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Phase III Trial Results Show Superiority of Rivaroxaban over,Enoxaparin for the Prevention of Venous Thromboembolism in Patients,Undergoing Knee Replacement Surgery

, MD, of Hoersholm Hospital, University of Copenhagen, Denmark, commented: "The RECORD3 results are exciting, as they indicate that rivaroxaban may better meet the needs of many patients undergoing orthopaedic surgery. It’s an important step for this category that a once-daily, oral medication has demonstrated better efficacy in preventing VTE than the current standard of care, while also displaying a promising safety profile. In addition, it is important to note that symptomatic VTE, a secondary endpoint of the study, showed results in favour of rivaroxaban."

Detailed Study Results RECORD3 is a 2,531-patient, Phase III, double-blind trial that assessed the safety and efficacy of 10 mg oral, once-daily rivaroxaban started 6-8 hours after surgery versus 40 mg subcutaneous, once-daily enoxaparin started the evening before surgery in elective total knee replacement (TKR) surgery. Both regimens were continued for 10-14 days. The primary efficacy endpoint of the study was the composite of DVT, as diagnosed by mandatory venography, non-fatal PE and all-cause mortality. The primary safety endpoint was major bleeding. Results showed that DVT, non-fatal PE and death occurred in 9.6% (79/824) of patients receiving rivaroxaban versus 18.9% (166/878) of patients receiving enoxaparin (RRR 49%; p < 0.001).

Major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) - the main secondary efficacy endpoint of the study - occurred in 1.0% of the rivaroxaban-treated group and in 2.6% of the enoxaparin-treated group. The difference was statistically significant (p=0.01) in favour of rivaroxaban, with an RRR of 62%.

A reduction was also demonstrated in symptomatic VTE, a pre-specified additional secondary endpoint in the study. Symptomatic VTE occurred in 1.0% of patients who received rivaroxaban, compared to 2.7% of those in the enoxaparin comparator group, resulting in an RRR of 64%.

In the rivaroxaban and enoxaparin groups, major bl
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