International Journal of Orthopaedics Sciences 2020; 6(3): 90-95 E-ISSN: 2395-1958 P-ISSN: 2706-6630 IJOS 2020; 6(3): 90-95 Rivaroxaban versus enoxaparin for © 2020 IJOS www.orthopaper.com thromboprophylaxis after hip arthroplasty Received: 20-05-2020 Accepted: 22-06-2020 Dr. Lenin Ligu and Dr. Moji Jini Dr. Lenin Ligu Assistant professor. Tomo Riba Institute of Health and Medical DOI: https://doi.org/10.22271/ortho.2020.v6.i3b.2183 Sciences (TRIHMS), Arunachal Pradesh, India Abstract Background: Introduction: Total hip arthroplasty (THA) is a successful surgical procedure for reducing Dr. Moji Jini pain and improving physical function in osteoarthritis. It is one of the most effective orthopaedic Director, Tomo Riba Institute of procedures. Health and Medical Sciences, Material and methods: Patients were eligible for the study if they were aged 18 years or older and were Arunachal Pradesh, India scheduled for total hip arthroplasty. Patients were ineligible if they were scheduled to undergo staged, bilateral hip arthroplasty were pregnant or breastfeeding, had active bleeding or a high risk of bleeding, or any disorder contraindicating the use of Rivaroxaban/enoxaparin that might necessitate enoxaparin dose adjustment. Results: Of the 52 patients enrolled in study, 52 patients were randomized to receive either Rivaroxaban (n=26) or enoxaparin (n=26). The baseline demographic characteristics of the two randomized treatment groups are well balanced as described in Table 1. The surgical characteristics are described in Table 2. Conclusion: Rivaroxaban, given as a once-daily 10 mg fixed dose 6–8 h postoperatively, is the first new oral anticoagulant to significantly reduce the incidence of venous thromboembolism after total knee arthroplasty, compared with enoxaparin 30 mg twice daily, starting 12–24 h postoperatively, without a significant difference in the risk of major or clinically relevant bleeding. Keywords: Rivaroxaban versus enoxaparin Total hip arthroplasty successful surgical patients Introduction Total hip arthroplasty (THA) is a successful surgical procedure for reducing pain and improving physical function in osteoarthritis [1]. Severe osteoarthritis and hip fragility fractures due to osteoporosis are the chief conditions needful of THA. In India, osteoarthritis, secondary to avascular necrosis and/or trauma to the hip joint as well as arthritis are the commonest signs for THA. It is one of the most effective orthopaedic procedures. The requirement for THA is [2] probable to continually rise . Venous thromboembolism (VTE) is a main, possibly fatal problem after major orthopaedic procedure such as total knee arthroplasty. [3] Subsequently total hip arthroplasty, extensive prophylaxis for 5 weeks after surgery decreases the frequency of characteristic and [2] asymptomatic venous thromboembolism more efficiently than short-term prophylaxis . Deep-vein thromboses (DVT) have been exposed to form after the cessation of short-term prophylaxis [4]. Numerous meta-analyses recommend that extended thromboprophylaxis after total hip arthroplasty results to a decrease in symptomatic venous thromboembolic events, without increasing the risk of major bleeding [5]. The present possibilities for prolonged thromboprophylaxis are inadequate. Low-molecular- weight heparin (LMWH) preparations decreases thromboembolic incidence but essential to be managed subcutaneously, and their cost-effectiveness has been shown only if patients or relative can be taught to inject the medicine at home [6]. Vitamin K antagonists, alike warfarin, have variable pharmacologic properties and several food and drug interactions, need [7] Corresponding Author: continuous supervision, and hence difficult to manage . Moreover, there is sign to Dr. Lenin Ligu recommend that the frequency of major bleeding is more with vitamin K antagonists than with Assistant professor. Tomo Riba low-molecular-weight heparin preparations given after total hip arthroplasty [8]. Institute of Health and Medical Rivaroxaban is an oral, direct factor Xa inhibitor that is approved globally for the prevention Sciences (TRIHMS), Arunachal of venous thromboembolism after elective hip and knee arthroplasty, in some countries, it has Pradesh, India ~ 90 ~ International Journal of Orthopaedics Sciences www.orthopaper.com a broader label to include use after lower-limb orthopaedic drug group with permuted blocks and stratification according surgery [9]. Despite widespread approval, there are still to centre by means of a central telephone system with outstanding questions from clinicians relating to the everyday generated randomization list. Patients received either once use of rivaroxaban. These questions relate to the optimal daily oral rivaroxaban 10 mg tablets or subcutaneous duration of thromboprophylaxis after surgery; its use with injections of 40 mg enoxaparin sodium. Drug was dispensed other medications; the risk of adverse events, such as bleeding by nurses in the hospital and by nurse, relative, or patient after or wound-related complications; the optimal timing of the discharge. Rivaroxaban was started 6–8 h after wound closure first thromboprophylactic dose; periprocedural care of the or after adequate haemostasis had been achieved. Enoxaparin anticoagulated patient; use with general and regional was started 12–24 h after wound closure. Thereafter, study anaesthesia; and use in fracture-related cases [10]. drugs were administered every 24 hours (range, 22 to 26) in Enoxaparin dose adjustment is commonly recommended for the evening through day 35 (range, 31 to 39) after surgery thromboprophylaxis in patients with severe renal (with the day of surgery defined as day 1). insufficiency (CrCl of <30 mL/minute); however, the exact Patients underwent mandatory bilateral venography the day dose reduction varies among different countries and practice after the last dose of the study drug, at 36 days (range, 30 to guidelines [11]. The American College of Chest Physicians 42). No further study medication was given after venography, (ACCP) guidelines and enoxaparin US labelling recommend although further thromboprophylaxis was continued at the 30 mg subcutaneously (SC) daily for deep vein thrombosis investigator’s discretion. Patients had a follow-up visit 30 to prophylaxis in hip or knee replacement, and in medical 35 days after the last dose of the study drug. patients during acute illness when the CrCl rate is <30 The study was done in accordance with the Declaration of mL/minute [12]. Moreover, different medical associations and Helsinki and local regulations. Independent ethics committees countries may adopt different enoxaparin dosing protocols in or institutional review boards for each study centre approved patients with renal failure, and prescribers tend to reflect the the protocol. practices predominant in the institutions where they completed their medical specialty training [13]. In practice, Outcome measures medical centers in Europe and the Middle East use a further All outcome was assessing by central independent reduced dose of enoxaparin (20 mg) for prophylaxis in adjudication committees masked to allocation assessed all patients with a CrCl rate of 20 to 30 mL/minute and then outcomes. The primary efficacy outcome was the composite switch to UFH at 5000 units SC twice daily for patients with a of any deep-vein thrombosis, non-fatal pulmonary embolism, CrCl rate of <20 mL/minute [14]. or death from any cause up to 36 days after surgery. The main To date, the safety and efficacy of reduced-dose enoxaparin secondary efficacy outcome was major venous (20 mg) have not been completely assessed for the prevention thromboembolism (ie, proximal deep-vein thrombosis, non- of VTE in THA patients. In fact, large dose-finding studies fatal pulmonary embolism, or death related to venous have not been conducted, and contemporary studies either thromboembolism). Other efficacy outcomes included the omitted patients with renal failure or did not stipulate whether incidence of asymptomatic deep-vein thrombosis (any, any such patients were recruited [15]. To our knowledge, no proximal, and distal only), symptomatic venous randomized study has been done to compare the standard thromboembolism in the treatment and follow-up (30 to 35 prophylactic enoxaparin dose (30 mg) with a reduced dose days) periods, and death during the follow-up period. (20 mg) in THA patients. Consequently, inadequate data exist Deep-vein thrombosis was assessed at 36 days between days on the preference of one dose over the other in THA patients 30 and 45 by systematic, ascending, bilateral venography with [16]. This pilot study reports the initial findings of the efficacy a standardised technique. Suspected symptomatic deep vein and safety of enoxaparin at 20 mg daily for DVT prophylaxis thrombosis was assessed by ultrasound and, if positive, was to in hospitalized THA patients was good. The study was be confirmed with venography. Suspected pulmonary completed in accordance with the hospital’s ethics code and embolism was confirmed by pulmonary angiography, by approved by the hospital’s institutional review board. Because ventilation-perfusion lung scintigraphy with chest this was a retrospective cohort study with a comprehensive radiography, or by contrast-enhanced spiral CT. chart review, patient consent was not necessary per the The main safety outcome was the incidence of major bleeding institutional review board. between intake of the first dose of study drug and 2 days after the last dose (on-treatment).