Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: Results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial

被引：38

作者：

Garcia, David A. ^{[1
]}

Wallentin, Lars ^{[2
]}

Lopes, Renato D. ^{[3
]}

Thomas, Laine ^{[3
]}

Alexander, John H. ^{[3
]}

Hylek, Elaine M. ^{[4
]}

Ansell, Jack ^{[5
]}

Hanna, Michael ^{[6
]}

Lanas, Fernando ^{[7
]}

Flaker, Greg ^{[8
]}

Commerford, Patrick ^{[9
]}

Xavier, Denis ^{[10
]}

Vinereanu, Dragos ^{[11
]}

Yang, Hongqiu ^{[3
]}

Granger, Christopher B. ^{[3
]}

机构：

[1] Univ Washington, Div Hematol, Seattle, WA 98195 USA

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

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

[4] Boston Univ Med Ctr, Boston, MA USA

[5] Lenox Hill Hosp, New York, NY USA

[6] Bristol Myers Squibb Co, Princeton, NJ USA

[7] Univ La Frontera, Temuco, Chile

[8] Univ Missouri Hlth Care, Columbia, MO USA

[9] Univ Cape Town, Dept Med, ZA-7925 Cape Town, South Africa

[10] St Johns Res Inst, Bangalore, Karnataka, India

[11] Univ Hosp Bucharest, Bucharest, Romania

来源：

AMERICAN HEART JOURNAL | 2013年 / 166卷 / 03期

关键词：

PREVENTION; THERAPY; COHORTS; RISK;

D O I：

10.1016/j.ahj.2013.05.016

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Patients with atrial fibrillation who are vitamin K antagonist (VKA)-naive may have a higher risk of thrombosis and/or bleeding than VKA-experienced patients. Methods and results Using data from ARISTOTLE, we assessed baseline characteristics and the treatment effect of apixaban versus warfarin in the VKA-naive and VKA-experienced cohorts. We compared rates of study drug discontinuation and time-in-therapeutic range. Overall, 7,800 (43%) were VKA naive, and 10,401 were VKA experienced. At baseline, both groups were similar with respect to age and congestive heart failure, hypertension, age, diabetes, stroke score (CHADS(2)). Fewer VKA-naive patients had a history of prior stroke (18% vs 21%) or prior bleeding (10% vs 22%) and were more often female (39% vs 33%). The effect of apixaban on the primary efficacy and safety outcomes was similar in VKA-naive (stroke/systemic embolism: hazard ratio [ HR] 0.86, 95% CI 0.67-1.11 and major bleeding: HR 0.73, 95% CI 0.59-0.91) and VKA-experienced populations (stroke/systemic embolism: HR 0.73, 95% CI 0.57-0.95, P value for interaction = 0.39 and major bleeding: HR 0.66, 95% CI 0.55-0.80, P value for interaction = 0.50). Permanent study drug discontinuation was numerically less likely in patients receiving apixaban whether they were VKA naive (HR for discontinuation: 0.87, 95% CI 0.79-0.95) or VKA experienced (HR for discontinuation: 0.93, 95% CI 0.85-1.02). Among patients receiving warfarin, the mean/median times in therapeutic range were lower in the VKA-naive group (VKA-naive: 57.5/61.4, VKA-experienced: 66.0/69.1, P < .001). Conclusion The treatment effects of apixaban (vs warfarin) were not modified by VKA naivety. The rates of stroke/systemic embolism and major bleeding were numerically lower among the patients assigned to apixaban, irrespective of prior VKA use.

引用

页码：549 / 558

页数：10

共 11 条

[1] Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial [J].

Connolly, S. ;

Pogue, J. ;

Hart, R. ;

Pfeffer, M. ;

Hohnloser, S. ;

Chrolavicius, S. ;

Yusuf, S. .

LANCET, 2006, 367 (9526) :1903-1912

[2] Dabigatran and Warfarin in Vitamin K Antagonist-Naive and -Experienced Cohorts With Atrial Fibrillation [J].

Ezekowitz, Michael D. ;

Wallentin, Lars ;

Connolly, Stuart J. ;

Parekh, Amit ;

Chernick, Michael R. ;

Pogue, Janice ;

Aikens, Timothy H. ;

Yang, Sean ;

Reilly, Paul A. ;

Lip, Gregory Y. H. ;

Yusuf, Salim .

CIRCULATION, 2010, 122 (22) :2246-2253

[3] New-onset atrial fibrillation and warfarin initiation: High risk periods and implications for new antithrombotic drugs [J].

Garcia, David A. ;

Lopes, Renato D. ;

Hylek, Elaine M. .

THROMBOSIS AND HAEMOSTASIS, 2010, 104 (06) :1099-1105

[4] 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

[5] Disparate Stroke Rates on Warfarin Among Contemporaneous Cohorts With Atrial Fibrillation Potential Insights Into Risk From a Comparative Analysis of SPORTIF III Versus SPORTIF V [J].

Hylek, Elaine M. ;

Frison, Lars ;

Henault, Lori E. ;

Cupples, Adrienne .

STROKE, 2008, 39 (11) :3009-3014

[6] Major Hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation [J].

Hylek, Elaine M. ;

Evans-Molina, Carmella ;

Shea, Carol ;

Henault, Lori E. ;

Regan, Susan .

CIRCULATION, 2007, 115 (21) :2689-2696

[7] Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism - A meta-analysis [J].

Linkins, LA ;

Choi, PT ;

Douketis, JD .

ANNALS OF INTERNAL MEDICINE, 2003, 139 (11) :893-900

[8] Apixaban for Reduction In Stroke and Other ThromboemboLic Events in Atrial Fibrillation (ARISTOTLE) trial: Design and rationale [J].

Lopes, Renato D. ;

Alexander, John H. ;

Al-Khatib, Sana M. ;

Ansell, Jack ;

Diaz, Raphael ;

Easton, J. Donald ;

Gersh, Bernard J. ;

Granger, Christopher B. ;

Hanna, Michael ;

Horowitz, John ;

Hylek, Elaine M. ;

McMurray, John J. V. ;

Verheugt, Freek W. A. ;

Wallentin, Lars .

AMERICAN HEART JOURNAL, 2010, 159 (03) :331-339

[9]

ROSENDAAL FR, 1993, THROMB HAEMOSTASIS, V69, P236

[10] Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients [J].

Schulman, S ;

Kearon, C .

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2005, 3 (04) :692-694

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