Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Primary Outcome of Stage 1: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care |
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant' |
12 months after baseline |
|
| Primary |
Primary Outcome of Stage 2: The composite of cardiovascular death, all stroke, worsening of heart failure or acute coronary syndrome, and emergency visits due to AF |
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death. All strokes included ischemic stroke and hemorrhagic stroke. A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the A component in the ABC pathway |
The 'A' criterion referred to stroke prevention or anticoagulation. Thus, 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant' |
12 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the B component in the ABC pathway |
The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an European Heart Rhythm Association (EHRA) score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled |
12 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the C component in the ABC pathway |
The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant' |
12 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: All-cause mortality |
all-cause death |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: Cardiovascular death |
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: Ischemic or hemorrhagic Stroke |
All strokes: ischemic or hemorrhagic Stroke |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: Worsening of heart failure or acute coronary syndrome |
A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: Emergency visit due to AF |
Emergency visit due to AF |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: Major bleeding |
Major bleeding was defined as fatal bleeding, bleeding in a critical area or organ, or clinically overt bleeding leading to a decrease in the hemoglobin level =2 g/dl or transfusion of =2 units of packed red cells |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: Clinically relevant non-major bleeding |
Clinically relevant non-major bleeding referred to bleeding that does not meet the criteria for the ISTH definition of major bleeding but is clinically overt bleeding associated with hospital admission, physician-guided medical or surgical treatment, or a change in antithrombotic therapy. |
36 months after baseline |
|
| Secondary |
Secondary Outcome of Stage 2: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care |
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant' |
36 months after baseline |
|
