A novel risk prediction score in atrial fibrillation for a net clinical outcome from the ENGAGE AF-TIMI 48 randomized clinical trial

European Heart Journal

Volumn 38, Issue 12, 2017, Pages 888-896

  Fanola, Christina L ^a   Giugliano, Robert P ^a   Ruff, Christian T ^a   Trevisan, Marco ^a   Nordio, Francesco ^a   Mercuri, Michele F ^b   Antman, Elliott M ^a   Braunwald, Eugene ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b DAIICHI SANKYO INC   (United States)

Author keywords

Anticoagulants; Atrial fibrillation; Edoxaban; Stroke; Warfarin

Indexed keywords

CREATININE; EDOXABAN; HEMOGLOBIN; WARFARIN; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR 10A INHIBITOR; PYRIDINE DERIVATIVE; THIAZOLE DERIVATIVE;

AGED; ANTICOAGULANT THERAPY; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; CARDIOVASCULAR DISEASE ASSESSMENT; CARDIOVASCULAR MORTALITY; CEREBROVASCULAR ACCIDENT; CLINICAL ASSESSMENT; CLINICAL OUTCOME; CONTROLLED STUDY; DISEASE ASSOCIATION; FEMALE; HIGH RISK PATIENT; HUMAN; INTERMEDIATE RISK PATIENT; LOW DRUG DOSE; LOW RISK PATIENT; MAJOR CLINICAL STUDY; MALE; PATIENT IDENTIFICATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; RISK PREDICTION SCORE; TIME TO TREATMENT; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; DOUBLE BLIND PROCEDURE; MIDDLE AGED; MULTICENTER STUDY; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ATRIAL FIBRILLATION; DOUBLE-BLIND METHOD; FACTOR XA INHIBITORS; FEMALE; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; PYRIDINES; RISK ASSESSMENT; RISK FACTORS; STROKE; THIAZOLES; TREATMENT OUTCOME; WARFARIN;

EID: 85019187882     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehw565     Document Type: Article

References (28)

1. Gattellari M, Goumas C, Aitken R, Worthington JM. Outcomes for patients with ischaemic stroke and atrial fibrillation: the PRISM study (A program of research informing stroke management). Cerebrovasc Dis 2011;32:370-382.
2. January CT, Wann LS, Alpert JS, Calkins H, Cleveland JC, Cigarroa JE, Yancy CW. AHA/ACC/HRS Guideline for the management of patients with atrial fibrillation: executive summary: a report of the American college of cardiology/ American heart association task force on practice guidelines and the heart rhythm society. J Am Coll Cardiol 2014;64:2246-2280.
3. Lip GY, Andreotti F, Fauchier L, Huber K, Knight E, Lane D, Levi M, Marin F, Palareti G, Kichhof P. Bleeding risk assessment and management in atrial fibrillation patients. Executive summary of a position document from the European Heart Rhythm Association [EHRA], endorsed by the European Society of Cardiology [ESC] working group on thrombosis. Thromb Haemost 2011;106:997-1011.
4. Gladstone DJ, Bui E, Fang J, Laupacis A, Lindsay MP, Tu JV, Silver FL, Kapral MK. Potentially preventable strokes in high-risk patients with atrial fibrillation who are not adequately anticoagulated. Stroke 2009;40:235-240.
5. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 2014;383:955-962.
6. Desai NR, Krumme AA, Schneeweiss S, Shrank WH, Brill G, Pezalla EJ, Choudhry NK. Patterns of initiation of oral anticoagulants in patients with atrial fibrillation-quality and cost implications. Am J Med 2014;127:1075-1082. e1.
7. Gage B, Waterman A, Shannon W, Boechler M, Rich M, Radford M. Validation of clinical classification schemes for predicting stroke: results from the National registry of atrial fibrillation. JAMA 2001;285:2864-2870.
8. 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;137:263-272.
9. Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KAA, Califf RM. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R2CHADS2 index in the ROCKET AF. Circulation 2013;127:224-232.
10. Singer DE, Chang Y, Borowsky LH, Fang MC, Pomernacki NK, Udaltsova N, Reynolds K, Go AS. A new risk scheme to predict ischemic stroke and other thromboembolism in atrial fibrillation: the ATRIA study stroke risk score. J Am Heart Assoc 2013;2:e000250.
11. Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Wallentin L. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J 2016;37:1582-1590.
12. Gage BF, Yan Y, Milligan PE, Waterman AD, Culverhouse R, Rich MW, Radford MJ. Clinical classification schemes for predicting hemorrhage: results from the National Registry of Atrial Fibrillation (NRAF). Am Heart J 2006;151:713-719.
13. 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;138:1093-1100.
14. Fang MC, Go AS, Chang Y, Borowsky LH, Pomernacki NK, Udaltsova N, Singer DE. A new risk scheme to predict warfarin-associated hemorrhage: The ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) study. J Am Coll Cardiol 2011;58:395-401.
15. Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Wallentin L. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet 2016;387:2302-2311.
16. Apostolakis S, Sullivan RM, Olshansky B, Lip GYH. Factors affecting quality of anticoagulation control among patients with atrial fibrillation on warfarin: the SAMe-TT2R2 score. Chest 2013;144:1555-1563.
17. Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in atrial fibrillation-thrombolysis in myocardial infarction study 48 (ENGAGE AF-TIMI 48. Am Heart J 2010;160:635-641.
18. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, -Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369:2093-2104.
19. O'Donoghue ML, Ruff CT, Giugliano RP, Murphy SA, Grip LT, Mercuri MF, Rutman H, Shi M, Kania G, Cermak O, Braunwald E, Antman EM. Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillation. Eur Heart J 2015;36:1470-1477.
20. Collins GS, Reitsma JB, Altman DG, Moons KGM. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med 2015;162:55-63.
21. Grønnesby JK, Borgan Ø. A method for checking regression models in survival analysis based on the risk score. Lifetime Data Anal 1996;2:315-328.
22. Martinez C, Katholing A, Wallenhorst C, Freedman SB. Therapy persistence in newly diagnosed non-valvular atrial fibrillation treated with warfarin or NOAC: a cohort study. Thromb Haemost 2016;115:31-39.
23. Björck F, Renlund H, Lip GYH, Wester P, Svensson PJ, Sjalander A. Outcomes in a warfarin-treated population with atrial fibrillation. JAMA Cardiol 2016;1:172-180.
24. Esteve-Pastor MA, Roldan V, Valdés M, Lip GYH, Marin F. The SAMe-TT2R2 score and decision-making between a vitamin K antagonist or a non-vitamin K antagonist oral anticoagulant in patients with atrial fibrillation. Expert Rev Cardiovasc Ther 2016;14:177-187.
25. Senoo K, Lip GYH, Lane DA, Büller HR, Kotecha D. Residual risk of stroke and death in anticoagulated patients according to the type of atrial fibrillation: AMADEUS Trial. Stroke 2015;46:2523-2528.
26. Ezekowitz MD, Wallentin L, Connolly SJ, Parekh A, Chernick MR, Pogue J, Aikens TH, Yang S, Reilly PA, Lip GYH, Yusuf S. Dabigatran and warfarin in vitamin K antagonist-naive and-experienced cohorts with atrial fibrillation. Circulation 2010;122:2246-2253.
27. Garcia DA, Wallentin L, Lopes RD, Thomas L, Alexander JH, Hylek EM, Ansell J, Hanna M, Lanas F, Flaker G, Commerford P, Xavier D, Vinereanu D, Yang H, Granger CB. Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: results from the Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation trial. Am Heart J 2013;166:549-558.
28. Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, Patel MR, Berkowitz SD, Becker RC, Halperin JL, Singer DE, Califf RM, Fox KAA, Breithardt G, Hacke W. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med 2013;158:861-868.