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Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
Renato D Lopes1, Gretchen Heizer1, Ronald Aronson1
1From 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.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).
Insights
For atrial fibrillation patients with acute coronary syndrome or after PCI, apixaban without aspirin reduced bleeding and hospitalizations. This antithrombotic regimen proved safer than vitamin K antagonists or aspirin alone.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Optimal antithrombotic strategies for patients with atrial fibrillation (AF) experiencing acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) remain uncertain.
- Balancing the risk of bleeding against the prevention of ischemic events is a critical challenge in managing these high-risk patients.
Purpose of the Study:
- To evaluate the efficacy and safety of apixaban compared to vitamin K antagonists (VKAs) and aspirin compared to placebo in patients with AF who have had ACS or PCI.
- To determine the optimal antithrombotic regimen balancing bleeding risk and ischemic event prevention.
Main Methods:
- An international, randomized, two-by-two factorial trial involving 4614 patients with AF, ACS, or recent PCI, planned for P2Y12 inhibitor therapy.
- Patients were assigned to receive either apixaban or a VKA, and either aspirin or a matching placebo for 6 months.
- Primary outcome was major or clinically relevant nonmajor bleeding; secondary outcomes included death or hospitalization and ischemic events.
Main Results:
- Apixaban significantly reduced major or clinically relevant nonmajor bleeding compared to VKAs (10.5% vs. 14.7%; HR, 0.69; P<0.001).
- Aspirin significantly increased bleeding compared to placebo (16.1% vs. 9.0%; HR, 1.89; P<0.001).
- Apixaban use was associated with a lower incidence of death or hospitalization (23.5% vs. 27.4%; HR, 0.83; P=0.002) without increasing ischemic events. Aspirin use did not significantly alter these outcomes compared to placebo.
Conclusions:
- In patients with AF and recent ACS or PCI on a P2Y12 inhibitor, apixaban without aspirin led to less bleeding and fewer hospitalizations.
- This regimen demonstrated comparable efficacy in preventing ischemic events to regimens involving VKAs or aspirin.
- The findings support apixaban-based, aspirin-free antithrombotic therapy as a safer alternative in this patient population.
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.).
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