TY - JOUR
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 J.
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.
N1 - Publisher Copyright:
© 2015 American Heart Association, Inc.
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
UR - http://www.scopus.com/inward/record.url?scp=84940653422&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84940653422&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.114.014807
DO - 10.1161/CIRCULATIONAHA.114.014807
M3 - Article
C2 - 26106009
AN - SCOPUS:84940653422
SN - 0009-7322
VL - 132
SP - 624
EP - 632
JO - Circulation
JF - Circulation
IS - 8
ER -