Rupert Bauersachs

Johannes Gutenberg-Universität Mainz, Mayence, Rheinland-Pfalz, Germany

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Publications (125)518.84 Total impact

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    ABSTRACT: Low-molecular-weight heparin is recommended over warfarin for the treatment of acute venous thromboembolism (VTE) in patients with active cancer largely based on results of a single, large trial. To study the efficacy and safety of tinzaparin vs warfarin for treatment of acute, symptomatic VTE in patients with active cancer. A randomized, open-label study with blinded central adjudication of study outcomes enrolled patients in 164 centers in Asia, Africa, Europe, and North, Central, and South America between August 2010 and November 2013. Adult patients with active cancer (defined as histologic diagnosis of cancer and receiving anticancer therapy or diagnosed with, or received such therapy, within the previous 6 months) and objectively documented proximal deep vein thrombosis (DVT) or pulmonary embolism, with a life expectancy greater than 6 months and without contraindications for anticoagulation, were followed up for 180 days and for 30 days after the last study medication dose for collection of safety data. Tinzaparin (175 IU/kg) once daily for 6 months vs conventional therapy with tinzaparin (175 IU/kg) once daily for 5 to 10 days followed by warfarin at a dose adjusted to maintain the international normalized ratio within the therapeutic range (2.0-3.0) for 6 months. Primary efficacy outcome was a composite of centrally adjudicated recurrent DVT, fatal or nonfatal pulmonary embolism, and incidental VTE. Safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and overall mortality. Nine hundred patients were randomized and included in intention-to-treat efficacy and safety analyses. Recurrent VTE occurred in 31 of 449 patients treated with tinzaparin and 45 of 451 patients treated with warfarin (6-month cumulative incidence, 7.2% for tinzaparin vs 10.5% for warfarin; hazard ratio [HR], 0.65 [95% CI, 0.41-1.03]; P = .07). There were no differences in major bleeding (12 patients for tinzaparin vs 11 patients for warfarin; HR, 0.89 [95% CI, 0.40-1.99]; P = .77) or overall mortality (150 patients for tinzaparin vs 138 patients for warfarin; HR, 1.08 [95% CI, 0.85-1.36]; P = .54). A significant reduction in clinically relevant nonmajor bleeding was observed with tinzaparin (49 of 449 patients for tinzaparin vs 69 of 451 patients for warfarin; HR, 0.58 [95% CI, 0.40-0.84]; P = .004). Among patients with active cancer and acute symptomatic VTE, the use of full-dose tinzaparin (175 IU/kg) daily compared with warfarin for 6 months did not significantly reduce the composite measure of recurrent VTE and was not associated with reductions in overall mortality or major bleeding, but was associated with a lower rate of clinically relevant nonmajor bleeding. Further studies are needed to assess whether the efficacy outcomes would be different in patients at higher risk of recurrent VTE. Identifier: NCT01130025.
    JAMA The Journal of the American Medical Association 08/2015; 314(7):677-86. DOI:10.1001/jama.2015.9243 · 35.29 Impact Factor
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    ABSTRACT: Since the introduction of new oral anticoagulants (NOACs), besides vitamin-K antagonists, an additional option for stroke prevention of patients with atrial fibrillation (AF) is available. The objective of this study was to assess AF patients' preferences with regard to the attributes of these different treatment options. We conducted a multicenter study among randomly selected physicians. Preferences were assessed by computer-assisted telephone interviews. We used a discrete-choice-experiment (DCE) with four convenience-related treatment dependent attributes (need of bridging: yes/no, interactions with food/nutrition: yes/no, need of INR controls/dose adjustment: yes/no; frequency of intake: once/twice daily) and one comparator attribute (distance to practitioner: <1 km/>15 km). Preferences measured in the interviews were analyzed descriptively and based on a conditional logit regression model. A total of 486 AF patients (age: 73.9 ± 8.2 years; 43.2 % female; mean CHA2DS2-VASc: 3.7 ± 1.6; current medication: 48.1 % rivaroxaban, 51.9 % VKA) could be interviewed. Regardless of type of medication, patients significantly preferred the attribute levels (in order of patients' importance) "once daily intake" (Level: once = 1 vs. twice = 0; Coefficient = 0.615; p < 0.001), "bridging necessary" (yes = 1 vs. no = 0; -0.558; p < 0.001), "distance to practitioner of ≤1 km (>15 km = 0 vs. ≤1 km = 1; 0.494; p < 0.001), "interactions with food/nutrition" (yes = 1 vs. no = 0; -0.332; p < 0.001) and "need of INR controls/dose adjustment" (yes = 1 vs. no = 0; -0.127; p < 0.001). In our analyses, "once daily frequency of intake" was the most important OAC-attribute for patients' choice followed by "no bridging necessary" and "no interactions with food/nutrition". Thus, patients with AF seem to prefer treatment options which are easier to administer.
    Journal of Thrombosis and Thrombolysis 08/2015; DOI:10.1007/s11239-015-1263-x · 2.17 Impact Factor
  • Thomas Wilke · Martin Wehling · Steffen Amann · Rupert M Bauersachs · Björn Böttger
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    ABSTRACT: Background and study objectives | The assessment of the renal function of patients with a deep vein thrombosis / pulmonary embolism (VTE patients) is of utmost importance for the selection / dosage of an agent in the initial anticoagulation management of these patients because the majority of available anticoagulants are cleared renally. Specifically, there is a high risk of drug accumulation and subsequent bleedings in patients with severe renal insufficiency. Consequently, specific recommendations have been made for the initial anticoagulation management of these patients in both product labels and AWMF treatment recommendations: some drugs should not be used in these patients, for other drugs a careful use, intensified screening (anti-Xa), or, in the case of enoxaparin, a dose-adjustment are recommended.This literature review aimed to answer the following questions: · What is the prevalence of renal insufficiency in VTE patients?. · Which data are available with regard to the real-world initial anticoagulation management and corresponding clinical outcomes (recurrent VTE events, bleedings, mortality) of these patients?. Methodology | We did a systematic review of existing publications in german or english published in 2004-2014. Only quantitative analyses have been included in the review. Results | We identified 1,135 publications, 37 of them were included in our review. The prevalence of renal insufficiency in VTE patients, defined as CrCl < 60 ml / min, was reported to be 12.3 %-71.9 % related to all VTE patients. The prevalence of severe renal insufficiency, defined as CrCl < 30 ml / min, was reported to be 3,3 %-13,6 %. The substantial ranges in reported prevalences are mainly due to differences in the characteristics of patients addressed in the different publications.A CrCl < 30 ml / min is an independent predictor for both mortality and lethal recurrent pulmonary embolism, possibly also for severe bleedings in VTE patients. In addition to that, a severe renal insufficiency may also be a predictor for the probability that a first VTE event occurs.Several anticoagulants approved for the initial anticoagulation management of VTE patients face the risk of drug accumulation in renally insufficent patients. So, for example, a standard enoxaparin dosage was shown to be associated with elevated bleeding risk compared to adjusted enoxaparin dosage in renally insufficient patients. However, similar data do not exist for other low molecular weight heparins (LMWHs) or unfractioned heparins (UFHs). Only for two LMWHs, Certoparin and Tinzaparin, safety data with regard to renally insufficient patients have been published so far.None of the included studies showed advantages of UFH therapy in comparison to LMWH therapy in initial anicoagulation management of VTE patients. In contrast to that, available evidence shows disadvantageous efficacy / safety of UFH in comparison to LMWH treatment. However, this evidence is not based on head-to-head comparisons but is derived from registry and observational study data only. Conclusion | A detailed knowledge of product labels is of utmost importance in the inital anticoagulation treatment of VTE patients because several agents may not be used in the addressed patients with severe renal insufficiency at all while others may be used based on specific dosage / surveillance schemes only. We also recommend to critically appraise the current AWMF treatment guidline because it still recommends initial anticoagulation management with UFHs in VTE patients with severe renal insufficiency. Available data do not support that recommendation. © Georg Thieme Verlag KG Stuttgart · New York.
    DMW - Deutsche Medizinische Wochenschrift 08/2015; 140(17):e166-e174. DOI:10.1055/s-0041-103168 · 0.54 Impact Factor
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    ABSTRACT: Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once-daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once-daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6-12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin ( NCT02064439).
    Thrombosis and Haemostasis 05/2015; 114(3). DOI:10.1160/TH15-02-0131 · 4.98 Impact Factor
  • Rupert M. Bauersachs
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    ABSTRACT: Occurrence of venous thromboembolism (VTE) in patients with cancer is associated with unfavorable prognosis, and VTE treatment is less effective and more complicated in cancer patients. Several women specific aspects related to the underlying cancer type and VTE management need to be considered. Guidelines on VTE prevention and treatment in cancer patients issued from several international bodies are reviewed with respect to women specific recommendations, and general guideline recommendations are summarized. All guidelines recommend an initial parenteral treatment, preferably with low-molecular-weight heparin (LMWH), while fondaparinux or unfractionated heparin (UFH) can also be used. Long-term treatment, comprising 3 to 6 months after initial anticoagulation should preferably be performed with LMWH, or vitamin K antagonists (VKA), if LMWH is not available. For extended treatment beyond six months, there are no specific recommendations due to lack of evidence, and anticoagulation can be performed with LMWH or VKA. Novel or non-VKA oral anticoagulants (NOACs) have been studied in several trials in comparison to VKA in VTE patients, including 3-9% cancer patients. While NOACs showed comparable efficacy and safety to VKA in those cancer patients, results from trials comparing NOACs with LMWH are not available. Because of the paucity of data, there are no guideline recommendations for women specific cancer types or women specific issues in the prevention and treatment of VTE. While there is agreement on general VTE management in cancer patients across different international guidelines, there is insufficient guidance on many women specific aspects commonly encountered during clinical practice. Future trials are required that specifically and prospectively address women specific issues in the management of VTE in cancer. © 2015 Elsevier Ltd. All rights reserved.
    Thrombosis Research 02/2015; 135:S16-S22. DOI:10.1016/S0049-3848(15)50434-9 · 2.45 Impact Factor
  • Value in Health 12/2014; 17(7):A495. DOI:10.1016/j.jval.2014.08.1475 · 3.28 Impact Factor
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    ABSTRACT: Patients with renal impairment receiving classical anticoagulation for venous thromboembolism (VTE) are at increased risk of bleeding and possibly pulmonary embolism. We examined the efficacy and safety of oral rivaroxaban in patients with VTE with and without renal impairment. Prespecified subgroup analysis of the EINSTEIN DVT and EINSTEIN PE studies comparing fixed-dose rivaroxaban with enoxaparin/a vitamin K antagonist (VKA), performed in 8246 patients enrolled from 2007 to 2011 in 314 hospitals. Outcomes were recurrent VTE and major or clinically relevant nonmajor bleeding in patients with normal renal function (n = 5569; 67.3%) or mild (n = 2037; 24.6%), moderate (n = 636; 7.7%), or severe (n = 21; 0.3%) renal impairment. Rates of recurrent VTE were 1.8%, 2.8%, 3.3%, and 4.8% in patients with normal renal function and mild, moderate, and severe renal impairment, respectively (ptrend = 0.001). Hazard ratios for recurrent VTE were similar between treatment groups across renal function categories (pinteraction = 0.72). Major bleeding in rivaroxaban recipients occurred in 0.8%, 1.4%, 0.9%, and 0%, respectively (ptrend = 0.50). Respective rates in enoxaparin/VKA recipients were 1.0%, 3.0%, 3.9%, and 9.1% (ptrend < 0.001). Rivaroxaban-enoxaparin/VKA hazard ratios were 0.79 (95% confidence interval [CI] 0.46-1.36) for normal renal function, 0.44 (95% CI 0.24-0.84) for mild renal impairment, and 0.23 (95% CI 0.06-0.81) for moderate renal impairment (pinteraction = 0.034). Patients with symptomatic VTE and renal impairment are at increased risk of recurrent VTE. Renal impairment increased the risk of major bleeding in enoxaparin/VKA-treated patients but not in rivaroxaban-treated patients. NCT00440193 and NCT00439777.
    Thrombosis Journal 11/2014; 12(1):25. DOI:10.1186/1477-9560-12-25 · 1.31 Impact Factor
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    ABSTRACT: Rivaroxaban is an oral, direct Factor Xa inhibitor, approved for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) and the secondary prevention of recurrent PE and DVT as a fixed-dose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. Approval in this indication was supported by results from EINSTEIN PE, a large, randomised, open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic PE with or without DVT. Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and, therefore, patient compliance. As part of EINSTEIN PE, 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction, the Anti-Clot Treatment Scale (ACTS) throughout the duration of treatment (up to 12months). Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm. Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy, and the benefits of treatment were significantly greater. Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients, particularly in reducing patient-reported anticoagulation burden. Copyright © 2014. Published by Elsevier Ltd.
    Thrombosis Research 11/2014; 135(2). DOI:10.1016/j.thromres.2014.11.008 · 2.45 Impact Factor
  • Value in Health 11/2014; 17(7):A493-A494. DOI:10.1016/j.jval.2014.08.1465 · 3.28 Impact Factor
  • Value in Health 11/2014; 17(7):A472-A473. DOI:10.1016/j.jval.2014.08.1345 · 3.28 Impact Factor
  • Value in Health 11/2014; 17(7):A496-A497. DOI:10.1016/j.jval.2014.08.1483 · 3.28 Impact Factor
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    European Heart Journal 11/2014; 35(43):3033-3073. DOI:10.1093/eurheartj/ehu283 · 15.20 Impact Factor
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    ABSTRACT: Renal impairment (RI) is an important factor in the selection of anticoagulant therapy in venous thromboembolic event (VTE) patients. In particular, the risk of bleeding events is higher for VTE patients with a glomerular filtration rate (GFR) below 30 mL/min. The aim of this study was to collect data on the prevalence of RI in hospitalised VTE patients in Germany. Furthermore, we investigated how renal function changed during inpatient treatment. We conducted a retrospective chart review in six German hospitals. All patients with a VTE diagnosis who were treated as inpatients from 2007–2011 were included. Patients were categorised according to their renal function. RI was estimated from serum creatinine values. Persistent RI was defined as an estimated glomerular filtration rate (eGFR) of < 30 mL/min over at least 72 hours. Renal function could be determined for 5,710 VTE patients. Of these 21.4% had an eGFR > 90 mL/min, 38.1% had an eGFR of 60–89 mL/min, 17.3% had an eGFR of 45–59 mL/min, 12.5% had an eGFR of 30–44 mL/min, 7.2% had an eGFR of 15–29 mL/min and 3.6% of the VTE patients had end-stage renal disease. Persistent severe RI was observed in 74.8% of patients with an eGFR < 30 mL/min. Overall, 40.6% of the VTE patients investigated had an eGFR < 60 mL/min; 10.8% had an eGFR < 30 mL/min. Almost three quarters of RI-VTE patients suffered from persistent severe RI. These results suggest that more than one in ten VTE patients is exposed to a high risk of accumulating anticoagulants; most of these RI patients also face an increased risk of mortality.
    Thrombosis Research 09/2014; 134(5). DOI:10.1016/j.thromres.2014.09.003 · 2.45 Impact Factor
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    Rupert M. Bauersachs
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    ABSTRACT: The novel oral anticoagulants represent a new era of anticoagulation for patients with deep vein thrombosis and pulmonary embolism. These agents may offer advantages to patients in whom the use of traditional anticoagulants is typically challenging, such as elderly patients, patients with renal impairment and those with low body weight. Currently, rivaroxaban and dabigatran are the only approved novel oral anticoagulants for the treatment and secondary prevention of venous thromboembolism. It is likely that additional agents will become available in the near future. This review summarises recent phase III data for these agents, focusing, where possible, on results obtained in frail patients.
    European Journal of Internal Medicine 09/2014; 25(7). DOI:10.1016/j.ejim.2014.05.017 · 2.89 Impact Factor
  • Rupert Bauersachs
    07/2014; 4(7):619-639. DOI:10.4155/cli.14.49
  • A. Cohen · R. Bauersachs · A. Gitt · P. Laeis · P. Mismetti · M. Monreal · S. Willich · G. Agnelli
    Thrombosis Research 05/2014; 133:S122. DOI:10.1016/S0049-3848(14)50383-0 · 2.45 Impact Factor
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    ABSTRACT: The aims of this study were to evaluate the quality of oral anticoagulation (OAC) in AF patients in the practices of general practitioners (GPs) in Germany and to investigate possible causal factors which influence OAC quality. We conducted a multi-center, non-interventional, prospective observational cohort study among general practitioners (GPs) in Germany. To assess the quality of OAC on the basis of the prospectively documented international normalized ratio (INR) values, the time in therapeutic range (TTR) was calculated using the Rosendaal linear trend method. The causes of poor OAC quality were identified by a multivariate analysis model (logistical regression; poor OAC quality: TTR <60%). For 525 OAC patients (66.8%; patients with at least 2 prospectively documented INR values) the average TTR (target range of 2.0-3.0) was 67.6%. About 34.7% of the patients had a TTR <60%. None of the variables representing characteristics of the medical practices were capable of explaining the occurrence of poor OAC quality. However, with regard to care provision-based variables, the existence of a brief discontinuation of medication was important. As the existence of adherence barriers increased, the probability of poor anticoagulation quality increased. In conclusion, the provision of OAC in the German health care system is to be regarded as good, but far from ideal. Our causal analysis shows that patient-based factors should be addressed through the provision of improved training and that the rationale behind the interruption of OAC treatment should be critically examined.
    European Journal of Internal Medicine 01/2014; 25(3). DOI:10.1016/j.ejim.2013.12.013 · 2.89 Impact Factor
  • B. Boettger · M. Wehling · R. Bauersachs · S. Amann · T. Wilke
    Journal of Public Health 01/2014; · 2.06 Impact Factor
  • Rupert M. Bauersachs · Bernd Krabbe
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    ABSTRACT: Venous thromboembolism (VTE) comprises deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT occurs at an incidence of 1/1,000 and risk factors include immobilization, hospitalization, surgery, thrombophilia and positive family history, cancer, pregnancy, and other hormonal effects. Commonly, clinical signs and symptoms for DVT are unreliable, especially in hospitalized patients, but the clinical assessment of the pretest probability, for example, with the Wells score, is an important component in the diagnostic algorithm, where compression ultrasound also plays a central role. Treatment of DVT aims to acutely prevent PE and short-term and long-term VTE recurrence and to avoid the long-term complication of the postthrombotic syndrome (PTS). The immediate, sufficient, and uninterrupted anticoagulation is the most important therapeutic modality in the treatment of DVT and is achieved with subcutaneous LMWH and overlapping use of vitamin K antagonists (VKA) as standard treatment. After the initial anticoagulation, a long-term anticoagulation is used to prevent recurrences. The duration of anticoagulation is determined by balancing the risk of recurrence against the risk for bleeding with VKA and also considering the patient’s preference. In patients in whom anticoagulation could be discontinued, aspirin was shown to reduce the risk of VTE recurrence by one third compared to placebo. Novel (non-vitamin K antagonist) oral anticoagulants (NOACs) have been compared to the standard treatment in several large phase 3 trials in patients with VTE. NOACs, which are given at a fixed dose without coagulation monitoring, have been shown to be non-inferior to standard treatment with respect to recurrent VTE, but have consistently shown lower bleeding rates, in particular less intracerebral hemorrhages. Practical issues of NOACs have to be observed, including their label and dosing regimen, their effect on coagulation assays, periprocedural management, and management of bleeding complications. Long-term use of compression stockings has been shown to reduce the PTS in several independent trials and meta-analyses, but new interventional techniques are being introduced in order to further reduce the PTS, particularly in iliac vein thrombosis. Cancer patients suffering from VTE require special attention, as both their bleeding and recurrence risk is increased, and LMWH has been shown to be more effective than VKA. VKA and NOACs should also be avoided in pregnant women suffering from VTE; VKA can cause embryopathy and an increased risk of bleeding both for mother and child. Thus, LMWH is the anticoagulant treatment of choice in pregnant women. Upper-extremity deep vein thrombosis (UEDVT) has a somewhat different pathophysiology and complication rates compared to DVT of the lower extremities. Therefore, diagnostic and therapeutic management of UEDVT may differ from the standard treatment of DVT.
    PanVascular Medicine, 01/2014: pages 1-31; , ISBN: 978-3-642-37393-0
  • Böttger B · Wehling M · Bauersachs RM · Amann S · Wilke T.
    German medical science : GMS e-journal 01/2014;

Publication Stats

2k Citations
518.84 Total Impact Points


  • 2015
    • Johannes Gutenberg-Universität Mainz
      Mayence, Rheinland-Pfalz, Germany
  • 2004–2015
    • Klinikum Darmstadt
      Darmstadt, Hesse, Germany
  • 2014
    • Technical University Darmstadt
      Darmstadt, Hesse, Germany
    • Universitätsklinikum Freiburg
      Freiburg an der Elbe, Lower Saxony, Germany
  • 2005–2010
    • Alice-Hospital Darmstadt
      Darmstadt, Hesse, Germany
  • 2007
    • University of Cologne
      Köln, North Rhine-Westphalia, Germany
  • 1998–2005
    • Goethe-Universität Frankfurt am Main
      • • Schwerpunkt Kardiologie
      • • Center for Internal Medicine
      Frankfurt, Hesse, Germany
  • 2000–2003
    • University Hospital Frankfurt
      Frankfurt, Hesse, Germany
  • 1991
    • University of Southern California
      • Department of Physiology and Biophysics
      Los Ángeles, California, United States