ORIGINAL ARTICLES   

Minerva Ortopedica e Traumatologica 2012 August;63(4):289-94

Copyright © 2012 EDIZIONI MINERVA MEDICA

language: Italian

Efficacy, safety and tolerability of rivaroxaban for the prophylaxis of thromboembolism after surgery for hip or knee arthroplasty in routine clinical practice

Falez F. ¹, Di Minno G. ²,

¹ Unità Operativa Complessa di Ortopedia e Traumatologia, Ospedale S. Spirito, Roma, Italia; ² Dipartimento di Medicina Clinica e Sperimentale, Università Federico II, Napoli, Italia

Aim. In order to analyze the efficacy and safety of rivaroxaban in patients that had attended Orthopedic Centers, a retrospective study was carried out on patients who underwent surgery to replace hip or knee.
Methods. All subjects ≥18 years of age who underwent elective knee or hip arthroplasty between February 2011 and June 2011 in 17 Italian orthopedic centers were eligible for the study. All had been treated with rivaroxaban for thromboprophylaxis. In July 2011, age, sex, weight, body mass index (BMI, kg/m2), medical history, type of intervention, anesthesia, mode of administration of rivaroxaban, and the occurrence of venous thromboembolic (VTE) or of hemorrhagic events of eligible patients (N.=501) was collected through their clinical records.
Results. Of the 501 subjects, 236 (47.1%) underwent hip surgery and 265 knee surgery (52.9%), 176 were male (35.1%) and the average age was equal to 67 years (range 31-91). Two out of 501 developed thromboembolic events (0.4%, confidence interval [CI] at 95%=0.1-3.3). Eleven out of 501 suffered from bleeding events (2.2%, 95% CI=1.2-4.4). Twenty-eight subjects stopped receiving rivaroxaban: only in nine cases this was due to side effects of the drug. Seventeen adverse events were documented. Among those there were an acute myocardial infarction (because of which rivaroxaban was withdrawn) and one case of high platelet counts.
Conclusion. A favorable efficacy and safety profile of rivaroxaban are documented in this population that is representative of patients who undergo hip or knee arthroplasty in Italy.