OBJECTIVE: To compare the effectiveness and safety of rivaroxaban to those of enoxaparin for the prophylaxis of deep venous thrombosis (DVT) after total hip arthroplasty. METHODS: From September 2006 to April 2007, at the Orthopedics and Traumatology Clinic of the Hospital Complex of the Santa Casa of Porto Alegre, State of Rio Grande do Sul, a randomized, double-blind clinical trial was carried out in which 67 patients were selected (n = 67), all of them submitted to total hip arthroplasty (ATQ). Of these patients, two were excluded for lack of adherence to the prophylaxis proposed after hospital release (n = 65). One of the groups was given subcutaneous 40 mg enoxaparin 6 hours to 8 hours before surgery, and after surgery a placebo pill was added, for once a day oral intake, during the first 32 to 36 days. The other group was given oral 10 mg rivaroxaban, once a day, during the first 32 to 36 post-operative days. In order to have the double-blind feature of the study, a subcutaneous placebo injection was given 6 hours to 8 hours before surgery and on the 32 to 36 days following surgery. The main outcome aimed at was the effectiveness in preventing DVT, which was evaluated by bilateral venography carried out between days 32 and 36 after surgery, or through documented symptoms of deep venous thrombosis or pulmonary thromboembolism (PTE). The secondary outcome studied was administration safety, that was evaluated through major bleeding or liver toxicity. RESULTS: Rivaroxaban and enoxaparin showed similar results (the differences were not statistically significant) when compared for the reduction of DVT incidence till the 36th post-operative day. There was no difference in blood loss and liver toxicity when the drugs were compared. CONCLUSION: In patients submitted to total hip arthroplasty, rivaroxaban showed as effective and safe as enoxaparin to prevent deep venous thrombosis and pulmonary thromboembolism.
Venous thrombosis; Pulmonary embolism; Arthroplasty, replacement, hip; Enoxaparin; Heparin; Comparative study
