Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation

Lopes, Renato D.; Heizer, Gretchen; Aronson, Ronald; Vora, Amit N.; Massaro, Tyler; Mehran, Roxana; Goodman, Shaun G.; Windecker, Stephan; Darius, Harald; Li, Jia; Averkov, Oleg; Bahit, M. Cecilia; Berwanger, Otavio; Budaj, Andrzej; Hijazi, Ziad; Parkhomenko, Alexander; Sinnaeve, Peter; Storey, Robert F.; Thiele, Holger; Vinereanu, Dragos; Granger, Christopher B.; Alexander, John H.

doi:10.1056/nejmoa1817083

Cited by 1,228Atrial Fibrillation Management and OutcomesAntiplatelet Therapy and Cardiovascular DiseasesAcute Myocardial Infarction Research

Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation

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Lopes, Renato D., Heizer, Gretchen, Aronson, Ronald, Vora, Amit N., Massaro, Tyler, Mehran, Roxana, Goodman, Shaun G., Windecker, Stephan +14 more·2019·New England Journal of Medicine

DOI 10.1056/nejmoa1817083

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Abstract

BACKGROUND: Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).

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RCTs comparing TAT with DAT in patients with AF and ACS or post-PCI had limited sample size with few patients with diabetes (28-37% across RCTs).
“limited sample size with few patients with diabetes (28-37% across RCTs; Supplementary data online, Table S14).”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [340]
These RCTs had relatively short follow-up (6-14 months).
“relatively short follow-up (6-14 months)”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [340]
These RCTs are underpowered to assess both the efficacy of DAT and the safety of major bleeding of TAT in patients with diabetes.
“Thus, these RCTs are underpowered to assess both the efficacy of DAT and the safety of major bleeding of TAT in patients with diabetes.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [340]

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Self-citation

Authors: Lopes, R. D., Heizer, G., Aronson, R., Vora, A. N., Massaro, T., Mehran, R., Goodman, S. G., Windecker, S., Darius, H., Li, J., Averkov, O., Bahit, M. C., Berwanger, O., Budaj, A., Hijazi, Z., Parkhomenko, A., Sinnaeve, P., Storey, R. F., Thiele, H., Vinereanu, D., Granger, C. B., & Alexander, J. H.
Affiliations: From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael’s Hospital, University of Toronto, Toronto (S.G.G...
St. Michael's Hospital (CA)
Uppsala University (SE)
ORCID: Aronson, Ronald
Vora, Amit N.
Massaro, Tyler
Mehran, Roxana
Goodman, Shaun G.
Windecker, Stephan
Li, Jia
Bahit, M. Cecilia
Berwanger, Otavio
Budaj, Andrzej
Hijazi, Ziad
Parkhomenko, Alexander
Sinnaeve, Peter
Storey, Robert F.
Granger, Christopher B.
Alexander, John H.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2019-04-18
Volume: 380
Issue: 16
Pages: 1509-1524
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1817083
OpenAlex: W2921724943
Cited by: 1,228
References: 32
Citations by year: 2026: 116 · 2025: 109 · 2024: 112 · 2023: 124 · 2022: 159 · 2021: 215 · 2020: 241 · 2019: 151 · 2018: 1
FWCI: 138.39
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
SZTE Publicatio Repozitórium (University of Szeged) (acceptedVersion, other-oa)
BORIS (University Library Bern) (submittedVersion)
Digital Access to Libraries (submittedVersion, other-oa)
Lirias (submittedVersion)
Funders: Bristol-Myers Squibb
Pfizer
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Keywords: atrial fibrillation, acute coronary syndrome, percutaneous coronary intervention, antithrombotic therapy, apixaban, vitamin K antagonists, aspirin, bleeding risk, ischemic events, non-inferiority, hospitalization
MeSH terms: Aged, Aged, 80 and over, Anticoagulants, Aspirin, Atrial Fibrillation, Double-Blind Method, Drug Therapy, Combination, Female, Hemorrhage, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors, Pyrazoles, Pyridones, Vitamin K, Acute Coronary Syndrome, Purinergic P2Y Receptor Antagonists, Percutaneous Coronary Intervention, Factor Xa Inhibitors

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Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation

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