Use of concomitant aspirin in patients with atrial fibrillation: Findings from the ROCKET AF trial.
We aimed to investigate the relationship between aspirin use and clinical outcomes in patients enrolled in 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), in particular, those with known coronary artery disease (CAD).



Patients in ROCKET AF, comparing rivaroxaban and warfarin, were analyzed. Aspirin use was assessed at baseline. Stroke and systemic embolism, myocardial infarction, death, and major or nonmajor clinically relevant (NMCR) bleeding were compared between groups. Multivariable modeling was done adjusting for baseline risk factors.



A total of 5,205 (36.5%) patients were receiving aspirin at baseline (mean dose 99.2mg); 30.6% of those had known CAD. Patients receiving aspirin were more likely to have prior myocardial infarction (22% vs 14%; P<.001) and heart failure (68% vs 59%; P<.001). Relative efficacy of rivaroxaban versus warfarin was similar with and without aspirin use for both stroke/systemic embolism (P=.95 for interaction), and major or NMCR bleeding (P=.76 for interaction). After adjustment, aspirin use was associated with similar rates of stroke/systemic embolism (hazard ratio [HR] 1.16, 95% CI 0.98-1.37; P=.094) but higher rates of all-cause death (HR 1.27, 95% CI 1.13-1.42; P<.0001) and major or NMCR bleeding (HR 1.32, 95% CI 1.21-1.43; P<.0001). There was a significant interaction between no CAD at baseline and aspirin for all-cause death (P=.009).



Aspirin use at baseline was associated with an increased risk for bleeding and all-cause death in ROCKET AF, a risk most pronounced in patients without known CAD. Although these findings may reflect unmeasured clinical factors, further investigation is warranted to determine optimal aspirin use in patients with AF.
Duke Clinical Research Institute, Durham, NC.
Rohan
R
Shah
Duke Clinical Research Institute, Durham, NC.
Anne
A
Hellkamp
Duke Clinical Research Institute, Durham, NC.
Yuliya
Y
Lokhnygina
University of Cincinnati College of Medicine, Cincinnati, OH.
Richard C
RC
Becker
Bayer HealthCare Pharmaceuticals, Whippany, NJ.
Scott D
SD
Berkowitz
Department of Cardiovascular Medicine, Hospital of the University of Münster, Münster, Germany.
Günter
G
Breithardt
Ruprecht-Karls-University, Heidelberg, Germany.
Werner
W
Hacke
Cardiovascular Institute, Mount Sinai Medical Center, New York, NY.
Jonathan L
JL
Halperin
School of Medicine and Pharmacology, The University of Western Australia, Crawley, Australia.
Graeme J
GJ
Hankey
University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
Keith A A
KA
Fox
Janssen Research and Development LLC, Raritan, NJ.
Christopher C
CC
Nessel
Stanford University School of Medicine, Stanford, CA.
Kenneth W
KW
Mahaffey
Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC.
Jonathan P
JP
Piccini
Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Daniel E
DE
Singer
Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC. Electronic address: manesh.patel@duke.edu.
Manesh R
MR
Patel
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D004359:Drug Therapy, Combination; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D065427:Factor Xa Inhibitors / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000453:epidemiology; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009026:Mortality; D009203:Myocardial Infarction / Q000453:epidemiology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D000069552:Rivaroxaban / Q000627:therapeutic use*; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D014859:Warfarin / Q000627:therapeutic use*
D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D010975:Platelet Aggregation Inhibitors; D014859:Warfarin; D000069552:Rivaroxaban; D001241:Aspirin