Abstract:Objective To systematically assess the clinical efficacy and safety of apixaban versus enoxaparin in the prevention of venous thromboembolism (VTE) after major orthopedic surgery.Methods Based on the principles and methods of Cochrane systematic review,the Cochrane Library,PubMed,EMBASE,Chinese Bio-medicine Database,China Journal Full-text Database,VIP Database were searched from their establishment to March 2012 in whatever languages.Related journals were handsearched as well.Randomized controlled trials (RCTs) of comparing apixaban and enoxaparin in the prevention of venous thromboembolism after major orthopedic operation were included.Cochrane Collaboration' s tool was used for assessing risk of bias in the included trials.Cochrane Collaboration' s software RevMan 5.1 was used for statistical analysis.Results Four RCTs totaling 12 897 patients were included.Apixaban treatment showed significant differences in aspects of total VTE and all-cause mortality [relative risk (RR) =0.63,95% CI(0.41,0.96)],major VTE [RR =0.59,95% CI(0.19,0.98)] and symptomatic deep vein thrombosis (DVT) [RR =0.50,95% CI(0.26,0.97)] when compared with enoxaparin,but the difference in fatal pulmonary embolism was insignificant[RR =1.57,95% CI(0.41,5.99)].For patients undergoing total knee arthroplasty,apixaban was associated with significantly fewer major bleeding events[RR =0.55,95% CI(0.32,0.96)] and fewer total bleeding events[RR =0.79,95% CI(0.66,0.95)] than enoxaparin.For patients undergoing total hip replacement,however,the two treatments revealed no statistically significant differences.With regard to the incidence of drug-related serious adverse events,the two treatments displayed no significant difference[RR =0.97,95% CI(0.59,1.58)].Conclusion Apixaban is effective in the prevention of VTE after major orthopedic surgery and can significantly reduce the risk of postoperative VTE.
. Apixaban for prevention of venous thromboembolism after major orthopedic surgery: a Meta-analysis[J]. CHINESE JOURNAL OF TRAUMA, 2013, 29(10): 960-965.
[1]Falck-Ytter Y, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest, 2012, 141(2 Suppl):e278S-325S.
[2]Hill J, Treasure T, Reducing the risk of venous thromboembolism in patients admitted to hospital: summary of NICE guidance. BMJ, 2010, 340:c95.
[3]Kassim RA, Saleh KJ, Badra M, et al. Thromboembolic complications after total hip arthroplasty. J South Orthop Assoc, 2003, 12(2):103-105.
[4]Silbersack Y, Taute BM, Hein W, et al. Prevention of deep-vein thrombosis after total hip and knee replacement. Low-molecular-weight heparin in combination with intermittent pneumatic compression. J Bone Joint Surg (Br), 2004, 86(6):809-812.
[5]Pinto DJ, Orwat MJ, Koch S, et al. 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(22):5339-5356.
[6]Jiménez D, Yusen RD, Ramacciotti E. Apixaban: an oral direct factor-xa inhibitor. Adv Ther, 2012, 29(3):187-201.
[7]Mak A, Cheung MW, Fu EH, et al. Meta-analysis in medicine: an introduction. Int J Rheum Dis, 2010, 13(2):101-104.
[8]Higgins JP,Thompson SG,Decks JJ,et al. Measuring inconsistency in meta-analyses. BMJ,2003,327(7414):557-560.
[9]Lassen MR, Davidson BL, Gallus A, et al. The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. J Thromb Haemost, 2007, 5(12):2368-2375.
[10]Lassen MR, Raskob GE, Gallus A, et al. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med, 2009, 361(6): 594-604.
[11]Lassen MR, Raskob GE, Gallus A, et al. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet, 2010, 375(9717):807-815.
[12]Lassen MR, Gallus A, Raskob GE, et al. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med, 2010, 363(26):2487-2498.
[13]Johanson NA, Lachiewicz PF, Lieberman JR, et al. Prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. J Am Acad Orthop Surg, 2009, 17(3):183-196.
[14]Ageno W, Spyropoulos AC, Turpie AG. Role of new anticoagulants for the prevention of venous thromboembolism after major orthopaedic surgery and in hospitalised acutely ill medical patients. Thromb Haemost, 2012, 107(6):1027-1034.
[15]Migliaccio-Walle K, Rublee D, Simon TA. Anticoagulation prophylaxis in orthopedic surgery: an efficiency frontier approach. Postgrad Med, 2012, 124(1):41-49.
[16]Perka C. Preoperative versus postoperative initiation of thromboprophylaxis following major orthopedic surgery: safety and efficacy of postoperative administration supported by recent trials of new oral anticoagulants. Thromb J, 2011, 9:17.
[17]Martin MT, Nutescu EA. Therapeutic potential of apixaban in the prevention of venous thromboembolism in patients undergoing total knee replacement surgery. Curr Med Res Opin, 2011, 27(11):2123-2131.
[18]Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg, 2011, 9(8):672-677.