Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial

被引：150

作者：

Breithardt, Gunter ^{[1
]}

Baumgartner, Helmut ^{[2
]}

Berkowitz, Scott D. ^{[3
]}

Hellkamp, Anne S. ^{[4
]}

Piccini, Jonathan P. ^{[4
,5
]}

Stevens, Susanna R. ^{[4
]}

Lokhnygina, Yuliya ^{[4
]}

Patel, Manesh R. ^{[4
]}

Halperin, Jonathan L.

Singer, Daniel E. ^{[6
,7
]}

Hankey, Graeme J. ^{[8
]}

Hacke, Werner ^{[9
]}

Becker, Richard C. ^{[4
]}

Nessel, Christopher C. ^{[10
]}

Mahaffey, Kenneth W. ^{[11
]}

Fox, Keith A. A. ^{[12
,13
]}

Califf, Robert M. ^{[14
]}

机构：

[1] Univ Hosp Munster, Dept Cardiovasc Med, Div Electrophysiol, D-48149 Munster, Germany

[2] Univ Hosp Munster, Dept Cardiovasc Med, Div Adult Congenital & Valvular Heart Dis, D-48149 Munster, Germany

[3] Bayer Healthcare Pharmaceut LP, Whippany, NJ USA

[4] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA

[5] Mt Sinai Med Ctr, Ctr Cardiovasc, New York, NY 10029 USA

[6] Massachusetts Gen Hosp, Clin Epidemiol Unit, Div Gen Med, Boston, MA 02114 USA

[7] Harvard Univ, Sch Med, Boston, MA USA

[8] Univ Western Australia, Sch Med & Pharmacol, Perth, WA 6009, Australia

[9] Heidelberg Univ, Heidelberg, Germany

[10] Johnson & Johnson Pharmaceut Res & Dev, Raritan, NJ USA

[11] Stanford Univ, Dept Med, Stanford, CA 94305 USA

[12] Univ Edinburgh, Edinburgh, Midlothian, Scotland

[13] Royal Infirm Edinburgh NHS Trust, Edinburgh, Midlothian, Scotland

[14] Duke Univ, Med Ctr, Duke Translat Med Inst, Durham, NC USA

来源：

EUROPEAN HEART JOURNAL | 2014年 / 35卷 / 47期

关键词：

Fibrillation; Anticoagulants; Heart diseases; Regurgitation; Stenosis; MANAGEMENT; DESIGN; RATIONALE; STROKE; APIXABAN; RISK; PREVENTION; GUIDELINES; COUNTRIES; EDOXABAN;

D O I：

10.1093/eurheartj/ehu305

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

We investigated clinical characteristics and outcomes of patients with significant valvular disease (SVD) 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) trial. ROCKET AF excluded patients with mitral stenosis or artificial valve prostheses. We used Cox regression to adjust comparisons for potential confounders. Among 14 171 patients, 2003 (14.1%) had SVD; they were older and had more comorbidities than patients without SVD. The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [2.01 vs. 2.43%; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.55-1.27] and without SVD (1.96 vs. 2.22%; HR 0.89, 95% CI 0.75-1.07; interaction P = 0.76). However, rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders. In intracranial haemorrhage, there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban. Many patients with 'non-valvular atrial fibrillation' have significant valve lesions. Their risk of stroke is similar to that of patients without SVD after controlling for stroke risk factors. Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD; however, the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD. Atrial fibrillation patients with and without SVD experience the same stroke-preventive benefit of oral anticoagulants.

引用

页码：3377 / 3385

页数：9

共 25 条

[1]

Albers GW, 2003, LANCET, V362, P1691

[2] Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation [J].

Blackshear, JL ;

Odell, JA .

ANNALS OF THORACIC SURGERY, 1996, 61 (02) :755-759

[3] Atrial fibrillation management, outcomes and predictors of stable disease in daily practice: Prospective non-interventional study [J].

Bosch, Ralph F. ;

Kirch, Wilhelm ;

Theuer, Juergen-Detlef ;

Pittrow, David ;

Kohlhaussen, Annette ;

Willich, Stefan N. ;

Bonnemeier, Hendrik .

INTERNATIONAL JOURNAL OF CARDIOLOGY, 2013, 167 (03) :750-756

[4] 2012 focused update of the ESC Guidelines for the management of atrial fibrillation [J].

Camm, A. John ;

Lip, Gregory Y. H. ;

De Caterina, Raffaele ;

Savelieva, Irene ;

Atar, Dan ;

Hohnloser, Stefan H. ;

Hindricks, Gerhard ;

Kirchhof, Paulus ;

Bax, Jeroen J. ;

Baumgartner, Helmut ;

Ceconi, Claudio ;

Dean, Veronica ;

Deaton, Christi ;

Fagard, Robert ;

Funck-Brentano, Christian ;

Hasdai, David ;

Hoes, Arno ;

Knuuti, Juhani ;

Kolh, Philippe ;

McDonagh, Theresa ;

Moulin, Cyril ;

Popescu, Bogdan A. ;

Reiner, Zeljko ;

Sechtem, Udo ;

Sirnes, Per Anton ;

Tendera, Michal ;

Torbicki, Adam ;

Vahanian, Alec ;

Windecker, Stephan ;

Vardas, Panos ;

Al-Attar, Nawwar ;

Alfieri, Ottavio ;

Angelini, Annalisa ;

Blomstrom-Lundqvist, Carina ;

Colonna, Paolo ;

De Sutter, Johan ;

Ernst, Sabine ;

Goette, Andreas ;

Gorenek, Bulent ;

Hatala, Robert ;

Heidbuchel, Hein ;

Heldal, Magnus ;

Kristensen, Steen Dalby ;

Le Heuzey, Jean-Yves ;

Mavrakis, Hercules ;

Mont, Lluis ;

Filardi, Pasquale Perrone ;

Ponikowski, Piotr ;

Prendergast, Bernard ;

Rutten, Frans H. .

EUROPEAN HEART JOURNAL, 2012, 33 (21) :2719-2747

[5] Distribution and Risk Profile of Paroxysmal, Persistent, and Permanent Atrial Fibrillation in Routine Clinical Practice Insight From the Real-Life Global Survey Evaluating Patients With Atrial Fibrillation International Registry [J].

Chiang, Chern-En ;

Naditch-Brule, Lisa ;

Murin, Jan ;

Goethals, Marnix ;

Inoue, Hiroshi ;

O'Neill, James ;

Silva-Cardoso, Jose ;

Zharinov, Oleg ;

Gamra, Habib ;

Alam, Samir ;

Ponikowski, Piotr ;

Lewalter, Thorsten ;

Rosenqvist, Marten ;

Steg, Philippe Gabriel .

CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY, 2012, 5 (04) :632-639

[6] Rationale and design of ACTIVE: The atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events [J].

Connolly, S. ;

Yusuf, S. ;

Budaj, A. ;

Camm, J. ;

Chrolavicius, S. ;

Commerford, P. J. ;

Flather, M. ;

Fox, K. A. A. ;

Hart, R. ;

Hohnloser, S. ;

Joyner, C. ;

Pfeffer, M. ;

Anand, I. ;

Arthur, H. ;

Avezum, A. ;

Bethala-Sithya, M. ;

Blumenthal, M. ;

Ceremuzynski, L. ;

De Caterina, R. ;

Diaz, R. ;

Flaker, G. ;

Frangin, G. ;

Franzosi, M. -G. ;

Gaudin, C. ;

Golitsyn, S. ;

Goldhaber, S. ;

Granger, C. ;

Halon, D. ;

Hermosillo, A. ;

Hunt, D. ;

Jansky, P. ;

Karatzas, N. ;

Keltai, M. ;

Lanas, F. ;

Lau, C. P. ;

Le Heuzey, J. -Y. ;

Lewis, B. S. ;

Morais, J. ;

Morillo, C. ;

Oto, A. ;

Paolasso, E. ;

Peters, R. J. ;

Pfisterer, M. ;

Piegas, L. ;

Pipillis, T. ;

Proste, C. ;

Sitkei, E. ;

Swedberg, K. ;

Synhorst, D. ;

Talajic, M. .

AMERICAN HEART JOURNAL, 2006, 151 (06) :1187-1193

[7] Apixaban in Patients with Atrial Fibrillation [J].

Connolly, Stuart J. ;

Eikelboom, John ;

Joyner, Campbell ;

Diener, Hans-Christoph ;

Hart, Robert ;

Golitsyn, Sergey ;

Flaker, Greg ;

Avezum, Alvaro ;

Hohnloser, Stefan H. ;

Diaz, Rafael ;

Talajic, Mario ;

Zhu, Jun ;

Pais, Prem ;

Budaj, Andrzej ;

Parkhomenko, Alexander ;

Jansky, Petr ;

Commerford, Patrick ;

Tan, Ru San ;

Sim, Kui-Hian ;

Lewis, Basil S. ;

Van Mieghem, Walter ;

Lip, Gregory Y. H. ;

Kim, Jae Hyung ;

Lanas-Zanetti, Fernando ;

Gonzalez-Hermosillo, Antonio ;

Dans, Antonio L. ;

Munawar, Muhammad ;

O'Donnell, Martin ;

Lawrence, John ;

Lewis, Gayle ;

Afzal, Rizwan ;

Yusuf, Salim .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (09) :806-817

[8] Dabigatran versus Warfarin in Patients with Atrial Fibrillation. [J].

Connolly, Stuart J. ;

Ezekowitz, Michael D. ;

Yusuf, Salim ;

Eikelboom, John ;

Oldgren, Jonas ;

Parekh, Amit ;

Pogue, Janice ;

Reilly, Paul A. ;

Themeles, Ellison ;

Varrone, Jeanne ;

Wang, Susan ;

Alings, Marco ;

Xavier, Denis ;

Zhu, Jun ;

Diaz, Rafael ;

Lewis, Basil S. ;

Darius, Harald ;

Diener, Hans-Christoph ;

Joyner, Campbell D. ;

Wallentin, Lars .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (12) :1139-1151

[9] Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment [J].

Eikelboom, John W. ;

O'Donnell, Martin ;

Yusuf, Salim ;

Diaz, Rafael ;

Flaker, Greg ;

Hart, Robert ;

Hohnloser, Stefan ;

Joyner, Campbell ;

Lawrence, Jack ;

Pais, Prem ;

Pogue, Janice ;

Synhorst, David ;

Connolly, Stuart J. .

AMERICAN HEART JOURNAL, 2010, 159 (03) :348-U38

[10] Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran [J].

Ezekowitz, Michael D. ;

Connolly, Stuart ;

Parekh, Amit ;

Reilly, Paul A. ;

Varrone, Jeanne ;

Wang, Susan ;

Oldgren, Jonas ;

Themeles, Ellison ;

Wallentin, Lars ;

Yusuf, Salim .

AMERICAN HEART JOURNAL, 2009, 157 (05) :805-810

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