Recurrent venous thromboembolism and abnormal uterine bleeding with anticoagulant and hormone therapy use

Blood

Volumn 127, Issue 11, 2016, Pages 1417-1425

  Martinelli, Ida ^a   Lensing, Anthonie W A ^b   Middeldorp, Saskia ^c   Levi, Marcel ^c   Beyer Westendorf, Jan ^d   Bellen, Bonno Van ^e   Bounameaux, Henri ^f   Brighton, Timothy A ^g   Cohen, Alexander T ^h   Trajanovic, Mila ⁱ   Gebel, Martin ^b   Lam, Phuong ^j   Wells, Philip S ^k   Prins, Martin H ^l  

^a FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^b BAYER PHARMA AG   (Germany)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

^d UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^e HOSPITAL BENEFICÊNCIA PORTUGUESA DE SÃO PAULO   (Brazil)

^f GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^g PRINCE OF WALES HOSPITAL   (Australia)

^h GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

ⁱ BAYER CORPORATION   (United States)

^j Bayer HealthCare   (Viet Nam)

^k UNIVERSITY OF OTTAWA   (Canada)

^l MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVITAMIN K; ENOXAPARIN; ESTROGEN; ETHINYLESTRADIOL; GESTAGEN; ORAL CONTRACEPTIVE AGENT; RIVAROXABAN; ANTICOAGULANT AGENT;

ADULT; ANTICOAGULATION; ARTICLE; BLOOD TRANSFUSION; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; FEMALE; HORMONAL THERAPY; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RECURRENCE RISK; UTERUS BLEEDING; VENOUS THROMBOEMBOLISM; WORLD HEALTH ORGANIZATION; ADVERSE EFFECTS; CHEMICALLY INDUCED; DRUG POTENTIATION; ESTROGEN THERAPY; MIDDLE AGED; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; RETROSPECTIVE STUDY; UTERINE HEMORRHAGE; YOUNG ADULT;

ADULT; ANTICOAGULANTS; CONTRACEPTIVES, ORAL, HORMONAL; DRUG SYNERGISM; ENOXAPARIN; ESTROGEN REPLACEMENT THERAPY; ESTROGENS; FEMALE; HUMANS; MIDDLE AGED; PROGESTINS; PROPORTIONAL HAZARDS MODELS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; RETROSPECTIVE STUDIES; RIVAROXABAN; UTERINE HEMORRHAGE; VENOUS THROMBOEMBOLISM; YOUNG ADULT;

EID: 84962573834     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2015-08-665927     Document Type: Article

References (42)

1. Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2 Suppl):e419S-e494S.
2. Hall JG, Pauli RM, Wilson KM. Maternal and fetal sequelae of anticoagulation during pregnancy. Am J Med. 1980;68(1):122-140.
3. Bates SM, Greer IA, Hirsh J, Ginsberg JS. Use of antithrombotic agents during pregnancy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):627S-644S.
4. Ginsberg JS, Hirsh J, Turner DC, Levine MN, Burrows R. Risks to the fetus of anticoagulant therapy during pregnancy. Thromb Haemost. 1989;61(2):197-203.
5. van der Hulle T, Kooiman J, den Exter PL, Dekkers OM, Klok FA, Huisman MV. Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta-analysis. J Thromb Haemost. 2014;12(3):320-328.
6. Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet. 1995;346(8990):1589-1593.
7. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case-control study. Lancet. 1995;346(8990):1575-1582.
8. Spitzer WO, Lewis MA, Heinemann LA, Thorogood M, MacRae KD; Transnational Research Group on Oral Contraceptives and the Health of Young Women. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. BMJ. 1996;312(7023):83-88.
9. Farmer RD, Lawrenson RA, Thompson CR, Kennedy JG, Hambleton IR. Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet. 1997;349(9045):83-88.
10. Todd J, Lawrenson R, Farmer RD, Williams TJ, Leydon GM. Venous thromboembolic disease and combined oral contraceptives: A re-analysis of the MediPlus database. Hum Reprod. 1999;14(6):1500-1505.
11. Parkin L, Skegg DC, Wilson M, Herbison GP, Paul C. Oral contraceptives and fatal pulmonary embolism. Lancet. 2000;355(9221):2133-2134.
12. Lidegaard Ø, Edström B, Kreiner S. Oral contraceptives and venous thromboembolism: a five-year national case-control study. Contraception. 2002;65(3):187-196.
13. Pearce HM, Layton D, Wilton LV, Shakir SA. Deep vein thrombosis and pulmonary embolism reported in the Prescription Event Monitoring Study of Yasmin. Br J Clin Pharmacol. 2005;60(1):98-102.
14. van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, Doggen CJ, Rosendaal FR. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ. 2009;339:b2921.
15. Lidegaard Ø, Løkkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ. 2009;339:b2890.
16. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. Geneva: World Health Organization; 2010.
17. Baglin T, Bauer K, Douketis J, Buller H, Srivastava A, Johnson G; SSC of the ISTH. Duration of anticoagulant therapy after a first episode of an unprovoked pulmonary embolus or deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2012;10(4):698-702.
18. Burkman R, Schlesselman JJ, Zieman M. Safety concerns and health benefits associated with oral contraception. Am J Obstet Gynecol. 2004;190(4 Suppl):S5-S22.
19. Alotaibi GS, Almodaimegh H, McMurtry MS, Wu C. Do women bleed more than men when prescribed novel oral anticoagulants for venous thromboembolism? A sex-based meta-analysis. Thromb Res. 2013;132(2):185-189.
20. Büller HR, Prins MH, Lensin AW, et al; EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297.
21. Bauersachs R, Berkowitz SD, Brenner B, et al; EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
22. De Crem N, Peerlinck K, Vanassche T, et al. Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists. Thromb Res. 2015;136(4):749-753.
23. Pfizer Canada Inc., Bristol-Myers Squibb Canada. Eliquis (apixaban tablets 2.5 mg and 5 mg) Canadian Product Monograph. Available at: http://www.pfizer.ca/sites/g/files/g10017036/f/201505/Marketed-ELIQUIS-178226-PM-200215.pdf. Accessed July 13, 2015.
24. Prins MH, Lensing AWA, Bauersachs R, et al; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21.
25. Bamber L, Wang MY, Prins MH, et al. Patientreported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost. 2013;110(4):732-741.
26. Prins MH, Bamber L, Cano SJ, et al. Patientreported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial. Thromb Res. 2015;135(2):281-288.
27. Andersson JK, Rybo G. Levonorgestrel-releasing intrauterine device in the treatment of menorrhagia. Br J Obstet Gynaecol. 1990;97(8):690-694.
28. Apgar BS, Kaufman AH, George-Nwogu U, Kittendorf A. Treatment of menorrhagia. Am Fam Physician. 2007;75(12):1813-1819.
29. Lethaby A, Irvine G, Cameron I. Cyclical progestogens for heavy menstrual bleeding. Cochrane Database Syst Rev. 2000; (2): CD001016.
30. Henry DA, Carless PA, Moxey AJ, et al. Antifibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011; (1): CD001886.
31. Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007;356(22):2301-2311.
32. National Institute for Heath and Clinical Excellence. Heavy menstrual bleeding. NICE guidelines [CG44]. Available at: https://www.nice.org.uk/guidance/cg44. Accessed October 12, 2015.
33. Davidson BL, Verheijen S, Lensing AWA, et al. Bleeding risk of patients with acute venous thromboembolism taking nonsteroidal antiinflammatory drugs or aspirin. JAMA Intern Med. 2014;174(6):947-953.
34. Prins MH, Lensing AWA. Derivation of the noninferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J. 2013;11(1):13.
35. Hall KS, Trussell J, Schwarz EB. Progestin-only contraceptive pill use among women in the United States. Contraception. 2012;86(6):653-658.
36. Hall KS, Trussell J. Types of combined oral contraceptives used by US women. Contraception. 2012;86(6):659-665.
37. Lidegaard Ø, Nielsen LH, Skovlund CW, Skjeldestad FE, Løkkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ. 2011;343:d6423.
38. Mantha S, Karp R, Raghavan V, Terrin N, Bauer KA, Zwicker JI. Assessing the risk of venous thromboembolic events in women taking progestin-only contraception: a meta-analysis. BMJ. 2012;345:e4944.
39. van Hylckama Vlieg A, Helmerhorst FM, Rosendaal FR. The risk of deep venous thrombosis associated with injectable depotmedroxyprogesterone acetate contraceptives or a levonorgestrel intrauterine device. Arterioscler Thromb Vasc Biol. 2010;30(11):2297-2300.
40. Apgar BS, Greenberg G. Using progestins in clinical practice. Am Fam Physician. 2000;62(8):1839-18461849-1850.
41. Grimes DA, Lopez LM, O'Brien PA, Raymond EG. Progestin-only pills for contraception. Cochrane Database Syst Rev. 2013;11:CD007541.
42. Abdel-Aleem H, d'Arcangues C, Vogelsong KM, Gülmezoglu AM. Treatment of vaginal bleeding irregularities induced by progestin only contraceptives. Cochrane Database Syst Rev. 2007; (4): CD003449.