The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study

被引：187

作者：

Connolly, Stuart J. ^{[1
]}

Wallentin, Lars ^{[2
,3
]}

Ezekowitz, Michael D.

Eikelboom, John ^{[1
]}

Oldgren, Jonas ^{[2
,3
]}

Reilly, Paul A. ^{[4
]}

Brueckmann, Martina ^{[5
,6
]}

Pogue, Janice ^{[1
]}

Alings, Marco ^{[7
]}

Amerena, John V. ^{[8
]}

Avezum, Alvaro ^{[9
]}

Baumgartner, Iris ^{[10
]}

Budaj, Andrzej J. ^{[11
]}

Chen, Jyh-Hong ^{[12
]}

Dans, Antonio L. ^{[13
]}

Darius, Harald ^{[14
]}

Di Pasquale, Giuseppe ^{[15
]}

Ferreira, Jorge

Flaker, Greg C.

Flather, Marcus D. ^{[16
,17
]}

Franzosi, Maria Grazia ^{[18
]}

Golitsyn, Sergey P. ^{[19
]}

Halon, David A. ^{[20
]}

Heidbuchel, Hein ^{[21
]}

Hohnloser, Stefan H. ^{[22
]}

Huber, Kurt ^{[23
]}

Jansky, Petr ^{[24
]}

Kamensky, Gabriel ^{[25
]}

Keltai, Matyas ^{[26
]}

Kim, Sung Soon ^{[27
]}

Lau, Chu-Pak ^{[28
]}

Le Heuzey, Jean-Yves ^{[29
]}

Lewis, Basil S. ^{[20
]}

Liu, Lisheng ^{[30
]}

Nanas, John ^{[31
]}

Omar, Razali ^{[32
]}

Pais, Prem ^{[33
]}

Pedersen, Knud E. ^{[34
]}

Piegas, Leopoldo S. ^{[9
]}

Raev, Dimitar ^{[35
]}

Smith, Pal J. ^{[36
]}

Talajic, Mario ^{[37
]}

Tan, Ru San ^{[38
]}

Tanomsup, Supachai ^{[39
]}

Toivonen, Lauri ^{[40
]}

Vinereanu, Dragos ^{[41
]}

Xavier, Denis ^{[34
]}

Zhu, Jun ^{[42
]}

Wang, Susan Q. ^{[4
]}

Duffy, Christine O. ^{[4
]}

机构：

[1] McMaster Univ & Hamilton Hlth Sci, Populat Hlth Res Inst, Hamilton, ON, Canada

[2] Uppsala Univ, Uppsala Clin Res Ctr, Uppsala, Sweden

[3] Uppsala Univ, Dept Med Sci, Uppsala, Sweden

[4] Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT 06877 USA

[5] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany

[6] Heidelberg Univ, Fac Med Mannheim, Mannheim, Germany

[7] WCN, Amphia Ziekenhuis, Breda, Netherlands

[8] Deakin Univ, Geelong, Vic 3217, Australia

[9] Dante Pazzanese Inst Cardiol, Sao Paulo, Brazil

[10] Univ Hosp Bern, Swiss Cardiovasc Ctr, CH-3010 Bern, Switzerland

[11] Grochowski Hosp, Postgrad Med Sch, Warsaw, Poland

[12] Natl Cheng Kung Univ, Tainan 70101, Taiwan

[13] Univ Philippines, Manila, Philippines

[14] Vivantes Neukoelln Med Ctr, Berlin, Germany

[15] Maggiore Hosp, Bologna, Italy

[16] Lankenau Inst Med Res, Wynnewood, PA USA

[17] Ctr Heart, Wynnewood, PA USA

[18] Ist Mario Negri, Milan, Italy

[19] Russian Cardiol Res Ctr, Moscow, Russia

[20] Lady Davis Carmel Med Ctr, Haifa, Israel

[21] Univ Leuven, Louvain, Belgium

[22] Goethe Univ Frankfurt, Frankfurt, Germany

[23] Wilhelminenhosp, Vienna, Austria

[24] Univ Hosp Motol, Prague, Czech Republic

[25] Univ Hosp Bratislava, Bratislava, Slovakia

[26] Semmelweis Univ, Hungarian Inst Cardiol, H-1085 Budapest, Hungary

[27] Yonsei Univ, Coll Med, Seoul, South Korea

[28] Univ Hong Kong, Queen Mary Hosp, Hong Kong, Hong Kong, Peoples R China

[29] Univ Paris 05, AP HP, Hop Georges Pompidou, Paris, France

[30] Fu Wai Hosp, Chinese Hypertens League Inst, Beijing, Peoples R China

[31] Natl & Kapodistrian Univ Athens, Athens 11528, Greece

[32] Inst Jantung Negara, Kuala Lumpur, Malaysia

[33] St Johns Med Coll & Res Inst, Bangalore, Karnataka, India

[34] Odense Univ Hosp, DK-5000 Odense, Denmark

[35] Inst Med, Minist Interior, Sofia, Bulgaria

[36] Akershus Univ Hosp, Nordbyhagen, Norway

[37] Univ Montreal, Montreal Heart Inst, Montreal, PQ, Canada

[38] Natl Heart Ctr, Singapore, Singapore

[39] Mahidol Univ, Ramathibodi Hosp, Bangkok, Thailand

[40] Univ Helsinki Hosp, Helsinki, Finland

[41] Univ Med & Pharm Carol Davila, Bucharest, Romania

[42] Fuwai Hosp, CAMS & PUMC, Beijing, Peoples R China

来源：

CIRCULATION | 2013年 / 128卷 / 03期

关键词：

atrial fibrillation; dabigatran; hemorrhage; stroke; WARFARIN;

D O I：

10.1161/CIRCULATIONAHA.112.001139

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. Methods and Results Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04-1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y. Conclusions During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death. Clinical Trial Registration URL: . Unique identifier: NCT00808067.

引用

页码：237 / 243

页数：7

共 9 条

[1] Anticoagulant Options - Why the FDA Approved a Higher but Not a Lower Dose of Dabigatran [J].

Beasley, B. Nhi ;

Unger, Ellis F. ;

Temple, Robert .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (19) :1788-1790

[2] Use and effectiveness of warfarin in medicare beneficiaries with atrial fibrillation [J].

Birman-Deych, E ;

Radford, MJ ;

Nilasena, DS ;

Gage, BF .

STROKE, 2006, 37 (04) :1070-1074

[3] Newly Identified Events in the RE-LY Trial [J].

Connolly, Stuart J. ;

Ezekowitz, Michael D. ;

Yusuf, Salim ;

Reilly, Paul A. ;

Wallentin, Lars .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (19) :1875-1876

[4] 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

[5] ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation - Executive summary [J].

Fuster, Valentin ;

Ryden, Lars E. ;

Cannom, David S. ;

Crijns, Harry J. ;

Curbs, Anne B. ;

Ellenbogen, Kenneth A. ;

Halperin, Jonathan L. ;

Le Heuzey, Jean-Yves ;

Kay, G. Neal ;

Lowe, James E. ;

Olsson, S. Bertil ;

Prystowsky, Eric N. ;

Tamargo, Juan Luis ;

Wann, Samuel ;

Smith, Sidney C., Jr. ;

Jacobs, Alice K. ;

Adams, Cynthia D. ;

Anderson, Jeffery L. ;

Antman, Elliott M. ;

Halperin, Jonathan L. ;

Hunt, Sharon Ann ;

Nishimura, Rick ;

Ornato, Joseph P. ;

Page, Richard L. ;

Riegel, Barbara ;

Priori, Silvia G. ;

Blanc, Jean-Jacques ;

Budaj, Andrzej ;

Camm, A. John ;

Dean, Veronica ;

Deckers, Jaap W. ;

Despres, Catherine ;

Dickstein, Kenneth ;

Lekakis, John ;

McGregor, Keith ;

Metra, Marco ;

Morais, Joao ;

Osterspey, Ady ;

Tamargo, Juan Luis ;

Zamorano, Jose Luis .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2006, 48 (04) :854-906

[6] Apixaban versus Warfarin in Patients with Atrial Fibrillation [J].

Granger, Christopher B. ;

Alexander, John H. ;

McMurray, John J. V. ;

Lopes, Renato D. ;

Hylek, Elaine M. ;

Hanna, Michael ;

Al-Khalidi, Hussein R. ;

Ansell, Jack ;

Atar, Dan ;

Avezum, Alvaro ;

Cecilia Bahit, M. ;

Diaz, Rafael ;

Easton, J. Donald ;

Ezekowitz, Justin A. ;

Flaker, Greg ;

Garcia, David ;

Geraldes, Margarida ;

Gersh, Bernard J. ;

Golitsyn, Sergey ;

Goto, Shinya ;

Hermosillo, Antonio G. ;

Hohnloser, Stefan H. ;

Horowitz, John ;

Mohan, Puneet ;

Jansky, Petr ;

Lewis, Basil S. ;

Luis Lopez-Sendon, Jose ;

Pais, Prem ;

Parkhomenko, Alexander ;

Verheugt, Freek W. A. ;

Zhu, Jun ;

Wallentin, Lars .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (11) :981-992

[7] Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation [J].

Hart, Robert G. ;

Pearce, Lesly A. ;

Aguilar, Maria I. .

ANNALS OF INTERNAL MEDICINE, 2007, 146 (12) :857-867

[8] Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation [J].

Patel, Manesh R. ;

Mahaffey, Kenneth W. ;

Garg, Jyotsna ;

Pan, Guohua ;

Singer, Daniel E. ;

Hacke, Werner ;

Breithardt, Guenter ;

Halperin, Jonathan L. ;

Hankey, Graeme J. ;

Piccini, Jonathan P. ;

Becker, Richard C. ;

Nessel, Christopher C. ;

Paolini, John F. ;

Berkowitz, Scott D. ;

Fox, Keith A. A. ;

Califf, Robert M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (10) :883-891

[9] Dabigatran and Postmarketing Reports of Bleeding [J].

Southworth, Mary Ross ;

Reichman, Marsha E. ;

Unger, Ellis F. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (14) :1272-1274

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