TY - JOUR
T1 - Use of concomitant aspirin in patients with atrial fibrillation
T2 - Findings from the ROCKET AF trial
AU - on behalf of the
AU - ROCKET AF Steering Committee Investigators
AU - Shah, Rohan
AU - Hellkamp, Anne
AU - Lokhnygina, Yuliya
AU - Becker, Richard C.
AU - Berkowitz, Scott D.
AU - Breithardt, Günter
AU - Hacke, Werner
AU - Halperin, Jonathan L.
AU - Hankey, Graeme J.
AU - Fox, Keith A.A.
AU - Nessel, Christopher C.
AU - Mahaffey, Kenneth W.
AU - Piccini, Jonathan P.
AU - Singer, Daniel E.
AU - Patel, Manesh R.
N1 - Funding Information:
Shah, Hellkamp, Lokhnygina: none. Becker: Consultant/Advisory Board: Bayer, Janssen, Daiichi Sankyo, Portola, Regado Biosciences, Boehringer Ingelheim. Berkowitz: employee of Bayer HealthCare. Breithardt: honoraria: Bayer HealthCare, BMS/Pfizer; Consultant/Advisory Board: Bayer HealthCare, BMS/Pfizer, Sanofi Aventis. Hacke: research grant: Boehringer Ingelheim; Consultant/Advisory Board: Sygnis Pharma Germany, Boehringer Ingelheim, Photothera USA, Codman USA, Bayer. Halperin: Consultant/Advisory Board: Bayer AG HealthCare, Biotronik, Boehringer Ingelheim, Daiichi Sankyo, Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, Pfizer, Sanofi Aventis, AstraZeneca, Boston Scientific, Janssen, Medtronic. Hankey: honoraria: Bayer, Medscape (Heart.org). Fox: research grant: Eli Lilly; Consultant/Advisory Board: Boehringer Ingelheim, Sanofi Aventis, AstraZeneca, Johnson & Johnson/Bayer. Nessel: employee of Janssen Research & Development. Mahaffey: full disclosures prior to August 1, 2013, available at www.dcri.org ; disclosures after August 1, 2013, available at https://med.stanford.edu/profiles/47970?tab=research-and-scholarship . Piccini: research grant: ARCA Biopharma, GE Healthcare, Johnson & Johnson, ResMed; Consultant/Advisory Board: Johnson & Johnson, Forest Laboratories, Spectranetics, Medtronic. Singer: research grant: Johnson & Johnson, Bristol-Myers Squibb; Consultant/Advisory Board: Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson, Merck, Pfizer. Patel: research grant: Johnson & Johnson, AstraZeneca; Consultant/Advisory Board: Bayer, Janssen, AstraZeneca, Genzyme.
Funding Information:
This work was supported by Janssen Research & Development LLC, Raritan, NJ , and Bayer HealthCare AG, Leverkusen, Germany .
Publisher Copyright:
© 2016
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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). Methods 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. Results A total of 5,205 (36.5%) patients were receiving aspirin at baseline (mean dose 99.2 mg); 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). Conclusions 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.
AB - 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). Methods 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. Results A total of 5,205 (36.5%) patients were receiving aspirin at baseline (mean dose 99.2 mg); 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). Conclusions 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.
UR - http://www.scopus.com/inward/record.url?scp=84977661347&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84977661347&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2016.05.019
DO - 10.1016/j.ahj.2016.05.019
M3 - Article
C2 - 27595682
AN - SCOPUS:84977661347
VL - 179
SP - 77
EP - 86
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -