The New Oral Anticoagulants. Yes

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1 Improving Improving protection protection against against venous venous thromboembolism thromboembolism with new oral anticoagulants with new oral? anticoagulants? The New Oral Anticoagulants will replace the LMWH? Yes Patrick Mouret Orthopedic Department Klinikum Frankfurt Höchst, Germany 2nd International SAVTE Symposium Sheraton Hotel, Casablanca May 2012

2 What is new to be improved small tablet daily injection needle injuries allergic reactions HIT monitoring, platelet count haematoma at injection site patient teaching for selfinjection SAVTE Symposium Casablanca 2nd May 2012

3 Asking physicians and nurses about advantages in oral vs. injections Unneeded injections No haematoma at injection site No allergic reactions important neutral not important physicians important neutral not important nurses important neutral not important No platelet count No more needle injuries No more patient self-teaching important neutral not important important neutral not important important neutral not important Wilke,T.et al. Prozessanalysen in Akut- und Rehakliniken. Orthopäde ;

4 and heparins have several limitations Limitation Clinical consequence Parenteral administration Indirect mode of action requiring cofactors Potential of HIT Compliance problems and unsuitable for long-term administration No inhibition of clot bound activated clotting factors Monitoring of platelet count required Negative influence on bone metabolism Development of osteoporosis under long-term administration Hirsh et al. Chest 2004

5 Approved new oral anticoagulants Dabigatran Apixaban O N N O Cl O H S N O O O N N NH 2 O O N N O Prophylaxis EMA 6-10 heures SPAF EMA

6 Our own experience with NOAC Xarelto => start more than 3 ½ years experience (1650 patients) 850 THR and 680 TKR 90 revisions THR/TKR 30 femoral neck/ periprothetic fractures

7 Our own experience with Xarelto Events symptomatic VTE in THR* symptomatic VTE in TKR** Major bleeding cardiovascular events*** large wound haematoma Frankfurt/Höchst 0 (0) 3 ( 0,4 ) 0 (0 ) 36 ( 2,5 ) RECORD Studies Enoxaparin RECORD Studies N = 1650 N = N = (0,2 ) (0,5 ) (0,7 ) (2,0 ) (0,3 ) (0,5 ) 3 (0,2 ) (0,5 ) (0,5 ) (1,8 ) (1,8 ) deaths 0 (0) (0,1 ) (0,4 ) */** Prophylaxis 35 days in THR and TKR (German Guidelines) Follow up 3 months SAVTE Symposium Casablanca 2nd May 2012 Klinik/Bereich

8 Oral vs LMWH in fractures (Ukraine) Опыт применения ривароксабана (КСАРЕЛТО ) при лечении переломов нижних конечностей Compliance analysis in 35 days VTE prevention in femoral and tibial fracture surgery, treated by osteosynthesis. 2 patient groups compared: Group 1: Enoxaparine (Clexane 40mg) Group 2: (Xarelto ). In out-patient conditions, VTE prevention was respected: Groupe Groupe «Ортопедия, травматология и протезирование» 2010, 2: 73 74

9 LMWH & in polytraumatisme Профілактика тромбоемболічних ускладнень у Постраждалих з Політравмою Analysis on efficacy /Safety of combined VTE prevention in polytraumatisme. 40 cases including fracture of lower limb. VTE prevention initiated pre/post op with LMWH for 5 days still stabilisation of patient. Prolongation of VTE prevention with 1omg od for 35 jours. => no symptomatic VTE => no specific major cliniacl adverse events. => good patient compliance (85 completed period) Ортопедия, травматология и протезирование 2010, 4: 65 67

10 Design ORTHOTEP register Retrospective analysis University Hospital Dresden, Germany; cohort of 5346 unselected patients in major orthopedic surgery LMWH Fondaparinux 1683 patients 2069 patients 2010 June patients July 2011 Clinically relevant endpoints: In-hospital incidence of symptomatic VTE Severe bleeding (ISTH definition) Complications leading to surgical revisions Length of hospitalization Comparison of oral rivaroxaban, fondaparinux and LMWH for results from the ORTHOTEP registry for VTE prophylaxis in major orthopaedic surgery Jan Beyer-Westendorf, Dresden University Hospital, Dept. Vascular Medecine

11 ORTHOTEP: symptomatic VTE Efficacy endpoints LMWH n=1683 (n) Fondaparinux (F) n=2069 (n) (R) n=1055 (n) p-value LMWH vs R p-value F vs R all VTE (n) 3.92 (66) 5.51 (114) 2.46 (26) <0.001 major VTE (n) 1.43 (24) 1.74 (36) 1.04 (11) All VTE 3 Proximal DVT / PE / death of VTE LMWH F RRR 39 / LMWH F R RRR 29 / 42 p<0.05 Not significant Comparison of oral rivaroxaban, fondaparinux and LMWH for results from the ORTHOTEP registry for VTE prophylaxis in major orthopaedic surgery Jan Beyer-Westendorf, Dresden University Hospital, Dept. Vascular Medecine

12 ORTHOTEP: safety Primary safety endpoint LMWH n=1683 (n) Fondaparinux (F) n=1994 (n) (R) n=1055 (n) p-value LMWH vs R p-value F vs R severe bleeding (251) (230) 7.39 (78) < LMWH severe bleeding F R RRR 51/ Bleeding leading to surgery LMWH F RRR 76/64 p=0.001 p<0.001/p=0.058 RECORD1 4 Rates <1 Definition: overt major bleed outside of surgical site

13 Length of hospital stay: correlation with severe bleeding Secondary safety endpoint Length of hospital stay, days (95 CI) Length of hospital stay (days), median (25 th and 75 th percentile) LMWH n=1683 Fondaparinux (F) n=1994 (R) n=1055 p-value LMWH vs R p-value F vs R 11.6 ( ) 9.3 ( ) 8.3 ( ) <0.001 < ( ) 9.0 (8.0-.0) 8.0 ( ) <0.001 <0.001 without with severe bleeding without with severe bleeding patients LMWH without with severe bleeding patients Fondaparinux without with severe bleeding Lengh of hospital stay (days) Lengh of hospital stay (days) Shorter hospitalization with rivaroxaban prophylaxis correlated with fewer severe bleeding complications

14 XAMOS: in real world orthopedic prophylaxis Résults presented at British Society of Hematology 2012 in Glasgow, 17th april 2012 Phase IV postmarketing study by EMA (European Medicines Agency) after approve in Europe. Xamos recruted patients in THR, TKR and hip fractures in 37 countries. Patients treated with or standard of care. Xamos resultast reflects the results of RECORD studies, e.d. risk/benefit profil in favor of.

15 Results: used treatments Number of treated patients Standard of care LMWH Fondaparinux Dabigatran UFH ASA VKA Herbals Other

16 Xamos: main results Standard of care OR (95IC) Symptomatic TE 0,89 0,65 ( 0,49-0,87) 1,35 arterial sympt. TE 0,23 0,34 0,68 (0,38-1,20) Symptomatic VTE Major bleeding (RECORD definition) Major bleeding (EMA definition) 0,65 1,02 0,63 (0,45.0,89) 0,40 0,34 1,19 (0,73-1,95) 1,70 1,44 1,19 (0,93-1,51) All bleeding 4,67 3,24 1,46 (1,25-1,71) SAE 4,00 3,91 1,02 (0,88-1,19) thrombocytopenia 0,08 0,23 0,34 (0,15-0,81)

17 Xamos: safety results AG. Turpie déclares that the increase of minor bleeding was mainly represented by ecchymosis : we expected to see these bleedings under use of anticoagulants, and maybe they are underestimated in the standard treatment arm British Society of Hematology, 17 Avril 2012

18 VTE Treatment: only approved! Initial treatment 15mg bid. for 3 weeks Treatment continuation 20mg o.d.for 6 or 12 months In patients with CrCl 30-50ml/min: 15 mg o.d. No need to initiate with LMWH No need to continue on VKA treatment SAVTE Symposium Casablanca 2nd May Klinik/Bereich 2012

19 Case report: perioperative fracture in SPAF patient under 20mg pre OP discontinuation of medication (at least 24 hours before surgery) post OP Xarelto 20mg 10 hours post op, depending on haemostasis continuing treatment as before trauma

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