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Observational Study
. 2020 Feb 5;3(2):e200107.
doi: 10.1001/jamanetworkopen.2020.0107.

Outcomes Associated With Oral Anticoagulants Plus Antiplatelets in Patients With Newly Diagnosed Atrial Fibrillation

Keith A A Fox  1 , Priscilla Velentgas  2 , A John Camm  3 , Jean-Pierre Bassand  4   5 , David A Fitzmaurice  6 , Bernard J Gersh  7 , Samuel Z Goldhaber  8 , Shinya Goto  9 , Sylvia Haas  10 , Frank Misselwitz  11 , Karen S Pieper  4   12 , Alexander G G Turpie  13 , Freek W A Verheugt  14 , Elizabeth Dabrowski  2 , Kaiyi Luo  2 , Liza Gibbs  2 , Ajay K Kakkar  4   15 ; GARFIELD-AF Investigators
Affiliations
Observational Study

Outcomes Associated With Oral Anticoagulants Plus Antiplatelets in Patients With Newly Diagnosed Atrial Fibrillation

Keith A A Fox et al. JAMA Netw Open. .

Abstract

Importance: Patients with nonvalvular atrial fibrillation at risk of stroke should receive oral anticoagulants (OAC). However, approximately 1 in 8 patients in the Global Anticoagulant Registry in the Field (GARFIELD-AF) registry are treated with antiplatelet (AP) drugs in addition to OAC, with or without documented vascular disease or other indications for AP therapy.

Objective: To investigate baseline characteristics and outcomes of patients who were prescribed OAC plus AP therapy vs OAC alone.

Design, setting, and participants: Prospective cohort study of the GARFIELD-AF registry, an international, multicenter, observational study of adults aged 18 years and older with recently diagnosed nonvalvular atrial fibrillation and at least 1 risk factor for stroke enrolled between March 2010 and August 2016. Data were extracted for analysis in October 2017 and analyzed from April 2018 to June 2019.

Exposure: Participants received either OAC plus AP or OAC alone.

Main outcomes and measures: Clinical outcomes were measured over 3 and 12 months. Outcomes were adjusted for 40 covariates, including baseline conditions and medications.

Results: A total of 24 436 patients (13 438 [55.0%] male; median [interquartile range] age, 71 [64-78] years) were analyzed. Among eligible patients, those receiving OAC plus AP therapy had a greater prevalence of cardiovascular indications for AP, including acute coronary syndromes (22.0% vs 4.3%), coronary artery disease (39.1% vs 9.8%), and carotid occlusive disease (4.8% vs 2.0%). Over 1 year, patients treated with OAC plus AP had significantly higher incidence rates of stroke (adjusted hazard ratio [aHR], 1.49; 95% CI, 1.01-2.20) and any bleeding event (aHR, 1.41; 95% CI, 1.17-1.70) than those treated with OAC alone. These patients did not show evidence of reduced all-cause mortality (aHR, 1.22; 95% CI, 0.98-1.51). Risk of acute coronary syndrome was not reduced in patients taking OAC plus AP compared with OAC alone (aHR, 1.16; 95% CI, 0.70-1.94). Patients treated with OAC plus AP also had higher rates of all clinical outcomes than those treated with OAC alone over the short term (3 months).

Conclusions and relevance: This study challenges the practice of coprescribing OAC plus AP unless there is a clear indication for adding AP to OAC therapy in newly diagnosed atrial fibrillation.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Fox reported receiving grants and personal fees from Bayer during the conduct of the study and grants from AstraZeneca, personal fees from Sanofi/Regeneron, and personal fees from Verseon outside the submitted work. Dr Velentgas reported receiving grants from Bayer during the conduct of the study. Dr Camm reported receiving grants and personal fees from Bayer, Boehringer Ingelheim, Daiichi Sankyo, and Pfizer BMS Alliance outside the submitted work. Dr Fitzmaurice reported receiving grants from the University of Warwick during the conduct of the study. Dr Goldhaber reported receiving grants from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Boston Scientific’s BTG EKOS, Daiichi Sankyo, Janssen, and the National Heart, Lung, and Blood Institute and consulting fees from Bayer and Boehringer Ingelheim outside the submitted work. Dr Goto reported receiving personal fees from the Thrombosis Research Institute during the conduct of the study. Dr Haas reported receiving personal fees from Aspen, Bayer, Daiichi Sankyo, Bristol-Myers Squibb/Pfizer, and Portola outside the submitted work. Dr Turpie reported receiving personal fees from the Thrombosis Research Institute during the conduct of the study and personal fees from Janssen and Portola outside the submitted work. Dr Verheugt reported receiving personal fees from Bayer, Daiichi Sankyo, Boehringer Ingelheim, and Bristol-Meyers Squibb/Pfizer during the conduct of the study. Ms Dabrowski reported receiving personal fees from Aetion, Inc during the conduct of the study. Ms Luo reported receiving personal fees from Aetion, Inc during the conduct of the study. Ms Gibbs reported receiving personal fees from Aetion, Inc during the conduct of the study. Dr Kakkar reported receiving grants and personal fees from Bayer AG during the conduct of the study and personal fees from Bayer AG, Boehringer Ingelheim, Daiichi Sankyo, Janssen, Sanofi, and Verseon outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patients’ Disposition in the Study
Figure 2.
Figure 2.. Relative Risk (Hazard Ratios [HRs], Unadjusted and Adjusted) for Study Outcomes in Patients With Newly Diagnosed Atrial Fibrillation Treated With Oral Anticoagulants (OAC) Plus Antiplatelet Drugs (AP) or OAC Alone (Reference) Over 12 Months (Intent-to-Treat Analyses)
Hazard ratios were adjusted for 40 covariates as shown in eTable 1 in the Supplement. AP indicates antiplatelet drugs; and OAC, oral anticoagulants. ACS indicates acute coronary syndromes; MI, myocardial infarction; NMCR, nonmajor, clinically relevant; and SE, systemic embolism.
Figure 3.
Figure 3.. Relative Risk (Hazard Ratios [HRs], Unadjusted and Adjusted) for Study Outcomes in Patients With Newly Diagnosed Atrial Fibrillation Treated With Oral Anticoagulants (OAC) Plus Antiplatelet Drugs (AP) or OAC Alone (Reference) Over 3 Months (Intent-to-Treat Analyses)
Hazard ratios were adjusted for 40 covariates as shown in eTable 1 in the Supplement. ACS indicates acute coronary syndromes; MI, myocardial infarction; NMCR, nonmajor, clinically relevant; and SE, systemic embolism.
See this image and copyright information in PMC

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