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Dipartimento di Scienze Anatomiche, Istologiche Medico Legali e dell’Apparato Locomotore Università La Sapienza, Roma, Italia
Aim: A retrospective database collection data study was carried out on patients undergoing knee arthroplasty to confirm the duration of thromboprophylaxis with rivaroxaban in the Italian clinical practice, and whether treatment longer than 2 weeks is associated with changes in thromboembolism and bleeding rates.
Methods: All patients >18 years who underwent elective knee arthroplasty between January 2011 and May 2012 at 14 Italian orthopedic centers and were given rivaroxaban for thromboprophylaxis were eligible. Following data were collected and analyzed descriptively: age, gender, body mass index, medical history, type of anesthesia, mode of administration of rivaroxaban (time of introduction after surgery and duration of treatment), time of mobilization, duration of hospital stay and follow-up, as well as occurrence of thromboembolism, bleeding and other adverse events.
Results: A total of 217 patients were included. Duration of therapy was 5 weeks long in 151 patients (70,2%) and only one patients had a shorter duration of 2 weeks. The thromboembolism rate was 0.46% (IC95% 0,08-2,56%), due to an event occurred 2 weeks after the end of pharmacological prophylaxis, much less than the registrative trials, and the bleeding rate was comparable to the registrative RECORD trials.
Conclusion: This retrospective database collection data study shows that thromboprophylaxis with rivaroxaban is generally continued for 5 weeks after knee arthroplasty in clinical practice in Italy. It suggests that a 5-week therapeutic regimen with rivaroxaban is advisable, due to the residual thromboembolic risk, and safe, as it does not increase bleeding vs the much shorter (2 weeks) registrative regimen.