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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Antithrombotic Strategies in Atrial Fibrillation After ACS and/or PCI: A 4-Way Comparison From AUGUSTUS
Otavio Berwanger1, Daniel M Wojdyla2, Alexander C Fanaroff3
1The George Institute for Global Health UK, London, United Kingdom; Imperial College London, London, United Kingdom; Academic Research Organization (ARO), Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Insights
For patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), apixaban without aspirin reduced death, bleeding, and hospitalization compared to other regimens. This finding optimizes antithrombotic therapy.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Optimal antithrombotic strategy for patients with atrial fibrillation (AF) experiencing acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) remains unclear.
- Balancing the risks of thrombosis and bleeding is critical in this high-risk patient population.
Purpose of the Study:
- To compare the safety and efficacy of different antithrombotic regimens in patients with AF and recent ACS or PCI.
- To determine the optimal combination of apixaban versus vitamin K antagonist (VKA) and aspirin versus placebo.
Main Methods:
- The AUGUSTUS trial was a multicenter, 2x2 factorial randomized controlled trial.
- Patients with AF and recent ACS/PCI, treated with a P2Y12 inhibitor, were randomized to apixaban or VKA, and aspirin or placebo.
- The primary outcome was a composite of all-cause death, major/clinically relevant nonmajor bleeding, or cardiovascular hospitalization over 6 months.
Main Results:
- 4,614 patients were enrolled, all receiving a P2Y12 inhibitor.
- Apixaban plus placebo resulted in a lower incidence of the primary endpoint (21.9%) compared to apixaban plus aspirin (27.3%), VKA plus placebo (28.0%), and VKA plus aspirin (33.3%).
- Rates of bleeding and cardiovascular hospitalization were significantly lower with apixaban and placebo; all-cause death rates were similar across groups.
Conclusions:
- In patients with AF and recent ACS/PCI, apixaban combined with a P2Y12 inhibitor and placebo (no aspirin) demonstrated superior safety and efficacy.
- This regimen led to a lower composite incidence of death, bleeding, or cardiovascular hospitalization compared to regimens involving VKA or aspirin.
- The findings suggest that avoiding aspirin in favor of apixaban may optimize antithrombotic therapy in this patient cohort.
Background:
The optimal antithrombotic regimen for patients with atrial fibrillation (AF) who had an acute coronary syndrome (ACS) or have undergone percutaneous coronary intervention (PCI) is not known.
Objectives:
The authors sought to determine which antithrombotic regimen best balances safety and efficacy.
Methods:
AUGUSTUS, a multicenter 2 × 2 factorial design randomized trial compared apixaban with vitamin K antagonist (VKA) and aspirin with placebo in patients with AF with recent ACS and/or PCI treated with a P2Y12 inhibitor. We conducted a 4-way analysis comparing safety and efficacy outcomes in the 4 randomized groups. The primary outcome was a composite of all-cause death, major or clinically relevant nonmajor bleeding, or hospitalization for cardiovascular causes over 6-month follow-up. Secondary outcomes included individual components of the primary endpoint.
Results:
A total of 4,614 patients were enrolled. All patients were treated with a P2Y12 inhibitor. The primary endpoint occurred in 21.9% of patients randomized to apixaban plus placebo, 27.3% randomized to apixaban plus aspirin, 28.0% randomized to VKA plus placebo, and 33.3% randomized to VKA plus aspirin. Rates of major or clinically relevant nonmajor bleeding and hospitalization for cardiovascular causes were lower with apixaban and placebo compared with the other 3 antithrombotic strategies. There was no difference between the 4 randomized groups with respect to all-cause death.
Conclusions:
In patients with AF and a recent ACS and/or PCI, an antithrombotic regimen that included a P2Y12 inhibitor and apixaban without aspirin resulted in a lower incidence of the composite of death, bleeding, or cardiovascular hospitalization than regimens including VKA, aspirin, or both. (An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention; NCT02415400).
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