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; ... (2019). Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. The New England journal of medicine, 380(16), pp. 1509-1524. Massachusetts Medical Society 10.1056/NEJMoa1817083

[img] Text
103_30883055 Antithrombotic Therapy after ACS.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (346kB) | Request a copy

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 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 P2Y12 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 In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 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.).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1533-4406

Publisher:

Massachusetts Medical Society

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

12 Feb 2020 09:32

Last Modified:

12 Feb 2020 09:32

Publisher DOI:

10.1056/NEJMoa1817083

PubMed ID:

30883055

BORIS DOI:

10.7892/boris.139152

URI:

https://boris.unibe.ch/id/eprint/139152

Actions (login required)

Edit item Edit item
Provide Feedback