RESULTS: In the period October 2007-September 2008, 139 serum samples met the inclusion criteria. In 23 serum samples the ELISA was positive (IgM positive and/or Ig total positive); in 16/23 serum samples immunoblot assay was also positive. The percentage of confirmed HEV infections was 11.5% (16/139). In only one patient was the originally documented diagnosis correct. Several patients underwent invasive diagnostic procedures and treatment as a result of an incorrect diagnosis. CONCLUSION: Hepatitis E serology should be a standard tool in the diagnostic workup of infectious hepatitis patients in the Netherlands.
Robbrecht D.G.,Amphia Ziekenhuis
Nederlands tijdschrift voor geneeskunde | Year: 2012
Mesenteric panniculitis is a non-specific inflammation of the mesenteric adipose tissue, with varying degrees of fibrosis and fat necrosis. It can be associated with varying diseases and conditions, such as autoimmune disease and cancer. Many doctors are not familiar with this disease or do not know how to interpret the signs and symptoms. Here, we describe three patients illustrating the variety of clinical course, diagnostics, prognosis and treatment. A 44-year-old woman suffering from episodic abdominal pain was diagnosed with uncomplicated mesenteric panniculitis. The disease was stable while maintaining a conservative approach. In a 43-year-old woman, mesenteric panniculitis was complicated by autoimmune haemolytic anaemia. After treatment with corticosteroids, she made a full recovery from both disorders. Finally, a 73-year-old man was diagnosed with mesenteric panniculitis and auto-immune haemolytic anaemia, which both appeared to be consequences of an angioimmunoblastic T-cell lymphoma.
Roth T.,Ford Motor Company |
Van Seventer R.,Amphia Ziekenhuis |
Current Medical Research and Opinion | Year: 2010
Objective: Postherpetic neuralgia and painful diabetic peripheral neuropathy are common chronic neuropathic pain conditions associated with sleep disturbances. Pregabalin is indicated in the treatment of neuropathic pain. The objective of this review is to summarize the efficacy and safety of pregabalin in painful diabetic peripheral neuropathy and postherpetic neuralgia and the effect of pregabalin on sleep interference in these patients. Methods: MEDLINE and ISI Web of Knowledge databases were searched for randomized double-blind, placebo-controlled clinical trials of pregabalin reporting sleep measures in addition to pain endpoints in patients with painful diabetic peripheral neuropathy and postherpetic neuralgia published from inception through March 2009. Results: Nine trials met the inclusion criteria, providing data for a total of 2399 patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated twice or three times per day with pregabalin (75600mg/day) or placebo on a fixed or flexible schedule. Interpretation of sleep outcomes in two studies may be limited by trial inclusion criteria which permitted benzodiazepines for sleep problems. Also, none of the studies reported objective sleep measures. Pregabalin was well tolerated. Pregabalin (150600mg/day) significantly reduced pain and improved pain-related sleep interference. Conclusions: In addition to an analgesic benefit, pregabalin may decrease pain-related sleep interference in patients with painful diabetic peripheral neuropathy and postherpetic neuralgia. © 2010 Informa UK Ltd.
Tiren D.,Amphia Ziekenhuis |
Vroemen J.P.A.M.,Amphia Ziekenhuis
Journal of Orthopaedics and Traumatology | Year: 2013
Background: Until now there have been no prospective studies describing the results of using the superior clavicle plate with lateral extension in patients with displaced lateral clavicle fractures (Neer type 2). The purpose of this study was to evaluate the results of applying this plate for this specific type of fracture. Materials and methods: In this prospective study, seven patients (mean age 43, M:F; 6:1) with a fresh displaced lateral clavicle fracture were evaluated with a mean follow-up of 10 months. Analysis included functional and subjective outcome, time until union, time until return to work, and complications. Results: All patients achieved clinical and radiological union within 6-12 weeks. Full range of motion as well as a return to work was achieved in most cases within 2 weeks. The mean Constant score was 98 (range 90-100), the DASH score was 3.6 (range 0-11.4), and the Shoulder Rating Questionnaire score was 97 (range 96-100). No major complications were encountered. Three patients required plate removal: two because of a prominent and subcutaneous plate and one because of an intra-articular screw. Conclusions: In this study, use of the superior clavicle plate with lateral extension yielded excellent results in the treatment of this difficult fracture. In particular, patients acquired full range of motion within 2 weeks, reflecting the stability of the osteosynthesis achieved with this implant. © 2013 The Author(s).
Hulsmann A.R.,Amphia Ziekenhuis |
Oranje A.P.,Erasmus University Rotterdam
European Journal of Pediatrics | Year: 2014
Although most skin lesions in neonates are transient or benign, they may also be the presenting symptom of a life-threatening disease such as herpes neonatorum. In the present review, we present a short overview of neonatal skin lesions and a practical table to guide the general paediatrician in the diagnosis and management of neonatal skin lesions. Recent reviews are cited for further reading. © 2013 Springer-Verlag.
Vorstius Kruijff E.P.,Amphia Ziekenhuis
Nederlands tijdschrift voor geneeskunde | Year: 2012
Over the past ten years, the mortality rate at the Amphia Hospital in the Netherlands has decreased and the average age at death has increased significantly. This downward trend in hospital mortality rates is a national trend in the Netherlands. In addition, in recent years road traffic fatalities have steadily decreased. Both trends have had a significant impact on the availability of potential organ and tissue donors. Currently the main barriers to donation are the limited number of registrations in the donor registry and obtaining permission from relatives. To achieve the maximum number of donors, several initiatives must be undertaken. These include hospitals encouraging registration in the donor registry, training of professionals in communication skills concerning donation, increasing opportunities for organ donations in the emergency department and recruiting donors extramurally. If no measures are taken, a decreasing number of patients with end-stage organ failure will be able to profit from organ transplantation.