Deep vein thrombosis and novel oral anticoagulants: A clinical review

European Review for Medical and Pharmacological Sciences

Volumn 17, Issue 23, 2013, Pages 3123-3131

  Burgazli, K Mehmet ^a   Atmaca, N ^b   Mericliler, M ^a   Parahuleva, M ^c   Erdogan, A ^c   Daebritz, S H ^b  

^a Medical and Research Center Wuppertal   (Germany)

^b EJK   (Germany)

^c JUSTUS LIEBIG UNIVERSITY   (Germany)

Author keywords

Deep venous thrombosis; DVT; Factor Xa inhibitors; Heparin; New oral anticoagulants; Thrombin inhibitors; Warfarin

Indexed keywords

ANTICOAGULANT AGENT; ANTIVITAMIN K; APIXABAN; BLOOD CLOTTING FACTOR 10A; D DIMER; DABIGATRAN ETEXILATE; EDOXABAN; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; RIVAROXABAN; THROMBIN; WARFARIN;

ANTICOAGULANT THERAPY; CONTRAST ENHANCEMENT; DEEP VEIN THROMBOSIS; DIAGNOSTIC IMAGING; DRUG HALF LIFE; FOOD DRUG INTERACTION; HUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHLEBOGRAPHY; PHYSICAL DISEASE BY BODY FUNCTION; PREDICTION; REVIEW;

ADMINISTRATION, ORAL; ANIMALS; ANTICOAGULANTS; BLOOD COAGULATION; FOOD-DRUG INTERACTIONS; HEMORRHAGE; HUMANS; TREATMENT OUTCOME; VENOUS THROMBOSIS;

EID: 84891821119     PISSN: 11283602     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (62)

1. GO AS, MOZAFFARIAN D, ROGER VL, BENJAMIN EJ, BERRY JD, BORDEN WB, BRAVATA DM, DAI S, FORD ES, FOX CS, FRANCO S, FULLERTON HJ, GILLESPIE C, HAILPERN SM, HEIT JA, HOWARD VJ, HUFFMAN MD, KISSELA BM, KITTNER SJ, LACKLAND DT, LICHTMAN JH, LISA-BETH LD, MAGID D, MARCUS GM, MARELLI A, MATCHAR DB, MCGUIRE DK, MOHLER ER, MOY CS, MUSSOLINO ME, NICHOL G, PAYNTER NP, SCHREINER PJ, SORLIE PD, STEIN J, TURAN TN, VIRANI SS, WONG ND, WOO D, TURNER MB; AMERICAN HEART ASSOCIATION STATISTICS COMMITTEE AND STROKE STATISTICS SUBCOMMITTEE. Heart disease and stroke statistics - 2013 update: a report from the American Heart Association. Circulation 2013; 127: e6-e245.
2. RD. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 1998; 158: 585-593.
3. KAHN SR. The clinical diagnosis of deep venous thrombosis: integrating incidence, risk factors, and symptoms and signs. Arch Intern Med 1998; 158: 2315-2323.
4. BAGOT CN, ARYA R. Virchow and his triad: a question of attribution. Br J Haematol 2008; 143: 180-190.
5. ZHU T, MARTINEZ I, EMMERICH J. Venous thromboembolism: risk factors for recurrence. Arterioscler Thromb Vasc Biol 2009; 29: 298-310.
6. SCHWARZ N, REUTTER K, EDS. General and Visceral Surgery Review. Stuttgart, Thieme, 2011.
7. WELLS PS, ANDERSON DR, BORMANIS J, GUY F, MITCHELL M, GRAY L, CLEMENT C, ROBIN-SON KS, LEWANDOWSKI B. Value of assessment of pretest probability of deep-vein thrombosis in clinical management. Lancet 1997; 350: 1795-1798.
8. WELLS PS, OWEN C, DOUCETTE S, FERGUSSON D, TRAN H. Does this patient have deep vein thrombosis? JAMA 2006; 295: 199-207.
9. ROSSI R, AGNELLI G. Current role of venography in the diagnosis of deep-vein thrombosis. Minerva Cardioangiol 1998; 46: 507-514.
10. PABINGER I, AY C. Biomarkers and venous thromboembolism. Arterioscler Thromb Vasc Biol 2009; 29: 332-336.
11. LENNOX AF, DELIS KT, SERUNKUMA S, ZARKA ZA, DASKALOPOULOU SE, NICOLAIDES AN. Combination of a clinical risk assessment score and rapid whole blood D-dimer testing in the diagnosis of deep vein thrombosis in symptomatic patients J Vasc Surg 1999; 30: 794-803.
12. DOUKETIS J. A negative d-dimer test result alone or combined with low risk clinical status effectively ruled out symptomatic DVT. Evid Based Med 2000; 5: 93.
13. KEARON C, JULIAN JA, NEWMAN TE, GINSBERG JS. Noninvasive diagnosis of deep venous thrombosis. McMaster Diagnostic Imaging Practice Guidelines Initiative. Ann Intern Med 1998; 1288: 663-677.
14. ZIERLER BK. Ultrasonography and diagnosis of venous thromboembolism. Circulation 2004; 109: 9-14.
15. BURGAZLI KM, AKDERE H, BILGIN M, KAVUKCU E, PAFGEN W, ERTAN AK. Iliofemoral-popliteal deep vein thrombosis at 35th week of pregnancy: treated with cesarean section and vena cava blockage plus thrombectomy. J Turkish-German Gynecol Assoc 2012; 13: 139-141.
16. KESIEME E, KESIEME C, JEBBIN N, IREKPITA E, DONGO A. Deep vein thrombosis: a clinical review. J Blood Med 2011; 2: 59-69.
17. BASU D, GALLUS A, HIRSH J, CADE J. A prospective study of the value of monitoring heparin treatment with the activated partial thromboplastin time. N Engl J Med 1972; 287: 324-327.
18. HULL RD, RASKOB GE, BRANT RF, PINEO GF, VALENTINE KA. Relation between the time to achieve the lower limit of the APTT therapeutic range and recurrent venous thromboembolism during heparin treatment for deep venous thrombosis. Arch Intern Med 1997; 157: 2562-2568.
19. HIRSH J. Low-molecular-weight heparin: A review of the results of recent studies of the treatment of venous thromboembolism and unstable angina. Circulation 1998; 98: 1575-1582.
20. VAN DONGEN CJ, VAN DEN BELT AG, PRINS MH, LENSING AW. Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for venous thromboembolism (review). Cochrane Datebase Syst Rev 2004; 18: CD001100.
21. ROTHBERG MB, PEKOW PS, LAHTI M, LINDENAUER PK. Comparative effectiveness of low-molecularweight heparin versus unfractionated heparin for thromboembolism prophylaxis for medical patients. J Hosp Med 2012; 7: 457-463.
22. HULL R, DELMORE T, GENTON E, HIRSH J, GENT M, SACKETT D, MCLOUGHLIN D, ARMSTRONG P. Warfarin sodium versus low-dose heparin in the long-term treatment of venous thrombosis. N Engl J Med 1979; 301: 855-858.
23. GALLUS AS, BAKER RI, CHONG BH, OCKELFORD PA, STREET AM. Consensus guidelines for warfarin therapy. Recommendations from the Australasian Society of Thrombosis and Haemostasis. Med J Aust 2000; 172: 600-605.
24. VAN DER MEER FJ, ROSENDAAL FR, VANDENBROUCKE JP, BRIËT E. Bleeding complications in oral anticoagulant therapy. An analysis of risk factors. Arch Intern Med 1993; 153: 1557-1562.
25. WEITZ JI, GROSS PL. New oral anticoagulants: which one should my patient use? Hema-tology 2012; 2012: 536-540.
26. STEFFEL J, BRAUNWALD E. Novel oral anticoagulants: focus on stroke prevention and treatment of venous thrombo-embolism. Eur Heart J 2011; 32: 1968-1976.
27. STANGIER J, RATHGEN K, STAHLE H, GANSSER D, ROTH W . The pharmacokinetics, pharma-codynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007; 64: 292-303.
28. STANGIER J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008; 47: 285-295.
29. SCHULMAN S, KEARON C, KAKKAR AK, MISMETTI P, SCHELLONG S, ERIKSSON H, BAANSTRA D, SCHNEE J, GOLDHABER SZ; RE-COVER STUDY GROUP. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. The N Engl J Med 2009; 361: 2342-2352.
30. 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: 949-956.
31. ERIKSSON BI, DAHL OE, ROSENCHER N, KURTH AA, VAN DIJK CN, FROSTICK SP, KÄLEBO P, CHRISTIANSEN AV, HANTEL S, HETTIARACHCHI R, SCHNEE J, BÜLLER HR; RE-MODEL STUDY GROUP. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of ve-nous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007; 5: 2178-2185.
32. FRIEDMAN RJ, DAHL OE, ROSENCHER N, CAPRINI JA, KURTH AA, FRANCIS CW, CLEMENS A, HANTEL S, SCHNEE JM, ERIKSSON BI; RE-MOBILIZE, RE-MODEL, RE-NOVATE STEER-ING COMMITTEES. Dabigatran versus enoxaparin for prevention of venous thromboembolism after hip or knee arthroplasty: a pooled analysis of three trials. Thromb Res 2010; 126: 175-182.
33. TURPIE AG, FISHER WD, BAUER KA, KWONG LM, IRWIN MW, KÄLEBO P, MISSELWITZ F, GENT M; ODIXA-KNEE STUDY GROUP. BAY 59-7939: an oral, direct factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study. J Thromb Haemost 2005; 3: 2479-2486.
34. ERIKSSON BI, BORRIS L, DAHL OE, HAAS S, HUISMAN MV, KAKKAR AK, MISSELWITZ F, KÄLEBO P; ODIXA-HIP STUDY INVESTIGATORS. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost 2006; 4: 121-128.
35. HUISMAN MV, QUINLAN DJ, DAHL OE, SCHULMAN S. Enoxaparin versus dabigatran or rivaroxaban for thromboprophylaxis after hip or knee arthroplasty: Results of separate pooled analyses of phase III multicenter randomized trials. Circ Cardiovasc Qual Outcomes 2010; 3: 652-660.
36. EINSTEIN INVESTIGATORS, BAUERSACHS R, BERKOWITZ SD, BRENNER B, BULLER HR, DE-COUSUS H, GALLUS AS, LENSING AW, MISSELWITZ F, PRINS MH, RASKOB GE, SEGERS A, VERHAMME P, WELLS P, AGNELLI G, BOUNAMEAUX H, COHEN A, DAVIDSON BL, PIOVELLA F, SCHELLONG S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-2510.
37. MUÑOA L, GONZÁLEZ AB, DÍAZ DE RADA P, VALENTÍ A, VALENTÍ JR. Rivaroxaban is as efficient and safe as bemipar in as thromboprophylaxis in knee arthroscopy. Musculoskelet Surg 2013 Jul 14. [Epub ahead of print].
38. TUN NM, OO TH. Prevention and treatment of venous thromboembolism with new oral anticoagulants: a practical update for clinicians. Thrombosis 2013; 2013: 183616.
39. 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: 820-829.
40. 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 8464 patients from the ADVANCE-2 and ADVANCE-3 trials. J Bone Joint Surg Br 2012; 94: 257-264.
41. 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.
42. RASKOB G, COHEN AT, ERIKSSON BI, PUSKAS D, SHI M, BOCANEGRA T, WEITZ JI. Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomised double-blind dose-response study. Thromb Haemost 2010; 104: 642-649.
43. WELLS PS, FORSTER AJ. Thrombolysis in deep vein thrombosis: is there still an indication? Thromb Haemost 2001; 86: 499-508.
44. STREIFF MB. Vena caval filters: a comprehensive review. Blood 2000; 95: 3669-3677.
45. PREPIC STUDY GROUP. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation 2005; 112: 416-422.
46. th Edition). Chest 2008; 133: 160S-198S.
47. HIRSH J, RASCHKE R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 188S-203S.
48. VAN RYN J, STANGIER J, HAERTTER S, LIESENFELD KH, WIENEN W, FEURING M, CLEMENS A. Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010; 103: 1116-1127.
49. EERENBERG ES, KAMPHUISEN PW, SIJPKENS MK, MEIJERS JC, BULLER HR, LEVI M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011; 124: 1573-1579.
50. SCHIELE F, VAN RYN J, CANADA K, NEWSOME C, SEPULVEDA E, PARK J, NAR H, LITZENBURGER T. A specific antidote for dabigatran: functional and structural characterization. Blood 2013; 121: 3554-3562.
51. LU G, DEGUZMAN FR, HOLLENBACH SJ, KARBARZ MJ, ABE K, LEE G, LUAN P, HUTCHALEELAHA A, INAGAKI M, CONLEY PB, PHILLIPS DR, SINHA U. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 2013; 19: 446-451.
52. MCCULLAGH L, TILSON L, WALSH C, BARRY M. A cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium as thromboprophylaxis after total hip and total knee replacement in the irish healthcare setting. Pharmacoeconomics 2009; 27: 829-846.
53. MAHMOUDI M, SOBIERAJ DM. The cost-effectiveness of oral direct factor xa inhibitors compared with low-molecular-weight heparin for the prevention of venous thromboembolism prophylaxis in total hip or knee replacement surgery. Pharmacotherapy 2013 [Epub ahead of print].
54. FREEMAN JV, ZHU RP, OWENS DK, GARBER AM, HUTTON DW, GO AS, WANG PJ, TURAKHIA MP. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med 2011; 154: 1-11.
55. WELLS PS, HOLBROOK AM, CROWTHER NR, HIRSH J. Interactions of warfarin with drugs and food. Ann Intern Med 1994; 121: 676-683.
56. WALENGA JM, ADIGUZEL C. Drug and dietary interactions of the new and emerging oral anticoagulants. Int J Clin Pract 2010; 64: 956-967.
57. SAMAMA MM, CONTANT G, SPIRO TE, PERZBORN E, GUINET C, GOURMELIN Y, LE FLEM L, ROHDE G, MARTINOLI JL; RIVAROXABAN ANTI-FACTOR XA CHROMOGENIC ASSAY FIELD TRIAL LABORATORIES. Evaluation of the antifactor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls. Thromb Haemost 2012; 107: 379-387.
58. MANTHA S, CABRAL K, ANSELL J. New avenues for anticoagulation in atrial fibrillation. Clin Pharmacol Ther 2013; 93: 68-77.
59. KREUTZ R. Pharmacodynamic and pharmacokinetic basics of rivaroxaban. Fundam Clin Pharmacol 2012; 26: 27-32.
60. GRAFF J, HARDER S. Anticoagulant therapy with the oral direct factor Xa inhibitors rivaroxaban, apixaban and edoxaban and the thrombin inhibitor dabigatran etexilate in patients with hepatic impairment. Clin Pharmacokinet 2013; 52: 243-254.
61. VAN DE WERF F, BRUECKMANN M, CONNOLLY SJ, FRIEDMAN J, GRANGER CB, HÄRTTER S, HARPER R, KAPPETEIN AP, LEHR T, MACK MJ, NOACK H, EIKELBOOM JW. A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: the randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN). Am Heart J 2012; 163: 931-937.
62. U.S. FOOD AND DRUG ADMINISTRATION. (2012, December 19. FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm332912.htm