Acute Coronary Syndrome, Antithrombotic Therapy, Non-valvular Atrial Fibrillation, Percutaneous Coronary Intervention
Conditions
Keywords
Non-valvular AF, ACS, PCI, NOAC, Rivaroxaban
Brief summary
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
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.
Interventions
None listed
Sponsors
Bayer
IHF GmbH - Institut für Herzinfarktforschung
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antithrombotic combination therapies (treatment patterns) in patients with non-valvular AF undergoing PCI | 18 months | Real-life data on the prescription of antithrombotic medication for patients with atrial fibrillation after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of antithrombotic medication during long-term follow-up | 14 months | 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) |
| Adverse Events during baseline and follow-up | 32 months | Documentation of Adverse Events during baseline hospital stay (by treating physician) and during long-term follow-up (patient-reported) |
| Treatment adherence of patients | 14 months | Patient-reported information on their adherence to the antithrombotic treatment strategy |
Countries
Germany
Outcome results
None listed