Rivaroxaban in Patients With Atrial Fibrillation Undergoing PCI

Study Overview
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Brief Summary
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This study evaluates the antithrombotic therapy in patients suffering from atrial fibrillation after stent implantation in Germany. Patients prescribed with the novel oral anticoagulant Rivaroxaban will be followed up over 14 months for their adherence to the medication schedule and for complications that occurred after index PCI.

Detailed Description
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Patients suffering from non-valvular atrial fibrillation and presenting with an acute coronary syndrome require special attention with regard to antithrombotic therapy. Current guidelines recommend use of oral anticoagulation for almost all of these patients, the optimal antithrombotic strategy, however, has still to be defined. As with the use of any antithrombotic drug, clinicians need to balance the risks of ischemic stroke and thromboembolism, recurrent cardiac ischemia and/or stent thrombosis, and bleeding and haemorrhagic stroke. A recently published randomized clinical trial (PIONEER AF) compared the combination of a novel oral anticoagulant (NOAC; Rivaroxaban) plus dual anti-platelet therapy (DAPT) with standard therapy consisting of vitamine K inhibitor plus DAPT. Patients treated with Rivaroxaban showed less incidence of bleedings, whereas ischemic complications, death or stroke were equal in the groups compared. The RIVA-PCI Registry aims at providing an overview of the current antithrombotic treatment regimen in Germany in real life. Moreover, for patients receiving Rivaroxaban as part of their medication follow-up data with regard to their adherence to antithrombotic medication as well as complications over an interval of 14 months after index procedure will be evaluated.

Official Title
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RIVA-PCI Registry - Prospective Registry of Rivaroxaban in Patients With Atrial Fibrillation

Conditions
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Non-valvular Atrial Fibrillation, Acute Coronary Syndrome, Percutaneous Coronary Intervention, Antithrombotic Therapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and capable of giving written informed consent Known or newly diagnosed non-valvular atrial fibrillation PCI with stent implantation during index hospital stay Written informed consent for participation in observational study (incl. telephone follow-up) Not simultaneously participating in any randomized trial Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI | Real-life data on the prescription of antithrombotic medication for patients with atrial fibrillation after PCI | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of antithrombotic medication during long-term follow-up | Patients receiving Rivaroxaban after index PCI are asked for their further antithrombotic medication in two telephone interviews (3 months and 14 months after index PCI) | 14 months | 
| Adverse Events during baseline and follow-up | Documentation of Adverse Events during baseline hospital stay (by treating physician) and during long-term follow-up (patient-reported) | 32 months | 
| Treatment adherence of patients | Patient-reported information on their adherence to the antithrombotic treatment strategy | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, Non-valvular AF, PCI, NOAC, Rivaroxaban