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Darmstadt, Germany

Bauersachs R.M.,Klinikum Darmstadt GmbH
Thrombosis Research | Year: 2015

Background: 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. Methods: 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. Results: 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. Conclusions: 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.

Wohrle J.,University of Ulm | Werner G.S.,Klinikum Darmstadt GmbH
Catheterization and Cardiovascular Interventions | Year: 2013

Objectives: We sought to evaluate the efficacy and safety of paclitaxel-coated balloon plus bare-metal stenting (BMS) in chronic total occlusions (CTOs). Background: Drugeluting stent implantation after recanalization of CTOs is limited by the occurrence of restenosis and risk for late stent thromboses. Methods: In this prospective, bicenter trial we treated 48 patients after successful chronic total occlusion (CTO) recanalization in a native coronary artery with paclitaxel-coated balloon plus BMS. Patients were matched according to stent length, reference diameter, and diabetes mellitus with 48 patients treated with Taxus stent implantation. Dual antiplatelet therapy was prescribed for 6 months. Angiographic (clinical) follow-up was obtained after 6 (12) months. Primary endpoint was in-stent late lumen loss. Results: There was no difference in patient baseline characteristics or procedural results. Stent length was 59.7 ± 32.4 mm (16-151 mm) for paclitaxel-coated balloon plus BMS versus 56.2 ± 25.9 mm (16-132 mm) for Taxus stent. Late loss was statistically not different within the stent with 0.64 ± 0.69 mm versus 0.43 ± 0.64 mm (difference 0.20 mm, 95% confidence interval 20.07 to 0.47, P = 0.14) and at the occlusion site with 0.33 ± 0.69 mm versus 0.26 ± 0.70 mm, respectively. Restenosis rate was 27.7% compared with 20.8% (P 5 0.44) and the combined clinical endpoint (cardiac death, myocardial infarction attributed to the target vessel, target lesion revascularization) was 14.6% versus 18.8% (P 5 0.58), respectively. Conclusions: In conclusion, for patients with complex CTOs in native coronary arteries the use of paclitaxel-coated balloon after bare-metal stenting was associated with similar clinical results and a nonsignificantly higher in-stent late loss compared with a matched population with paclitaxel-eluting stent implantation (ClinicalTrials.gov NCT00670436). © 2012 Wiley Periodicals, Inc.

The prevalence of atrial fibrillation and venous thromboembolism will rise over the next decades due to foreseeable demographic developments. Anticoagulation treatment for these patients will become increasingly challenging due to the rising prevalence of chronic kidney disease (CKD), which is associated with both an increased risk of bleeding and impaired efficacy of oral anticoagulation (OAC). New oral anticoagulants (NOAC) are excreted by the kidneys and may thus accumulate in patients with CKD leading to an increased risk of bleeding; therefore, the pharmacological properties of NOACs have to be considered in order to avoid serious complications. Analysis of the currently available evidence for patients with CKD provides important insights for everyday clinical practice. © 2012 Springer-Verlag Berlin Heidelberg.

Bauersachs R.M.,Klinikum Darmstadt GmbH
Thrombosis Research | Year: 2012

Thromboembolic disorders are a major cause of morbidity and mortality, and the risk of thromboembolism increases with age. Anticoagulants are recommended for indications including the prevention of venous thromboembolism in surgical and medical patients, treatment of venous thromboembolism and stroke prevention in patients with atrial fibrillation. Traditional anticoagulants that have been used include unfractionated heparin, low molecular weight heparin, fondaparinux and vitamin K antagonists. However, these agents are all associated with drawbacks (i.e. parenteral administration or frequent coagulation monitoring/dose titration), and it has been particularly challenging to treat elderly patients with anticoagulants. Some specific characteristics of elderly patients may influence the safety of anticoagulant therapy, such as decreased renal function, co-morbidities and the use of multiple medications. The complexity of anticoagulation therapy and the increased risk of bleeding complications in elderly patients may prevent some physicians from prescribing anticoagulants to these patients, which leaves them at risk of thromboembolic events. Thus, safer and more convenient anticoagulants are needed, particularly for elderly patients. New oral anticoagulants have been developed in recent years and have shown promise in clinical studies that included elderly patients. These agents could simplify the management of thromboembolic disorders and improve the safety of anticoagulation. © 2011 Elsevier Ltd. All rights reserved.

Bauersachs R.M.,Klinikum Darmstadt GmbH
Best Practice and Research: Clinical Haematology | Year: 2012

Background: In the past, the clinical diagnosis of venous thromboembolism (VTE), which comprises deep vein thrombosis (DVT) and pulmonary embolism (PE) had been very challenging, because clinical presentation is non-specific and inaccurate. Objective: To review and assess clinical signs, symptoms and risk factors of DVT and PE and identify most common differential diagnoses. Results: Important components for the clinical diagnosis of VTE include risk factors such as immobilization, presence of cancer, confinement to bed, previous major surgery, prior VTE and - specific for DVT - whole limb enlargement, one-sided calf enlargement and dilatation of superficial veins. Additional items specific for PE include tachycardia, dyspnea chest pain and hemoptysis. Many of these clinical characteristics are included into clinical prediction rules, such as the Wells pre-test probability score for DVT or PE or the Geneva score for PE. These scores are used to determine the pre-test probability for VTE and they constitute the basis for a diagnostic algorithm. Various clinical prediction rules for DVT or PE show comparable accuracy. Conclusion: Even though the clinical presentation of DVT and PE varies substantially in individual patients and settings and may be misleading, diagnostic prediction rules based on clinical presentation and risk factors are very useful to assess pre-test probability, which is a very important concept for the diagnosis of DVT and PE. © 2012 Published by Elsevier Ltd.

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