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Wells G, Coyle D, Cameron C, et al. Safety, Effectiveness, and Cost-Effectiveness of New Oral Anticoagulants Compared with Warfarin in Preventing Stroke and Other Cardiovascular Events in Patients with Atrial Fibrillation [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2012 Apr 9.
Safety, Effectiveness, and Cost-Effectiveness of New Oral Anticoagulants Compared with Warfarin in Preventing Stroke and Other Cardiovascular Events in Patients with Atrial Fibrillation [Internet].
Show details7.8.1. List of included studies (n = 15)
Table 43Included Studies
Unique RCT | Companion or Subgroup Studies | Updated or Readjudicated data | Other |
---|---|---|---|
PETRO Ezekowitz et al., 200710 | |||
RE-LY Connolly et al.al., 20099 | Eikelbloom et al, 201175 Oldgren et al., 201181 Ezekowitz et al., 201076 Wallentin et al., 201082 Connolly 201074 | Supplemental. appendix available online with main RCT publication at NEJM† | FDA Report, 201079 |
ARISTOTLE Granger et al., 201111 | Wallentin, 2011 (PPT)83 | ||
ARISTOTLE-J Ogawa et al., 201112 | |||
ROCKET-AF Patel et al., 201113 | Fox et al., 201177 Mahaffey and Fox, 2010 (PPT)78 | Supplemental appendix available online with main RCT publication at NEJM* | FDA Report, 201180 |
FDA = Food and Drug Administration; NEJM = New England Journal of Medicine; RCT = randomized controlled trial.
- *
Not included in reference count for PRISMA
7.8.2. List of excluded studies (n=51)
Table 44Excluded Studies
Author, Year | Full Citation |
---|---|
Review or commentary (n = 5) | |
Augoustides et al., 2011 | Augoustides JG. Advances in anticoagulation: focus on dabigatran, an oral direct thrombin inhibitor. J Cardiothorac Vasc Anesth. 2011;25(6):1208–12. |
Camm, 2009 | Camm AJ. The RE-LY study: Randomized evaluation of long-term anticoagulant therapy: dabigatran vs. warfarin. Eur Heart J. 2009;30(21):2554–55. |
Battistelli et al., 2009 | Battistelli S, Genovese A, Gori T. Heparin-induced thrombocytopenia in surgical patients. Am J Surg. 2010;199(1):43–51. |
Aymanns, 2010 | Aymanns C, Keller F, Maus S, et al. Review on pharmacokinetics and pharmacodynamics and the aging kidney. Clin J the Am Soc Nephrol. 2010;5(2):314–27. |
Hankey, 2009 | Hankey GJ. At last, a RE-LYable alternative to warfarin for atrial fibrillation. Int J stroke. 2009;4(6):454–5. |
Population not of interest (n = 5) | |
Huang et al., 2011 | Huang J, Cao Y, Liao C, et al. Apixaban versus enoxaparin in patients with total knee arthroplasty. A meta-analysis of randomized trials. Thromb Haemost. 2011;105(2):245–53. |
Barrett et al., 2003 | Barrett YC, Wang J, Knabb R, et al. Apixaban decreases coagulation activity in patients with acute deep-vein thrombosis. Thromb Haemost. 2003;105(1):181–9. |
Bauer et al., 2009 (poster) | Bauer KA, Turpie AGG, Lassen MR, et al. Effects of age, weight, gender and renal function in a pooled analysis of four rivaroxaban studies. Poster presented at: 22nd Congress of the International Society on Thrombosis and Haemostasis; 2009 Jun 11–18; Boston, MA. |
Lassen et al., 2008 | Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776–86. |
Berges et al., 2007 | Berges A, Laporte S, Epinat M, et al. Anti-factor Xa activity of enoxaparin administered at prophylactic dosage to patients over 75 years old. Br J Clin Pharmacol. 2007;64(4):428–38. |
Study design not of interest (n = 25) | |
Banerjee et al., 2011 | Banerjee A, Marin F, Lip GY. A new landscape for stroke prevention in atrial fibrillation: focus on new anticoagulants, antiarrhythmic drugs, and devices. Stroke. 2011;42(11);3316–22. |
Roskell et al., 2010 | Roskell NS, Lip GY, Noack H, et al. Treatments for stroke prevention in atrial fibrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate. Thromb Haemost. 2010;104(6):1106–15. |
Ezekowitz et al., 2011 | Ezekowitz MD, Nagarakanti R. Dabigatran in atrial fibrillation: pharmacology and clinical trials. J Interv Card Electrophysiology. 2011;32(3):173–80. |
Atay et al., 2011 (poster) | Atay J, Fiumara K, Piazza G, et al. Cost analysis of substituting dabigatran for warfarin in an anticoagulation management service. JACC. 2011;57(14 Suppl):E1188. (Poster presented at: ACC.11 & i2 60th Annual Scientific Session and Expo; 2011 Apr 2–5; New Orleans, LA). |
Beyer-Westendorf et al., 2011 | Beyer-Westendorf J, Buller H. External and internal validity of open label or double-blind trials in oral anticoagulation: better, worse or just different? J Thromb Haemost. 2011;9(11):2153–8. |
Camm et al., 2011 | Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor Xa inhibitor. Drugs. 2011;71(12):1503–26. |
Cooper et al., 2009 | Cooper NJ, Sutton AJ, Morris D, et al. Addressing between-study heterogeneity and inconsistency in mixed treatment comparisons: application to stroke prevention treatments in individuals with non-rheumatic atrial fibrillation. Stat Med. 2009;28(14):1861–81. |
Cooper et al., 2011 | Cooper PC, Coath FL, Daly M, et al. Assessment of antithrombin deficiency in the real world. Int J Lab Hematol. 2011;33(6):659–60. |
Deremer et al., 2011 | Deremer CE, Gujral JS, Thornton JW, et al. Dabigatran falsely elevates point of care international normalized ratio results. Am J Med. 2011;124(9):e5–6. |
Ezekowitz et al., 2009 | 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(5):805–10. |
Freeman et al., 2004 | Freeman JV, Zhu RP, Owens DK, et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2004;154(1):1–11. |
From et al., 2002 | From AM, Hoganson DD, Erwin PJ. Does a longer duration of oral factor Xa therapy increase the risk of bleeding or transaminitis? Thromb Res. 2002;127(3):2–209. |
Gage, 2011 | Gage L. Dabigatran in Patients With Nonvalvular Atrial Fibrillation. J Am Coll Cardiol. 2011;58(5):551. |
Garcia et al., 2010 | Garcia D, Libby E, Crowther MA. The NOAC. Blood. 2010;115:15–20. |
Hankey et al., 2011 | Hankey GJ, Eikelboom JW. Dabigatran etexilate: a new oral thrombin inhibitor. Circ. 2011;123:1436–50. |
Holmes, 2010 | Holmes DR. Atrial fibrillation and stroke management: present and future. Semin Neurol. 2010;30(5):528–36. |
Nutescu, 2009 | Nutescu E. A pound of cure: prevention of ischemic stroke in atrial fibrillation. Pharm Times. 2009;75(12):110–9. |
Patel et al., 2009 | Patel M, Becker R, Breithardt G, et al. Rationale and design of the ROCKET-AF study: comparison of rivaroxaban with warfarin for the prevention of stroke and SE in patients with atrial fibrillation. Eur Heart J. 2009;30:705. (Presented at: European Society of Cardiology, ESC Congress; 2009 Aug 29 to Sep 2; Barcelona, Spain). |
Pengo et al,. 2011 | Pengo V, Crippa L, Falanga A, et al. Questions and answers on the use of dabigatran and perpectives on the use of other NOAC in patients with atrial fibrillation; a consensus document of the Italian federation of thrombosis centers (FCSA). Thromb Haemost. 2011;106(5):868–76. |
Becker et al., 2010 | Becker R, Berkowitz SC, Breithardt G, et al. 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 ROCKET-AF study. Am Heart J. 2010;159(3):340–7e1. |
Shah et al., 2011 | Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circ. 2011;123(22):2562–70. |
Siddiqui et al., 2008 | Siddiqui FA, Ehrinpreis MN, Janisse J, et al. Demographics of a large cohort of urban chronic hepatitis C patients. Hepatol Int. 2008 Sep;2(3):376–81. |
Sorensen et al., 2011 | Sorensen SV, Kansal AR, Connolly S, et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and SE in atrial fibrillation: a Canadian payer perspective. Thromb Haemost. 2011;105(5):908–19. |
Steffel et al., 2011 | Steffel J, Braunwald E. Novel oral anticoagulants: focus on stroke prevention and treatment of venous thrombo-embolism. Eur Heart J. 2011;32:1968–76. |
Wyse, 2007 | Wyse DG. Bleeding while starting anticoagulation for thromboembolism prophylaxis in elderly patients with atrial fibrillation: from bad to worse. Circ. 2007;115(21):2684–86. |
Comparator not of interest (n = 1) | |
Connolly et al., 2011 | Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364(9):806–17. |
Outcome not of interest (n = 1) | |
Braidy et al., 2011 | Braidy N, Bui K, Bajorek B. Evaluating the impact of new anticoagulants in the hospital setting. Pharm Prac. 2011;9(1):1–10. |
Intervention not of interest (n = 1) | |
Flaker et al., 2006 | Flaker GC, Gruber M, Connolly SJ, et al. Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation: an exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials. Am Heart J. 2006;152(5):967–73. |
Subgroup – population or outcome not of interest, no useable data (n = 14) | |
Hori et al., 2011 | Hori M, Connolly SJ, Ezekowitz MD, et al. Efficacy and safety of dabigatran vs. warfarin in patients with atrial fibrillation — sub-analysis in Japanese population in RE-LY trial. Circ J. 2011;75(4):800–5. |
Chung et al., 2011 | Chung N, Jeon HK, Lien LM, et al. Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. Thromb & Haemost. 2011;105(3):535–44. |
Diener et al., 2010 | Diener HC, Connolly SJ, Ezekowitz MD, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010;9(12):1157–63. |
Panichpisal et al., 2011 | Panichpisal K, Szarek M, Sareen A. Dabigatran for stroke prevention in patients with atrial fibrillation and previous stroke or transient ischemic attack: does dose matter? Future Neurol. 2011;6(2):155–8. |
Nagarakanti et al., 2011 | Nagarakanti R, Ezekowitz MD, Oldgren J, et al. Dabigatran versus warfarin in patients with atrial fibrillation: An analysis of patients undergoing cardioversion. Circ. 2011;123(2):131–6. |
Eikelboom et al., 2010 (conference abstract) | Eikelboom J, Hijazi Z, Oldgren J, et al. D-dimer is prognostic for stroke, major bleeding and death during anticoagulation of atrial fibrillation — a RE-LY substudy; Circ 2010; 122 (21 Suppl): A18321. (Abstract presented at: American Heart Association (AHA) Scientific Sessions 2010; 2010 Nov 13–17; Chicago, IL). |
Flaker et al., 2011 (poster) | Flaker GC, Reilly P, Yusuf S, et al. Dabigatran etexilate versus warfarin in patients with different types of atrial fibrillation: A RE-LY subgroup analysis. J Am Coll Cardiol. 2011; 57(14 Suppl): E62. (Poster presented at: ACC.11 & i2 American College of Cardiology's 60th Annual Scientific Session and Expo; 2011 Apr 2 to 5; New Orleans, LA). |
Ferreiral et al., 2011 | Ferreiral J, Ezekowitz MD, Connolly SJ, et al. Dabigatran compared with warfarin in patients with atrial fibrillation and symptomatic heart failure: a subgroup analysis of the RE-LY trial. Circ. 2011;124(21 Suppl):A10956. (Abstract presented at: American Heart Association (AHA) Scientific Sessions 2011; 2011 Nov 12 to 16; Orlando, FL). |
Healey et al., 2010 (poster) | Healey JS, Eikelboom J, Wallentin L, et al. Effect of age and renal function on the risks of stroke and major bleeding with dabigatran compared to warfarin: an analysis from the RE-LY study. J Am Coll Cardiol. 2010;55(10A):A4.E37. (Poster presented at: ACC.10 & i2 American College of Cardiology's 59th Annual Scientific Session and Expo; 2010 Mar 14 to 16; Atlanta, GA). |
Koti et al., 2010 (poster) | Koti MJ, Parekh A, Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation — an analysis of patients undergoing cardioversion. J Am Coll Cardiol. 2010;55(10A):A4.E40. (Poster session presented at: ACC.10 & i2 American College of Cardiology's 59th Annual Scientific Session and Expo; 2010 Mar 14 to 16; Atlanta, GA). |
Nagarakanti et al., 2008 | Nagarakanti R, Ezekowitz MD, Parcham-Azad K, et al. Long-term open label extension of the prevention of embolic and thrombotic events on dabigatran in atrial fibrillation (PETRO- Ex study). Circ. 2008;118(18 Suppl):S_922. (Abstract presented at: American Heart Association (AHA) Scientific Sessions 2008; 2008 Nov 8 to 12; New Orleans, LA). |
Oldgren et al., 2010 (poster) | Oldgren J, Alings M, Darius H, et al. Dabigatran versus warfarin in atrial fibrillation patients with low, moderate and high CHADS2 score: a RE-LY subgroup analysis. J Am Coll Cardiol. 2010;55(10A):A1.E2. (Oral session presented at: ACC.10 & i2 American College of Cardiology's 59th Annual Scientific Session and Expo; 2010 Mar 14 to 16; Atlanta, GA.) |
Uchino et al., 2011 | Uchino K, Hernandez AV. Dabigatran is associated with higher risk of MI or acute coronary syndromes: a meta-analysis of non-inferiority randomized controlled trials. Circ. 2011;124(21 Suppl):A15500. (Abstract presented at: American Heart Association (AHA) Scientific Sessions 2011; 2011 Nov 12–16; Orlando, FL.) |
- Included and Excluded Studies - Safety, Effectiveness, and Cost-Effectiveness of...Included and Excluded Studies - Safety, Effectiveness, and Cost-Effectiveness of New Oral Anticoagulants Compared with Warfarin in Preventing Stroke and Other Cardiovascular Events in Patients with Atrial Fibrillation
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