Practical Experience of Thromboprophylaxis After Lower Limb Replacement – Rivaroxaban Versus Enoxaparin

Abstract

AbstractAbstract 4369 BACKGROUNDSince October 2010, rivaroxaban has been approved by Korean government to be covered by national health insurance reimbursement system as thromboprophylaxis after total hip arthroplasty and total knee arthroplasty. However, there is no available data on outcomes of rivaroxaban as thromboprophylaxis in Korea. We performed a retrospective study to compare the efficacy and safety of venous thromboembolism prophylaxis with enoxaparin or rivaroxaban in 195 consecutive patients undergoing major orthopaedic surgery at our center. METHODSThis study retrospectively reviewed the medical records of the 195 patients who underwent a total hip replacement arthroplasty or total knee replacement arthroplasty and received thromboprophoylaxis with enoxaparin or rivaroxaban at Soonchunhyang University Hospital between March 2009 and May 2012.Each patient's medical records included information on age, sex, comorbidities (active malignant disease, renal insufficiency), treatment details (type of surgery, type of anesthesia, duration of surgery,), duration of prophylaxis, efficacy (death, pulmonary embolism, deep vein thrombosis), safety (major bleeding, cerebrovascular accident), cause of drug interruption. RESULTSOf 195 patients, 129 patients received thromboprophylaxis with enoxaparin (group 1; our hospital standard since March 2009), 66 received rivaroxaban (group 2; our hospital standard since February 2011). Symptomatic venous thromboembolism was found in 0.7 % of patients in the group 1 (1/129 patients) compared to 1.5 % of group 2 (1/66 patients; p=0.627). No significant differences in the rates of symptomatic VTE were found. However, patients with received rivaroxaban had significantly more rates of major bleeding (0 in group 1 vs 3% (2/66 patients) in group 2; p=0.047). Although group 1 patients were planed receiving thromboprophylaxis with rivaroxaban from day one post operatively, mean time from the end of surgery to first rivaroxaban intatake was 4.2 days. CONCLUSIONSDespite lower compliance in rivaroxaban group, venous thromboembolism prophylaxis with rivaroxaban is not inferior to prophylaxis with enoxaparin with regard to the prevention of symptomatic venous thromboembolisms. But, more bleeding complications and wound problems revealed in rivaroxaban group. Further studies and experiences are needed to assess the efficacy and safety of rivaroxaban in clinical practice.Table 1Incidence of Events for Efficacy AnalysisEnoxaparinRivaroxabanEventsTKRA (N=67)THRA (N=62)Total (N=129)TKRA (N=39)THRA (N=27)Total (N=66)Occurrence of VTE01.6%0.7%2.5%01.5%PE, n011000DVT, n000000PE + DVT, n000101All cause mortality (3 months), n(%)02 (3.2)2 (1.5)000Table 2Safety outcomesEnoxaparinRivaroxabanOutcomeTKRA (N=67)THRA (N=62)Total (N=129)TKRA (N=39)THRA (N=27)Total (N=66)major bleeding following thromboprophylaxis -no. (%)0002 (5.1)02 (3.0)Clinically overt surgical site bleeding, leading to a decreased Hb — no. (%)0001 (2.5)01 (1.5)Clinically overt extra-surgical site bleeding, leading to a decreased Hb — no. (%)0001 (2.5)01 (1.5)Cardiovascular adverse event ≤1 day after last dose of study medication — no. (%)Ischemic stroke0001 (2.5)01 (1.5) Disclosures:No relevant conflicts of interest to declare.