Direct oral anticoagulants for stroke prevention in patients with atrial fibrillation: meta-analysis by geographic region with a focus on European patients

British Journal of Clinical Pharmacology

Volumn , Issue , 2016, Pages 633-644

  Gómez Outes, Antonio ^a   Terleira Fernández, Ana Isabel ^b,c   Calvo Rojas, Gonzalo ^d   Suárez Gea, M Luisa ^a   Vargas Castrillón, Emilio ^b,c  

^a Agencia Espanola de Medicamentos y Productos Sanitarios   (Spain)

^b HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^c UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^d HOSPITAL CLÍNIC   (Spain)

Author keywords

anticoagulants; arrhythmia; meta analysis; stroke; warfarin

Indexed keywords

APIXABAN; DABIGATRAN; EDOXABAN; RIVAROXABAN; WARFARIN;

ASIA; ATRIAL FIBRILLATION; BLEEDING; BLEEDING TENDENCY; CEREBROVASCULAR ACCIDENT; DRUG DOSE REDUCTION; DRUG MEGADOSE; DRUG SAFETY; EASTERN EUROPE; EMBOLISM; EUROPEAN; GEOGRAPHIC DISTRIBUTION; HUMAN; LOW DRUG DOSE; MEDICAL LITERATURE; MEDLINE; META ANALYSIS; METHODOLOGY; NORTH AMERICA; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK REDUCTION; SOUTH AND CENTRAL AMERICA; SYSTEMATIC REVIEW; THROMBOSIS PREVENTION; WESTERN EUROPE;

EID: 84982921575     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.13005     Document Type: Review

References (39)

1. Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, et al. 2012 focused update of the ESC guidelines for the management of atrial fibrillation. Eur Heart J 2012; 33: 2719–47.
2. Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Terleira-Fernández AI, Vargas-Castrillón E. Direct-acting oral anticoagulants: pharmacology, indications, management, and future perspectives. Eur J Haematol 2015; 95: 389–404.
3. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, et al. 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: 955–62.
4. Mullins CD, Onwudiwe NC, Brando de Araújo GT, Chen W, Xuan J, Tichopád A, et al. Guidance document: global pharmacoeconomic model adaption strategies. ViHRI 2014; 5: 7–13.
5. Lip GY, Wang KL, Chiang CE. Non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in Asian patients with atrial fibrillation: time for a reappraisal. Int J Cardiol 2015; 180: 246–54.
6. Eikelboom JW, Connolly SJ, Hart RG, Wallentin L, Reilly P, Oldgren J, et al. Balancing the benefits and risks of 2 doses of dabigatran compared with warfarin in atrial fibrillation. J Am Coll Cardiol 2013; 62: 900–8.
7. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928.
8. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996; 17: 1–12.
9. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009; 339: b2700.
10. DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clin Trials 1986; 7: 177–88.
11. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran vs. warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139–51.
12. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban vs. warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883–91.
13. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al. Apixaban vs. warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981–92.
14. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, et al. Edoxaban vs. warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369: 2093–104.
15. Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, et al. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation – the J-ROCKET AF study. Circ J 2012; 76: 2104–11.
16. Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R, Parcham-Azad K, et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). Am J Cardiol 2007; 100: 1419–26.
17. Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor Xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. The ARISTOTLE-J study. Circ J 2011; 75: 1852–9.
18. Yamashita T, Koretsune Y, Yasaka M, Inoue H, Kawai Y, Yamaguchi T, et al. Randomized, multicenter, warfarin-controlled phase II study of edoxaban in Japanese patients with non-valvular atrial fibrillation. Circ J 2012; 76: 1840–7.
19. Chung N, Jeon HK, Lien LM, Lai WT, Tse HF, Chung WS, et al. Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. Thromb Haemost 2011; 105: 535–44.
20. Weitz JI, Connolly SJ, Patel I, Salazar D, Rohatagi S, Mendell J, et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost 2010; 104: 633–41.
21. Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364: 806–17.
22. Beasley N, Thompson A. Pradaxa (dabigatran). FDA Draft Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM247244.pdf (last accessed 5 August 2015).
23. Beasley N, Dunnmon P, Rose M. Xarelto (rivaroxaban). FDA Draft Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC). September 8, 2011. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm270796.pdf (last accessed 5 August 2015).
24. Rose M, Beasley N. Eliquis (apixaban). Clinical Review Addendum December 17, 2012. Available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202155Orig1s000MedR.pdf (last accessed 5 August 2015).
25. Blank M, McDowell TY, Rose M. Savaysa (edoxaban). FDA Draft Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC). October 30, 2014. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM420704.pdf (last accessed 5 August 2015).
26. Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, et al. 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.
27. Salazar CA, del Aguila D, Cordova EG. Direct thrombin inhibitors vs. vitamin K antagonists for preventing cerebral or systemic embolism in people with non-valvular atrial fibrillation. Cochrane Database Syst Rev 2014; 3: CD009893.
28. Mentz RJ, Kaski JC, Dan GA, Goldstein S, Stockbridge N, Alonso-Garcia A, et al. Implications of geographical variation on clinical outcomes of cardiovascular trials. Am Heart J 2012; 164: 303–12.
29. Connolly SJ, Pogue J, Eikelboom J, Flaker G, Commerford P, Franzosi MG, et al. Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of international normalized ratio control achieved by centers and countries as measured by time in therapeutic range. Circulation 2008; 118: 2029–37.
30. Van Walraven C, Jennings A, Oake N, Fergusson D, Forster AJ. Effect of study setting on anticoagulation control: a systematic review and metaregression. Chest 2006; 129: 1155–66.
31. Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, et al. 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: 975–83.
32. Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, et al. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry. Circulation 2014; 129: 1568–76.
33. Mearns ES, White CM, Kohn CG, Hawthorne J, Song JS, Meng J, et al. Quality of vitamin K antagonist control and outcomes in a trial fibrillation patients: a meta-analysis and meta-regression. Thromb J 2014; 12: 14.
34. Fauchier L, Taillandier S. Geographic variations in the quality of oral anticoagulation with vitamin K antagonists in the era of new anticoagulants. J Am Heart Assoc 2013; 2: e000088.
35. Gómez-Outes A, Terleira-Fernández AI, Calvo-Rojas G, Suárez-Gea ML, Vargas-Castrillón E. Dabigatran, rivaroxaban, or apixaban vs. warfarin in patients with nonvalvular atrial fibrillation: a systematic review and meta-analysis of subgroups. Thrombosis 2013; 2013: 640723.
36. Mega JL, Walker JR, Ruff CT, Vandell AG, Nordio F, Deenadayalu N, et al. Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet 2015; 385: 2280–7.
37. Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, et al. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol 2014; 63: 891–900.
38. Björck F, Renlund H, Lip GYH, Wester P, Svensson PJ, Själander A. Outcomes in a warfarin-treated population with atrial fibrillation. JAMA Cardiol 2016; 1: 172–80.
39. Gallagher AM, van Staa TP, Murray-Thomas T, Schoof N, Clemens A, Ackermann D, et al. Population-based cohort study of warfarin-treated patients with atrial fibrillation: incidence of cardiovascular and bleeding outcomes. BMJ Open 2014; 4: e003839.