Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (Aristotle) trial

Alvaro Avezum, Renato D. Lopes, Phillip Schulte, Fernando Lanas, Bernard J. Gersh, Michael Hanna, Prem Pais, Cetin Erol, Rafael Diaz, M. Cecilia Bahit, Jozef Bartunek, Raffaele De Caterina, Shinya Goto, Witold Ruzyllo, Jun Zhu, Christopher B. Granger, John H. Alexander

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

Background - Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves. Methods and Results - We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, major bleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heart disease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.97 and HR, 0.84; 95%, CI 0.67-1.04; interaction P=0.38), causing less major bleeding (HR, 0.79; 95% CI, 0.61-1.04 and HR, 0.65; 95% CI, 0.55-0.77; interaction P=0.23), and reducing mortality (HR, 1.01; 95% CI, 0.84-1.22 and HR, 0.84; 95% CI, 0.73-0.96; interaction P=0.10). Conclusions - More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease.

Original languageEnglish (US)
Pages (from-to)624-632
Number of pages9
JournalCirculation
Volume132
Issue number8
DOIs
StatePublished - Aug 25 2015
Externally publishedYes

Fingerprint

Heart Valve Diseases
Warfarin
Atrial Fibrillation
Stroke
Embolism
Confidence Intervals
Hemorrhage
apixaban
Mitral Valve Stenosis
Heart Valves

Keywords

  • apixaban
  • atrial fibrillation
  • heart diseases
  • hemorrhage
  • oral anticoagulant
  • stroke
  • valvular heart disease

ASJC Scopus subject areas

  • Medicine(all)
  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease : Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (Aristotle) trial. / Avezum, Alvaro; Lopes, Renato D.; Schulte, Phillip; Lanas, Fernando; Gersh, Bernard J.; Hanna, Michael; Pais, Prem; Erol, Cetin; Diaz, Rafael; Bahit, M. Cecilia; Bartunek, Jozef; De Caterina, Raffaele; Goto, Shinya; Ruzyllo, Witold; Zhu, Jun; Granger, Christopher B.; Alexander, John H.

In: Circulation, Vol. 132, No. 8, 25.08.2015, p. 624-632.

Research output: Contribution to journalArticle

Avezum, A, Lopes, RD, Schulte, P, Lanas, F, Gersh, BJ, Hanna, M, Pais, P, Erol, C, Diaz, R, Bahit, MC, Bartunek, J, De Caterina, R, Goto, S, Ruzyllo, W, Zhu, J, Granger, CB & Alexander, JH 2015, 'Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (Aristotle) trial', Circulation, vol. 132, no. 8, pp. 624-632. https://doi.org/10.1161/CIRCULATIONAHA.114.014807
Avezum, Alvaro ; Lopes, Renato D. ; Schulte, Phillip ; Lanas, Fernando ; Gersh, Bernard J. ; Hanna, Michael ; Pais, Prem ; Erol, Cetin ; Diaz, Rafael ; Bahit, M. Cecilia ; Bartunek, Jozef ; De Caterina, Raffaele ; Goto, Shinya ; Ruzyllo, Witold ; Zhu, Jun ; Granger, Christopher B. ; Alexander, John H. / Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease : Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (Aristotle) trial. In: Circulation. 2015 ; Vol. 132, No. 8. pp. 624-632.
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abstract = "Background - Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves. Methods and Results - We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, major bleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4{\%}) had a history of moderate or severe valvular heart disease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR], 0.70; 95{\%} confidence interval [CI], 0.51-0.97 and HR, 0.84; 95{\%}, CI 0.67-1.04; interaction P=0.38), causing less major bleeding (HR, 0.79; 95{\%} CI, 0.61-1.04 and HR, 0.65; 95{\%} CI, 0.55-0.77; interaction P=0.23), and reducing mortality (HR, 1.01; 95{\%} CI, 0.84-1.22 and HR, 0.84; 95{\%} CI, 0.73-0.96; interaction P=0.10). Conclusions - More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease.",
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T1 - Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease

T2 - Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (Aristotle) trial

AU - Avezum, Alvaro

AU - Lopes, Renato D.

AU - Schulte, Phillip

AU - Lanas, Fernando

AU - Gersh, Bernard J.

AU - Hanna, Michael

AU - Pais, Prem

AU - Erol, Cetin

AU - Diaz, Rafael

AU - Bahit, M. Cecilia

AU - Bartunek, Jozef

AU - De Caterina, Raffaele

AU - Goto, Shinya

AU - Ruzyllo, Witold

AU - Zhu, Jun

AU - Granger, Christopher B.

AU - Alexander, John H.

PY - 2015/8/25

Y1 - 2015/8/25

N2 - Background - Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves. Methods and Results - We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, major bleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heart disease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.97 and HR, 0.84; 95%, CI 0.67-1.04; interaction P=0.38), causing less major bleeding (HR, 0.79; 95% CI, 0.61-1.04 and HR, 0.65; 95% CI, 0.55-0.77; interaction P=0.23), and reducing mortality (HR, 1.01; 95% CI, 0.84-1.22 and HR, 0.84; 95% CI, 0.73-0.96; interaction P=0.10). Conclusions - More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease.

AB - Background - Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves. Methods and Results - We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, major bleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heart disease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.97 and HR, 0.84; 95%, CI 0.67-1.04; interaction P=0.38), causing less major bleeding (HR, 0.79; 95% CI, 0.61-1.04 and HR, 0.65; 95% CI, 0.55-0.77; interaction P=0.23), and reducing mortality (HR, 1.01; 95% CI, 0.84-1.22 and HR, 0.84; 95% CI, 0.73-0.96; interaction P=0.10). Conclusions - More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease.

KW - apixaban

KW - atrial fibrillation

KW - heart diseases

KW - hemorrhage

KW - oral anticoagulant

KW - stroke

KW - valvular heart disease

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