Edoxaban versus Warfarin in high-risk patients with atrial fibrillation: A comprehensive analysis of high-risk subgroups

American Heart Journal - Tập 247 - Trang 24-32 - 2022
Baris Gencer1,2,3, Alon Eisen4, David Berger4, Francesco Nordio1, Sabina A. Murphy1, Laura T. Grip1, Cathy Chen5, Hans Lanz6, Christian T. Ruff1, Elliott M Antman1, Eugene Braunwald1, Robert P Giugliano1
1TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA
2Cardiology Division, Geneva University Hospitals, Geneva, Switzerland
3Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
4Cardiology Department, Rabin Medical Center, Petah Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
5Daiichi Sankyo Inc , Banking Ridge, NJ
6Daiichi Sankyo Europe GmbH, Munich, Germany

Tài liệu tham khảo

Hindricks, 2021, 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European association for cardio-thoracic surgery (EACTS), Eur Heart J, 42, 373, 10.1093/eurheartj/ehaa612 Giugliano, 2013, Edoxaban versus warfarin in patients with atrial fibrillation, N Engl J Med, 369, 2093, 10.1056/NEJMoa1310907 Ruff, 2010, Am Heart J, 160, 635, 10.1016/j.ahj.2010.06.042 Lip, 2019, The safety of NOACs in atrial fibrillation patient subgroups: a narrative review, Int J Clin Pract, 73, e13285, 10.1111/ijcp.13285 Ferreira, 2018, Individualizing treatment choices in the systolic blood pressure intervention trial, J Hypertens, 36, 428, 10.1097/HJH.0000000000001535 Pocock, 2014, Individualizing treatment choices using quantitative methods, Am Heart J, 168, 607, 10.1016/j.ahj.2014.08.003 Hayward, 2006, Multivariable risk prediction can greatly enhance the statistical power of clinical trial subgroup analysis, BMC Med Res Methodol, 6, 18, 10.1186/1471-2288-6-18 Kent, 2020, The predictive approaches to treatment effect heterogeneity (PATH) statement, Ann Intern Med., 172, 35, 10.7326/M18-3667 Zelniker, 2021, Comparison of the efficacy and safety outcomes of Edoxaban in 8040 women versus 13 065 men with atrial fibrillation in the ENGAGE AF-TIMI 48 Trial, Circulation, 143, 673, 10.1161/CIRCULATIONAHA.120.052216 Plitt, 2020, Efficacy and safety of edoxaban in patients with diabetes mellitus in the ENGAGE AF-TIMI 48 trial, Int J Cardiol, 304, 185, 10.1016/j.ijcard.2020.01.009 Qamar, 2019, Edoxaban versus warfarin in patients with atrial fibrillation and history of liver disease, J Am Coll Cardiol, 74, 179, 10.1016/j.jacc.2019.04.061 Kato, 2016, Efficacy and safety of Edoxaban in elderly patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial, J Am Heart Assoc, 5, 10.1161/JAHA.116.003432 Steffel, 2016, Edoxaban versus warfarin in atrial fibrillation patients at risk of falling: ENGAGE AF-TIMI 48 analysis, J Am Coll Cardiol, 68, 1169, 10.1016/j.jacc.2016.06.034 Bohula, 2016, Impact of renal function on outcomes with Edoxaban in the ENGAGE AF-TIMI 48 trial, Circulation, 134, 24, 10.1161/CIRCULATIONAHA.116.022361 Rost, 2016, Outcomes with edoxaban versus warfarin in patients with previous cerebrovascular events: findings from ENGAGE AF-TIMI 48 (effective anticoagulation with factor Xa next generation in atrial fibrillation-thrombolysis in myocardial infarction 48), Stroke, 47, 2075, 10.1161/STROKEAHA.116.013540 Xu, 2016, Concomitant use of single antiplatelet therapy with edoxaban or warfarin in patients with atrial fibrillation: analysis From the ENGAGE AF-TIMI48 trial, J Am Heart Assoc, 5, 10.1161/JAHA.115.002587 O'Donoghue, 2015, Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillationdagger, Eur Heart J, 36, 1470, 10.1093/eurheartj/ehv014 Magnani, 2016, Efficacy and safety of edoxaban compared with warfarin in patients with atrial fibrillation and heart failure: insights from ENGAGE AF-TIMI 48, Eur J Heart Fail, 18, 1153, 10.1002/ejhf.595 De Caterina, 2017, Valvular heart disease patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 trial, J Am Coll Cardiol, 69, 1372, 10.1016/j.jacc.2016.12.031 Fanola, 2018, Efficacy and safety of Edoxaban in patients with active malignancy and atrial fibrillation: analysis of the ENGAGE AF - TIMI 48 trial, J Am Heart Assoc, 7, 10.1161/JAHA.118.008987 Zelniker, 2019, Edoxaban in atrial fibrillation patients with established coronary artery disease: insights from ENGAGE AF-TIMI 48, Eur Heart J Acute Cardiovasc Care, 8, 176, 10.1177/2048872618790561 Chao, 2019, Clinical outcomes, Edoxaban concentration, and anti-factor Xa activity of Asian patients with atrial fibrillation compared with non-Asians in the ENGAGE AF-TIMI 48 trial, Eur Heart J, 40, 1518, 10.1093/eurheartj/ehy807 Boriani, 2021, Edoxaban versus Warfarin in patients with atrial fibrillation at the extremes of body weight: an analysis from the ENGAGE AF-TIMI 48 Trial, Thromb Haemost, 121, 140, 10.1055/s-0040-1716540 Piccini, 2013, Circulation, 127, 224, 10.1161/CIRCULATIONAHA.112.107128 Kirchhof, 2016, ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS, Eur Heart J, 37, 2893, 10.1093/eurheartj/ehw210 Yasuda, 2019, Antithrombotic therapy for atrial fibrillation with stable coronary disease, N Engl J Med, 381, 1103, 10.1056/NEJMoa1904143 De Caterina, 2014, What is 'valvular' atrial fibrillation? A reappraisal, Eur Heart J, 35, 3328, 10.1093/eurheartj/ehu352 Mosarla, 2019, Anticoagulation strategies in patients with cancer: JACC review topic of the week, J Am Coll Cardiol, 73, 1336, 10.1016/j.jacc.2019.01.017 Okumura, 2020, Low-dose Edoxaban in very elderly patients with atrial fibrillation, N Engl J Med, 383, 1735, 10.1056/NEJMoa2012883 Steffel, 2021, Double-blind comparison of half-dose versus full-dose Edoxaban in 14,014 patients with atrial fibrillation, J Am Coll Cardiol, 77, 1197, 10.1016/j.jacc.2020.12.053 de Groot, 2021, Edoxaban versus warfarin in patients with atrial fibrillation in relation to the risk of stroke: a secondary analysis of the ENGAGE AF-TIMI 48 study, Am Heart J, 235, 132, 10.1016/j.ahj.2021.01.013 Fanola, 2017, A novel risk prediction score in atrial fibrillation for a net clinical outcome from the ENGAGE AF-TIMI 48 randomized clinical trial, Eur Heart J, 38, 888 Raskob, 2018, Edoxaban for the treatment of cancer-associated venous thromboembolism, N Engl J Med, 378, 615, 10.1056/NEJMoa1711948 Vranckx, 2019, Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial, Lancet, 394, 1335, 10.1016/S0140-6736(19)31872-0 Goette, 2016, Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial, Lancet, 388, 1995, 10.1016/S0140-6736(16)31474-X Moll, 2018, Edoxaban plus Aspirin vs dual antiplatelet therapy in endovascular treatment of patients with peripheral artery disease: results of the ePAD trial, J Endovasc Ther, 25, 158, 10.1177/1526602818760488 Van Mieghem, 2018, Edoxaban versus standard of care and their effects on clinical outcomes in patients having undergone transcatheter aortic valve implantation in atrial fibrillation-rationale and design of the ENVISAGE-TAVI AF trial, Am Heart J, 205, 63, 10.1016/j.ahj.2018.07.006 Colonna, 2020, Routine clinical practice in the periprocedural management of edoxaban therapy is associated with low risk of bleeding and thromboembolic complications: The prospective, observational, and multinational EMIT-AF/VTE study, Clin Cardiol, 43, 769, 10.1002/clc.23379 Hohnloser, 2019, Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial, Eur Heart J, 40, 3013, 10.1093/eurheartj/ehz190 Inoue, 2018, Prospective observational study in elderly patients with non-valvular atrial fibrillation: rationale and design of the All Nippon AF In the elderly (ANAFIE) registry, J Cardiol, 72, 300, 10.1016/j.jjcc.2018.02.018 Ohashi, 2018, Venous thromboembolism in patients with cancer: design and rationale of a multicentre, prospective registry (Cancer-VTE Registry), BMJ Open, 8, 10.1136/bmjopen-2017-018910 Salazar, 2012, Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation, Thromb Haemost, 107, 925, 10.1160/TH11-08-0566 Ruff, 2015, Association between edoxaban dose, concentration, anti-factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial, Lancet, 385, 2288, 10.1016/S0140-6736(14)61943-7 Yin, 2018, Linking endogenous factor Xa Activity, a biologically relevant pharmacodynamic marker, to edoxaban plasma concentrations and clinical outcomes in the ENGAGE AF-TIMI 48 trial, Circulation, 138, 1963, 10.1161/CIRCULATIONAHA.118.033933 de Groot, 2021, Edoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe study, Eur Heart J Cardiovasc Pharmacother, 7, f30, 10.1093/ehjcvp/pvaa079 De Caterina, 2019, The global Edoxaban treatment in routine clinical practice (ETNA) noninterventional study program: rationale and design, Clin Cardiol, 42, 1147, 10.1002/clc.23279