Dabigatran versus warfarin major bleeding in practice: an observational comparison of patient characteristics, management and outcomes in atrial fibrillation patients

Journal of Thrombosis and Thrombolysis

Volumn 40, Issue 3, 2015, Pages 280-287

  Smythe, Maureen A ^a,c   Forman, Michael J ^b   Bertran, Elizabeth A ^c   Hoffman, Janet L ^a,c   Priziola, Jennifer L ^b,c   Koerber, John M ^a,c  

^a BEAUMONT HOSPITAL   (United States)

^b WILLIAM BEAUMONT HOSPITAL   (United States)

^c WAYNE STATE UNIVERSITY   (United States)

Author keywords

Anticoagulant; Dabigatran; Major bleed; Thrombin inhibitor; Warfarin

Indexed keywords

DABIGATRAN; HEMOSTATIC AGENT; WARFARIN;

ADULT; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; BRAIN HEMORRHAGE; CLINICAL PRACTICE; COMPARATIVE STUDY; CONTROLLED STUDY; CREATININE CLEARANCE; DISEASE ASSOCIATION; DISEASE SEVERITY; DRUG SAFETY; END STAGE RENAL DISEASE; FEMALE; HOSPICE CARE; HOSPITALIZATION; HUMAN; INTERNATIONAL CLASSIFICATION OF DISEASES; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PATIENT; PATIENT IDENTIFICATION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; AGED; CHEMICALLY INDUCED; HEMORRHAGE; MIDDLE AGED; PATHOLOGY;

AGED; ATRIAL FIBRILLATION; DABIGATRAN; FEMALE; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; WARFARIN;

EID: 84940436591     PISSN: 09295305     EISSN: 1573742X     Source Type: Journal    
DOI: 10.1007/s11239-015-1213-7     Document Type: Article

References (27)

1. Boehringer Ingelheim Pharmaceuticals, Inc. (2014) PRADAXA (dabigatran extexilate mesylate) package insert. Ridgefield, CT
2. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L, the RE-LY Steering Committee and Investigators (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139–1151
3. Huisman MV, Lip GY, Diener HC, Brueckmann M, van Ryn J, Clemens A (2012) Dabigatran etexilate for stroke prevention in patients with atrial fibrillation: resolving uncertainties in routine practice. Thromb Haemost 107:838–847
4. The United States Food and Drug Administration (2014) FDA drug safety communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin. http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm. Accessed 1 Dec 2014
5. Institute for Safe Medication Practices QuarterWatch (2013) Monitoring FDA Med-Watch reports: update on anticoagulants. www.ismp.org/quarterwatch/pdfs/2012Q2.pdf. Accessed 1 Dec 2014
6. McConeghy KW, Bress A, Qato DM, Wing C, Nutescu EA (2014) Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval. Pharmacotherapy 34:561–569
7. Institute for Safe Medication Practices AlertQuarterWatch (2012) Monitoring FDA Med-Watch reports: serious bleeding with dabigatran. www.ismp.org/quarterwatch/pdfs/2011Q1.pdf. Accessed 1 Dec 2014
8. Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S (2013) Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation 128:2325–2332
9. Fontaine GV, Mathews KD, Woller SC, Stevens SM, Lloyd JF, Evans RS (2014) Major bleeding with dabigatran and rivaroxaban in patients with atrial fibrillation: a real-world setting. Clin Appl Thromb Hemost 20:665–672
10. Southworth MR, Reichman ME, Unger EF (2013) Dabigatran and postmarketing reports of bleeding. N Engl J Med 368:1272–1274
11. Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA (2014) Cardiovascular, bleeding, and mortality risks in elderly medicare patients treated with dabigatran or warfarin for non-valvular atrial fibrillation. Circulation 131(2):157–164. doi:10.1161/CIRCULATIONAHA.114.012061
12. Arnason T, Wells PS, van Walraven C, Forster AJ (2006) Accuracy of coding for possible warfarin complications in hospital discharge abstracts. Thromb Res 118(2):253–262
13. Baser O, Supina D, Sengupta N, Wang L (2011) Anticoagulation bridging therapy patterns in patients undergoing total hip or total knee replacement in a US health plan: real-world observations and implications. Am Health Drug Benefits 4:240–248
14. Birman-Deych E, Waterman AD, Yan Y, Nilasena DS, Radford MJ, Gage BF (2005) Accuracy of ICD-9-CM codes for identifying cardiovascular and stroke risk factors. Med Care 43:480–485
15. Schulman S, Kearon C (2005) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 3:692–694
16. Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W (2010) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost 8:202–204
17. Deyo RA, Cherkin DC, Ciol MA (1992) Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol 45:613–619
18. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ (2001) Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 285(22):2864–2870
19. Gage BF, Yan Y, Milligan PE, Waterman AD, Culverhouse R, Rich MW, Radford MJ (2006) Clinical classification schemes for predicting hemorrhage: results from the National Registry of Atrial Fibrillation (NRAF). Am Heart J 151:713–719
20. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY (2010) A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 138(5):1093–1100
21. Lindahl TL, Baghaei F, Blixter IF, Gustafsson KM, Stigendal L, Sten-Linder M, Strandberg K (2011) Effects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assays. Thromb Haemost 105:371–378
22. Hart RG, Diener HC, Yang S, Connolly SJ, Wallentin L, Reilly PA, Ezekowitz MD, Yusuf S (2012) Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trial. Stroke 43:1511–1517
23. E.M.A. E.U. (2014) Summary of product characteristic: PRADAXA. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf. Accessed 1 Dec 2014
24. Health Canada (2014) Boehringer Ingelheim Canada Ltd. PRADAXA product monograph. Date of Revision: October 28th, 2014. http://www.boehringer-ingelheim.ca/content/dam/internet/opu/ca_EN/documents/humanhealth/product_monograph/PradaxaPMEN.pdf. Accessed 1 Dec 2014
25. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, Yang S, Alings M, Kaatz S, Hohnloser SH, Diener HC, Franzosi MG, Huber K, Varrone J, Yusuf S (2011) Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 123:2363–2372
26. Kumar R, Smith RE, Henry BL (2014) A review of and recommendations for the management of patients with life-threatening dabigatran-associated hemorrhage: a single-center university hospital experience. J Intensive Care Med. doi:10.1177/0885066614527417
27. Berger R, Salhanick SD, Chase M, Ganetsky M (2013) Hemorrhagic complications in emergency department patients who are receiving dabigatran compared with warfarin. Ann Emerg Med 61:475–479