Deep vein thrombosis landmark trials in prevention
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Editor(s)-In-Chief: The APEX Trial Investigators, C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Justine Cadet
Overview
Randomized trials have compared the efficacy and safety of antithrombins and anticoagulants in the prevention of deep vein thrombosis in the setting of surgical procedures and in the context of hospitalization for a medical illness.
Total Hip Replacement
RECORD 1 Study[1]
Background: This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty.
Methods: In this randomized, double-blind study, the researchers assigned 4,541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep vein thrombosis (DVT) (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal PE or death from venous thromboembolism [VTE]). The primary safety outcome was major bleeding.
Results: A total of 3,153 patients were included in the superiority analysis (after 1,388 exclusions), and 4,433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1,595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction, 2.6%; 95% confidence interval [CI], 1.5 to 3.7; P<0.001). Major VTE occurred in 4 of 1686 patients (0.2%) in the rivaroxaban group and in 33 of 1678 patients (2%) in the enoxaparin group (absolute risk reduction, 1.7%; 95% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in six of 2,209 patients (0.3%) in the rivaroxaban group and in two of 2,224 patients (0.1%) in the enoxaparin group (P=0.18).
Conclusions: A once-daily, 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily, 40mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles.
RECORD 2 Study[2]
Background: The researchers investigated the efficacy of rivaroxaban, an orally active direct factor Xa inhibitor, in preventing venous thrombosis after total knee arthroplasty.
Methods: In this randomized, double-blind trial, 2,531 patients who were to undergo total knee arthroplasty received either oral rivaroxaban, 10 mg once daily, beginning six to eight hours after surgery, or subcutaneous enoxaparin, 40 mg once daily, beginning 12 hours before surgery. The primary efficacy outcome was the composite of any deep vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 13 to 17 days after surgery. Secondary efficacy outcomes included major venous thromboembolism (VTE) (i.e., proximal deep vein thrombosis, nonfatal pulmonary embolism or death related to venous thromboembolism) and symptomatic VTE. The primary safety outcome was major bleeding.
Results: The primary efficacy outcome occurred in 79 of 824 patients (9.6%) who received rivaroxaban and in 166 of 878 (18.9%) who received enoxaparin (absolute risk reduction, 9.2%; 95% confidence interval [CI], 5.9 to 12.4; P<0.001). Major VTE occurred in nine of 908 patients (1%) given rivaroxaban and 24 of 925 (2.6%) given enoxaparin (absolute risk reduction, 1.6%; 95% CI, 0.4 to 2.8; P=0.01). Symptomatic events occurred less frequently with rivaroxaban than with enoxaparin (P=0.005). Major bleeding occurred in 0.6% of patients in the rivaroxaban group and 0.5% of patients in the enoxaparin group. The incidence of drug-related adverse events, mainly gastrointestinal, was 12% in the rivaroxaban group and 13% in the enoxaparin group.
Conclusions: Rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee arthroplasty, with similar rates of bleeding.
Total Knee Replacement
RECORD 3
RECORD 4
Medically Ill Patients
MAGELLAN
ADOPT
References
- ↑ Eriksson BI, Borris LC, Friedman RJ; et al. (2008). "Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty". N. Engl. J. Med. 358 (26): 2765–75. doi:10.1056/NEJMoa0800374. PMID 18579811. Unknown parameter
|month=ignored (help) - ↑ Lassen MR, Ageno W, Borris LC; et al. (2008). "Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty". N. Engl. J. Med. 358 (26): 2776–86. doi:10.1056/NEJMoa076016. PMID 18579812. Unknown parameter
|month=ignored (help)