Apixaban after hip or knee arthroplasty versus enoxaparin: Efficacy and safety in key clinical subgroups

Journal of Thrombosis and Haemostasis

Volumn 11, Issue 3, 2013, Pages 444-451

  Pineo, G F ^a   Gallus, A S ^b   Raskob, G E ^c   Chen, D ^d   Ramirez, L M ^d   Ramacciotti, E ^d   Lassen, M R ^e   Wang, L ^d  

^a UNIVERSITY OF CALGARY   (Canada)

^b FLINDERS UNIVERSITY   (Australia)

^c UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

^e UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Apixaban; Body mass index; Enoxaparin; Oral anticoagulant; Renal function; Thromboprophylaxis

Indexed keywords

APIXABAN; ENOXAPARIN;

ADULT; AGE; AGED; ARTICLE; BLEEDING; BODY MASS; BODY WEIGHT; CONFIDENCE INTERVAL; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GENDER; HIP ARTHROPLASTY; HUMAN; KNEE ARTHROPLASTY; MAJOR CLINICAL STUDY; MALE; MULTIVARIATE LOGISTIC REGRESSION ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; UNIVARIATE ANALYSIS; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; AGE FACTORS; AGED; ANTICOAGULANTS; ARTHROPLASTY, REPLACEMENT, HIP; ARTHROPLASTY, REPLACEMENT, KNEE; BIOLOGICAL MARKERS; BODY MASS INDEX; BODY WEIGHT; CHI-SQUARE DISTRIBUTION; CLINICAL TRIALS, PHASE III AS TOPIC; CREATININE; DRUG ADMINISTRATION SCHEDULE; ENOXAPARIN; FEMALE; FIBRINOLYTIC AGENTS; HEMORRHAGE; HUMANS; LOGISTIC MODELS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PYRAZOLES; PYRIDONES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; RISK FACTORS; SEX FACTORS; TREATMENT OUTCOME; VENOUS THROMBOEMBOLISM;

EID: 84874990308     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.12109     Document Type: Article

References (19)

1. Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW, American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008; 133: 381S-453S.
2. Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W, RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008; 358: 2765-7.
3. Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S, RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008; 372: 31-9.
4. Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG, RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776-86.
5. Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD, RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373: 1673-80.
6. Turpie AG, Lassen MR, Eriksson BI, Gent M, Berkowitz SD, Misselwitz F, Bandel TJ, Homering M, Westermeier T, Kakkar AK. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost 2010; 105: 444-53.
7. Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Büller HR, RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007; 370: 949-56.
8. Erikssn BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Kalebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, Buller HR, for the RE-MODEL Study Group. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007; 5: 2178-2185.
9. The RE-MOBILIZE Writing Committee. Oral thrombin inhibitor dabigatran etexilate vs. North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty 2009; 24: 1-9.
10. Pinto DJ, Orwat MJ, Koch S, Rossi KA, Alexander RS, Smallwood A, Wong PC, Rendina AR, Luettgen JM, Knabb RM, He K, Xin B, Wexler RR, Lam PY. Discovery of 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4, 5, 6, 7-tetrahydro-1H-pyrazolo[3, 4-c]pyridine-3-carboxamide (apixaban, BMS-562247), a highly potent, selective, efficacious, and orally bioavailable inhibitor of blood coagulation factor Xa. J Med Chem 2007; 50: 5339-56.
11. Wong PC, Crain EJ, Xin B, Wexler RR, Lam PY, Pinto DJ, Luettgen JM, Knabb RM. Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies. J Thromb Haemost 2008; 6: 820-9.
12. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P, ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet 2010; 375: 807-15.
13. Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM, ADVANCE-3 investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med 2010; 363: 2487-98.
14. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med 2009; 361: 594-604.
15. Raskob GE, Gallus AS, Pineo GF, Chen D, Ramirez LM, Wright RT, Lassen MR. Apixaban versus enoxaparin for thromboprophylaxis after hip or knee replacement. Pooled analysis of major venous thromboembolism and bleeding in 8, 464 patients from the ADVANCE -2 and ADVANCE-3 trials. J Bone Joint Surg Br 2012;94-B:257-264.
16. Rabinov K, Paulin S. Roentgen diagnosis of venous thrombosis in the leg. Arch Surg 1972; 104: 134-44.
17. Guideline on Clinical Investigation of Medicinal Products for Prophylaxis of High Intra- and Post-Operative Venous Thromboembolic Risk. 2007. Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003302. Accessed 30 January 2011.
18. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine - reporting of subgroup analyses in clinical trials. N Engl J Med 2007; 357: 2189-94.
19. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf. Accessed 29 June 2012.