Published in:
01-04-2014 | Original Article
Initial anticoagulation therapy in patients with venous thromboembolism and impaired renal function: results of an observational study
Authors:
Bjoern Boettger, Martin Wehling, Rupert M. Bauersachs, Steffen Amann, Thomas Wilke
Published in:
Journal of Public Health
|
Issue 2/2014
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Abstract
Aim
Patients undergoing initial therapeutic anticoagulation after a venous thromboembolic event (VTE) with severely impaired renal function (RI-VTE-patients) are at high risk of accumulating the anticoagulants resulting in an increased risk of bleeding events. Current guidelines/approved summary of product characteristics (SPC) recommend usage of specific anticoagulants only, monitoring of aXa-activity, and/or dose adjustment (in the case of enoxaparin) for initial therapeutic anticoagulation of RI-VTE patients. This study investigates the treatment of German RI-VTE-patients and evaluates whether guideline/SPC recommendations are implemented in the practice of real life care.
Subjects and methods
We conducted a chart review in five German acute hospitals. All VTE patients treated in these hospitals from 01/01/2007–31/12/2011 were included. Renal insufficiency (RI) was defined as CrCl < 30 ml/min. Treatment did not conform to the recommendations in guidelines/SPCs, if (1) a drug was used that is contraindicated according to the SPC or no initial anticoagulation treatment was implemented at all; (2) the recorded daily dose of enoxaparin was higher than the recommended weight-adjusted dose.
Results
Of 5,263 VTE patients identified, 709 (13.5 %) cases could not be documented due to missing charts (601) or no documented creatinine serum levels (108). Of the remaining 4,554 patients (mean age ±SD 67.4 years ±15.7; 53.0 % female; weight 80.2 kg ±20.0; 54.5 % deep VT), 337 (7.4 %) had a mean estimated GFR < 30 ml/min. In 19 (5.6 %) of these cases, patients were treated with a drug not recommended for use, 21 (6.2 %) did not receive any initial anticoagulation treatment and 91 (27.0 %) received a higher than recommended dosage of enoxaparin. Additionally, for 22 patients (6.5 %) receiving enoxaparin, no weight information was recorded and it is therefore unlikely that the dosage was adjusted correctly.
Conclusion
VTE treatment in RI-VTE-patients differs remarkably from labelled recommendations; over-dosage of enoxaparin is common. It seems fair to assume that these patients face a higher risk of adverse reactions, in particular bleeding events.