Atrial Fibrillation
Conditions
Keywords
Elderly, Anticoagulation, Risk Assessment
Brief summary
This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the very old and attempt to identify risk factors which may impede safe and effective anticoagulation.
Detailed description
This is a prospective registry study with data being collected continuously for 24 months. Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison. Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.
Interventions
DRUGWarfarin
Patients on warfarin for atrial fibrillation
Sponsors
Robert Stein
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 70 years of age or older * electrocardiographically confirmed atrial fibrillation * anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services * Subject or legally authorized representative must be willing to provide informed consent
Exclusion criteria
\- Patients not being followed by the PBMC Anticoagulation Services
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Experiencing Stroke | 24 months | Every 6 months the medical record was reviewed for evidence of stroke of any cause. |
| Number of Patients Experiencing a Major Bleeding Event | 24 months | defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospitalizations Patients Experienced | 24 months | Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system. |
| Number of Patients Experiencing Cardiovascular Death | 24 months | Every 6 months the medical record was reviewed. All deaths were researched for cause and noted if the cause was related to the cardiovascular system. |
| Number of Patients Experiencing a Traumatic Subdural Hemorrhage | 24 months | Number of subjects who experienced a traumatic subdural hemorrhage in each age group |
| Mean Time in Therapeutic Range at End of Study Participation | up to 24 months | International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation. |
| Number of Patients Experiencing Death Related to Anticoagulation | 24 months | All deaths were reviewed in the medical record to determine the cause and if it was related in any way to the use of anticoagulation therapy. |
| Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage | 24 months | Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aged 90 and Older Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation | 44 |
| Aged 80-89 Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation | 44 |
| Aged 70-79 Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin: Patients on warfarin for atrial fibrillation | 44 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 15 | 5 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | Aged 80-89 | Aged 70-79 | Total | Aged 90 and Older |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 44 Participants | 44 Participants | 132 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 84 years | 74 years | 84 years | 93 years |
| Living at home alone | 18 Participants | 9 Participants | 38 Participants | 11 Participants |
| Living at home with family | 24 Participants | 34 Participants | 85 Participants | 27 Participants |
| Living at home with paid help | 2 Participants | 1 Participants | 5 Participants | 2 Participants |
| Living in assisted living | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Living in Long Term Care | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 44 Participants | 44 Participants | 132 Participants | 44 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 44 participants | 44 participants | 132 participants | 44 participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 79 Participants | 31 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 53 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 15 / 44 | 5 / 41 | 5 / 42 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Patients Experiencing a Major Bleeding Event
defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells
Time frame: 24 months
Population: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aged 90 and Older | Number of Patients Experiencing a Major Bleeding Event | 4 Participants |
| Aged 80-89 | Number of Patients Experiencing a Major Bleeding Event | 2 Participants |
| Aged 70-79 | Number of Patients Experiencing a Major Bleeding Event | 4 Participants |
Primary
Number of Patients Experiencing Stroke
Every 6 months the medical record was reviewed for evidence of stroke of any cause.
Time frame: 24 months
Population: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aged 90 and Older | Number of Patients Experiencing Stroke | 2 Participants |
| Aged 80-89 | Number of Patients Experiencing Stroke | 2 Participants |
| Aged 70-79 | Number of Patients Experiencing Stroke | 0 Participants |
Secondary
Mean Time in Therapeutic Range at End of Study Participation
International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation.
Time frame: up to 24 months
Population: All subjects were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aged 90 and Older | Mean Time in Therapeutic Range at End of Study Participation | 72 percent of time in therapeutic range | Standard Deviation 17 |
| Aged 80-89 | Mean Time in Therapeutic Range at End of Study Participation | 76 percent of time in therapeutic range | Standard Deviation 18 |
| Aged 70-79 | Mean Time in Therapeutic Range at End of Study Participation | 70 percent of time in therapeutic range | Standard Deviation 17 |
Secondary
Number of Hospitalizations Patients Experienced
Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system.
Time frame: 24 months
Population: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aged 90 and Older | Number of Hospitalizations Patients Experienced | 51 hospitalizations |
| Aged 80-89 | Number of Hospitalizations Patients Experienced | 41 hospitalizations |
| Aged 70-79 | Number of Hospitalizations Patients Experienced | 41 hospitalizations |
Secondary
Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage
Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group
Time frame: 24 months
Population: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aged 90 and Older | Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage | 0 Participants |
| Aged 80-89 | Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage | 0 Participants |
| Aged 70-79 | Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage | 0 Participants |
Secondary
Number of Patients Experiencing a Traumatic Subdural Hemorrhage
Number of subjects who experienced a traumatic subdural hemorrhage in each age group
Time frame: 24 months
Population: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aged 90 and Older | Number of Patients Experiencing a Traumatic Subdural Hemorrhage | 0 Participants |
| Aged 80-89 | Number of Patients Experiencing a Traumatic Subdural Hemorrhage | 0 Participants |
| Aged 70-79 | Number of Patients Experiencing a Traumatic Subdural Hemorrhage | 0 Participants |
Secondary
Number of Patients Experiencing Cardiovascular Death
Every 6 months the medical record was reviewed. All deaths were researched for cause and noted if the cause was related to the cardiovascular system.
Time frame: 24 months
Population: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aged 90 and Older | Number of Patients Experiencing Cardiovascular Death | 15 Participants |
| Aged 80-89 | Number of Patients Experiencing Cardiovascular Death | 5 Participants |
| Aged 70-79 | Number of Patients Experiencing Cardiovascular Death | 5 Participants |
Secondary
Number of Patients Experiencing Death Related to Anticoagulation
All deaths were reviewed in the medical record to determine the cause and if it was related in any way to the use of anticoagulation therapy.
Time frame: 24 months
Population: Three subjects in the 80-89 age group and two subjects in the 70-79 age group withdrew consent prior to end of study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aged 90 and Older | Number of Patients Experiencing Death Related to Anticoagulation | 0 Participants |
| Aged 80-89 | Number of Patients Experiencing Death Related to Anticoagulation | 0 Participants |
| Aged 70-79 | Number of Patients Experiencing Death Related to Anticoagulation | 0 Participants |