Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: Results from the ROCKET AF trial

Journal of the American Heart Association

Volumn 3, Issue 2, 2014, Pages

  Piccini, Jonathan P ^a   Hellkamp, Anne S ^a   Lokhnygina, Yuliya ^a   Patel, Manesh R ^a   Harrell Jr , Frank E ^c   Singer, Daniel E ^d   Becker, Richard C ^a   Breithardt, Günter ^e   Halperin, Jonathan L ^f   Hankey, Graeme J ^g,h   Berkowitz, Scott D ⁱ   Nessel, Christopher C ^j   Mahaffey, Kenneth W ^a   Fox, Keith A A ^k   Califf, Robert M ^b  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^f MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^h ROYAL PERTH HOSPITAL   (Australia)

ⁱ BAYER CORPORATION   (United States)

^j JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^k ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

more..

Author keywords

Rivaroxaban; Time in therapeutic range; Warfarin

Indexed keywords

RIVAROXABAN; WARFARIN; ANTICOAGULANT AGENT; MORPHOLINE DERIVATIVE; THIOPHENE DERIVATIVE;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTICLE; BRAIN HEMORRHAGE; CALCULATION; CEREBROVASCULAR ACCIDENT; CHADS2 SCORE; CONTROLLED STUDY; DRUG EFFECT; DRUG EFFICACY; EMBOLISM; FEMALE; GEOGRAPHY; HUMAN; INTERNATIONAL NORMALIZED RATIO; LOW RISK PATIENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); NORTH AMERICA; POINT OF CARE TESTING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TIME; TIME IN THERAPEUTIC RANGE; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME; WESTERN EUROPE; BLEEDING; BLOOD; BLOOD CLOTTING; CHEMICALLY INDUCED DISORDER; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG MONITORING; EUROPE; HEART ATRIUM FIBRILLATION; HOSPITAL INFORMATION SYSTEM; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PREDICTIVE VALUE; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; VERY ELDERLY;

RIVAROXABAN; TIME IN THERAPEUTIC RANGE; WARFARIN;

AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ATRIAL FIBRILLATION; BLOOD COAGULATION; DOUBLE-BLIND METHOD; DRUG MONITORING; EMBOLISM; EUROPE; FEMALE; HEMORRHAGE; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; MIDDLE AGED; MORPHOLINES; NORTH AMERICA; POINT-OF-CARE SYSTEMS; PREDICTIVE VALUE OF TESTS; RISK FACTORS; STROKE; THIOPHENES; TIME FACTORS; TREATMENT OUTCOME; WARFARIN;

EID: 84904597072     PISSN: None     EISSN: 20479980     Source Type: Journal    
DOI: 10.1161/JAHA.113.000521     Document Type: Article

References (21)

1. Jackson K, Gersh BJ, Stockbridge N, Fleming TR, Temple R, Califf RM, Connolly SJ, Wallentin L, Granger CB. Antithrombotic drug development for atrial fibrillation: proceedings, Washington, DC, July 25-27, 2005. Am Heart J. 2008;155:829-840.
2. Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, Bankhead C, Xu Y. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.
3. Estes NA III, Halperin JL, Calkins H, Ezekowitz MD, Gitman P, Go AS, McNamara RL, Messer JV, Ritchie JL, Romeo SJ, Waldo AL, Wyse DG. ACC/AHA/Physician Consortium 2008 clinical performance measures for adults with nonvalvular atrial fibrillation or atrial flutter. Circulation. 2008;117:1101-1120.
4. Singer DE, Chang Y, Fang MC, Borowsky LH, Pomernacki NK, Udaltsova N, Go AS. Should patient characteristics influence target anticoagulation intensity for stroke prevention in nonvalvular atrial fibrillation? The ATRIA study. Circ Cardiovasc Qual Outcomes. 2009;2:297-304.
5. Rosendaal FR, Cannegieter SC, van der Meer FJ, Briet E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost. 1993;69:236-239.
6. Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003;349:1019-1026.
7. Samsa GP, Matchar DB. Relationship between test frequency and outcomes of anticoagulation: a literature review and commentary with implications for the design of randomized trials of patient self-management. J Thromb Thrombolysis. 2000;9:283-292.
8. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.
9. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation: rationale and design of the ROCEKT AF study. Am Heart J. 2010;159:340- 347.e341.
10. Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, Halperin JL, Becker RC, Breithardt G, Hankey GJ, Hacke W, Nessel CC, Patel MR, Califf RM, Fox KA. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013;2:e000067.
11. Rose AJ, Hylek EM, Ozonoff A, Ash AS, Reisman JI, Berlowitz DR. Patient characteristics associated with oral anticoagulation control: results of the veterans affairs study to improve anticoagulation (VARIA). J Thromb Haemost. 2010;8:2182-2191.
12. Hasan SS, Shamala R, Syed IA, Basariah N, Chong DW, Mei TK, Chin OH. Factors affecting warfarin-related knowledge and INR control of patients attending physician- and pharmacist-managed anticoagulation clinics. J Pharm Pract. 2011;24:485-493.
13. Determinants of warfarin use and international normalized ratio levels in atrial fibrillation patients in Japan: subanalysis of the J-RHYTHM Registry. Circ J. 2011;75:2357-2362.
14. Van Spall HG, Wallentin L, Yusuf S, Eikelboom JW, Nieuwlaat R, Yang S, Kabali C, Reilly PA, Ezekowitz MD, Connolly SJ. Variation in warfarin dose adjustment practice is responsible for differences in the quality of anticoagulation control between centers and countries: an analysis of patients receiving warfarin in the randomized evaluation of long-term anticoagulation therapy (RE-LY) trial. Circulation. 2012;126:2309-2316.
15. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA. 1991;266:93-98.
16. Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, Pais P, Dans A, Eikelboom J, Oldgren J, Pogue J, Reilly PA, Yang S, Connolly SJ. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet. 2010;376:975-983.
17. Wallentin L, Lopes RD, Hanna M, Thomas L, Hellkamp A, Nepal S, Hylek EM, Al-Khatib SM, Alexander JH, Alings M, Amerena J, Ansell J, Aylward P, Bartunek J, Commerford P, De Caterina R, Erol C, Harjola VP, Held C, Horowitz JD, Huber K, Husted S, Keltai M, Lanas F, Lisheng L, McMurray JJ, Oh BH, Rosenqvist M, Ruzyllo W, Steg PG, Vinereanu D, Xavier D, Granger CB. Efficacy and safety of apixaban compared with warfarin at different levels of predicted international normalized ratio control for stroke prevention in atrial fibrillation. Circulation. 2013;127:2166-2176.
18. Yamaguchi T. Optimal intensity of warfarin therapy for secondary prevention of stroke in patients with nonvalvular atrial fibrillation: a multicenter, prospective, randomized trial. Japanese Nonvalvular Atrial Fibrillation-Embolism Secondary Prevention Cooperative Study Group. Stroke. 2000;31:817-821.
19. Inoue H. Thromboembolism in patients with nonvalvular atrial fibrillation: comparison between Asian and Western countries. J Cardiol. 2013;61:1-7.
20. Reynolds MW, Fahrbach K, Hauch O, Wygant G, Estok R, Cella C, Nalysnyk L. Warfarin anticoagulation and outcomes in patients with atrial fibrillation: a systematic review and metaanalysis. Chest. 2004;126:1938- 1945.
21. Baker WL, Cios DA, Sander SD, Coleman CI. Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. J Manag Care Pharm. 2009;15:244-252.