Treatment and Outcomes of Atrial Fibrillation and Acute Coronary Syndrome in Sweden

Study Overview
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Brief Summary
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Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it. However, people with atrial fibrillation are also at increased risk of acute myocardial infarction or unstable angina pectoris (another heart condition marked by a chest pain, comprising so-called acute coronary syndrome for which another type of treatment that prevents blood from clotting (antiplatelet treatment) is indicated. In particularly if such patients undergo percutaneous coronary intervention, a procedure aimed to open up diseased blood vessels and hence to treat acute coronary syndrome, this treatment is needed. If a patients takes several anti-clotting blood drugs, the risk of bleeding is high. The number of possible drug combinations and treatment durations is large. This study will help us to understand which anti-clotting drug combinations are prescribed in real life among patients with atrial fibrillation and acute coronary syndrome, how effective and safe they are for patients. The study will look into the data that are already available in several very large Swedish databases which contain information needed for the research.

Official Title
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Treatment and Outcomes Among Patients With Atrial Fibrillation and Acute Coronary Syndrome in Sweden

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Antithrombotic agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ACS defined by a hospital discharge (ICD-10 code of I21 for myocardial infarction or I20.0 for unstable angina pectoris (with or without sub-codes) during the study period and a diagnosis of AF (ICD-10 code I48 with or without sub-codes) in the Patient Register before or on the same day as the patient was discharged for ACS. Exclusion Criteria: - No exclusions will be made as the registries capture the entire life-time of entire population of Sweden.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AF and ACS patients: No PCI<br>Patients with Atrial Fibrillation and Acute Coronary Syndrom who did not undergo a Percutaneous Coronary Intervention | Drug: Antithrombotic agents<br>* Antiplatelets and anticoagulants purchased 4 months before and within 7 days after the index date<br>|
| AF and ACS patients: PCI without stent<br>Patients with Atrial Fibrillation and Acute Coronary Syndrom who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05) | Drug: Antithrombotic agents<br>* Antiplatelets and anticoagulants purchased 4 months before and within 7 days after the index date<br>|
| AF and ACS patients: PCI with stent<br>Patients with Atrial Fibrillation and Acute Coronary Syndrom who underwent PCI with stent implantation (NOMESCO code FNG05) | Drug: Antithrombotic agents<br>* Antiplatelets and anticoagulants purchased 4 months before and within 7 days after the index date<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of treatment regimens | combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05). | Minimum 3 months and up to 5 years and 1 month | 
| Frequency of treatment regimens | frequency of identified drug combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05). | Minimum 3 months and up to 5 years and 1 month | 
| Prescribed strength of the most common regimens | prescribed strength of identified drug combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05) | Minimum 3 months and up to 5 years and 1 month | 
| Prescribed treatment duration of the most common regimens | prescribed duration of identified drug combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05) | Minimum 3 months and up to 5 years and 1 month | 
| Hospitalization or death with a diagnosis of bleeding as safety outcome | Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05) | Minimum 3 months and up to 5 years and 1 month | 
| Hospitalization for recurrent Acute Coronary Syndrom (ACS) as effectiveness outcome | Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05) | Minimum 3 months and up to 5 years and 1 month | 
| Revascularization procedure ( percutaneous stenting procedure or coronary bypass grafting) as effectiveness outcome | Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05) | Minimum 3 months and up to 5 years and 1 month | 
| Ischaemic stroke or systemic embolism as effectiveness outcome | Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05) | Minimum 3 months and up to 5 years and 1 month | 
| Death from any cause as effectiveness outcome | Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05) | Minimum 3 months and up to 5 years and 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Acute Coronary Syndrome, Anticoagulation