An Open-label, 2 x 2 Factorial, Randomized Controlled Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention: Rationale and Design of the AUGUSTUS Trial

Publication date: Available online 9 March 2018 Source:American Heart Journal Author(s): Renato D. Lopes, Amit N. Vora, Danny Liaw, Christopher B. Granger, Harald Darius, Shaun G. Goodman, Roxana Mehran, Stephan Windecker, John H. Alexander The optimal antithrombotic strategy for patients with atrial fibrillation (AF) who develop acute coronary syndrome (ACS) and/or the need for percutaneous coronary intervention (PCI) is uncertain. The risk of bleeding is a major concern when oral anticoagulation is required to prevent stroke and concomitant therapy with antiplatelet agents is required to minimize recurrent ischemic events. Design AUGUSTUS is an international, multicenter randomized trial with a 2 x 2 factorial design to compare apixaban with vitamin K antagonists (VKAs) and aspirin with placebo in patients with AF who develop ACS and/or undergo PCI and are receiving a P2Y12 inhibitor. Patients will be evaluated for eligibility during their ACS and/or PCI hospitalization. The primary outcome is the composite of major and clinically relevant non-major bleeding defined by the International Society on Thrombosis and Haemostasis. A key secondary outcome is the composite of all-cause death and all-cause hospitalization. Other secondary objectives are to evaluate ischemic outcomes including the composite of death, myocardial infarction, stroke, stent thrombosis, urgent revascularization, and all-cause hospitalization and each individual component. The aim is to enroll approximate...
Source: American Heart Journal - Category: Cardiology Source Type: research

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Conclusion: In adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear. Primary Funding Source: None. PMID: 32176890 [PubMed - as supplied by publisher]
Source: Annals of Internal Medicine - Category: Internal Medicine Authors: Tags: Ann Intern Med Source Type: research
gro G Abstract Background: Combination of dual antiplatelet (DAPT) and oral anticoagulation therapy is required to decrease cardioembolic stroke and stent thrombosis risk in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS). We compared the safety and efficacy of dabigatran etexilate with vitamin K antagonist (VKA), in combination with DAPT (aspirin plus clopidogrel) treatment in AF patients who underwent percutaneous coronary intervention (PCI) with stenting for ACS. Methods: Consecutive nonvalvular AF patients who received twice-daily dabigatran 110 mg (n = 389) or VKA (n = 510) and D...
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Publication date: November 2018Source: Canadian Journal of Cardiology, Volume 34, Issue 11Author(s): Jason G. Andrade, Marc W. Deyell, Graham C. Wong, Laurent MacleAbstractAtrial fibrillation (AF) is a progressive chronic disease characterized by exacerbations and periods of remission. It is estimated that up to 20% to 30% of those with AF also have coronary artery disease (CAD), and 5% to 15% will require percutaneous coronary intervention (PCI). In patients with concomitant AF and CAD, management remains challenging and requires a careful and balanced assessment of the risk of bleeding against the anticipated impact on i...
Source: Canadian Journal of Cardiology - Category: Cardiology Source Type: research
Publication date: Available online 20 August 2018Source: Canadian Journal of CardiologyAuthor(s): Jason G. Andrade, Marc W. Deyell, Graham C. Wong, Laurent MacleABSTRACTAtrial fibrillation (AF) is a progressive chronic disease characterized by exacerbations and periods of remission. It is estimated that up to 20-30% of those with AF also have coronary artery disease (CAD), and 5-15% will require percutaneous coronary intervention (PCI). In patients with concomitant AF and CAD, management remains challenging and requires a careful and balanced assessment of the risk of bleeding against the anticipated impact on ischemic out...
Source: Canadian Journal of Cardiology - Category: Cardiology Source Type: research
ConclusionsIn this long-term study of high-risk and real-world AF-patients with PCI, DT with NOAC and P2Y12 inhibitor (6  months) followed by NOAC monotherapy was safe and effective.
Source: Cardiology and Therapy - Category: Cardiology Source Type: research
AbstractThe number of patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI) is increasing. Since these patients have a CHA2DS2-VASc score of 1 or higher, they should be treated with oral anticoagulation to prevent stroke. However, combination therapy with oral anticoagulation for prevention of embolic stroke and dual platelet inhibition for prevention of coronary thrombosis significantly increases bleeding complications. The optimal combination, intensity and duration of antithrombotic combination therapy is still not known. In the rather small randomized WOEST trial, the combination of a vi...
Source: Clinical Research in Cardiology - Category: Cardiology Source Type: research
ConclusionsIn this long-term study of high-risk and real-world AF-patients with PCI, DT with NOAC and P2Y12 inhibitor (6  months) followed by NOAC monotherapy was safe and effective.
Source: Cardiology and Therapy - Category: Cardiology Source Type: research
Publication date: June 2018 Source:American Heart Journal, Volume 200 Author(s): Renato D. Lopes, Amit N. Vora, Danny Liaw, Christopher B. Granger, Harald Darius, Shaun G. Goodman, Roxana Mehran, Stephan Windecker, John H. Alexander Background The optimal antithrombotic strategy for patients with atrial fibrillation (AF) who develop acute coronary syndrome (ACS) and/or the need for percutaneous coronary intervention (PCI) is uncertain. The risk of bleeding is a major concern when oral anticoagulation is required to prevent stroke, and concomitant therapy with antiplatelet agents is required to minimize recurrent ischemic ...
Source: American Heart Journal - Category: Cardiology Source Type: research
BackgroundMore evidence is needed on the optimal antithrombotic regimen in elderly patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). HypothesisOctogenarian patients (aged ≥80 years) with AF who underwent PCI have worse 12‐month clinical outcome, compared with younger patients. MethodsWe performed a post‐hoc analysis of data from the prospective, multicenter AFCAS registry, which enrolled consecutive patients with AF who underwent PCI and stenting. Outcome measures included major adverse cardiac/cerebrovascular events (MACCE; all‐cause death, myocardial infarction, repeat r...
Source: Clinical Cardiology - Category: Cardiology Authors: Tags: CLINICAL INVESTIGATIONS Source Type: research
Publication date: Available online 23 October 2017 Source:American Heart Journal Author(s): Pascal Vranckx, Thorsten Lewalter, Marco Valgimigli, Jan G. Tijssen, Paul-Egbert Reimitz, Lars Eckardt, Hans-Joachim Lanz, Wolfgang Zierhut, Rüdiger Smolnik, Andreas Goette Background The optimal antithrombotic treatment after percutaneous coronary intervention (PCI) with stenting in patients with atrial fibrillation (AF) is unknown. In the ENGAGE AF-TIMI 48 trial, edoxaban was non-inferior to a vitamin-K antagonist (VKA) with respect to the prevention of stroke or systemic embolism and was associated with significantly lower ...
Source: American Heart Journal - Category: Cardiology Source Type: research
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