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Review of an article: Rivaroxaban versus Enoxaparin for thromboprophylaxis after total knee arthroplasty. NEJM 2008:358;2776-2786.
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JOURNAL OF VASCULAR NURSING www.jvascnurs.net
JUNE 2009
Research Column Review of an article: Rivaroxaban versus Enoxaparin for thromboprophylaxis after total knee arthroplasty. NEJM 2008:358;2776-2786. Janice D. Nunnelee, PhD, RN
This article is a report for the RECORD3 Investigators, a large randomized controlled trial (RCT) that was double blind. An RCT involves administering a treatment for comparison with another established treatment (as in this case) or with a placebo. It is the optimal study design to assess cause and effect. In this case, patients were randomly assigned to receive either rivaroxaban (an orally active direct factor Xa inhibitor) or the conventional treatment, enoxaparin. Venous thromboembolism (VTE) is a significant and potentially fatal complication after surgery, such as total knee arthroplasty (TKA). Anticoagulants are customarily given after such surgeries. The anticoagulants also cause complications. Success with fondaparinux (a parenteral indirect factor Xa inhibitor) prompted the development of rivaroxaban (Xarelto, Bayer HealthCare). A study indicated efficacy and safety of the drug, so further study was planned. This RCT was a multicenter double-blind study that compared the outcome of treatment with 10 mg of rivaroxaban postoperatively with administration of 40 mg of enoxaparin subcutaneously
From the 126 Plant Avenue, St. Louis, Missouri 63119. Corresponding author: Dr. Janice D. Nunnelee, PhD, RN, 126 Plant Avenue, St. Louis, MO 63119). 1062-0303/2009/$36.00 Copyright Ó 2009 by the Society for Vascular Nursing, Inc. doi:10.1016/j.jvn.2009.02.002
preoperatively for prevention of VTE after TKA (then given every 24 hours). Researchers recruited 2,531 patients from 147 centers in 19 countries. Subjects were given study medications for 14 days, and mandatory venography was performed between day 11 and day 15. Follow-up was from 30 to 35 days after medication was stopped. The primary outcome was deep vein thrombosis (DVT), nonfatal pulmonary embolism (PE) or any cause of death within 13-17 days after surgery. The safety outcome studied was the incidence of major bleeding. Researchers found that rivaroxaban was more effective than enoxaparin in preventing VTE with similar rates of bleeding. Rivaroxaban reduced the absolute risk of the primary outcomes by 9.2% and the risk of major VTE by 1.6%. Absolute risk reduction was also greater in rivaroxaban group. No PEs or deaths occurred in the rivaroxaban group, but 4 patients suffered PEs on enoxaparin and 2 died. The 2 drugs had similar safety profiles. This report gives important information to vascular nurses about potential treatments for future prevention of VTE.
JOURNAL OF VASCULAR NURSING www.jvascnurs.net
JUNE 2009
Research Column Review of an article: Rivaroxaban versus Enoxaparin for thromboprophylaxis after total knee arthroplasty. NEJM 2008:358;2776-2786. Janice D. Nunnelee, PhD, RN
This article is a report for the RECORD3 Investigators, a large randomized controlled trial (RCT) that was double blind. An RCT involves administering a treatment for comparison with another established treatment (as in this case) or with a placebo. It is the optimal study design to assess cause and effect. In this case, patients were randomly assigned to receive either rivaroxaban (an orally active direct factor Xa inhibitor) or the conventional treatment, enoxaparin. Venous thromboembolism (VTE) is a significant and potentially fatal complication after surgery, such as total knee arthroplasty (TKA). Anticoagulants are customarily given after such surgeries. The anticoagulants also cause complications. Success with fondaparinux (a parenteral indirect factor Xa inhibitor) prompted the development of rivaroxaban (Xarelto, Bayer HealthCare). A study indicated efficacy and safety of the drug, so further study was planned. This RCT was a multicenter double-blind study that compared the outcome of treatment with 10 mg of rivaroxaban postoperatively with administration of 40 mg of enoxaparin subcutaneously
From the 126 Plant Avenue, St. Louis, Missouri 63119. Corresponding author: Dr. Janice D. Nunnelee, PhD, RN, 126 Plant Avenue, St. Louis, MO 63119). 1062-0303/2009/$36.00 Copyright Ó 2009 by the Society for Vascular Nursing, Inc. doi:10.1016/j.jvn.2009.02.002
preoperatively for prevention of VTE after TKA (then given every 24 hours). Researchers recruited 2,531 patients from 147 centers in 19 countries. Subjects were given study medications for 14 days, and mandatory venography was performed between day 11 and day 15. Follow-up was from 30 to 35 days after medication was stopped. The primary outcome was deep vein thrombosis (DVT), nonfatal pulmonary embolism (PE) or any cause of death within 13-17 days after surgery. The safety outcome studied was the incidence of major bleeding. Researchers found that rivaroxaban was more effective than enoxaparin in preventing VTE with similar rates of bleeding. Rivaroxaban reduced the absolute risk of the primary outcomes by 9.2% and the risk of major VTE by 1.6%. Absolute risk reduction was also greater in rivaroxaban group. No PEs or deaths occurred in the rivaroxaban group, but 4 patients suffered PEs on enoxaparin and 2 died. The 2 drugs had similar safety profiles. This report gives important information to vascular nurses about potential treatments for future prevention of VTE.