RECORD2

REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism 2 Study in Patients Undergoing Elective Total Hip Replacement (2008)

Condition

Prophylaxis for VTE after total hip replacement

Close this section

Objective

To compare the use of rivaroxaban for extended thromboprophylaxis with short-term thromboprophylaxis with enoxaparin in patients undergoing total hip arthroplasty

Close this section

Trial design

Randomized, double-blind phase 3 study
Active treatment: rivaroxaban 10 mg p.o. once daily, beginning 6–8 hours after wound closure, for 31–39 days, plus placebo injection for
10–14 days (n=1252)
Control treatment: enoxaparin 40 mg s.c. once daily, initiated 12 hours before surgery and restarted 6–8 hours after wound closure, for 10–14 days, plus placebo tablet for 31–39 days (n=1257)

Close this section

Endpoints

Primary efficacy endpoint: composite of any DVT, non-fatal PE, and allcause mortality up to day 36±6
Secondary efficacy endpoints: major VTE (proximal DVT, non-fatal PE, and VTE-related death), DVT (any, proximal, distal), symptomatic VTE during treatment and follow-up, and death during the follow-up period
Primary safety endpoint: major bleeding (beginning after the first blinded dose up to 2 days after the last dose)
Secondary safety endpoints: any on-treatment bleeding, non-major bleeding, hemorrhagic wound complications, adverse events, and death

Close this section

Trial participants

2509 patients ≥18 years scheduled for elective total hip replacement

Close this section

Results

Efficacy outcome: In the modified ITT population (n=1733), the primary efficacy endpoint occurred in 17 of 864 patients (2.0%) in the rivaroxaban group and in 81 of 869 patients (9.3%) in the enoxaparin group (absolute risk reduction 7.3%, relative risk reduction 79%)
Safety outcome: The incidence of any on-treatment bleeding was similar in both groups: 81 events in 1228 patients (6.6%) in the rivaroxaban safety population vs. 68 events in 1229 patients (5.5%) in the enoxaparin safety population (p=0.25). Major bleeding occurred in one patient in each group (<0.1%). Both treatments were associated with a similar number of adverse events (rivaroxaban 62.5% vs. enoxaparin 65.7%)

Close this section

Summary

Efficacy: Extended thromboprophylaxis with rivaroxaban was significantly more effective than short-term enoxaparin for the prevention of VTE in patients undergoing total hip arthroplasty
Safety: The rates of major and clinically relevant non-major bleeding were low and much the same in both groups

Close this section

Reference

Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008;372:31-39

Close this section

Corresponding author

Prof. Ajay K. Kakkar, Barts and the London School of Medicine and Dentistry, Turner Street, London E1 2AD, UK, e-mail: akkakkar@tri-london.ac.uk

Close this section

Back To List

Recommend pageBack to top