Atrial Fibrillation: Risk and Benefits of Anti-coagulation in the Elderly (Carebbean-e)

Analysis of the Risk and Benefits of Anti-coagulation in Elderly Patients (>=75 Years)

This study was designed to assess the effectiveness of oral anticoagulants in elderly patients (>=75 years) with atrial fibrillation. All patients discharged from one large hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017 with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to mandatory and qualitative national registries and review of the medical records until december 31 2018.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Frail Elderly Syndrome; Anticoagulants Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Anticoagulants

Detailed Description

The investigators established a prospective cohort of 2943 of elderly (>=75 years old) discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st 2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital. Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial fibrillation and atrial flutter) according to the International Classification of Diseases, 10th revision. The first admission to the hospital during the study period is recorded as the index admission.

Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at admission and at discharge have been recorded for each patient through the screening of medical journals.

• Study Type: Observational
• Enrollment (Actual): 2943

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prospective cardiovascular cohort

Description

Inclusion Criteria:

• All consecutive patients discharged with atrial fibrillation as main diagnosis from Danderyds Hospital from November 1st 2011 to December 31 2017 aged 75 years or more.

Exclusion Criteria:

• Patients who have not given their consensus to the use of medical journals for register based research.
• Patients who were discharged from the hospital with atrial fibrillation as main diagnosis but were admitted to the hospital for medical reasons unrelated to atrial fibrillation (as an example change of pacemakers batteries).
• Patients whose medical records are not consistent with the main diagnosis (as an example wrong ICD code).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic stroke and peripheral embolism	Ischemic stroke and peripheral embolism have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. Data are extracted from the swedish national patients register.	2011-11-01 to 2018-12-31
Bleeding requiring hospitalization	Intracranial and extracranial bleeding have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. I60, I62, K25.0, K25.2, K25.4, K25.6, K29.0, K65, K92, N02, R19.5, R31, M62.2, N95.0, DR029). Data are extracted from the swedish national patients register.	2011-11-01 to 2018-12-31
Cardiovascular death	Cardiovascualr death is defined according to the International Classification of Diseases (ICD-10) by the codes:I00-I99. Data are extracted from the swedish national cause of death register.	2011-11-01 to 2018-12-31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute coronary syndrome	Acute coronary syndrome have been defined according to the International Classification of Diseases (ICD-10) by the codes: I20-I24. Data are extracted from the swedish national patients register.	2011-11-01 to 2018-12-31

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure	Heart failure has been defined according to the International Classification of Diseases (ICD-10) by the code: I50. Data are extracted from the swedish national patients register.	2011-11-01 to 2018-12-31

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Bruna Gigante, MD PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anticoagulants
• Other Study ID Numbers: OAC and elderly

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be shared according to the rules on privacy at Karolinska Institutet and according to General Data Protection Regulations in Europe.

Individual data will not be shared, but summary statistics of the variable of interest will be provided upon request.

• IPD Sharing Time Frame: from January 2020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No