Journal article
Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
The New England journal of medicine, Vol.380(16), pp.1509-1524
04/18/2019
DOI: 10.1056/NEJMoa1817083
PMID: 30883055
Abstract
Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear.
In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y
inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events.
Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group.
In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y
inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.).
Details
- Title: Subtitle
- Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
- Creators
- Renato D Lopes - Duke UniversityGretchen Heizer - Duke UniversityRonald Aronson - Bristol-Myers SquibbAmit N Vora - Duke UniversityTyler Massaro - Duke UniversityRoxana Mehran - Cardiovascular Research FoundationShaun G Goodman - University of AlbertaStephan Windecker - University Hospital of BernHarald Darius - Vivantes Neukoelln Medical CenterJia Li - Bristol-Myers SquibbOleg Averkov - Pirogov Russian National Research Medical UniversityM Cecilia Bahit - National Scientific Center "M.D. Strazhesko Institute of Cardiology"Otavio Berwanger - Hospital Israelita Albert EinsteinAndrzej Budaj - Grochowski HospitalZiad Hijazi - Uppsala UniversityAlexander Parkhomenko - National Academy of Sciences of Ukraine,Peter Sinnaeve - KU LeuvenRobert F Storey - University of SheffieldHolger Thiele - Leipzig UniversityDragos Vinereanu - Carol Davila University of Medicine and PharmacyChristopher B Granger - Duke UniversityJohn H Alexander - Duke UniversityAUGUSTUS Investigators
- Contributors
- Phillip A Horwitz (Contributor) - University of Iowa, Cardiovascular Medicine
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.380(16), pp.1509-1524
- DOI
- 10.1056/NEJMoa1817083
- PMID
- 30883055
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Grant note
- DOI: 10.13039/100002491, name: Bristol-Myers Squibb; DOI: 10.13039/100004319, name: Pfizer
- Language
- English
- Date published
- 04/18/2019
- Academic Unit
- Cardiovascular Medicine; Internal Medicine
- Record Identifier
- 9984360149902771
Metrics
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