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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Antithrombotic agents

• Study Type: Observational
• Enrollment (Actual): 14226

Contacts and Locations

Study Locations

• Sweden
  • Multiple Locations, Sweden
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population-based national Swedish dataset covering entire population without selection

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): March 23, 2018

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Anticoagulation; Acute Coronary Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents
• Other Study ID Numbers: 19562

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No