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Influence of Fondaparinux Versus Nadroparin Calcium Thromboprophylaxis on Clinical Parameters Following Total Knee Arthroplasty

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Influence of Fondaparinux Versus Nadroparin Calcium Thromboprophylaxis on Clinical Parameters Following Total Knee Arthroplasty Acta Clin Croat 2016; 55:414-421 Original Scientifi c Paper doi: 10.20471/acc.2016.55.03.10 INFLUENCE OF FONDAPARINUX VERSUS NADROPARIN CALCIUM THROMBOPROPHYLAXIS ON CLINICAL PARAMETERS FOLLOWING TOTAL KNEE ARTHROPLASTY Zdravka Mihaljević1, Damjan Dimnjaković1, Branko Tripković1,2, Melita Buljan1, Ana Aljinović1, Domagoj Delimar1,2 and Goran Bićanić1,2 1Department of Orthopedic Surgery, Zagreb University Hospital Center; 2School of Medicine, University of Zagreb, Zagreb, Croatia SUMMARY – Fondaparinux has been shown to be as eff ective as low molecular weight heparin in orthopedic surgery, with no cases of heparin induced thrombocytopenia proven until today. Th e main goal of this prospective randomized controlled trial was to defi ne whether thromboprophylaxis in patients with primary osteoarthritis of the knee undergoing total knee arthroplasty (TKA) infl u- ences clinical parameters in the same manner in patients receiving fondaparinux as in those receiving nadroparin during the fi rst 7 postoperative days. Sixty patients with primary knee osteoarthritis un- derwent unilateral TKA performed by the same surgeon and were randomized into two groups of 30 patients receiving either fondaparinux or nadroparin thromboprophylaxis. Patients were compared according to the duration of operation, perioperative blood loss, laboratory results and clinical evalu- ation of the edema during the early postoperative period. No diff erences were found between the groups in the mean duration of surgery, perioperative blood loss, and most of laboratory results. Th e level of urea was signifi cantly lower in the nadroparin group on the fi rst and second postoperative day. No cases of heparin induced thrombocytopenia, deep vein thrombosis or pulmonary embolism were noted during the study. Study results showed both fondaparinux and nadroparin to have the same infl uence on clinical parameters during the fi rst 7 postoperative days in patients undergoing TKA. Key words: Arthroplasty, replacement, knee; Anticoagulants; Fondaparinux; Nadroparin; Hemorrhage Introduction thors, the rate of DVT can be by 50% higher if no thromboprophylaxis is used in orthopedic surgery2. Th e importance of thromboprophylaxis in ortho- Low molecular weight heparin (LMWH) is nowadays pedic surgery regarding the possible postoperative de- often used for prevention of thromboembolic compli- velopment of thromboembolic complications such as cations in patients undergoing TKA, with the inci- deep vein thrombosis (DVT) and pulmonary embo- dence of DVT and PE reduced by 60% when com- lism (PE) is well known. Th e American College of pared to the control group without thromboprophy- Chest Physicians (ACCP) guidelines from 2012 sug- laxis3. Th e known drawbacks in LMWH treatment are gest that the baseline risk in orthopedic surgery is 1% the possibility of heparin-induced thrombocytopenia 1 for PE and 1.8% for DVT . According to some au- (HIT) in 0.2% of patients with LMWH therapy and excessive bleeding4. Correspondence to: Damjan Dimnjaković, MD, Department of Great attention has been focused lately on devel- Orthopedic Surgery, Zagreb University Hospital Center, Šalata 7, HR-10000 Zagreb, Croatia oping an ‘ideal’ medication for prevention and treat- E-mail: [email protected] ment of thromboembolic diseases. Th e ideal drug Received January 9, 2015, accepted February 16, 2016 should be as eff ective as the best known drug used to- 414 Acta Clin Croat, Vol. 55, No. 3, 2016 Zdravka Mihaljević et al. Fondaparinux vs. nadroparin in total knee arthroplasty day, safe and simple to use, and widely applicable. Di- in subcutaneous injections. Th e fi rst dose was adminis- rect inhibitors of factor Xa are being investigated as tered 6 hours after the surgery and the same dose was the possible ‘new generation’ of anticoagulants for administered each day during the remaining hospital some time5. Fondaparinux is a Xa inhibitor demon- stay at 10 a.m. strated to be as eff ective as LMWH, with no cases of Th e second group received thromboprophylaxis HIT proven until today. It inhibits factor Xa via anti- with nadroparin calcium (Fraxiparine®, GlaxoSmith- thrombin III, but is, unlike LMWH, selective for fac- Kline-GSK, Brentford, United Kingdom) at a dose of tor Xa. Th e main goal of this prospective randomized 0.4 mL in subcutaneous injections. Th e fi rst dose was controlled trial was to defi ne whether thrombopro- administered 12 hours before the surgery, the second phylaxis in patients with primary osteoarthritis of the dose 8 to 10 hours after the surgery, and then the same knee undergoing TKA infl uences clinical parameters dose was administered every 24 hours during the hos- in the same manner in patients receiving fondaparinux pital stay. as in those receiving nadroparin calcium during the All patients received thromboprophylaxis during fi rst 7 days following surgery. the fi rst 6 postoperative weeks, which included throm- boprophylaxis using either fondaparinux or nadropa- Patients and Methods rin calcium throughout the hospital stay, which usually ended after the patients achieved at least 90° of fl exion Our study included 60 patients with primary os- and full extension of the operated knee. Upon dis- teoarthritis of the knee that underwent unilateral TKA charge from the hospital, thromboprophylaxis diff ered performed by the same surgeon at our Department. based on whether they were discharged to a rehabilita- Th e patients were examined by an anesthesiologist tion center or home. If the patients were transferred to working at our Department, 3-4 weeks before the sur- a rehabilitation center, they received thromboprophy- gery and at that time laboratory results were checked, laxis as suggested by the orthopedic surgeon in the dis- which included complete blood count (CBC), sodium charge letter. In cases they were discharged home, their and potassium levels, blood glucose level, liver enzymes thromboprophylaxis was converted to oral warfarin at (aspartate aminotransferase (AST) and alanine ami- a dose adjusted by the attending physician. notransferase (ALT)), as well as urea and creatinine Upon admission to the hospital, blood pressure was levels. Th e American Society of Anesthesiologists measured, as well as heart frequency and weight. At (ASA) physical status was assessed at that time6. Th e that time, blood sample was obtained to determine inclusion criteria were primary knee osteoarthritis, age CBC, activated partial thromboplastin time (aPTT) between 40 and 80 years, weight between 45 and 110 and prothrombin time (PT). Th is was repeated at 24 kg, and ASA status I and II. hours, 3 days and 7 days after the surgery. Th e level of Patients with secondary osteoarthritis of the knee, D-dimers was assessed at 24 hours and 7 days after the patients awaiting revision TKA, patients with malig- surgery. nancies, autoimmune diseases, coagulation disorders, All surgeries were performed with the patients in cardiovascular diseases (uncontrolled hypertension, spinal anesthesia. All patients preoperatively received unstable angina pectoris, acute myocardial infarction antibacterial prophylaxis with fi rst-generation cepha- and/or cerebrovascular insult up to 6 months prior to losporins or clindamycin, which is in accordance with surgery), gastrointestinal bleeding that had been pres- recent guidelines7,8. A thigh tourniquet was infl ated at ent for up to 6 months prior to surgery, and patients 250-300 mm Hg before the beginning of surgery. To- taking immunosuppressive or cytostatic drugs or anti- tal knee arthroplasty was performed in a standard coagulants were not included in the study. fashion in all patients, using the cemented total knee Upon approval by the Hospital Ethics Committee, endoprosthesis Multigen Plus (Lima Coorporate spa®, patients were randomized using the random number Udine, Italy). Th e tourniquet was defl ated after the table into two groups consisting of 30 patients each. original components had been implanted, followed by Th e fi rst group of patients received thromboprophy- detailed hemostasis and placement of two surgical laxis with fondaparinux (Arixtra®, GlaxoSmithKline- drains intra-articularly before suturing the wound. GSK, Brentford, United Kingdom) at a dose of 2.5 mg Surgical drains were connected to the autotransfusion Acta Clin Croat, Vol. 55, No. 3, 2016 415 Zdravka Mihaljević et al. Fondaparinux vs. nadroparin in total knee arthroplasty Drentech Surgical blood salvage system (REDAX®, sured at the level of the middle third of the patella. Poggio Rusco, Italy), which was used during the fi rst 6 Both measurements were repeated 24, 48 and 72 hours hours postoperatively. Upon removal of the blood sal- after the surgery, as well as 7 days postoperatively. vage system, surgical drains were connected to the Statistical analysis was performed using the standard ‘free-fall’ system. Smirnov-Kolmorgorov testing with ANOVA and Postoperative care was taken by anesthesiologists Kruskal-Wallis test for quantitative variables. Th e c2- in the Orthopedic Intensive Care Unit (ICU) for 24 or test and Fisher exact test were used on analysis of 48 hours following the surgery, after which the pa- qualitative variables. Th e STATISTICA ver. 9.1 soft- tients were transferred back to the orthopedic depart- ware was employed. Th e t-test and Wilcoxon test were ment. Intensive care included fl uid resuscitation and used to test diff erences, as well as Student’s t-test and continuous use of analgesics. Monitoring of the blood Mann Whitney test. Th e level of statistical
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