RECORD studies in total hip replacement
The RECORD1 and RECORD2 studies showed that oral rivaroxaban regimens offered significantly superior efficacy compared with subcutaneous enoxaparin regimens for the prevention of the primary efficacy endpoint (composite of any deep vein thrombosis [DVT], nonfatal pulmonary embolism [PE] and all-cause mortality), with a similar safety profile in adult patients after total hip replacement (THR) surgery. The duration of thromboprophylaxis in RECORD1 was 5 weeks in both study arms. In RECORD2 rivaroxaban was given for 5 weeks and enoxaparin for 2 weeks followed by placebo.2, 3
The American College of Chest Physicians (ACCP) guidelines recommend that patients undergoing THR receive thromboprophylaxis for up to 35 days after surgery. In clinical practice short-term prophylaxis with enoxaparin for approximately 2 weeks is more common as administering injectable therapy is difficult after hospital discharge.6
RECORD1: extended-duration rivaroxaban versus enoxaparin in THR
RECORD1 (N=4541) met its primary efficacy endpoint and showed that oral rivaroxaban (10 mg tablet once daily) offered significantly superior reductions in venous thromboembolism (VTE), with a similar safety profile to subcutaneous enoxaparin (40 mg once daily) for 35±4 days.2
Rivaroxaban demonstrated:
- Significantly superior efficacy for the primary endpoint (total VTE)
- Significantly lower rates of major VTE
- Low rates of symptomatic venous thromboembolic events
- A similar safety profile to enoxaparin
Primary efficacy endpoint
Rivaroxaban significantly reduced the incidence of the primary efficacy endpoint, total VTE, defined as the composite of any DVT, non-fatal PE and all-cause mortality: relative risk reduction 70%.
Secondary efficacy endpoints
Rivaroxaban reduced the relative risk of major VTE (proximal DVT, PE and VTE-related death) by 88% compared with enoxaparin.
Reassuring safety
The incidence of major bleeding was low and similar with rivaroxaban or enoxaparin.
Adverse events
The overall occurrence of any adverse events, including serious drug-related adverse events, was similar for rivaroxaban and enoxaparin.
RECORD2: extended-duration rivaroxaban versus short-duration enoxaparin in THR
RECORD2 (N=2509) met its primary efficacy endpoint and showed that oral rivaroxaban (10 mg tablet once daily) for 35±4 days offered significantly superior reductions in VTE, with a similar safety profile to subcutaneous enoxaparin (40 mg once daily) for 12±2 days followed by placebo.3
Rivaroxaban demonstrated:
Primary efficacy endpoint
Extended prophylaxis with rivaroxaban significantly reduced the primary efficacy endpoint, total VTE, compared with short-term prophylaxis with enoxaparin: relative risk reduction 79%.
Secondary efficacy endpoints
Extended prophylaxis with rivaroxaban significantly reduced the relative risk of major VTE (proximal DVT, PE and VTE-related death) by 88% and symptomatic VTE by 80% compared with short-term prophylaxis with enoxaparin.4
Reassuring safety
Despite the fact that rivaroxaban was given for an extended duration compared with enoxaparin the rates of major bleeding were low and similar between groups.
Adverse events
The overall incidence of any adverse events, including serious drug-related adverse events, was similar for extended-duration rivaroxaban and short-duration enoxaparin.
- 2 - Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
- 3 - Kakkar AK, Brenner B, Dahl OE, et al; 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(9632):31-39.
- 6 - Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 suppl):381S-453S.
- 4 - Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
- Efficacy
- The ability of a drug to produce the desired effect.
- Subcutaneous
- Introduced beneath the skin.
- Thrombosis
- Formation of a clot inside a blood vessel.
- Thromboprophylaxis
- Preventative treatment for blood clotting.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Relative Risk Reduction
- Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
