Net Clinical Benefit of Non-Vitamin K Antagonist vs Vitamin K Antagonist Anticoagulants in Elderly Patients with Atrial Fibrillation

被引:43
作者
Patti, Giuseppe [1 ]
Pecen, Ladislav [2 ]
Lucerna, Markus [3 ]
Huber, Kurt [4 ,5 ]
Rohla, Miklos [4 ,5 ]
Renda, Giulia [6 ]
Siller-Matula, Jolanta [7 ,8 ]
Ricci, Fabrizio [9 ,10 ]
Kirchhof, Paulus [11 ,12 ]
De Caterina, Raffaele [6 ,13 ]
机构
[1] Univ Rome, Dept Cardiovasc Sci, Campus Biomed,Via Alvaro del Portillo 200, I-00128 Rome, Italy
[2] Charles Univ Prague, Med Fac Pilsen, Prague, Czech Republic
[3] Daiichi Sankyo Europe, Munich, Germany
[4] Wilhelminenhosp, Med Dept 3, Cardiol & Intens Care Med, Vienna, Austria
[5] Sigmund Freud Univ, Med Sch, Vienna, Austria
[6] Univ G dAnnunzio, Inst Cardiol, Chieti, Italy
[7] Med Univ Vienna, Dept Cardiol, Vienna, Austria
[8] Poznan Univ Med Sci, Dept Cardiol 1, Poznan, Poland
[9] Univ G dAnnunzio, Dept Neurosci Imaging & Clin Sci, Inst Adv Biomed Technol, Chieti, Italy
[10] Lund Univ, Dept Clin Sci, Malmo, Sweden
[11] Univ Birmingham, Inst Cardiovasc Sci, Birmingham, W Midlands, England
[12] SWBH & UHB NHS Trust, Birmingham, W Midlands, England
[13] Fdn G Monasterio, Pisa, Italy
关键词
Atrial fibrillation; Cardiovascular events; Elderly; Major bleeding; Net clinical benefit; NOACs; VKAs; ORAL ANTICOAGULANTS; EUROPEAN COUNTRIES; STROKE PREVENTION; WARFARIN; METAANALYSIS; EFFICACY; THERAPY; SAFETY; DEFINITION; MANAGEMENT;
D O I
10.1016/j.amjmed.2018.12.036
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND: The risks of thromboembolic and hemorrhagic events in patients with atrial fibrillation both increase with age; therefore, net clinical benefit analyses of anticoagulant treatments in the elderly population are crucial to guide treatment. We evaluated the 1-year clinical outcomes with non-vitamin-K antagonist and vitamin K antagonist oral anticoagulants (NOACs vs VKAs) in elderly (>= 75 years) patients with atrial fibrillation in a prospective registry setting. METHODS: Data on 3825 elderly patients were pooled from the PREFER in AF and PREFER in AF PROLONGATION registries. The primary outcome was the incidence of the net composite endpoint, including major bleeding and ischemic cardiovascular events on NOACs (n = 1556) compared with VKAs (n = 2269). Results: The rates of the net composite endpoint were 6.6%/year with NOACs vs 9.1%/year with VKAs (odds ratio [OR] 0.71; 95% confidence interval [CI], 0.51-0.99; P = .042). NOAC therapy was associated with a lower rate of major bleeding compared with VKA use (OR 0.58; 95% CI, 0.38-0.90; P = .013). Ischemic events were nominally reduced too (OR 0.71; 95% CI, 0.51-1.00; P = .050). Major bleeding with NOACs was numerically lower in higher-risk patients with low body mass index (BMI; OR 0.50; 95% CI, 0.22-1.12; P = .07) or with age >= 85 years (OR 0.44; 95% CI, 0.13-1.49; P = .17). Conclusions: Our real-world data indicate that, compared with VKAs, NOAC use is associated with a better net clinical benefit in elderly patients with atrial fibrillation, primarily due to lower rates of major bleeding. Major bleeding with NOACs was numerically lower also in higher-risk patients with low BMI or age >= 85 years. (C) 2019 The Authors. Published by Elsevier Inc.
引用
收藏
页码:749 / +
页数:14
相关论文
共 26 条
[1]   Oral Anticoagulation in Very Elderly Patients With Atrial Fibrillation: A Nationwide Cohort Study [J].
Chao, Tze-Fan ;
Liu, Chia-Jen ;
Lin, Yenn-Jiang ;
Chang, Shih-Lin ;
Lo, Li-Wei ;
Hu, Yu-Feng ;
Tuan, Ta-Chuan ;
Liao, Jo-Nan ;
Chung, Fa-Po ;
Chen, Tzeng-Ji ;
Lip, Gregory Y. H. ;
Chen, Shih-Ann .
CIRCULATION, 2018, 138 (01) :37-47
[2]   Frequent and possibly inappropriate use of combination therapy with an oral anticoagulant and antiplatelet agents in patients with atrial fibrillation in Europe [J].
De Caterina, Raffaele ;
Ammentorp, Bettina ;
Darius, Harald ;
Le Heuzey, Jean-Yves ;
Renda, Giulia ;
Schilling, Richard John ;
Schliephacke, Tessa ;
Reimitz, Paul-Egbert ;
Schmitt, Josef ;
Schober, Christine ;
Luis Zamorano, Jose ;
Kirchhof, Paulus .
HEART, 2014, 100 (20) :1625-1635
[3]   Balancing the Benefits and Risks of 2 Doses of Dabigatran Compared With Warfarin in Atrial Fibrillation [J].
Eikelboom, John W. ;
Connolly, Stuart J. ;
Hart, Robert G. ;
Wallentin, Lars ;
Reilly, Paul ;
Oldgren, Jonas ;
Yang, Sean ;
Yusuf, Salim .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2013, 62 (10) :900-908
[4]   Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial Fibrillation An Analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) Trial [J].
Eikelboom, John W. ;
Wallentin, Lars ;
Connolly, Stuart J. ;
Ezekowitz, Mike ;
Healey, Jeff S. ;
Oldgren, Jonas ;
Yang, Sean ;
Alings, Marco ;
Kaatz, Scott ;
Hohnloser, Stefan H. ;
Diener, Hans-Christoph ;
Franzosi, Maria Grazia ;
Huber, Kurt ;
Reilly, Paul ;
Varrone, Jeanne ;
Yusuf, Salim .
CIRCULATION, 2011, 123 (21) :2363-U72
[5]   Efficacy and Safety of Rivaroxaban Compared With Warfarin Among Elderly Patients With Nonvalvular Atrial Fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) [J].
Halperin, Jonathan L. ;
Hankey, Graeme J. ;
Wojdyla, Daniel M. ;
Piccini, Jonathan P. ;
Lokhnygina, Yuliya ;
Patel, Manesh R. ;
Breithardt, Guenter ;
Singer, Daniel E. ;
Becker, Richard C. ;
Hacke, Werner ;
Paolini, John F. ;
Nessel, Christopher C. ;
Mahaffey, Kenneth W. ;
Califf, Robert M. ;
Fox, Keith A. A. .
CIRCULATION, 2014, 130 (02) :138-U45
[6]   Efficacy and safety of apixaban compared with warfarin according to age for stroke prevention in atrial fibrillation: observations from the ARISTOTLE trial [J].
Halvorsen, Sigrun ;
Atar, Dan ;
Yang, Hongqiu ;
De Caterina, Raffaele ;
Erol, Cetin ;
Garcia, David ;
Granger, Christopher B. ;
Hanna, Michael ;
Held, Claes ;
Husted, Steen ;
Hylek, Elaine M. ;
Jansky, Petr ;
Lopes, Renato D. ;
Ruzyllo, Witold ;
Thomas, Laine ;
Wallentin, Lars .
EUROPEAN HEART JOURNAL, 2014, 35 (28) :1864-1872
[7]   ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation [J].
Hamm, Christian W. ;
Bassand, Jean-Pierre ;
Agewall, Stefan ;
Bax, Jeroen ;
Boersma, Eric ;
Bueno, Hector ;
Caso, Pio ;
Dudek, Dariusz ;
Gielen, Stephan ;
Huber, Kurt ;
Ohman, Magnus ;
Petrie, Mark C. ;
Sonntag, Frank ;
Uva, Miguel Sousa ;
Storey, Robert F. ;
Wijns, William ;
Zahger, Doron .
EUROPEAN HEART JOURNAL, 2011, 32 (23) :2999-3054
[8]   Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial [J].
Kato, Eri Toda ;
Giugliano, Robert P. ;
Ruff, Christian T. ;
Koretsune, Yukihiro ;
Yamashita, Takeshi ;
Kiss, Robert Gabor ;
Nordio, Francesco ;
Murphy, Sabina A. ;
Kimura, Tetsuya ;
Jin, James ;
Lanz, Hans ;
Mercuri, Michele ;
Braunwald, Eugene ;
Antman, Elliott M. .
JOURNAL OF THE AMERICAN HEART ASSOCIATION, 2016, 5 (05)
[9]   2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS [J].
Kirchhof, Paulus ;
Benussi, Stefano ;
Kotecha, Dipak ;
Ahlsson, Anders ;
Atar, Dan ;
Casadei, Barbara ;
Castella, Manuel ;
Diener, Hans-Christoph ;
Heidbuchel, Hein ;
Hendriks, Jeroen ;
Hindricks, Gerhard ;
Manolis, Antonis S. ;
Oldgren, Jonas ;
Popescu, Bogdan Alexandru ;
Schotten, Ulrich ;
Van Putte, Bart ;
Vardas, Panagiotis .
EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 2016, 50 (05) :E1-E88
[10]   Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboemolic events-European Registry in Atrial Fibrillation (PREFER in AF) [J].
Kirchhof, Paulus ;
Ammentorp, Bettina ;
Darius, Harald ;
De Caterina, Raffaele ;
Le Heuzey, Jean-Yves ;
Schilling, Richard John ;
Schmitt, Josef ;
Zamorano, Jose Luis .
EUROPACE, 2014, 16 (01) :6-14