Prediction of rates of thromboembolic and major bleeding outcomes with dabigatran or warfarin among patients with atrial fibrillation: New initiator cohort study

BMJ (Online)

Volumn 353, Issue , 2016, Pages

  Wang, Shirley V ^a   Franklin, Jessica M ^a   Glynn, Robert J ^a   Schneeweiss, Sebastian ^a   Eddings, Wesley ^a   Gagne, Joshua J ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVITAMIN K; DABIGATRAN; WARFARIN; ANTICOAGULANT AGENT;

AGED; ANTICOAGULANT THERAPY; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; COHORT ANALYSIS; DEEP VEIN THROMBOSIS; DRUG EFFICACY; DRUG RESPONSE; FEMALE; HUMAN; HYPERTENSION; LUNG EMBOLISM; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PREVALENCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; RISK FACTOR; THROMBOEMBOLISM; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME; VERY ELDERLY; ADULT; CHEMICALLY INDUCED; HEMORRHAGE; INCIDENCE; MALE; UNITED STATES;

ADULT; AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ATRIAL FIBRILLATION; COHORT STUDIES; DABIGATRAN; FEMALE; HEMORRHAGE; HUMANS; INCIDENCE; MALE; THROMBOEMBOLISM; UNITED STATES; WARFARIN;

EID: 84973160199     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.i2607     Document Type: Article

References (28)

1. Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010;137:263-72. doi:10.1378/chest.09-1584.
2. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJGM, Lip GYH. 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 2010;138:1093-100. doi:10.1378/chest.10-0134.
3. Connolly SJ, Ezekowitz MD, Yusuf S, et al. RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51. doi:10.1056/NEJMoa0905561.
4. Granger CB, Alexander JH, McMurray JJV, et al. ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-92. doi:10.1056/NEJMoa1107039.
5. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857-67. doi:10.7326/0003-4819-146-12-200706190-00007.
6. Bungard TJ, Ghali WA, Teo KK, McAlister FA, Tsuyuki RT. Why do patients with atrial fibrillation not receive warfarin? Arch Intern Med 2000;160:41-6. doi:10.1001/archinte.160.1.41.
7. Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GY. Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am J Med 2010;123:638-645.e4. doi:10.1016/j.amjmed.2009.11.025.
8. Camm AJ, Lip GY, De Caterina R, et al. ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012;33:2719-47. doi:10.1093/eurheartj/ehs253.
9. National Institute for Health and Care Excellence. Atrial fibrillation: management. NICE guidelines [CG180]. 2014. https://www.nice.org.uk/guidance/cg180.
10. Manning WJ, Singer DE, Lip GYH. Antithrombotic therapy to prevent embolization in nonvalvular atrial fibrillation. 2012. www.uptodate.com.
11. Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare Patients treated with dabigatran or warfarin for non-valvular atrial fibrillation. Circulation 2015;131:157-64. doi:10.1161/CIRCULATIONAHA.114.012061.
12. Larsen TB, Rasmussen LH, Skjøth F, et al. Efficacy and safety of dabigatran etexilate and warfarin in "real-world" patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol 2013;61:2264-73. doi:10.1016/j.jacc.2013.03.020.
13. Optum Life Science. Claims data. https://www.optum.com/life-sciences/data/claims-data.html, 2016.
14. Walker AM, Patrick AR, Lauer MS, et al. A tool for assessing the feasibility of comparative effectiveness research. Comparative Effectiveness Research, 2013:3.
15. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726-32. doi:10.7326/0003-4819-152-11-201006010-00232.
16. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001;285:2864-70. doi:10.1001/jama.285.22.2864.
17. Lopes RD, Al-Khatib SM, Wallentin L, et al. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. Lancet 2012;380:1749-58. doi:10.1016/S0140-6736(12)60986-6.
18. Schulman S, Kearon C. Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005;3:692-4. doi:10.1111/j.1538-7836.2005.01204.x.
19. Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123:2736-47. doi:10.1161/CIRCULATIONAHA.110.009449.
20. Steyerberg EW. Clinical prediction models: a practical approach to development, validation, and updating. Springer, 2008.
21. Gage BF, van Walraven C, Pearce L, et al. Selecting patients with atrial fibrillation for anticoagulation: stroke risk stratification in patients taking aspirin. Circulation 2004;110:2287-92. doi:10.1161/01.CIR.0000145172.55640.93.
22. Frank E, Harrell J. Regression modeling strategies. Springer-Verlag, 2006.
23. Demler OV, Paynter NP, Cook NR. Tests of calibration and goodness-of-fit in the survival setting. Stat Med 2015;34:1659-80. doi:10.1002/sim.6428.
24. Stürmer T, Wyss R, Glynn RJ, Brookhart MA. Propensity scores for confounder adjustment when assessing the effects of medical interventions using nonexperimental study designs. J Intern Med 2014;275:570-80. doi:10.1111/joim.12197.
25. Ezekowitz MD, Connolly S, Parekh A, et al. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J 2009;157:805-10, 810.e1-2. doi:10.1016/j.ahj.2009.02.005.
26. Kent DM, Rothwell PM, Ioannidis JP, Altman DG, Hayward RA. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials 2010;11:85. doi:10.1186/1745-6215-11-85.
27. Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007;115:2689-96. doi:10.1161/CIRCULATIONAHA.106.653048.
28. Cohen D. Concerns over data in key dabigatran trial. BMJ 2014;349:g4747. doi:10.1136/bmj.g4747.