Artikel
Safety and effectiveness of dabigatran and rivaroxaban in patients with total hip- or knee replacement: results of a prospective cohort-study
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Autoren
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Susanne Nehls
- Institute for Clinical Pharmacology, University Medicine Rostock, Rostock, Germany
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Günther Kundt
- Institute for Biostatistics and Informatics in Medicine and Aging Research, University Medicine Rostock, Rostock, Germany
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Änne Glass
- Institute for Biostatistics and Informatics in Medicine and Aging Research, University Medicine Rostock, Rostock, Germany
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Frank Thiessen
- Institute for Biostatistics and Informatics in Medicine and Aging Research, University Medicine Rostock, Rostock, Germany
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Wolfram Mittelmeier
- Clinic for Orthopaedics, University Medicine Rostock, Rostock, Germany
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Dirk Flachsmeyer
- Department of Trauma and Orthopaedic Surgery, Klinikum Suedstadt Rostock, Rostock, Germany
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Bernd Drewelow
- Institute for Clinical Pharmacology, University Medicine Rostock, Rostock, Germany
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Silke Müller
- Institute for Clinical Pharmacology, University Medicine Rostock, Rostock, Germany
| Veröffentlicht: | 25. November 2013 |
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Gliederung
Text
Background: Venous thromboembolism (VTE) is a serious complication in patients after major orthopedic surgery. Dabigatran and rivaroxaban as orally administered anticoagulants (OAK) are new options for the prophylaxis of VTE after total hip (THR) and total knee replacement (TKR). The aim of the study was to evaluate the safety and effectiveness of the new OAK in routine use.
Materials and Methods: All patients undergoing THR or TKR at two major hospitals between 07/2009 and 12/2011 were suitable to participate in the prospective observational cohort-study. After written consent patients were followed for three months using patient interviews and chart review. Risk factors were identified by multivariate logistic regression analyses.
Results: 613 patients (399 THR, 214 TKR) participated in this trial and were followed for 3 month: 127 (20.7%) received rivaroxaban, 209 (34.1%) dabigatran and 277 (45.2%) patients a LMWH. During this period 14 venous thromboembolic events (VTE) were observed with higher incidence rate (IR) after TKR than after THR (3.74% vs. 1.50%) and higher IR with LMWH (3.25%) than after dabigatran (1.44%) or rivaroxaban (1.57%). Multivariate logistic regression identified history of VTE (adjusted OR 3.34, 95%CI 1.00–11.2, p = 0.050) and complications within surgery (a OR 6.32, 95%CI 1.17–34.0, p = 0.032), but not the anticoagulant as independent risk factors for VTE. During follow-up no unexpected adverse events (AE) occurred; 48 AE were considered as serious according to ICH-GCP-guidelines. In 41.7% of the AE an adverse drug reaction to one of the anticoagulants was considered at least possible, most of them minor bleeding events. 36 (5.9%) patients had a major bleeding event (MB) predominantly in close relation to surgery. MB occurred more often under LMWH (IR 7.94%) than dabigatran (IR 4.78%) or rivaroxaban (IR 3.25%). Multivariate analysis, however, revealed only duration of surgery as a risk factor for MB (p=0.009).
Conclusion: Safety profile and effectiveness of dabigatran and rivaroxaban were confirmed in routine use. The new OAK appear to be a reasonable alternative in THR and TKR.
The study was supported by BfArM V-11343/68605
