This article is more than 5 years old. Information may no longer be current.

RECORD pooled analysis: Rivaroxaban reduced symptomatic VTE, death by >50% compared with enoxaparin

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

50th ASH Annual Meeting

The oral Factor Xa inhibitor rivaroxaban was superior to enoxaparin for the prevention of venous thromboembolism after knee or hip replacement surgery, according to the results of a pre-specified pooled analysis of the four RECORD trials.

“The conclusion from this pooled analysis of the RECORD program evaluating rivaroxaban in major orthopedic surgery is that in patients undergoing hip or knee replacement surgery, rivaroxaban once a day significantly improved composite outcomes of symptomatic VTE, cardiovascular events, all-cause mortality and major bleeding compared with enoxaparin regimens,” said Alexander G. Turpie, MD, professor of medicine, McMaster University, Canada, who presented the results at the 50th Annual Meeting of the American Society of Hematology.

“We had a pre-specified pooled analysis of the RECORD program in order to identify if there was an effect on important clinical outcomes because we were aware that the number of clinical events was expected to be lower in the individual trials,” Turpie said.

The pooled analysis of the four randomized, double blind, phase-3 studies looked at 12,729 patients who were randomly assigned to 10 mg once daily rivaroxaban six to eight hours after hip or knee replacement surgery or 40 mg once daily enoxaparin prior to surgery (RECORD 1-3) or to 30 mg twice daily enoxaparin 12 to 24 hours after surgery (RECORD 4).

The first time-point analysis was at day 12, which was called the active treatment pool. The second time- analysis point — the primary assessment — was the total treatment duration pool, which was at day 35 for RECORD 1 and 2 and at day 12 for RECORD 3 and 4.

The primary efficacy outcome for the study was total VTE defined as the composite of any deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality. Patients assigned to all regimens of rivaroxaban had a 58% reduction in symptomatic VTE and all-cause mortality for the total treatment duration (0.6% vs. 1.3%; P<.001) and a 52% reduction in the active treatment pool (0.5% vs. 1.0%, P<.001).

Rivaroxaban was not associated with a clinically significant increased risk in major bleeding (0.4% vs. 0.2%; P=.076). – by Leah Lawrence

For more information:

• Turpie AG. #36. Presented at: 50th Annual Meeting of the American Society of Hematology; Dec. 5-9, 2008; San Francisco.